A Phase II Study of M2951 in SLE

A Phase II, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study To Evaluate the Safety and Efficacy of M2951 in Subjects With SLE

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02975336

Enrollment

469

Registered

2016-11-29

Start date

2017-01-04

Completion date

2020-03-23

Last updated

2021-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Systemic Lupus Erythematosus

Keywords

Systemic Lupus Erythematosus, M2951, Placebo, Dose response, Oral Corticosteroids, Safety, Efficacy, Autoimmune And Inflammatory Disorders

Brief summary

M2951 is an investigational drug under evaluation for treatment of autoimmune and inflammatory disorders. The purpose of the study was to assess the Safety and Efficacy of M2951 in participants with Systemic Lupus Erythematosus (SLE).

Interventions

DRUGPlacebo

Participants received placebo matched to M2951 orally for 52 weeks.

DRUGM2951

Participants received 25 milligrams (mg) of M2951 orally once daily (QD) for 52 weeks.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* Eligible male and female participants, aged 18 to 75 years * Must have diagnosis of SLE with either the Systemic Lupus International Collaborating Clinics (SLICC) criteria for SLE, or at least four of the 11 American College of Rheumatology (ACR) classification criteria for SLE, of at least six months duration prior to Screening * SLEDAI-2K total score greater than or equal to (\>=) 6 (including clinical SLEDAI greater than or equal to (\>=) 4) at Screening Visit * And be positive for anti-double-stranded Deoxyribonucleic Acid (DNA) and/or anti-nuclear antibody (ANA greater than or equal to (\>=) 1:80) and/or anti-Smith (anti-Sm) antibody at the time of Screening * Other protocol defined inclusion criteria could apply

Exclusion criteria

* Participants are not eligible for this study if they have active, clinically significant interstitial lung disease or pulmonary arterial hypertension * Proteinuria (urine protein to creatinine ratio \[UPCR\] \> 4 mg/mg) * Acutely worsened renal function * Central nervous system SLE * Or within two weeks prior to Screening or during Screening: use of oral corticosteroids greater than (\>) 30 mg daily prednisone equivalent * Use of injectable corticosteroids, or change in dose of corticosteroids. * Other protocol defined

Design outcomes

Primary

Measure	Time frame	Description
DBPC Period: Change From Baseline in Total B Cell Count at Week 56	Baseline and Week 56	Change from baseline in Total B cell count were assessed. Flow cytometry analysis of lymphocyte populations using four-color fluorescence-activated cell sorting was performed for the analysis of B cell counts.
DBPC Period: Number of Participants With Response Based on Systemic Lupus Erythematosus Responder Index 6 (SRI-6) at Week 52	Week 52	SRI-6 response was defined as \>= 6-point reduction in SLEDAI-2K total score, no new BILAG A and no more than 1 new BILAG B domain score and no worsening (less than 10 percent increase) from baseline in Physician's Global Assessment of Disease Activity (PGA) and treatment failure. SLEDAI-2K assessment consists of 24 items with total score of 0 (no symptoms) to 105 (presence of all defined symptoms) with higher scores representing increased disease activity. BILAG Index: assessing clinical signs, symptoms, or laboratory parameters related to SLE, divided into 9 organ systems. For each organ system :A=severe disease, B=moderate disease, C=mild stable disease, D=inactive, but previously active, E=inactive and never affected. The PGA assess disease activity on a visual analogue scale =from 0(very well) to 100(very poor).
DBPC Period: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs According to National Cancer Institute-Common Terminology Criteria for Adverse Events Version 4.03 (NCI-CTCAE v4.03)	Baseline up to Week 56	Adverse event (AE) was defined as any untoward medical occurrence in a participant, which does not necessarily have causal relationship with treatment. A serious AE was defined as an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged in participant hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. TEAEs: events between first dose of study drug that were absent before treatment/that worsened relative to pre-treatment state up to 56 weeks. TEAEs included both serious TEAEs and non-serious TEAEs. Number of participants with TEAEs and serious TEAEs were reported.
DBPC Period: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) by Severity According to National Cancer Institute-Common Terminology Criteria for Adverse Events Version 4.03 (NCI-CTCAE v4.03)	Baseline up to Week 56	Severity of TEAEs were graded using NCI-CTCAE v4.03 toxicity grades, as follows: Grade 1= Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Life-threatening and Grade 5 = Death. Number of participants with TEAEs by severity were reported.
DBPC Period: Number of Participants With Clinically Significant Change From Baseline in Vital Signs	Baseline up to Week 56	Vital signs included body temperature, systolic and diastolic blood pressure, pulse rate, respiratory rate, weight and height. Clinical significance was determined by the investigator. The number of participants with clinically significant changes from baseline in vital signs were reported.
DBPC Period: Number of Participants With Clinically Significant Changes From Baseline in 12-Lead Electrocardiogram (ECG) Findings	Baseline up to Week 56	12-lead ECG recordings included rhythm, heart rate (as measured by RR interval), PR interval, QRS duration, and QT interval. The corrected QT interval (QTcF) was calculated using Fridericia's formula. 12-lead ECG recordings were obtained after the participants have rested for at least 10 minutes in semisupine position. Clinical significance was determined by the investigator. The number of participants with clinically significant changes from baseline in 12-lead ECG findings were reported.
DBPC Period: Number of Participants With Clinically Significant Changes From Baseline in Laboratory Parameters	Baseline up to Week 56	Laboratory investigation included hematology, biochemistry, urinalysis and coagulation. Clinical significance was determined by the investigator. The number of participants with clinically significant changes from baseline in laboratory parameters were reported.
DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 2	Week 2	Mean absolute value of serum levels of IgG, IgA, IgM were assessed at Week 2.
DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 4	Week 4	Mean absolute value of serum levels of IgG, IgA, IgM were assessed at Week 4.
DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 12	Week 12	Mean absolute value of serum levels of IgG, IgA, IgM were assessed at Week 12.
DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 24	Week 24	Mean absolute value of serum levels of IgG, IgA, IgM were assessed at Week 24.
DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 36	Week 36	Mean absolute value of serum levels of IgG, IgA, IgM were assessed at Week 36.
DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 52	Week 52	Mean absolute value of serum levels of IgG, IgA, IgM were assessed at Week 52
DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 56	Week 56	Mean absolute value of serum levels of IgG, IgA, IgM were assessed at Week 56
DBPC Period: Mean Absolute Total B Cell Count at Week 4	Week 4	Mean total B cell count were assessed. Flow cytometry analysis of lymphocyte populations using four-color fluorescence activated cell sorting was performed for the analysis of B cell counts.
DBPC Period: Mean Absolute Total B Cell Count at Week 24	Week 24	Mean absolute total B cell count were assessed. Flow cytometry analysis of lymphocyte populations using four-color fluorescence activated cell sorting was performed for the analysis of B cell counts.
DBPC Period: Mean Absolute Total B Cell Count at Week 52	Week 52	Mean absolute total B cell count were assessed. Flow cytometry analysis of lymphocyte populations using four-color fluorescence activated cell sorting was performed for the analysis of B cell counts.
DBPC Period: Mean Absolute Total B Cell Count at Week 56	Week 56	Mean absolute total B cell count were assessed. Flow cytometry analysis of lymphocyte populations using four-color fluorescence activated cell sorting was performed for the analysis of B cell counts.
DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 2	Baseline and Week 2	Change from baseline in the serum levels of IgG, IgA, IgM were assessed.
DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 4	Baseline and Week 4	Change from baseline in the serum levels of IgG, IgA, IgM were assessed.
DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 12	Baseline and Week 12	Change from baseline in the serum levels of IgG, IgA, IgM were assessed.
DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 24	Baseline and Week 24	Change from baseline in the serum levels of IgG, IgA, IgM were assessed.
DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 36	Baseline and Week 36	Change from baseline in the serum levels of IgG, IgA, IgM were assessed.
DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 52	Baseline and Week 52	Change from baseline in the serum levels of IgG, IgA, IgM were assessed.
DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 56	Baseline and Week 56	Change from baseline in the serum levels of IgG, IgA, IgM were assessed.
DBPC Period: Change From Baseline in Total B Cell Count at Week 4	Baseline and Week 4	Change from baseline in Total B cell count were assessed. Flow cytometry analysis of lymphocyte populations using four-color fluorescence-activated cell sorting was performed for the analysis of B cell counts.
DBPC Period: Change From Baseline in Total B Cell Count at Week 24	Baseline and Week 24	Change from baseline in Total B cell count were assessed. Flow cytometry analysis of lymphocyte populations using four-color fluorescence-activated cell sorting was performed for the analysis of B cell counts.
DBPC Period: Change From Baseline in Total B Cell Count at Week 52	Baseline and Week 52	Change from baseline in Total B cell count were assessed. Flow cytometry analysis of lymphocyte populations using four-color fluorescence-activated cell sorting was performed for the analysis of B cell counts.
DBPC Period: Number of Participants With Response Based on Systemic Lupus Erythematosus Responder Index 4 (SRI-4) at Week 52	Week 52	SRI-4 response was defined as greater than or equal to (\>=) 4-point reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) total score, no new British Isles Lupus Assessment Group (BILAG) A and no more than 1 new BILAG B domain score, no worsening (less than 10 percent increase) from baseline in Physician's Global Assessment of Disease Activity (PGA) and no treatment failure. SLEDAI-2K assessment consists of 24 items with total score of 0(no symptoms) to 105 (presence of all defined symptoms) with higher scores representing increased disease activity. BILAG Index: assessing clinical signs, symptoms, or laboratory parameters related to Systemic Lupus Erythematosus (SLE) divided into 9 organ systems. For each organ system A=severe disease, B=moderate disease, C=mild stable disease, D=inactive, but previously active, E=inactive and never affected. The PGA assess disease activity on a visual analogue scale =from 0(very well) to 100(very poor).

Secondary

Measure	Time frame	Description
DBPC Period: Number of Participants With Response Based on Systemic Lupus Erythematosus Responder Index 4 (SRI-4) at Week 52 in Serologically Active (SA) Subgroup	Week 52	SRI-4 response was defined as greater than or equal to (\>=) 4-point reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) total score, no new British Isles Lupus Assessment Group (BILAG) A and no more than 1 new BILAG B domain score, no worsening (less than 10 percent increase) from baseline in Physician's Global Assessment of Disease Activity (PGA) and no treatment failure. SLEDAI-2K assessment consists of 24 items with total score of 0(no symptoms) to 105 (presence of all defined symptoms) with higher scores representing increased disease activity. BILAG Index: assessing clinical signs, symptoms, or laboratory parameters related to Systemic Lupus Erythematosus (SLE), divided into 9 organ systems. For each organ system A=severe disease, B=moderate disease, C=mild stable disease, D=inactive, but previously active, E=inactive and never affected. The PGA assess disease activity on a visual analogue scale =from 0(very well) to 100(very poor).
DBPC Period: Number of Participants With Response Based on Systemic Lupus Erythematosus Responder Index 6 (SRI-6) at Week 52 in Serologically Active Subgroup	Week 52	SRI-6 response was defined as \>= 6-point reduction in SLEDAI-2K total score, no new BILAG A and no more than 1 new BILAG B domain score and no worsening (less than 10 percent increase) from baseline in Physician's Global Assessment of Disease Activity (PGA) and treatment failure. SLEDAI-2K assessment consists of 24 items with total score of 0 (no symptoms) to 105 (presence of all defined symptoms) with higher scores representing increased disease activity. BILAG Index: assessing clinical signs, symptoms, or laboratory parameters related to SLE, divided into 9 organ systems. For each organ system :A=severe disease, B=moderate disease, C=mild stable disease, D=inactive, but previously active, E=inactive and never affected. The PGA assess disease activity on a visual analogue scale = from 0(very well) to 100(very poor).
DBPC Period: Time to First British Isles Lupus Assessment Group (BILAG) A or 2B Moderate to Severe Flare	Baseline up to Week 56	BILAG Index: assessing clinical signs, symptoms, or laboratory parameters related to SLE, divided into 9 organ systems. For each organ system based on alphabetic score: A=severe disease, B=moderate disease, C=mild stable disease, D=inactive, but previously active, E=inactive and never affected. BILAG evaluated by scoring each of a list of signs and symptoms as: improving (1); same (2); worse (3); new (4); not present (0); not done (ND). Total BILAG score is sum of scores of 9 domains where A=12, B=8, C=1, D=0, and E=0. Total score ranges from 0 to 108 with a higher score indicating greater lupus activity. A Moderate to Severe (BILAG A or 2B) flare is defined as at least one BILAG A (severe disease activity) grade or two BILAG B (moderate disease activity) grade in any organ system due to items that are new or worse, compared to the BILAG evaluation at the previous visit, during the 52 week treatment. It was measured using Kaplan-Meier (KM) estimates.
DBPC Period: Number of Participants With British Isles Lupus Assessment Group (BILAG) 2004 Flare-Free Status During the 52-Week Treatment Period	up to Week 52	A participant has a flare-free status if no flare has been reported during the 52-week treatment period. Participants who discontinued treatment prior to Week 52, without having a flare are counted as not being flare free at Week 52. A flare was defined as either 1 or more new BILAG-2004 A (severe disease activity) or 2 or more new BILAG-2004 B (moderate disease activity) items compared to the previous visit. BILAG Index: assessing clinical signs, symptoms, or laboratory parameters related to SLE, divided into 9 organ systems. For each organ system based on alphabetic score: A=severe disease, B=moderate disease, C=mild stable disease, D=inactive, but previously active, E=inactive and never affected.
DBPC Period: Annualized Flare Rate	Baseline up to Week 52	A flare was defined as either 1 or more new BILAG-2004 A (severe disease activity) or 2 or more new BILAG-2004 B (moderate disease activity) items compared to the previous visit. The occurrence of a new flare was checked for each available visit versus the previous available visit up to Week 52. If no new flares occurred, the number of flares was set to 0. Otherwise all flares were counted leading to the maximum number of flares of 13. The annualized flare rate was calculated as the number of flares divided by the flare exposure time in days multiplied with 365.25 (1 year). The flare exposure time is the time up to Week 52 (date of BILAG-2004 assessment at Week 52) or up to the date of last available BILAG 2004 assessment.
DBPC Period: Number of Participants With Low Disease Activity Status, Defined by Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) Score of Less Than or Equal (<= ) 2 at Week 52	Week 52	Low disease activity is defined as SLEDAI-2K score \<=2. SLEDAI-2K is an activity index that measures disease activity and records feature of active lupus as present or not present. SLEDAI-2K uses a weighted checklist to assign a numerical score based on the presence or absence of 24 symptoms at the time of assessment or during the previous 30 days. Each symptom present is assigned between 1 and 8 points based on its usual clinical importance, yielding a total score that ranges from 0 points (no symptoms) to 105 points (presence of all defined symptoms).
DBPC Period: Number of Participants With Low Disease Activity Status, Defined by Clinical Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) Score of Less Than or Equal (<= ) 2 at Week 52	Week 52	Low disease activity is defined as SLEDAI-2K score \<=2. SLEDAI-2K is an activity index that measures disease activity and records feature of active lupus as present or not present. SLEDAI-2K uses a weighted checklist to assign a numerical score based on the presence or absence of 24 symptoms at the time of assessment or during the previous 30 days. Each symptom present is assigned between 1 and 8 points based on its usual clinical importance, yielding a total score that ranges from 0 points (no symptoms) to 105 points (presence of all defined symptoms). Clinical SLEDAI-2K score is equal to the SLEDAI-2K score from electronic case report form (eCRF) excluding the components 'Increased Deoxyribonucleic acid (DNA) Binding' and 'Low Complement'.
DBPC Period: Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Baseline, Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	SLEDAI-2K is an activity index that measures disease activity and records feature of active lupus as present or not present. SLEDAI-2K uses a weighted checklist to assign a numerical score based on the presence or absence of 24 symptoms at the time of assessment or during the previous 30 days. Each symptom present is assigned between 1 and 8 points based on its usual clinical importance, yielding a total score that ranges from 0 points (no symptoms) to 105 points (presence of all defined symptoms).
DBPC Period: Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	CLASI is an validated measurement instrument for lupus erythematosus developed for use in clinical studies that consists of separate scores for the activity of the disease (CLASI-A). The CLASI activity score is calculated on the basis of erythema, scale/hyperkeratosis, mucous membrane involvement, acute hair loss and non-scarring alopecia. The CLASI activity score ranges from 0-70, with higher scores indicating more severe skin disease. Severity categories based on the CLASI activity score are as follows: mild (0-9), moderate (10-20), and severe (21-70).
DBPC Period: Number of Participants With Response Based on BILAG-Based Composite Lupus Assessment (BICLA) at Week 52	Week 52	BICLA response defined as participants meeting following criteria: \[1\] At least one gradation of improvement in baseline BILAG scores in all body systems with moderate or severe disease activity at entry (example: all A (severe disease) scores falling to B (moderate), C (mild), or D (no activity) and all B scores falling to C or D; \[2\] No new BILAG A or more than one new BILAG B scores; \[3\] No worsening of total SLEDAI-2K score from baseline; \[4\] No significant deterioration (=\<10%) in physician's global assessment and \[5\] No treatment failure (initiation of non-protocol treatment).
DBPC Period: Change From Baseline in British Isles Lupus Assessment Group (BILAG)-2004 Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Baseline, Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	BILAG 2004 disease activity Index: assessing clinical signs, symptoms, or laboratory parameters related to SLE, divided into 9 organ systems. For each organ system based on alphabetic score: A=severe disease, B=moderate disease, C=mild stable disease, D=inactive, but previously active, E=inactive and never affected. BILAG evaluated by scoring each of a list of signs and symptoms as: improving (1); same (2); worse (3); new (4); not present (0); not done (ND). Total BILAG score is sum of scores of 9 domains where A=12, B=8, C=1, D=0, and E=0. Total score ranges from 0 to 108 with a higher score indicating greater lupus activity.
DBPC Period: Change From Baseline in Physician's Global Assessment (PGA) Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Baseline, Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	The Physician's Global Assessment of Disease Activity was recorded using the 100 millimeter horizontal Visual Analog Scale (VAS). Physician rated participant's disease activity on a scale ranged from 0-100 millimeter (mm), where 0 indicated no disease activity and 100 represented maximum disease activity.
DBPC Period: Change From Baseline in Study 36-Item Short Form Health Survey Version 2 (SF-36v2) Physical Component Summary Score and Mental Component Summary Scores at Week 4, 8, 12, 16, 24, 32, 40 and 52	Baseline, Week 4, 8, 12, 16, 24, 32, 40 and 52	The 36-Item Short-Form Health Survey (SF-36) was a standardized survey evaluating 8 aspects of functional health and well-being. These eight subscales were summarized as relating to either physical health or mental health. Physical component summary (PCS) was based primarily on physical functioning, role-physical, bodily pain, and general health scales and mental component summary (MCS) encompasses vitality, social functioning, role-emotional, and mental health scales. Score from mental health, role emotional, social functioning, and vitality domains were averaged to calculate MCS. Total score range for MCS was 0 - 100 (100 = highest level of mental functioning). Score from physical function, role physical, bodily pain, and general health domains were averaged to calculate PCS. Total score range for PCS was 0-100 (100 = highest level of physical functioning).
DBPC Period: Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Health Outcome Questionnaire at Week 4, 8, 12, 16, 24, 32, 40 and 52	Baseline, Week 4, 8, 12, 16, 24, 32, 40, and 52	The EQ-5D-5L questionnaire is a generic measure of health status that provides a simple descriptive profile and a single index value. The EQ-5D-5L profile defines health in terms of mobility, self-care, usual activities, pain or discomfort, and anxiety or depression. Each dimension has five levels: 1: no problems, 2: slight problems, 3: moderate problems, 4: severe problems, and 5: extreme problems. Responses were used to generate a weighted summary index (EQ-5D index), which ranges from 0 (dead) to 1.00 (perfect health). A higher score indicates better health and positive changes from baseline indicate improvement of health.
DBPC Period: Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Visual Analog Scale (VAS) at Week 4, 8, 12, 16, 24, 32, 40 and 52	Baseline, Week 4, 8, 12, 16, 24, 32, 40, and 52	The EQ-5D-5L questionnaire is a generic measure of health status that provides a simple descriptive profile and a single index value. The EQ-5D-5L profile defines health in terms of mobility, self-care, usual activities, pain or discomfort, and anxiety or depression. Each dimension has five levels: 1: no problems, 2: slight problems, 3: moderate problems, 4: severe problems, and 5: extreme problems. The responses were used to derive overall score using a visual analog scale (VAS) that ranged from 0 to 100 millimeter (mm), where 0 was the worst health you can imagine and 100 was the best health you can imagine.
DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Baseline, Week 4, 8, 12, 16, 24, 32, 40, and 52	The Lupus QoL assessment is a 34 item questionnaire across 8 domains that is designed to find out how systemic lupus erythematosus (SLE) affects a participant's life. Domains include physical health, pain, planning, intimate relationships, burden to others, emotional health, body image, and fatigue. Participants indicate their responses on a 5-point Likert response format, where 4=never, 3=occasionally, 2= a good bit of the time, 1=most of the time, and 0=worst of the time. Summary scores can be calculated for all 8 domains. A LupusQoL score for each domain was reported on a 0 to 100 scale, with greater values indicating better health related QoL.
DBPC Period: Number of Participants With Patient Global Impression of Change (PGIC) Scale Score of Any Improvement, no Change and Any Worsening	Week 4, 8, 12, 16, 24, 32, 40, and 52	The PGIC is a self-rated scale that asks the participant to describe the change in activity limitations, symptoms, emotions, and overall quality of life (QoL) related to the participants painful condition on the following scale: 1 (very much improved), 2 (much improved), 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (much worse) and 7 (very much worse). Number of participants in the PGIC categories of any improvement (that is PGIC scale score 1, 2 or 3), no change (that is PGIC scale score 4) and any worsening (that is PGIC scale score 5, 6 or 7) are reported.
DBPC Period: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Baseline, Week 4, 8, 12, 16, 24, 32, 40, and 52	The FACIT-Fatigue score was calculated according to a 13-item questionnaire that assess self reported fatigue and its impact upon daily activities and function. It uses a 5-point Likert-type scale (0 = not at all; 1 = a little bit; 2 = somewhat; 3 = quite a bit; 4 = very much). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse possible score) to 52 (best score). A higher score reflected an improvement in the participant's health status.
DBPC Period: Number of Participants With Change From Baseline in Prednisone Equivalent Corticosteroid (CS) Dose by >=25% to a Dose of <=7.5 Milligram Per Day (mg/Day), With no BILAG A or 2B Flare in Disease Activity at Week 52	Baseline and Week 52	BILAG A or 2B flare is defined as at least one BILAG A grade or two BILAG B grade in any organ system due to items that are new or worse, compared to the BILAG evaluation at the previous visit, during the 52 week treatment period. BILAG Index: assessing clinical signs, symptoms, or laboratory parameters related to systemic lupus erythematosus (SLE), divided into 9 organ systems. For each organ system based on alphabetic score: A=severe disease, B=moderate disease, C=mild stable disease, D=inactive, but previously active, E=inactive and never affected.
DBPC Period: Change From Baseline to Week 52 in Prednisone Equivalent Corticosteroid (CS) Daily Dose at at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Baseline, Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Change From Baseline in Prednisone-equivalent CS Daily Dose at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 were reported.
DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Baseline, Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52	Number of Participants With Reduction From Baseline in Prednisone-equivalent Corticosteroid (CS) Daily Dose by \> 0 to 25%, \>25% to 50%, \>50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 were reported.
DBPC Period: Cumulative Prednisone Equivalent Corticosteroid (CS) Dose at Week 52	Week 52	Cumulative Prednisone-equivalent Corticosteroid (CS) Dose was calculated at Week 52.
DBPC Period: Number of Participants With a Sustained Reduction of Oral Corticosteroids (OCS) Dose to 7.5 mg Prednisone Equivalent Per Day or Less With Response Based on Systemic Lupus Erythematosus Responder Index 4 (SRI-4) at Week 52	Week 52	SRI-4 response was defined as greater than or equal to (\>=) 4-point reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) total score, no new British Isles Lupus Assessment Group (BILAG) A and no more than 1 new BILAG B domain score, no worsening (less than 10 percent increase) from baseline in Physician's Global Assessment of Disease Activity (PGA) and no treatment failure. SLEDAI-2K assessment consists of 24 items with total score of 0(no symptoms) to 105 (presence of all defined symptoms) with higher scores representing increased disease activity. BILAG Index: assessing clinical signs, symptoms, or laboratory parameters related to Systemic Lupus Erythematosus (SLE), divided into 9 organ systems. For each organ system A=severe disease, B=moderate disease, C=mild stable disease, D=inactive, but previously active, E=inactive and never affected. The PGA assess disease activity on a visual analogue scale =from 0(very well) to 100(very poor).
DBPC Period: Number of Participants With a Sustained Reduction of Oral Corticosteroids (OCS) Dose to 7.5 mg Prednisone Equivalent Per Day or Less With Response Based on Systemic Lupus Erythematosus Responder Index 6 (SRI-6) at Week 52	Week 52	SRI-6 response was defined as \>= 6-point reduction in SLEDAI-2K total score, no new BILAG A and no more than 1 new BILAG B domain score and no worsening (less than 10 percent increase) from baseline in Physician's Global Assessment of Disease Activity (PGA) and treatment failure. SLEDAI-2K assessment consists of 24 items with total score of 0 (no symptoms) to 105 (presence of all defined symptoms) with higher scores representing increased disease activity. BILAG Index: assessing clinical signs, symptoms, or laboratory parameters related to SLE, divided into 9 organ systems. For each organ system :A=severe disease, B=moderate disease, C=mild stable disease, D=inactive, but previously active, E=inactive and never affected. The PGA assess disease activity on a visual analogue scale =from 0(very well) to 100(very poor).
DBPC Period: Number of Participants With a Sustained Reduction of Oral Corticosteroids (OCS) Dose to 7.5 mg Prednisone Equivalent Per Day or Less With Response Based on SRI-4 at Week 52 in Serologically Active Subgroup	Week 52	SRI-4 response was defined as greater than or equal to (\>=) 4-point reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) total score, no new British Isles Lupus Assessment Group (BILAG) A and no more than 1 new BILAG B domain score, no worsening (less than 10 percent increase) from baseline in Physician's Global Assessment of Disease Activity (PGA) and no treatment failure. SLEDAI-2K assessment consists of 24 items with total score of 0(no symptoms) to 105 (presence of all defined symptoms) with higher scores representing increased disease activity. BILAG Index: assessing clinical signs, symptoms, or laboratory parameters related to Systemic Lupus Erythematosus (SLE), divided into 9 organ systems. For each organ system A=severe disease, B=moderate disease, C=mild stable disease, D=inactive, but previously active, E=inactive and never affected. The PGA assess disease activity on a visual analogue scale = from very well(0)-very poor(100).
DBPC Period: Number of Participants With Lupus Low Disease Activity State (LLDAS) at Week 52	Week 52	Lupus low disease activity state will be measured as: SLEDAI-2K \<= 4; No activity in any major organ systems (renal, central nervous system, cardiopulmonary, vasculitis, fever); No new features of disease activity compared with the previous assessment; Prednisone-equivalent \<= 7.5 milligram per day; Unchanged background immunosuppressive therapy.
DBPC Period: Time to First Severe British Isles Lupus Assessment Group (BILAG) A Flare	Baseline up to Week 56	BILAG Index: assessing clinical signs, symptoms, or laboratory parameters related to SLE, divided into 9 organ systems. For each organ system based on alphabetic score: A=severe disease, B=moderate disease, C=mild stable disease, D=inactive, but previously active, E=inactive and never affected. BILAG evaluated by scoring each of a list of signs and symptoms as: improving (1); same (2); worse (3); new (4); not present (0); not done (ND). Total BILAG score is sum of scores of 9 domains where A=12, B=8, C=1, D=0, and E=0. Total score ranges from 0 to 108 with a higher score indicating greater lupus activity. Time to first severe flare, where a severe flare is defined as at least one BILAG A (Severe disease activity) score in any organ system due to items that are new or worse, compared to the BILAG evaluation at the previous visit, during the 52-Week Treatment. It was measured using Kaplan-Meier (KM) estimates.

Countries

Argentina, Bulgaria, Chile, Colombia, Germany, Italy, Japan, Malaysia, Mauritius, Mexico, Peru, Philippines, Poland, Romania, Russia, South Africa, South Korea, Taiwan, United States

Participant flow

Recruitment details

A total of 1053 participants with Systemic Lupus Erythematosus (SLE) were screened. Out of which 469 participants were randomized in ratio of 1:1:1:1 to 1 of 4 treatment groups: Placebo; M2951 25mg QD, M2951 75 mg QD and M2951 50 mg BID. 283 out of 348 participants that completed Double-Blind Placebo-Controlled (DBPC) period, entered the Long-Term Extension (LTE) period of study.

Participants by arm

Arm	Count
DBPC Period: Placebo Participants received placebo matched to M2951 orally for 52 weeks.	117
DBPC Period: M2951 25 mg QD Participants received 25 milligrams (mg) of M2951 orally once daily (QD) for 52 weeks.	118
DBPC Period: M2951 75 mg QD Participants received 75 mg of M2951 orally QD for 52 weeks.	117
DBPC Period: M2951 50 mg BID Participants received 50 mg of M2951 orally twice daily (BID) for 52 weeks.	117
Total	469

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002	FG003	FG004	FG005	FG006	FG007
DBPC (52 Weeks)	Adverse Event	16	17	13	18	0	0	0	0
DBPC (52 Weeks)	Lack of Efficacy	4	4	2	3	0	0	0	0
DBPC (52 Weeks)	Lost to Follow-up	2	1	2	4	0	0	0	0
DBPC (52 Weeks)	Premature termination of the study	5	6	6	4	0	0	0	0
DBPC (52 Weeks)	Protocol Violation	4	1	3	1	0	0	0	0
DBPC (52 Weeks)	Withdrawal by Subject	1	0	1	3	0	0	0	0
LTE (104 Weeks)	Adverse Event	0	0	0	0	7	4	2	0
LTE (104 Weeks)	Lack of Efficacy	0	0	0	0	0	1	2	0
LTE (104 Weeks)	Lost to Follow-up	0	0	0	0	0	1	0	0
LTE (104 Weeks)	Other	0	0	0	0	55	63	76	72

Baseline characteristics

Characteristic	DBPC Period: Placebo	DBPC Period: M2951 25 mg QD	DBPC Period: M2951 75 mg QD	DBPC Period: M2951 50 mg BID	Total
Age, Continuous	40.2 Years STANDARD_DEVIATION 12.49	38.8 Years STANDARD_DEVIATION 12.45	41.5 Years STANDARD_DEVIATION 12.52	42.2 Years STANDARD_DEVIATION 11.78	40.7 Years STANDARD_DEVIATION 12.34
Ethnicity (NIH/OMB) Hispanic or Latino	45 Participants	51 Participants	47 Participants	42 Participants	185 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	72 Participants	67 Participants	70 Participants	75 Participants	284 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	23 Participants	17 Participants	21 Participants	13 Participants	74 Participants
Race (NIH/OMB) Black or African American	10 Participants	12 Participants	11 Participants	12 Participants	45 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	18 Participants	16 Participants	17 Participants	9 Participants	60 Participants
Race (NIH/OMB) White	66 Participants	73 Participants	68 Participants	83 Participants	290 Participants
Sex: Female, Male Female	110 Participants	112 Participants	111 Participants	112 Participants	445 Participants
Sex: Female, Male Male	7 Participants	6 Participants	6 Participants	5 Participants	24 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk	EG004 affected / at risk	EG005 affected / at risk	EG006 affected / at risk	EG007 affected / at risk
deaths Total, all-cause mortality	0 / 117	1 / 118	1 / 117	0 / 117	0 / 62	0 / 69	0 / 80	0 / 72
other Total, other adverse events	76 / 117	85 / 118	75 / 117	78 / 117	22 / 62	34 / 69	35 / 80	23 / 72
serious Total, serious adverse events	10 / 117	13 / 118	11 / 117	9 / 117	5 / 62	5 / 69	5 / 80	7 / 72

Outcome results

Primary

DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 12

Change from baseline in the serum levels of IgG, IgA, IgM were assessed.

Time frame: Baseline and Week 12

Arm	Measure	Group	Value (MEAN)	Dispersion
DBPC Period: Placebo	DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 12	IgG	-0.36 gram per liter (g/L)	Standard Deviation 2.073
DBPC Period: Placebo	DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 12	IgM	-0.01 gram per liter (g/L)	Standard Deviation 0.194
DBPC Period: Placebo	DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 12	IgA	0.00 gram per liter (g/L)	Standard Deviation 0.325
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 12	IgG	-0.62 gram per liter (g/L)	Standard Deviation 1.827
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 12	IgM	-0.20 gram per liter (g/L)	Standard Deviation 0.301
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 12	IgA	-0.02 gram per liter (g/L)	Standard Deviation 0.36
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 12	IgA	0.06 gram per liter (g/L)	Standard Deviation 0.518
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 12	IgG	-0.72 gram per liter (g/L)	Standard Deviation 2.552
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 12	IgM	-0.18 gram per liter (g/L)	Standard Deviation 0.277
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 12	IgG	-0.93 gram per liter (g/L)	Standard Deviation 1.64
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 12	IgM	-0.20 gram per liter (g/L)	Standard Deviation 0.25
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 12	IgA	-0.03 gram per liter (g/L)	Standard Deviation 0.34

Primary

DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 2

Change from baseline in the serum levels of IgG, IgA, IgM were assessed.

Time frame: Baseline and Week 2

Arm	Measure	Group	Value (MEAN)	Dispersion
DBPC Period: Placebo	DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 2	IgG	-0.51 gram per liter (g/L)	Standard Deviation 1.726
DBPC Period: Placebo	DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 2	IgM	0.00 gram per liter (g/L)	Standard Deviation 0.197
DBPC Period: Placebo	DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 2	IgA	-0.11 gram per liter (g/L)	Standard Deviation 0.435
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 2	IgG	-0.06 gram per liter (g/L)	Standard Deviation 1.361
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 2	IgM	-0.05 gram per liter (g/L)	Standard Deviation 0.194
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 2	IgA	-0.04 gram per liter (g/L)	Standard Deviation 0.431
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 2	IgA	-0.01 gram per liter (g/L)	Standard Deviation 0.381
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 2	IgG	-0.15 gram per liter (g/L)	Standard Deviation 1.772
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 2	IgM	-0.04 gram per liter (g/L)	Standard Deviation 0.155
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 2	IgG	-0.40 gram per liter (g/L)	Standard Deviation 1.025
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 2	IgM	-0.07 gram per liter (g/L)	Standard Deviation 0.116
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 2	IgA	-0.03 gram per liter (g/L)	Standard Deviation 0.268

Primary

DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 24

Change from baseline in the serum levels of IgG, IgA, IgM were assessed.

Time frame: Baseline and Week 24

Arm	Measure	Group	Value (MEAN)	Dispersion
DBPC Period: Placebo	DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 24	IgG	-0.21 gram per liter (g/L)	Standard Deviation 2.318
DBPC Period: Placebo	DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 24	IgM	-0.01 gram per liter (g/L)	Standard Deviation 0.264
DBPC Period: Placebo	DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 24	IgA	0.06 gram per liter (g/L)	Standard Deviation 0.332
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 24	IgG	0.11 gram per liter (g/L)	Standard Deviation 2.234
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 24	IgM	-0.23 gram per liter (g/L)	Standard Deviation 0.369
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 24	IgA	0.14 gram per liter (g/L)	Standard Deviation 0.39
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 24	IgA	0.19 gram per liter (g/L)	Standard Deviation 0.565
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 24	IgG	-0.46 gram per liter (g/L)	Standard Deviation 2.912
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 24	IgM	-0.23 gram per liter (g/L)	Standard Deviation 0.321
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 24	IgG	-0.57 gram per liter (g/L)	Standard Deviation 2.363
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 24	IgM	-0.25 gram per liter (g/L)	Standard Deviation 0.346
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 24	IgA	0.04 gram per liter (g/L)	Standard Deviation 0.563

Primary

DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 36

Change from baseline in the serum levels of IgG, IgA, IgM were assessed.

Time frame: Baseline and Week 36

Arm	Measure	Group	Value (MEAN)	Dispersion
DBPC Period: Placebo	DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 36	IgG	-0.15 gram per liter (g/L)	Standard Deviation 2.13
DBPC Period: Placebo	DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 36	IgM	-0.04 gram per liter (g/L)	Standard Deviation 0.255
DBPC Period: Placebo	DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 36	IgA	-0.02 gram per liter (g/L)	Standard Deviation 0.361
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 36	IgG	0.02 gram per liter (g/L)	Standard Deviation 2.487
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 36	IgM	-0.25 gram per liter (g/L)	Standard Deviation 0.416
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 36	IgA	0.22 gram per liter (g/L)	Standard Deviation 0.453
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 36	IgA	0.24 gram per liter (g/L)	Standard Deviation 0.583
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 36	IgG	-0.43 gram per liter (g/L)	Standard Deviation 2.572
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 36	IgM	-0.25 gram per liter (g/L)	Standard Deviation 0.284
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 36	IgG	-0.69 gram per liter (g/L)	Standard Deviation 2.189
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 36	IgM	-0.28 gram per liter (g/L)	Standard Deviation 0.392
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 36	IgA	0.08 gram per liter (g/L)	Standard Deviation 0.459

Primary

DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 4

Change from baseline in the serum levels of IgG, IgA, IgM were assessed.

Time frame: Baseline and Week 4

Arm	Measure	Group	Value (MEAN)	Dispersion
DBPC Period: Placebo	DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 4	IgG	-0.26 gram per liter (g/L)	Standard Deviation 1.76
DBPC Period: Placebo	DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 4	IgM	0.01 gram per liter (g/L)	Standard Deviation 0.195
DBPC Period: Placebo	DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 4	IgA	-0.01 gram per liter (g/L)	Standard Deviation 0.205
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 4	IgG	-0.16 gram per liter (g/L)	Standard Deviation 1.463
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 4	IgM	-0.09 gram per liter (g/L)	Standard Deviation 0.175
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 4	IgA	-0.04 gram per liter (g/L)	Standard Deviation 0.334
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 4	IgA	0.03 gram per liter (g/L)	Standard Deviation 0.447
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 4	IgG	-0.24 gram per liter (g/L)	Standard Deviation 1.657
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 4	IgM	-0.07 gram per liter (g/L)	Standard Deviation 0.192
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 4	IgG	-0.45 gram per liter (g/L)	Standard Deviation 1.15
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 4	IgM	-0.08 gram per liter (g/L)	Standard Deviation 0.159
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 4	IgA	-0.03 gram per liter (g/L)	Standard Deviation 0.301

Primary

DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 52

Change from baseline in the serum levels of IgG, IgA, IgM were assessed.

Time frame: Baseline and Week 52

Population: The Safety analysis set included all participants who received at least 1 dose of IMP (Evobrutinib or Placebo). Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure and Number Analyzed signified those participants who were evaluable for the specified category at given time points.

Arm	Measure	Group	Value (MEAN)	Dispersion
DBPC Period: Placebo	DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 52	IgG	0.41 gram per liter (g/L)	Standard Deviation 2.898
DBPC Period: Placebo	DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 52	IgM	-0.02 gram per liter (g/L)	Standard Deviation 0.235
DBPC Period: Placebo	DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 52	IgA	0.19 gram per liter (g/L)	Standard Deviation 0.42
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 52	IgG	0.29 gram per liter (g/L)	Standard Deviation 2.361
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 52	IgM	-0.25 gram per liter (g/L)	Standard Deviation 0.303
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 52	IgA	0.32 gram per liter (g/L)	Standard Deviation 0.492
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 52	IgA	0.39 gram per liter (g/L)	Standard Deviation 0.767
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 52	IgG	0.35 gram per liter (g/L)	Standard Deviation 2.688
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 52	IgM	-0.21 gram per liter (g/L)	Standard Deviation 0.318
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 52	IgG	-0.31 gram per liter (g/L)	Standard Deviation 2.344
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 52	IgM	-0.33 gram per liter (g/L)	Standard Deviation 0.456
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 52	IgA	0.18 gram per liter (g/L)	Standard Deviation 0.469

Primary

DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 56

Change from baseline in the serum levels of IgG, IgA, IgM were assessed.

Time frame: Baseline and Week 56

Arm	Measure	Group	Value (MEAN)	Dispersion
DBPC Period: Placebo	DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 56	IgG	0.74 gram per liter (g/L)	Standard Deviation 2.907
DBPC Period: Placebo	DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 56	IgM	0.01 gram per liter (g/L)	Standard Deviation 0.266
DBPC Period: Placebo	DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 56	IgA	0.23 gram per liter (g/L)	Standard Deviation 0.468
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 56	IgG	1.06 gram per liter (g/L)	Standard Deviation 2.607
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 56	IgM	-0.15 gram per liter (g/L)	Standard Deviation 0.219
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 56	IgA	0.48 gram per liter (g/L)	Standard Deviation 0.6
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 56	IgA	0.35 gram per liter (g/L)	Standard Deviation 0.488
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 56	IgG	0.74 gram per liter (g/L)	Standard Deviation 1.987
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 56	IgM	-0.11 gram per liter (g/L)	Standard Deviation 0.225
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 56	IgG	-0.40 gram per liter (g/L)	Standard Deviation 2.823
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 56	IgM	-0.21 gram per liter (g/L)	Standard Deviation 0.488
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 56	IgA	0.26 gram per liter (g/L)	Standard Deviation 0.498

Primary

DBPC Period: Change From Baseline in Total B Cell Count at Week 24

Change from baseline in Total B cell count were assessed. Flow cytometry analysis of lymphocyte populations using four-color fluorescence-activated cell sorting was performed for the analysis of B cell counts.

Time frame: Baseline and Week 24

Arm	Measure	Value (MEAN)	Dispersion
DBPC Period: Placebo	DBPC Period: Change From Baseline in Total B Cell Count at Week 24	2 Cells per microliter	Standard Deviation 98.1
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Total B Cell Count at Week 24	5 Cells per microliter	Standard Deviation 112
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Total B Cell Count at Week 24	3 Cells per microliter	Standard Deviation 103.2
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Total B Cell Count at Week 24	-7 Cells per microliter	Standard Deviation 134.7

Primary

DBPC Period: Change From Baseline in Total B Cell Count at Week 4

Time frame: Baseline and Week 4

Arm	Measure	Value (MEAN)	Dispersion
DBPC Period: Placebo	DBPC Period: Change From Baseline in Total B Cell Count at Week 4	-5 Cells per microliter	Standard Deviation 93.7
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Total B Cell Count at Week 4	65 Cells per microliter	Standard Deviation 146.6
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Total B Cell Count at Week 4	87 Cells per microliter	Standard Deviation 146.2
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Total B Cell Count at Week 4	67 Cells per microliter	Standard Deviation 109.1

Primary

DBPC Period: Change From Baseline in Total B Cell Count at Week 52

Time frame: Baseline and Week 52

Population: The safety analysis set included all participants who received at least 1 dose of IMP (Evobrutinib or Placebo). Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure.

Arm	Measure	Value (MEAN)	Dispersion
DBPC Period: Placebo	DBPC Period: Change From Baseline in Total B Cell Count at Week 52	-14 Cells per microliter	Standard Deviation 103
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Total B Cell Count at Week 52	-19 Cells per microliter	Standard Deviation 133.3
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Total B Cell Count at Week 52	-14 Cells per microliter	Standard Deviation 147.5
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Total B Cell Count at Week 52	-52 Cells per microliter	Standard Deviation 215.7

Primary

DBPC Period: Change From Baseline in Total B Cell Count at Week 56

Time frame: Baseline and Week 56

Arm	Measure	Value (MEAN)	Dispersion
DBPC Period: Placebo	DBPC Period: Change From Baseline in Total B Cell Count at Week 56	7 Cells per microliter	Standard Deviation 96.2
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Total B Cell Count at Week 56	-70 Cells per microliter	Standard Deviation 138.2
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Total B Cell Count at Week 56	-75 Cells per microliter	Standard Deviation 192.1
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Total B Cell Count at Week 56	-48 Cells per microliter	Standard Deviation 85.8

Primary

DBPC Period: Mean Absolute Total B Cell Count at Week 24

Mean absolute total B cell count were assessed. Flow cytometry analysis of lymphocyte populations using four-color fluorescence activated cell sorting was performed for the analysis of B cell counts.

Time frame: Week 24

Arm	Measure	Value (MEAN)	Dispersion
DBPC Period: Placebo	DBPC Period: Mean Absolute Total B Cell Count at Week 24	161 Cells per microliter	Standard Deviation 125.8
DBPC Period: M2951 25 mg QD	DBPC Period: Mean Absolute Total B Cell Count at Week 24	184 Cells per microliter	Standard Deviation 152.6
DBPC Period: M2951 75 mg QD	DBPC Period: Mean Absolute Total B Cell Count at Week 24	204 Cells per microliter	Standard Deviation 158.3
DBPC Period: M2951 50 mg BID	DBPC Period: Mean Absolute Total B Cell Count at Week 24	151 Cells per microliter	Standard Deviation 129.2

Primary

DBPC Period: Mean Absolute Total B Cell Count at Week 4

Mean total B cell count were assessed. Flow cytometry analysis of lymphocyte populations using four-color fluorescence activated cell sorting was performed for the analysis of B cell counts.

Time frame: Week 4

Arm	Measure	Value (MEAN)	Dispersion
DBPC Period: Placebo	DBPC Period: Mean Absolute Total B Cell Count at Week 4	150 Cells per microliter	Standard Deviation 126.9
DBPC Period: M2951 25 mg QD	DBPC Period: Mean Absolute Total B Cell Count at Week 4	236 Cells per microliter	Standard Deviation 197.4
DBPC Period: M2951 75 mg QD	DBPC Period: Mean Absolute Total B Cell Count at Week 4	296 Cells per microliter	Standard Deviation 243.8
DBPC Period: M2951 50 mg BID	DBPC Period: Mean Absolute Total B Cell Count at Week 4	229 Cells per microliter	Standard Deviation 232.9

Primary

DBPC Period: Mean Absolute Total B Cell Count at Week 52

Mean absolute total B cell count were assessed. Flow cytometry analysis of lymphocyte populations using four-color fluorescence activated cell sorting was performed for the analysis of B cell counts.

Time frame: Week 52

Arm	Measure	Value (MEAN)	Dispersion
DBPC Period: Placebo	DBPC Period: Mean Absolute Total B Cell Count at Week 52	169 Cells per microliter	Standard Deviation 121.9
DBPC Period: M2951 25 mg QD	DBPC Period: Mean Absolute Total B Cell Count at Week 52	167 Cells per microliter	Standard Deviation 168.7
DBPC Period: M2951 75 mg QD	DBPC Period: Mean Absolute Total B Cell Count at Week 52	180 Cells per microliter	Standard Deviation 170.7
DBPC Period: M2951 50 mg BID	DBPC Period: Mean Absolute Total B Cell Count at Week 52	119 Cells per microliter	Standard Deviation 84.1

Primary

DBPC Period: Mean Absolute Total B Cell Count at Week 56

Mean absolute total B cell count were assessed. Flow cytometry analysis of lymphocyte populations using four-color fluorescence activated cell sorting was performed for the analysis of B cell counts.

Time frame: Week 56

Arm	Measure	Value (MEAN)	Dispersion
DBPC Period: Placebo	DBPC Period: Mean Absolute Total B Cell Count at Week 56	164 Cells per microliter	Standard Deviation 113.3
DBPC Period: M2951 25 mg QD	DBPC Period: Mean Absolute Total B Cell Count at Week 56	129 Cells per microliter	Standard Deviation 100
DBPC Period: M2951 75 mg QD	DBPC Period: Mean Absolute Total B Cell Count at Week 56	156 Cells per microliter	Standard Deviation 127.1
DBPC Period: M2951 50 mg BID	DBPC Period: Mean Absolute Total B Cell Count at Week 56	104 Cells per microliter	Standard Deviation 71.9

Primary

DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 12

Mean absolute value of serum levels of IgG, IgA, IgM were assessed at Week 12.

Time frame: Week 12

Arm	Measure	Group	Value (MEAN)	Dispersion
DBPC Period: Placebo	DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 12	IgG:	14.91 gram per liter (g/L)	Standard Deviation 5.312
DBPC Period: Placebo	DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 12	IgM	1.11 gram per liter (g/L)	Standard Deviation 0.683
DBPC Period: Placebo	DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 12	IgA	2.72 gram per liter (g/L)	Standard Deviation 1.321
DBPC Period: M2951 25 mg QD	DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 12	IgG:	12.92 gram per liter (g/L)	Standard Deviation 4.332
DBPC Period: M2951 25 mg QD	DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 12	IgM	1.05 gram per liter (g/L)	Standard Deviation 0.7
DBPC Period: M2951 25 mg QD	DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 12	IgA	2.73 gram per liter (g/L)	Standard Deviation 1.34
DBPC Period: M2951 75 mg QD	DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 12	IgA	2.88 gram per liter (g/L)	Standard Deviation 1.363
DBPC Period: M2951 75 mg QD	DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 12	IgG:	13.64 gram per liter (g/L)	Standard Deviation 4.035
DBPC Period: M2951 75 mg QD	DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 12	IgM	0.95 gram per liter (g/L)	Standard Deviation 0.61
DBPC Period: M2951 50 mg BID	DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 12	IgG:	12.38 gram per liter (g/L)	Standard Deviation 3.52
DBPC Period: M2951 50 mg BID	DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 12	IgM	1.02 gram per liter (g/L)	Standard Deviation 0.695
DBPC Period: M2951 50 mg BID	DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 12	IgA	2.68 gram per liter (g/L)	Standard Deviation 1.021

Primary

DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 2

Mean absolute value of serum levels of IgG, IgA, IgM were assessed at Week 2.

Time frame: Week 2

Arm	Measure	Group	Value (MEAN)	Dispersion
DBPC Period: Placebo	DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 2	IgG	14.56 gram per liter (g/L)	Standard Deviation 5.367
DBPC Period: Placebo	DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 2	IgM	1.12 gram per liter (g/L)	Standard Deviation 0.662
DBPC Period: Placebo	DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 2	IgA	2.62 gram per liter (g/L)	Standard Deviation 1.207
DBPC Period: M2951 25 mg QD	DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 2	IgG	13.75 gram per liter (g/L)	Standard Deviation 4.652
DBPC Period: M2951 25 mg QD	DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 2	IgM	1.22 gram per liter (g/L)	Standard Deviation 0.89
DBPC Period: M2951 25 mg QD	DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 2	IgA	2.75 gram per liter (g/L)	Standard Deviation 1.374
DBPC Period: M2951 75 mg QD	DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 2	IgA	2.78 gram per liter (g/L)	Standard Deviation 1.328
DBPC Period: M2951 75 mg QD	DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 2	IgG	14.37 gram per liter (g/L)	Standard Deviation 5.536
DBPC Period: M2951 75 mg QD	DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 2	IgM	1.09 gram per liter (g/L)	Standard Deviation 0.697
DBPC Period: M2951 50 mg BID	DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 2	IgG	12.81 gram per liter (g/L)	Standard Deviation 3.847
DBPC Period: M2951 50 mg BID	DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 2	IgM	1.18 gram per liter (g/L)	Standard Deviation 0.776
DBPC Period: M2951 50 mg BID	DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 2	IgA	2.66 gram per liter (g/L)	Standard Deviation 1.137

Primary

DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 24

Mean absolute value of serum levels of IgG, IgA, IgM were assessed at Week 24.

Time frame: Week 24

Arm	Measure	Group	Value (MEAN)	Dispersion
DBPC Period: Placebo	DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 24	IgG	15.01 gram per liter (g/L)	Standard Deviation 5.19
DBPC Period: Placebo	DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 24	IgM	1.07 gram per liter (g/L)	Standard Deviation 0.609
DBPC Period: Placebo	DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 24	IgA	2.79 gram per liter (g/L)	Standard Deviation 1.43
DBPC Period: M2951 25 mg QD	DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 24	IgG	13.75 gram per liter (g/L)	Standard Deviation 4.783
DBPC Period: M2951 25 mg QD	DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 24	IgM	1.01 gram per liter (g/L)	Standard Deviation 0.686
DBPC Period: M2951 25 mg QD	DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 24	IgA	2.89 gram per liter (g/L)	Standard Deviation 1.46
DBPC Period: M2951 75 mg QD	DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 24	IgA	2.98 gram per liter (g/L)	Standard Deviation 1.391
DBPC Period: M2951 75 mg QD	DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 24	IgG	13.79 gram per liter (g/L)	Standard Deviation 4.165
DBPC Period: M2951 75 mg QD	DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 24	IgM	0.89 gram per liter (g/L)	Standard Deviation 0.583
DBPC Period: M2951 50 mg BID	DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 24	IgG	12.86 gram per liter (g/L)	Standard Deviation 3.725
DBPC Period: M2951 50 mg BID	DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 24	IgM	0.98 gram per liter (g/L)	Standard Deviation 0.656
DBPC Period: M2951 50 mg BID	DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 24	IgA	2.78 gram per liter (g/L)	Standard Deviation 1.091

Primary

DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 36

Mean absolute value of serum levels of IgG, IgA, IgM were assessed at Week 36.

Time frame: Week 36

Arm	Measure	Group	Value (MEAN)	Dispersion
DBPC Period: Placebo	DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 36	IgG	14.81 gram per liter (g/L)	Standard Deviation 5.217
DBPC Period: Placebo	DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 36	IgM	1.06 gram per liter (g/L)	Standard Deviation 0.63
DBPC Period: Placebo	DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 36	IgA	2.72 gram per liter (g/L)	Standard Deviation 1.378
DBPC Period: M2951 25 mg QD	DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 36	IgG	13.54 gram per liter (g/L)	Standard Deviation 4.242
DBPC Period: M2951 25 mg QD	DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 36	IgM	1.01 gram per liter (g/L)	Standard Deviation 0.669
DBPC Period: M2951 25 mg QD	DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 36	IgA	2.89 gram per liter (g/L)	Standard Deviation 1.418
DBPC Period: M2951 75 mg QD	DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 36	IgA	3.01 gram per liter (g/L)	Standard Deviation 1.42
DBPC Period: M2951 75 mg QD	DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 36	IgG	13.67 gram per liter (g/L)	Standard Deviation 3.934
DBPC Period: M2951 75 mg QD	DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 36	IgM	0.85 gram per liter (g/L)	Standard Deviation 0.541
DBPC Period: M2951 50 mg BID	DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 36	IgG	12.65 gram per liter (g/L)	Standard Deviation 3.48
DBPC Period: M2951 50 mg BID	DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 36	IgM	0.95 gram per liter (g/L)	Standard Deviation 0.656
DBPC Period: M2951 50 mg BID	DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 36	IgA	2.86 gram per liter (g/L)	Standard Deviation 1.073

Primary

DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 4

Mean absolute value of serum levels of IgG, IgA, IgM were assessed at Week 4.

Time frame: Week 4

Arm	Measure	Group	Value (MEAN)	Dispersion
DBPC Period: Placebo	DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 4	IgG	14.92 gram per liter (g/L)	Standard Deviation 5.497
DBPC Period: Placebo	DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 4	IgM	1.12 gram per liter (g/L)	Standard Deviation 0.699
DBPC Period: Placebo	DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 4	IgA	2.71 gram per liter (g/L)	Standard Deviation 1.284
DBPC Period: M2951 25 mg QD	DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 4	IgG	13.60 gram per liter (g/L)	Standard Deviation 4.59
DBPC Period: M2951 25 mg QD	DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 4	IgM	1.18 gram per liter (g/L)	Standard Deviation 0.824
DBPC Period: M2951 25 mg QD	DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 4	IgA	2.73 gram per liter (g/L)	Standard Deviation 1.349
DBPC Period: M2951 75 mg QD	DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 4	IgA	2.82 gram per liter (g/L)	Standard Deviation 1.293
DBPC Period: M2951 75 mg QD	DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 4	IgG	14.21 gram per liter (g/L)	Standard Deviation 4.828
DBPC Period: M2951 75 mg QD	DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 4	IgM	1.06 gram per liter (g/L)	Standard Deviation 0.676
DBPC Period: M2951 50 mg BID	DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 4	IgG	12.73 gram per liter (g/L)	Standard Deviation 3.771
DBPC Period: M2951 50 mg BID	DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 4	IgM	1.16 gram per liter (g/L)	Standard Deviation 0.745
DBPC Period: M2951 50 mg BID	DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 4	IgA	2.64 gram per liter (g/L)	Standard Deviation 1.109

Primary

DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 52

Mean absolute value of serum levels of IgG, IgA, IgM were assessed at Week 52

Time frame: Week 52

Arm	Measure	Group	Value (MEAN)	Dispersion
DBPC Period: Placebo	DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 52	IgG	15.21 gram per liter (g/L)	Standard Deviation 5.105
DBPC Period: Placebo	DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 52	IgM	1.08 gram per liter (g/L)	Standard Deviation 0.624
DBPC Period: Placebo	DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 52	IgA	2.82 gram per liter (g/L)	Standard Deviation 1.438
DBPC Period: M2951 25 mg QD	DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 52	IgG	13.90 gram per liter (g/L)	Standard Deviation 4.087
DBPC Period: M2951 25 mg QD	DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 52	IgM	0.94 gram per liter (g/L)	Standard Deviation 0.645
DBPC Period: M2951 25 mg QD	DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 52	IgA	2.95 gram per liter (g/L)	Standard Deviation 1.596
DBPC Period: M2951 75 mg QD	DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 52	IgA	3.17 gram per liter (g/L)	Standard Deviation 1.596
DBPC Period: M2951 75 mg QD	DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 52	IgG	14.32 gram per liter (g/L)	Standard Deviation 4.542
DBPC Period: M2951 75 mg QD	DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 52	IgM	0.82 gram per liter (g/L)	Standard Deviation 0.487
DBPC Period: M2951 50 mg BID	DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 52	IgG	13.01 gram per liter (g/L)	Standard Deviation 3.723
DBPC Period: M2951 50 mg BID	DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 52	IgM	0.96 gram per liter (g/L)	Standard Deviation 0.67
DBPC Period: M2951 50 mg BID	DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 52	IgA	2.95 gram per liter (g/L)	Standard Deviation 1.159

Primary

DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 56

Mean absolute value of serum levels of IgG, IgA, IgM were assessed at Week 56

Time frame: Week 56

Arm	Measure	Group	Value (MEAN)	Dispersion
DBPC Period: Placebo	DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 56	IgG	14.82 gram per liter (g/L)	Standard Deviation 5.504
DBPC Period: Placebo	DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 56	IgM	1.11 gram per liter (g/L)	Standard Deviation 0.642
DBPC Period: Placebo	DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 56	IgA	2.95 gram per liter (g/L)	Standard Deviation 1.549
DBPC Period: M2951 25 mg QD	DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 56	IgG	14.25 gram per liter (g/L)	Standard Deviation 4.435
DBPC Period: M2951 25 mg QD	DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 56	IgM	1.01 gram per liter (g/L)	Standard Deviation 0.601
DBPC Period: M2951 25 mg QD	DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 56	IgA	3.01 gram per liter (g/L)	Standard Deviation 1.459
DBPC Period: M2951 75 mg QD	DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 56	IgA	2.89 gram per liter (g/L)	Standard Deviation 1.655
DBPC Period: M2951 75 mg QD	DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 56	IgG	14.25 gram per liter (g/L)	Standard Deviation 4.626
DBPC Period: M2951 75 mg QD	DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 56	IgM	0.95 gram per liter (g/L)	Standard Deviation 0.624
DBPC Period: M2951 50 mg BID	DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 56	IgG	13.12 gram per liter (g/L)	Standard Deviation 4.507
DBPC Period: M2951 50 mg BID	DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 56	IgM	1.31 gram per liter (g/L)	Standard Deviation 0.869
DBPC Period: M2951 50 mg BID	DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 56	IgA	3.03 gram per liter (g/L)	Standard Deviation 1.164

Primary

DBPC Period: Number of Participants With Clinically Significant Change From Baseline in Vital Signs

Vital signs included body temperature, systolic and diastolic blood pressure, pulse rate, respiratory rate, weight and height. Clinical significance was determined by the investigator. The number of participants with clinically significant changes from baseline in vital signs were reported.

Time frame: Baseline up to Week 56

Population: The safety analysis set included all participants who received at least 1 dose of IMP (Evobrutinib or Placebo).

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
DBPC Period: Placebo	DBPC Period: Number of Participants With Clinically Significant Change From Baseline in Vital Signs	0 Participants
DBPC Period: M2951 25 mg QD	DBPC Period: Number of Participants With Clinically Significant Change From Baseline in Vital Signs	0 Participants
DBPC Period: M2951 75 mg QD	DBPC Period: Number of Participants With Clinically Significant Change From Baseline in Vital Signs	0 Participants
DBPC Period: M2951 50 mg BID	DBPC Period: Number of Participants With Clinically Significant Change From Baseline in Vital Signs	0 Participants

Primary

DBPC Period: Number of Participants With Clinically Significant Changes From Baseline in 12-Lead Electrocardiogram (ECG) Findings

12-lead ECG recordings included rhythm, heart rate (as measured by RR interval), PR interval, QRS duration, and QT interval. The corrected QT interval (QTcF) was calculated using Fridericia's formula. 12-lead ECG recordings were obtained after the participants have rested for at least 10 minutes in semisupine position. Clinical significance was determined by the investigator. The number of participants with clinically significant changes from baseline in 12-lead ECG findings were reported.

Time frame: Baseline up to Week 56

Population: The safety analysis set included all participants who received at least 1 dose of IMP (Evobrutinib or Placebo).

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
DBPC Period: Placebo	DBPC Period: Number of Participants With Clinically Significant Changes From Baseline in 12-Lead Electrocardiogram (ECG) Findings	0 Participants
DBPC Period: M2951 25 mg QD	DBPC Period: Number of Participants With Clinically Significant Changes From Baseline in 12-Lead Electrocardiogram (ECG) Findings	0 Participants
DBPC Period: M2951 75 mg QD	DBPC Period: Number of Participants With Clinically Significant Changes From Baseline in 12-Lead Electrocardiogram (ECG) Findings	0 Participants
DBPC Period: M2951 50 mg BID	DBPC Period: Number of Participants With Clinically Significant Changes From Baseline in 12-Lead Electrocardiogram (ECG) Findings	0 Participants

Primary

DBPC Period: Number of Participants With Clinically Significant Changes From Baseline in Laboratory Parameters

Laboratory investigation included hematology, biochemistry, urinalysis and coagulation. Clinical significance was determined by the investigator. The number of participants with clinically significant changes from baseline in laboratory parameters were reported.

Time frame: Baseline up to Week 56

Population: The safety analysis set included all participants who received at least 1 dose of IMP (Evobrutinib or Placebo).

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
DBPC Period: Placebo	DBPC Period: Number of Participants With Clinically Significant Changes From Baseline in Laboratory Parameters	0 Participants
DBPC Period: M2951 25 mg QD	DBPC Period: Number of Participants With Clinically Significant Changes From Baseline in Laboratory Parameters	0 Participants
DBPC Period: M2951 75 mg QD	DBPC Period: Number of Participants With Clinically Significant Changes From Baseline in Laboratory Parameters	0 Participants
DBPC Period: M2951 50 mg BID	DBPC Period: Number of Participants With Clinically Significant Changes From Baseline in Laboratory Parameters	0 Participants

Primary

DBPC Period: Number of Participants With Response Based on Systemic Lupus Erythematosus Responder Index 4 (SRI-4) at Week 52

SRI-4 response was defined as greater than or equal to (\>=) 4-point reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) total score, no new British Isles Lupus Assessment Group (BILAG) A and no more than 1 new BILAG B domain score, no worsening (less than 10 percent increase) from baseline in Physician's Global Assessment of Disease Activity (PGA) and no treatment failure. SLEDAI-2K assessment consists of 24 items with total score of 0(no symptoms) to 105 (presence of all defined symptoms) with higher scores representing increased disease activity. BILAG Index: assessing clinical signs, symptoms, or laboratory parameters related to Systemic Lupus Erythematosus (SLE) divided into 9 organ systems. For each organ system A=severe disease, B=moderate disease, C=mild stable disease, D=inactive, but previously active, E=inactive and never affected. The PGA assess disease activity on a visual analogue scale =from 0(very well) to 100(very poor).

Time frame: Week 52

Population: The modified Intent To Treat (mITT) analysis set included all randomized participants who had received at least one dose of Investigational Medicinal Product (IMP) \[Evobrutinib or placebo\] and have at least one Baseline and one post Baseline disease assessment (among the following: Systemic Lupus Erythematosus Disease Activity Index flare index \[SFI\], SLEDAI 2K, PGA, BILAG 2004, Cutaneous Lupus Erythematosus Disease Area and Severity Index \[CLASI\]).

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
DBPC Period: Placebo	DBPC Period: Number of Participants With Response Based on Systemic Lupus Erythematosus Responder Index 4 (SRI-4) at Week 52	52 Participants
DBPC Period: M2951 25 mg QD	DBPC Period: Number of Participants With Response Based on Systemic Lupus Erythematosus Responder Index 4 (SRI-4) at Week 52	64 Participants
DBPC Period: M2951 75 mg QD	DBPC Period: Number of Participants With Response Based on Systemic Lupus Erythematosus Responder Index 4 (SRI-4) at Week 52	60 Participants
DBPC Period: M2951 50 mg BID	DBPC Period: Number of Participants With Response Based on Systemic Lupus Erythematosus Responder Index 4 (SRI-4) at Week 52	55 Participants

p-value: 0.546295% CI: [0.91, 2.64]Regression, Logistic

p-value: 0.546295% CI: [0.76, 2.18]Regression, Logistic

p-value: 0.546295% CI: [0.67, 1.93]Regression, Logistic

Primary

DBPC Period: Number of Participants With Response Based on Systemic Lupus Erythematosus Responder Index 6 (SRI-6) at Week 52

SRI-6 response was defined as \>= 6-point reduction in SLEDAI-2K total score, no new BILAG A and no more than 1 new BILAG B domain score and no worsening (less than 10 percent increase) from baseline in Physician's Global Assessment of Disease Activity (PGA) and treatment failure. SLEDAI-2K assessment consists of 24 items with total score of 0 (no symptoms) to 105 (presence of all defined symptoms) with higher scores representing increased disease activity. BILAG Index: assessing clinical signs, symptoms, or laboratory parameters related to SLE, divided into 9 organ systems. For each organ system :A=severe disease, B=moderate disease, C=mild stable disease, D=inactive, but previously active, E=inactive and never affected. The PGA assess disease activity on a visual analogue scale =from 0(very well) to 100(very poor).

Time frame: Week 52

Population: The mITT analysis set included all randomized participants who had received at least one dose of IMP (Evobrutinib or placebo) and have at least one Baseline and one post Baseline disease assessment among the following: SFI, SLEDAI 2K, PGA, BILAG 2004, CLASI. Here, overall number of participants analyzed signifies those participants who achieved SLEDAI-2K total score \>= 10 at screening (High Disease Activity \[HDA\] participants).

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
DBPC Period: Placebo	DBPC Period: Number of Participants With Response Based on Systemic Lupus Erythematosus Responder Index 6 (SRI-6) at Week 52	22 Participants
DBPC Period: M2951 25 mg QD	DBPC Period: Number of Participants With Response Based on Systemic Lupus Erythematosus Responder Index 6 (SRI-6) at Week 52	27 Participants
DBPC Period: M2951 75 mg QD	DBPC Period: Number of Participants With Response Based on Systemic Lupus Erythematosus Responder Index 6 (SRI-6) at Week 52	30 Participants
DBPC Period: M2951 50 mg BID	DBPC Period: Number of Participants With Response Based on Systemic Lupus Erythematosus Responder Index 6 (SRI-6) at Week 52	24 Participants

p-value: 0.546295% CI: [0.69, 3.24]Regression, Logistic

p-value: 0.546295% CI: [0.68, 2.97]Regression, Logistic

p-value: 0.546295% CI: [0.59, 2.75]Regression, Logistic

Primary

DBPC Period: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs According to National Cancer Institute-Common Terminology Criteria for Adverse Events Version 4.03 (NCI-CTCAE v4.03)

Adverse event (AE) was defined as any untoward medical occurrence in a participant, which does not necessarily have causal relationship with treatment. A serious AE was defined as an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged in participant hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. TEAEs: events between first dose of study drug that were absent before treatment/that worsened relative to pre-treatment state up to 56 weeks. TEAEs included both serious TEAEs and non-serious TEAEs. Number of participants with TEAEs and serious TEAEs were reported.

Time frame: Baseline up to Week 56

Population: The safety analysis set included all participants who received at least 1 dose of IMP (Evobrutinib or Placebo).

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
DBPC Period: Placebo	DBPC Period: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs According to National Cancer Institute-Common Terminology Criteria for Adverse Events Version 4.03 (NCI-CTCAE v4.03)	Any TEAEs	96 Participants
DBPC Period: Placebo	DBPC Period: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs According to National Cancer Institute-Common Terminology Criteria for Adverse Events Version 4.03 (NCI-CTCAE v4.03)	Any serious TEAE	10 Participants
DBPC Period: M2951 25 mg QD	DBPC Period: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs According to National Cancer Institute-Common Terminology Criteria for Adverse Events Version 4.03 (NCI-CTCAE v4.03)	Any serious TEAE	13 Participants
DBPC Period: M2951 25 mg QD	DBPC Period: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs According to National Cancer Institute-Common Terminology Criteria for Adverse Events Version 4.03 (NCI-CTCAE v4.03)	Any TEAEs	103 Participants
DBPC Period: M2951 75 mg QD	DBPC Period: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs According to National Cancer Institute-Common Terminology Criteria for Adverse Events Version 4.03 (NCI-CTCAE v4.03)	Any TEAEs	100 Participants
DBPC Period: M2951 75 mg QD	DBPC Period: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs According to National Cancer Institute-Common Terminology Criteria for Adverse Events Version 4.03 (NCI-CTCAE v4.03)	Any serious TEAE	11 Participants
DBPC Period: M2951 50 mg BID	DBPC Period: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs According to National Cancer Institute-Common Terminology Criteria for Adverse Events Version 4.03 (NCI-CTCAE v4.03)	Any TEAEs	99 Participants
DBPC Period: M2951 50 mg BID	DBPC Period: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs According to National Cancer Institute-Common Terminology Criteria for Adverse Events Version 4.03 (NCI-CTCAE v4.03)	Any serious TEAE	9 Participants

Primary

DBPC Period: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) by Severity According to National Cancer Institute-Common Terminology Criteria for Adverse Events Version 4.03 (NCI-CTCAE v4.03)

Severity of TEAEs were graded using NCI-CTCAE v4.03 toxicity grades, as follows: Grade 1= Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Life-threatening and Grade 5 = Death. Number of participants with TEAEs by severity were reported.

Time frame: Baseline up to Week 56

Population: The Safety analysis set included all participants who received at least 1 dose of IMP (Evobrutinib or Placebo).

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
DBPC Period: Placebo	DBPC Period: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) by Severity According to National Cancer Institute-Common Terminology Criteria for Adverse Events Version 4.03 (NCI-CTCAE v4.03)	Grade 4	1 Participants
DBPC Period: Placebo	DBPC Period: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) by Severity According to National Cancer Institute-Common Terminology Criteria for Adverse Events Version 4.03 (NCI-CTCAE v4.03)	Grade 2	63 Participants
DBPC Period: Placebo	DBPC Period: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) by Severity According to National Cancer Institute-Common Terminology Criteria for Adverse Events Version 4.03 (NCI-CTCAE v4.03)	Grade 5	0 Participants
DBPC Period: Placebo	DBPC Period: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) by Severity According to National Cancer Institute-Common Terminology Criteria for Adverse Events Version 4.03 (NCI-CTCAE v4.03)	Grade 3	24 Participants
DBPC Period: Placebo	DBPC Period: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) by Severity According to National Cancer Institute-Common Terminology Criteria for Adverse Events Version 4.03 (NCI-CTCAE v4.03)	Grade 1	76 Participants
DBPC Period: M2951 25 mg QD	DBPC Period: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) by Severity According to National Cancer Institute-Common Terminology Criteria for Adverse Events Version 4.03 (NCI-CTCAE v4.03)	Grade 3	29 Participants
DBPC Period: M2951 25 mg QD	DBPC Period: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) by Severity According to National Cancer Institute-Common Terminology Criteria for Adverse Events Version 4.03 (NCI-CTCAE v4.03)	Grade 4	1 Participants
DBPC Period: M2951 25 mg QD	DBPC Period: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) by Severity According to National Cancer Institute-Common Terminology Criteria for Adverse Events Version 4.03 (NCI-CTCAE v4.03)	Grade 5	1 Participants
DBPC Period: M2951 25 mg QD	DBPC Period: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) by Severity According to National Cancer Institute-Common Terminology Criteria for Adverse Events Version 4.03 (NCI-CTCAE v4.03)	Grade 2	77 Participants
DBPC Period: M2951 25 mg QD	DBPC Period: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) by Severity According to National Cancer Institute-Common Terminology Criteria for Adverse Events Version 4.03 (NCI-CTCAE v4.03)	Grade 1	80 Participants
DBPC Period: M2951 75 mg QD	DBPC Period: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) by Severity According to National Cancer Institute-Common Terminology Criteria for Adverse Events Version 4.03 (NCI-CTCAE v4.03)	Grade 3	24 Participants
DBPC Period: M2951 75 mg QD	DBPC Period: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) by Severity According to National Cancer Institute-Common Terminology Criteria for Adverse Events Version 4.03 (NCI-CTCAE v4.03)	Grade 1	79 Participants
DBPC Period: M2951 75 mg QD	DBPC Period: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) by Severity According to National Cancer Institute-Common Terminology Criteria for Adverse Events Version 4.03 (NCI-CTCAE v4.03)	Grade 2	72 Participants
DBPC Period: M2951 75 mg QD	DBPC Period: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) by Severity According to National Cancer Institute-Common Terminology Criteria for Adverse Events Version 4.03 (NCI-CTCAE v4.03)	Grade 4	0 Participants
DBPC Period: M2951 75 mg QD	DBPC Period: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) by Severity According to National Cancer Institute-Common Terminology Criteria for Adverse Events Version 4.03 (NCI-CTCAE v4.03)	Grade 5	1 Participants
DBPC Period: M2951 50 mg BID	DBPC Period: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) by Severity According to National Cancer Institute-Common Terminology Criteria for Adverse Events Version 4.03 (NCI-CTCAE v4.03)	Grade 4	2 Participants
DBPC Period: M2951 50 mg BID	DBPC Period: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) by Severity According to National Cancer Institute-Common Terminology Criteria for Adverse Events Version 4.03 (NCI-CTCAE v4.03)	Grade 2	78 Participants
DBPC Period: M2951 50 mg BID	DBPC Period: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) by Severity According to National Cancer Institute-Common Terminology Criteria for Adverse Events Version 4.03 (NCI-CTCAE v4.03)	Grade 1	76 Participants
DBPC Period: M2951 50 mg BID	DBPC Period: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) by Severity According to National Cancer Institute-Common Terminology Criteria for Adverse Events Version 4.03 (NCI-CTCAE v4.03)	Grade 3	21 Participants
DBPC Period: M2951 50 mg BID	DBPC Period: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) by Severity According to National Cancer Institute-Common Terminology Criteria for Adverse Events Version 4.03 (NCI-CTCAE v4.03)	Grade 5	0 Participants

Secondary

DBPC Period: Annualized Flare Rate

A flare was defined as either 1 or more new BILAG-2004 A (severe disease activity) or 2 or more new BILAG-2004 B (moderate disease activity) items compared to the previous visit. The occurrence of a new flare was checked for each available visit versus the previous available visit up to Week 52. If no new flares occurred, the number of flares was set to 0. Otherwise all flares were counted leading to the maximum number of flares of 13. The annualized flare rate was calculated as the number of flares divided by the flare exposure time in days multiplied with 365.25 (1 year). The flare exposure time is the time up to Week 52 (date of BILAG-2004 assessment at Week 52) or up to the date of last available BILAG 2004 assessment.

Time frame: Baseline up to Week 52

Arm	Measure	Value (NUMBER)
DBPC Period: Placebo	DBPC Period: Annualized Flare Rate	0.15 Annualized flare rate ratio
DBPC Period: M2951 25 mg QD	DBPC Period: Annualized Flare Rate	0.23 Annualized flare rate ratio
DBPC Period: M2951 75 mg QD	DBPC Period: Annualized Flare Rate	0.13 Annualized flare rate ratio
DBPC Period: M2951 50 mg BID	DBPC Period: Annualized Flare Rate	0.19 Annualized flare rate ratio

p-value: 0.298995% CI: [0.66, 3.81]Negative binomial regression

p-value: 0.732595% CI: [0.33, 2.19]Negative binomial regression

p-value: 0.59195% CI: [0.51, 3.22]Negative binomial regression

Secondary

DBPC Period: Change From Baseline in British Isles Lupus Assessment Group (BILAG)-2004 Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

BILAG 2004 disease activity Index: assessing clinical signs, symptoms, or laboratory parameters related to SLE, divided into 9 organ systems. For each organ system based on alphabetic score: A=severe disease, B=moderate disease, C=mild stable disease, D=inactive, but previously active, E=inactive and never affected. BILAG evaluated by scoring each of a list of signs and symptoms as: improving (1); same (2); worse (3); new (4); not present (0); not done (ND). Total BILAG score is sum of scores of 9 domains where A=12, B=8, C=1, D=0, and E=0. Total score ranges from 0 to 108 with a higher score indicating greater lupus activity.

Time frame: Baseline, Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

Population: The mITT analysis set included all randomized participants who had received at least 1 dose of IMP (Evobrutinib or placebo) and have at least 1 Baseline and 1 post Baseline disease assessment among the following: SFI, SLEDAI 2K, PGA, BILAG 2004, CLASI. Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure and Number Analyzed signified those participants who were evaluable for the specified category at given time points.

Arm	Measure	Group	Value (MEAN)	Dispersion
DBPC Period: Placebo	DBPC Period: Change From Baseline in British Isles Lupus Assessment Group (BILAG)-2004 Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 4	-4 Units on a Scale	Standard Deviation 5.8
DBPC Period: Placebo	DBPC Period: Change From Baseline in British Isles Lupus Assessment Group (BILAG)-2004 Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 8	-6 Units on a Scale	Standard Deviation 6
DBPC Period: Placebo	DBPC Period: Change From Baseline in British Isles Lupus Assessment Group (BILAG)-2004 Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 12	-7 Units on a Scale	Standard Deviation 6.7
DBPC Period: Placebo	DBPC Period: Change From Baseline in British Isles Lupus Assessment Group (BILAG)-2004 Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 16	-7 Units on a Scale	Standard Deviation 6.9
DBPC Period: Placebo	DBPC Period: Change From Baseline in British Isles Lupus Assessment Group (BILAG)-2004 Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 20	-7 Units on a Scale	Standard Deviation 6.8
DBPC Period: Placebo	DBPC Period: Change From Baseline in British Isles Lupus Assessment Group (BILAG)-2004 Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 24	-8 Units on a Scale	Standard Deviation 6.9
DBPC Period: Placebo	DBPC Period: Change From Baseline in British Isles Lupus Assessment Group (BILAG)-2004 Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 28	-8 Units on a Scale	Standard Deviation 6.7
DBPC Period: Placebo	DBPC Period: Change From Baseline in British Isles Lupus Assessment Group (BILAG)-2004 Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 32	-9 Units on a Scale	Standard Deviation 6.7
DBPC Period: Placebo	DBPC Period: Change From Baseline in British Isles Lupus Assessment Group (BILAG)-2004 Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 36	-8 Units on a Scale	Standard Deviation 7.1
DBPC Period: Placebo	DBPC Period: Change From Baseline in British Isles Lupus Assessment Group (BILAG)-2004 Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 40	-9 Units on a Scale	Standard Deviation 6.8
DBPC Period: Placebo	DBPC Period: Change From Baseline in British Isles Lupus Assessment Group (BILAG)-2004 Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 44	-9 Units on a Scale	Standard Deviation 7.2
DBPC Period: Placebo	DBPC Period: Change From Baseline in British Isles Lupus Assessment Group (BILAG)-2004 Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 48	-8 Units on a Scale	Standard Deviation 7.1
DBPC Period: Placebo	DBPC Period: Change From Baseline in British Isles Lupus Assessment Group (BILAG)-2004 Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 52	-8 Units on a Scale	Standard Deviation 7
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in British Isles Lupus Assessment Group (BILAG)-2004 Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 16	-7 Units on a Scale	Standard Deviation 7.6
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in British Isles Lupus Assessment Group (BILAG)-2004 Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 52	-9 Units on a Scale	Standard Deviation 6.8
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in British Isles Lupus Assessment Group (BILAG)-2004 Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 44	-9 Units on a Scale	Standard Deviation 7.2
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in British Isles Lupus Assessment Group (BILAG)-2004 Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 32	-8 Units on a Scale	Standard Deviation 7.3
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in British Isles Lupus Assessment Group (BILAG)-2004 Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 12	-7 Units on a Scale	Standard Deviation 6.8
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in British Isles Lupus Assessment Group (BILAG)-2004 Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 4	-4 Units on a Scale	Standard Deviation 6.1
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in British Isles Lupus Assessment Group (BILAG)-2004 Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 40	-8 Units on a Scale	Standard Deviation 6.7
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in British Isles Lupus Assessment Group (BILAG)-2004 Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 36	-8 Units on a Scale	Standard Deviation 7.2
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in British Isles Lupus Assessment Group (BILAG)-2004 Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 24	-7 Units on a Scale	Standard Deviation 6.5
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in British Isles Lupus Assessment Group (BILAG)-2004 Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 20	-7 Units on a Scale	Standard Deviation 7.3
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in British Isles Lupus Assessment Group (BILAG)-2004 Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 8	-5 Units on a Scale	Standard Deviation 7
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in British Isles Lupus Assessment Group (BILAG)-2004 Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 48	-8 Units on a Scale	Standard Deviation 7.2
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in British Isles Lupus Assessment Group (BILAG)-2004 Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 28	-8 Units on a Scale	Standard Deviation 6.9
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in British Isles Lupus Assessment Group (BILAG)-2004 Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 44	-9 Units on a Scale	Standard Deviation 7.9
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in British Isles Lupus Assessment Group (BILAG)-2004 Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 16	-6 Units on a Scale	Standard Deviation 6.8
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in British Isles Lupus Assessment Group (BILAG)-2004 Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 20	-7 Units on a Scale	Standard Deviation 7.6
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in British Isles Lupus Assessment Group (BILAG)-2004 Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 52	-9 Units on a Scale	Standard Deviation 7.8
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in British Isles Lupus Assessment Group (BILAG)-2004 Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 24	-8 Units on a Scale	Standard Deviation 7.7
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in British Isles Lupus Assessment Group (BILAG)-2004 Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 28	-8 Units on a Scale	Standard Deviation 7.4
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in British Isles Lupus Assessment Group (BILAG)-2004 Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 48	-9 Units on a Scale	Standard Deviation 7.6
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in British Isles Lupus Assessment Group (BILAG)-2004 Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 32	-8 Units on a Scale	Standard Deviation 7.9
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in British Isles Lupus Assessment Group (BILAG)-2004 Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 36	-8 Units on a Scale	Standard Deviation 7.4
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in British Isles Lupus Assessment Group (BILAG)-2004 Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 40	-9 Units on a Scale	Standard Deviation 7.7
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in British Isles Lupus Assessment Group (BILAG)-2004 Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 4	-3 Units on a Scale	Standard Deviation 6.3
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in British Isles Lupus Assessment Group (BILAG)-2004 Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 8	-6 Units on a Scale	Standard Deviation 6.3
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in British Isles Lupus Assessment Group (BILAG)-2004 Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 12	-6 Units on a Scale	Standard Deviation 7
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in British Isles Lupus Assessment Group (BILAG)-2004 Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 40	-7 Units on a Scale	Standard Deviation 6.6
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in British Isles Lupus Assessment Group (BILAG)-2004 Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 32	-7 Units on a Scale	Standard Deviation 6
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in British Isles Lupus Assessment Group (BILAG)-2004 Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 16	-6 Units on a Scale	Standard Deviation 5.9
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in British Isles Lupus Assessment Group (BILAG)-2004 Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 4	-4 Units on a Scale	Standard Deviation 6.2
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in British Isles Lupus Assessment Group (BILAG)-2004 Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 28	-7 Units on a Scale	Standard Deviation 6.2
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in British Isles Lupus Assessment Group (BILAG)-2004 Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 24	-6 Units on a Scale	Standard Deviation 6.3
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in British Isles Lupus Assessment Group (BILAG)-2004 Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 12	-6 Units on a Scale	Standard Deviation 6.2
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in British Isles Lupus Assessment Group (BILAG)-2004 Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 8	-6 Units on a Scale	Standard Deviation 6.1
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in British Isles Lupus Assessment Group (BILAG)-2004 Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 20	-6 Units on a Scale	Standard Deviation 6.2
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in British Isles Lupus Assessment Group (BILAG)-2004 Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 36	-7 Units on a Scale	Standard Deviation 6.7
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in British Isles Lupus Assessment Group (BILAG)-2004 Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 52	-7 Units on a Scale	Standard Deviation 6.7
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in British Isles Lupus Assessment Group (BILAG)-2004 Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 48	-7 Units on a Scale	Standard Deviation 6.5
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in British Isles Lupus Assessment Group (BILAG)-2004 Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 44	-7 Units on a Scale	Standard Deviation 6.7

Secondary

DBPC Period: Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

CLASI is an validated measurement instrument for lupus erythematosus developed for use in clinical studies that consists of separate scores for the activity of the disease (CLASI-A). The CLASI activity score is calculated on the basis of erythema, scale/hyperkeratosis, mucous membrane involvement, acute hair loss and non-scarring alopecia. The CLASI activity score ranges from 0-70, with higher scores indicating more severe skin disease. Severity categories based on the CLASI activity score are as follows: mild (0-9), moderate (10-20), and severe (21-70).

Time frame: Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

Arm	Measure	Group	Value (MEAN)	Dispersion
DBPC Period: Placebo	DBPC Period: Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 32	-3 Units on a Scale	Standard Deviation 3.5
DBPC Period: Placebo	DBPC Period: Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 28	-3 Units on a Scale	Standard Deviation 3.7
DBPC Period: Placebo	DBPC Period: Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 16	-2 Units on a Scale	Standard Deviation 3.1
DBPC Period: Placebo	DBPC Period: Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 52	-3 Units on a Scale	Standard Deviation 3.6
DBPC Period: Placebo	DBPC Period: Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 24	-3 Units on a Scale	Standard Deviation 3.5
DBPC Period: Placebo	DBPC Period: Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 20	-3 Units on a Scale	Standard Deviation 3.6
DBPC Period: Placebo	DBPC Period: Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 44	-3 Units on a Scale	Standard Deviation 3.2
DBPC Period: Placebo	DBPC Period: Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 2	-1 Units on a Scale	Standard Deviation 1.9
DBPC Period: Placebo	DBPC Period: Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 8	-2 Units on a Scale	Standard Deviation 2.8
DBPC Period: Placebo	DBPC Period: Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 48	-3 Units on a Scale	Standard Deviation 3.2
DBPC Period: Placebo	DBPC Period: Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 40	-3 Units on a Scale	Standard Deviation 3
DBPC Period: Placebo	DBPC Period: Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 36	-3 Units on a Scale	Standard Deviation 3.5
DBPC Period: Placebo	DBPC Period: Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 12	-2 Units on a Scale	Standard Deviation 2.8
DBPC Period: Placebo	DBPC Period: Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 4	-1 Units on a Scale	Standard Deviation 1.9
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 40	-3 Units on a Scale	Standard Deviation 4.6
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 2	-1 Units on a Scale	Standard Deviation 1.6
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 4	-1 Units on a Scale	Standard Deviation 3.5
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 8	-1 Units on a Scale	Standard Deviation 4.2
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 12	-2 Units on a Scale	Standard Deviation 3.3
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 16	-2 Units on a Scale	Standard Deviation 3.9
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 20	-3 Units on a Scale	Standard Deviation 4.4
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 24	-3 Units on a Scale	Standard Deviation 4.7
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 28	-3 Units on a Scale	Standard Deviation 4.6
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 32	-3 Units on a Scale	Standard Deviation 4.4
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 36	-3 Units on a Scale	Standard Deviation 4.6
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 44	-3 Units on a Scale	Standard Deviation 4.5
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 48	-3 Units on a Scale	Standard Deviation 4.7
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 52	-4 Units on a Scale	Standard Deviation 4.8
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 40	-3 Units on a Scale	Standard Deviation 3.6
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 48	-3 Units on a Scale	Standard Deviation 3.7
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 4	-1 Units on a Scale	Standard Deviation 2.4
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 12	-2 Units on a Scale	Standard Deviation 3.2
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 44	-3 Units on a Scale	Standard Deviation 3.7
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 2	0 Units on a Scale	Standard Deviation 1.6
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 36	-3 Units on a Scale	Standard Deviation 3.4
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 28	-3 Units on a Scale	Standard Deviation 3.4
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 20	-3 Units on a Scale	Standard Deviation 3.4
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 8	-1 Units on a Scale	Standard Deviation 2.3
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 16	-2 Units on a Scale	Standard Deviation 3.3
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 52	-3 Units on a Scale	Standard Deviation 3.7
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 24	-3 Units on a Scale	Standard Deviation 3.6
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 32	-3 Units on a Scale	Standard Deviation 3.6
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 24	-2 Units on a Scale	Standard Deviation 2.7
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 28	-2 Units on a Scale	Standard Deviation 2.7
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 48	-3 Units on a Scale	Standard Deviation 3.9
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 32	-3 Units on a Scale	Standard Deviation 3.2
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 8	-1 Units on a Scale	Standard Deviation 2.5
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 36	-3 Units on a Scale	Standard Deviation 3.6
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 4	-1 Units on a Scale	Standard Deviation 2.2
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 40	-3 Units on a Scale	Standard Deviation 3.8
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 52	-3 Units on a Scale	Standard Deviation 4
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 44	-3 Units on a Scale	Standard Deviation 3.8
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 16	-2 Units on a Scale	Standard Deviation 2.7
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 2	0 Units on a Scale	Standard Deviation 1.2
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 20	-2 Units on a Scale	Standard Deviation 2.9
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 12	-2 Units on a Scale	Standard Deviation 2.7

Secondary

DBPC Period: Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Health Outcome Questionnaire at Week 4, 8, 12, 16, 24, 32, 40 and 52

The EQ-5D-5L questionnaire is a generic measure of health status that provides a simple descriptive profile and a single index value. The EQ-5D-5L profile defines health in terms of mobility, self-care, usual activities, pain or discomfort, and anxiety or depression. Each dimension has five levels: 1: no problems, 2: slight problems, 3: moderate problems, 4: severe problems, and 5: extreme problems. Responses were used to generate a weighted summary index (EQ-5D index), which ranges from 0 (dead) to 1.00 (perfect health). A higher score indicates better health and positive changes from baseline indicate improvement of health.

Time frame: Baseline, Week 4, 8, 12, 16, 24, 32, 40, and 52

Population: Quality of Life analysis set included all randomized participants who had received at least 1 dose of IMP (Evobrutinib or placebo) and had at least 1 Baseline and 1 post baseline QoL assessment. Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure and Number Analyzed signified those participants who were evaluable for the specified category at given time points.

Arm	Measure	Group	Value (MEAN)	Dispersion
DBPC Period: Placebo	DBPC Period: Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Health Outcome Questionnaire at Week 4, 8, 12, 16, 24, 32, 40 and 52	Week 4	0.036 Units on a Scale	Standard Deviation 0.1626
DBPC Period: Placebo	DBPC Period: Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Health Outcome Questionnaire at Week 4, 8, 12, 16, 24, 32, 40 and 52	Week 8	0.034 Units on a Scale	Standard Deviation 0.2164
DBPC Period: Placebo	DBPC Period: Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Health Outcome Questionnaire at Week 4, 8, 12, 16, 24, 32, 40 and 52	Week 12	0.061 Units on a Scale	Standard Deviation 0.2014
DBPC Period: Placebo	DBPC Period: Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Health Outcome Questionnaire at Week 4, 8, 12, 16, 24, 32, 40 and 52	Week 16	0.083 Units on a Scale	Standard Deviation 0.1818
DBPC Period: Placebo	DBPC Period: Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Health Outcome Questionnaire at Week 4, 8, 12, 16, 24, 32, 40 and 52	Week 24	0.080 Units on a Scale	Standard Deviation 0.1901
DBPC Period: Placebo	DBPC Period: Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Health Outcome Questionnaire at Week 4, 8, 12, 16, 24, 32, 40 and 52	Week 32	0.083 Units on a Scale	Standard Deviation 0.1758
DBPC Period: Placebo	DBPC Period: Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Health Outcome Questionnaire at Week 4, 8, 12, 16, 24, 32, 40 and 52	Week 40	0.093 Units on a Scale	Standard Deviation 0.1521
DBPC Period: Placebo	DBPC Period: Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Health Outcome Questionnaire at Week 4, 8, 12, 16, 24, 32, 40 and 52	Week 52	0.096 Units on a Scale	Standard Deviation 0.2092
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Health Outcome Questionnaire at Week 4, 8, 12, 16, 24, 32, 40 and 52	Week 32	0.067 Units on a Scale	Standard Deviation 0.2262
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Health Outcome Questionnaire at Week 4, 8, 12, 16, 24, 32, 40 and 52	Week 24	0.067 Units on a Scale	Standard Deviation 0.2271
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Health Outcome Questionnaire at Week 4, 8, 12, 16, 24, 32, 40 and 52	Week 8	0.064 Units on a Scale	Standard Deviation 0.2505
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Health Outcome Questionnaire at Week 4, 8, 12, 16, 24, 32, 40 and 52	Week 52	0.078 Units on a Scale	Standard Deviation 0.2197
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Health Outcome Questionnaire at Week 4, 8, 12, 16, 24, 32, 40 and 52	Week 40	0.061 Units on a Scale	Standard Deviation 0.185
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Health Outcome Questionnaire at Week 4, 8, 12, 16, 24, 32, 40 and 52	Week 16	0.072 Units on a Scale	Standard Deviation 0.2252
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Health Outcome Questionnaire at Week 4, 8, 12, 16, 24, 32, 40 and 52	Week 12	0.070 Units on a Scale	Standard Deviation 0.2189
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Health Outcome Questionnaire at Week 4, 8, 12, 16, 24, 32, 40 and 52	Week 4	0.045 Units on a Scale	Standard Deviation 0.1931
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Health Outcome Questionnaire at Week 4, 8, 12, 16, 24, 32, 40 and 52	Week 40	0.090 Units on a Scale	Standard Deviation 0.1853
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Health Outcome Questionnaire at Week 4, 8, 12, 16, 24, 32, 40 and 52	Week 12	0.055 Units on a Scale	Standard Deviation 0.1912
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Health Outcome Questionnaire at Week 4, 8, 12, 16, 24, 32, 40 and 52	Week 16	0.067 Units on a Scale	Standard Deviation 0.2287
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Health Outcome Questionnaire at Week 4, 8, 12, 16, 24, 32, 40 and 52	Week 24	0.086 Units on a Scale	Standard Deviation 0.211
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Health Outcome Questionnaire at Week 4, 8, 12, 16, 24, 32, 40 and 52	Week 32	0.075 Units on a Scale	Standard Deviation 0.2009
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Health Outcome Questionnaire at Week 4, 8, 12, 16, 24, 32, 40 and 52	Week 52	0.102 Units on a Scale	Standard Deviation 0.2224
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Health Outcome Questionnaire at Week 4, 8, 12, 16, 24, 32, 40 and 52	Week 4	0.036 Units on a Scale	Standard Deviation 0.1618
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Health Outcome Questionnaire at Week 4, 8, 12, 16, 24, 32, 40 and 52	Week 8	0.046 Units on a Scale	Standard Deviation 0.1842
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Health Outcome Questionnaire at Week 4, 8, 12, 16, 24, 32, 40 and 52	Week 12	0.065 Units on a Scale	Standard Deviation 0.1732
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Health Outcome Questionnaire at Week 4, 8, 12, 16, 24, 32, 40 and 52	Week 16	0.056 Units on a Scale	Standard Deviation 0.1738
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Health Outcome Questionnaire at Week 4, 8, 12, 16, 24, 32, 40 and 52	Week 8	0.061 Units on a Scale	Standard Deviation 0.1603
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Health Outcome Questionnaire at Week 4, 8, 12, 16, 24, 32, 40 and 52	Week 4	0.038 Units on a Scale	Standard Deviation 0.1908
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Health Outcome Questionnaire at Week 4, 8, 12, 16, 24, 32, 40 and 52	Week 24	0.055 Units on a Scale	Standard Deviation 0.1817
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Health Outcome Questionnaire at Week 4, 8, 12, 16, 24, 32, 40 and 52	Week 52	0.096 Units on a Scale	Standard Deviation 0.2051
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Health Outcome Questionnaire at Week 4, 8, 12, 16, 24, 32, 40 and 52	Week 40	0.084 Units on a Scale	Standard Deviation 0.2172
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Health Outcome Questionnaire at Week 4, 8, 12, 16, 24, 32, 40 and 52	Week 32	0.071 Units on a Scale	Standard Deviation 0.1941

Secondary

DBPC Period: Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Visual Analog Scale (VAS) at Week 4, 8, 12, 16, 24, 32, 40 and 52

The EQ-5D-5L questionnaire is a generic measure of health status that provides a simple descriptive profile and a single index value. The EQ-5D-5L profile defines health in terms of mobility, self-care, usual activities, pain or discomfort, and anxiety or depression. Each dimension has five levels: 1: no problems, 2: slight problems, 3: moderate problems, 4: severe problems, and 5: extreme problems. The responses were used to derive overall score using a visual analog scale (VAS) that ranged from 0 to 100 millimeter (mm), where 0 was the worst health you can imagine and 100 was the best health you can imagine.

Time frame: Baseline, Week 4, 8, 12, 16, 24, 32, 40, and 52

Arm	Measure	Group	Value (MEAN)	Dispersion
DBPC Period: Placebo	DBPC Period: Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Visual Analog Scale (VAS) at Week 4, 8, 12, 16, 24, 32, 40 and 52	Week 4	3 Millimeter	Standard Deviation 16.8
DBPC Period: Placebo	DBPC Period: Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Visual Analog Scale (VAS) at Week 4, 8, 12, 16, 24, 32, 40 and 52	Week 8	3 Millimeter	Standard Deviation 18.8
DBPC Period: Placebo	DBPC Period: Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Visual Analog Scale (VAS) at Week 4, 8, 12, 16, 24, 32, 40 and 52	Week 12	5 Millimeter	Standard Deviation 19.7
DBPC Period: Placebo	DBPC Period: Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Visual Analog Scale (VAS) at Week 4, 8, 12, 16, 24, 32, 40 and 52	Week 16	7 Millimeter	Standard Deviation 19.3
DBPC Period: Placebo	DBPC Period: Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Visual Analog Scale (VAS) at Week 4, 8, 12, 16, 24, 32, 40 and 52	Week 24	7 Millimeter	Standard Deviation 18.7
DBPC Period: Placebo	DBPC Period: Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Visual Analog Scale (VAS) at Week 4, 8, 12, 16, 24, 32, 40 and 52	Week 32	8 Millimeter	Standard Deviation 17.2
DBPC Period: Placebo	DBPC Period: Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Visual Analog Scale (VAS) at Week 4, 8, 12, 16, 24, 32, 40 and 52	Week 40	8 Millimeter	Standard Deviation 18.1
DBPC Period: Placebo	DBPC Period: Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Visual Analog Scale (VAS) at Week 4, 8, 12, 16, 24, 32, 40 and 52	Week 52	8 Millimeter	Standard Deviation 19.9
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Visual Analog Scale (VAS) at Week 4, 8, 12, 16, 24, 32, 40 and 52	Week 32	4 Millimeter	Standard Deviation 21.1
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Visual Analog Scale (VAS) at Week 4, 8, 12, 16, 24, 32, 40 and 52	Week 24	5 Millimeter	Standard Deviation 18.4
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Visual Analog Scale (VAS) at Week 4, 8, 12, 16, 24, 32, 40 and 52	Week 8	6 Millimeter	Standard Deviation 20
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Visual Analog Scale (VAS) at Week 4, 8, 12, 16, 24, 32, 40 and 52	Week 52	8 Millimeter	Standard Deviation 18.6
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Visual Analog Scale (VAS) at Week 4, 8, 12, 16, 24, 32, 40 and 52	Week 40	6 Millimeter	Standard Deviation 18.1
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Visual Analog Scale (VAS) at Week 4, 8, 12, 16, 24, 32, 40 and 52	Week 16	5 Millimeter	Standard Deviation 18.1
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Visual Analog Scale (VAS) at Week 4, 8, 12, 16, 24, 32, 40 and 52	Week 12	6 Millimeter	Standard Deviation 17.4
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Visual Analog Scale (VAS) at Week 4, 8, 12, 16, 24, 32, 40 and 52	Week 4	2 Millimeter	Standard Deviation 19
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Visual Analog Scale (VAS) at Week 4, 8, 12, 16, 24, 32, 40 and 52	Week 40	10 Millimeter	Standard Deviation 19.5
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Visual Analog Scale (VAS) at Week 4, 8, 12, 16, 24, 32, 40 and 52	Week 12	5 Millimeter	Standard Deviation 17.2
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Visual Analog Scale (VAS) at Week 4, 8, 12, 16, 24, 32, 40 and 52	Week 16	6 Millimeter	Standard Deviation 18.5
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Visual Analog Scale (VAS) at Week 4, 8, 12, 16, 24, 32, 40 and 52	Week 24	9 Millimeter	Standard Deviation 20.4
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Visual Analog Scale (VAS) at Week 4, 8, 12, 16, 24, 32, 40 and 52	Week 32	7 Millimeter	Standard Deviation 17.8
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Visual Analog Scale (VAS) at Week 4, 8, 12, 16, 24, 32, 40 and 52	Week 52	10 Millimeter	Standard Deviation 21.3
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Visual Analog Scale (VAS) at Week 4, 8, 12, 16, 24, 32, 40 and 52	Week 4	4 Millimeter	Standard Deviation 17.6
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Visual Analog Scale (VAS) at Week 4, 8, 12, 16, 24, 32, 40 and 52	Week 8	4 Millimeter	Standard Deviation 14.5
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Visual Analog Scale (VAS) at Week 4, 8, 12, 16, 24, 32, 40 and 52	Week 12	4 Millimeter	Standard Deviation 16.8
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Visual Analog Scale (VAS) at Week 4, 8, 12, 16, 24, 32, 40 and 52	Week 16	4 Millimeter	Standard Deviation 15.5
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Visual Analog Scale (VAS) at Week 4, 8, 12, 16, 24, 32, 40 and 52	Week 8	6 Millimeter	Standard Deviation 16.5
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Visual Analog Scale (VAS) at Week 4, 8, 12, 16, 24, 32, 40 and 52	Week 4	4 Millimeter	Standard Deviation 18.2
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Visual Analog Scale (VAS) at Week 4, 8, 12, 16, 24, 32, 40 and 52	Week 24	4 Millimeter	Standard Deviation 17.3
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Visual Analog Scale (VAS) at Week 4, 8, 12, 16, 24, 32, 40 and 52	Week 52	10 Millimeter	Standard Deviation 18.9
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Visual Analog Scale (VAS) at Week 4, 8, 12, 16, 24, 32, 40 and 52	Week 40	8 Millimeter	Standard Deviation 18.9
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Visual Analog Scale (VAS) at Week 4, 8, 12, 16, 24, 32, 40 and 52	Week 32	7 Millimeter	Standard Deviation 16.6

Secondary

DBPC Period: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 4, 8, 12, 16, 24, 32, 40 and 52

The FACIT-Fatigue score was calculated according to a 13-item questionnaire that assess self reported fatigue and its impact upon daily activities and function. It uses a 5-point Likert-type scale (0 = not at all; 1 = a little bit; 2 = somewhat; 3 = quite a bit; 4 = very much). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse possible score) to 52 (best score). A higher score reflected an improvement in the participant's health status.

Time frame: Baseline, Week 4, 8, 12, 16, 24, 32, 40, and 52

Arm	Measure	Group	Value (MEAN)	Dispersion
DBPC Period: Placebo	DBPC Period: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Week 4	3 Units on a scale	Standard Deviation 8
DBPC Period: Placebo	DBPC Period: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Week 8	3 Units on a scale	Standard Deviation 8.7
DBPC Period: Placebo	DBPC Period: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Week 12	3 Units on a scale	Standard Deviation 10
DBPC Period: Placebo	DBPC Period: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Week 16	4 Units on a scale	Standard Deviation 9.8
DBPC Period: Placebo	DBPC Period: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Week 24	3 Units on a scale	Standard Deviation 9.9
DBPC Period: Placebo	DBPC Period: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Week 32	4 Units on a scale	Standard Deviation 9.6
DBPC Period: Placebo	DBPC Period: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Week 40	4 Units on a scale	Standard Deviation 8.8
DBPC Period: Placebo	DBPC Period: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Week 52	4 Units on a scale	Standard Deviation 9.9
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Week 32	4 Units on a scale	Standard Deviation 9.5
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Week 24	4 Units on a scale	Standard Deviation 8.5
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Week 8	3 Units on a scale	Standard Deviation 8.3
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Week 52	4 Units on a scale	Standard Deviation 7.9
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Week 40	3 Units on a scale	Standard Deviation 8.6
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Week 16	3 Units on a scale	Standard Deviation 9.8
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Week 12	4 Units on a scale	Standard Deviation 9.7
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Week 4	2 Units on a scale	Standard Deviation 7.8
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Week 40	6 Units on a scale	Standard Deviation 9.9
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Week 12	3 Units on a scale	Standard Deviation 9.7
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Week 16	4 Units on a scale	Standard Deviation 10.2
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Week 24	5 Units on a scale	Standard Deviation 10.3
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Week 32	5 Units on a scale	Standard Deviation 9.7
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Week 52	5 Units on a scale	Standard Deviation 9.7
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Week 4	4 Units on a scale	Standard Deviation 9.1
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Week 8	3 Units on a scale	Standard Deviation 9.1
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Week 12	4 Units on a scale	Standard Deviation 8.1
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Week 16	3 Units on a scale	Standard Deviation 8.4
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Week 8	5 Units on a scale	Standard Deviation 8.2
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Week 4	3 Units on a scale	Standard Deviation 7.7
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Week 24	3 Units on a scale	Standard Deviation 7.5
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Week 52	5 Units on a scale	Standard Deviation 8.7
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Week 40	4 Units on a scale	Standard Deviation 8.5
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Week 32	4 Units on a scale	Standard Deviation 6.8

Secondary

DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52

The Lupus QoL assessment is a 34 item questionnaire across 8 domains that is designed to find out how systemic lupus erythematosus (SLE) affects a participant's life. Domains include physical health, pain, planning, intimate relationships, burden to others, emotional health, body image, and fatigue. Participants indicate their responses on a 5-point Likert response format, where 4=never, 3=occasionally, 2= a good bit of the time, 1=most of the time, and 0=worst of the time. Summary scores can be calculated for all 8 domains. A LupusQoL score for each domain was reported on a 0 to 100 scale, with greater values indicating better health related QoL.

Time frame: Baseline, Week 4, 8, 12, 16, 24, 32, 40, and 52

Arm	Measure	Group	Value (MEAN)	Dispersion
DBPC Period: Placebo	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Planning Week 4	4.8 Units on a scale	Standard Deviation 20.14
DBPC Period: Placebo	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Physical Health Week 8	2.8 Units on a scale	Standard Deviation 15.2
DBPC Period: Placebo	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Physical Health Week 12	4.8 Units on a scale	Standard Deviation 16.75
DBPC Period: Placebo	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Physical Health Week 16	6.6 Units on a scale	Standard Deviation 17.45
DBPC Period: Placebo	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Physical Health Week 24	6.9 Units on a scale	Standard Deviation 17.17
DBPC Period: Placebo	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Physical Health Week 32	5.7 Units on a scale	Standard Deviation 16.82
DBPC Period: Placebo	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Physical Health Week 40	7.6 Units on a scale	Standard Deviation 15.32
DBPC Period: Placebo	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Physical Health Week 52	7.1 Units on a scale	Standard Deviation 20.39
DBPC Period: Placebo	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Pain Week 4	3.6 Units on a scale	Standard Deviation 16.3
DBPC Period: Placebo	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Pain Week 8	4.8 Units on a scale	Standard Deviation 18.71
DBPC Period: Placebo	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Pain Week 12	7.5 Units on a scale	Standard Deviation 19.04
DBPC Period: Placebo	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Pain Week 16	9.4 Units on a scale	Standard Deviation 18.58
DBPC Period: Placebo	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Pain Week 24	9.4 Units on a scale	Standard Deviation 19.95
DBPC Period: Placebo	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Pain Week 32	6.7 Units on a scale	Standard Deviation 23.74
DBPC Period: Placebo	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Pain Week 40	11.0 Units on a scale	Standard Deviation 19.43
DBPC Period: Placebo	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Pain Week 52	10.2 Units on a scale	Standard Deviation 21.37
DBPC Period: Placebo	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Physical Health Week 4	1.9 Units on a scale	Standard Deviation 12.58
DBPC Period: Placebo	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Planning Week 8	5.5 Units on a scale	Standard Deviation 23.32
DBPC Period: Placebo	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Planning Week 12	7.8 Units on a scale	Standard Deviation 23.58
DBPC Period: Placebo	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Planning Week 16	8.3 Units on a scale	Standard Deviation 21.65
DBPC Period: Placebo	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Planning Week 24	7.9 Units on a scale	Standard Deviation 22.92
DBPC Period: Placebo	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Planning Week 32	6.5 Units on a scale	Standard Deviation 24.82
DBPC Period: Placebo	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Planning Week 40	9.0 Units on a scale	Standard Deviation 20.69
DBPC Period: Placebo	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Planning Week 52	9.9 Units on a scale	Standard Deviation 22.38
DBPC Period: Placebo	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Intimate Relationship Week 4	3.4 Units on a scale	Standard Deviation 26.11
DBPC Period: Placebo	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Intimate Relationship Week 8	8.2 Units on a scale	Standard Deviation 30.31
DBPC Period: Placebo	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Intimate Relationship Week 12	5.5 Units on a scale	Standard Deviation 27.31
DBPC Period: Placebo	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Intimate Relationship Week 16	8.8 Units on a scale	Standard Deviation 26.77
DBPC Period: Placebo	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Intimate Relationship Week 24	6.4 Units on a scale	Standard Deviation 30.12
DBPC Period: Placebo	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Intimate Relationship Week 32	2.5 Units on a scale	Standard Deviation 28.77
DBPC Period: Placebo	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Intimate Relationship Week 40	12.0 Units on a scale	Standard Deviation 27.59
DBPC Period: Placebo	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Intimate Relationship Week 52	7.4 Units on a scale	Standard Deviation 26.48
DBPC Period: Placebo	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Burden to Others Week 4	5.8 Units on a scale	Standard Deviation 23.83
DBPC Period: Placebo	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Burden to Others Week 8	5.6 Units on a scale	Standard Deviation 22.42
DBPC Period: Placebo	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Burden to Others Week 12	8.6 Units on a scale	Standard Deviation 25.86
DBPC Period: Placebo	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Burden to Others Week 16	11.8 Units on a scale	Standard Deviation 26.17
DBPC Period: Placebo	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Burden to Others Week 24	10.3 Units on a scale	Standard Deviation 28.68
DBPC Period: Placebo	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Burden to Others Week 32	10.6 Units on a scale	Standard Deviation 29.42
DBPC Period: Placebo	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Burden to Others Week 40	16.1 Units on a scale	Standard Deviation 25.07
DBPC Period: Placebo	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Burden to Others Week 52	15.3 Units on a scale	Standard Deviation 26.96
DBPC Period: Placebo	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Emotional Health Week 4	6.4 Units on a scale	Standard Deviation 15.37
DBPC Period: Placebo	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Emotional Health Week 8	4.5 Units on a scale	Standard Deviation 15.15
DBPC Period: Placebo	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Emotional Health Week 12	6.3 Units on a scale	Standard Deviation 17.23
DBPC Period: Placebo	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Emotional Health Week 16	8.3 Units on a scale	Standard Deviation 15.86
DBPC Period: Placebo	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Emotional Health Week 24	7.1 Units on a scale	Standard Deviation 17.31
DBPC Period: Placebo	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Emotional Health Week 32	6.3 Units on a scale	Standard Deviation 17.07
DBPC Period: Placebo	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Emotional Health Week 40	8.4 Units on a scale	Standard Deviation 16.08
DBPC Period: Placebo	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Emotional Health Week 52	8.5 Units on a scale	Standard Deviation 17.43
DBPC Period: Placebo	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Body Image Week 4	3.1 Units on a scale	Standard Deviation 17.7
DBPC Period: Placebo	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Body Image Week 8	5.7 Units on a scale	Standard Deviation 18.37
DBPC Period: Placebo	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Body Image Week 12	6.5 Units on a scale	Standard Deviation 18.57
DBPC Period: Placebo	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Body Image Week 16	6.7 Units on a scale	Standard Deviation 18.1
DBPC Period: Placebo	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Body Image Week 24	6.7 Units on a scale	Standard Deviation 20.84
DBPC Period: Placebo	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Body Image Week 32	5.1 Units on a scale	Standard Deviation 20.08
DBPC Period: Placebo	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Body Image Week 40	7.7 Units on a scale	Standard Deviation 14.11
DBPC Period: Placebo	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Body Image Week 52	6.6 Units on a scale	Standard Deviation 16.92
DBPC Period: Placebo	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Fatigue Week 4	4.4 Units on a scale	Standard Deviation 16.71
DBPC Period: Placebo	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Fatigue Week 8	5.0 Units on a scale	Standard Deviation 19.22
DBPC Period: Placebo	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Fatigue Week 12	6.7 Units on a scale	Standard Deviation 18.22
DBPC Period: Placebo	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Fatigue Week 16	7.7 Units on a scale	Standard Deviation 17.61
DBPC Period: Placebo	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Fatigue Week 24	7.5 Units on a scale	Standard Deviation 19.06
DBPC Period: Placebo	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Fatigue Week 32	7.0 Units on a scale	Standard Deviation 19.2
DBPC Period: Placebo	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Fatigue Week 40	11.3 Units on a scale	Standard Deviation 20.03
DBPC Period: Placebo	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Fatigue Week 52	8.9 Units on a scale	Standard Deviation 21.15
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Planning Week 32	7.6 Units on a scale	Standard Deviation 22.66
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Burden to Others Week 4	5.2 Units on a scale	Standard Deviation 22.84
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Pain Week 40	10.9 Units on a scale	Standard Deviation 23.68
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Emotional Health Week 52	6.4 Units on a scale	Standard Deviation 21.31
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Fatigue Week 4	4.3 Units on a scale	Standard Deviation 18.98
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Burden to Others Week 8	9.3 Units on a scale	Standard Deviation 27.17
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Pain Week 12	8.8 Units on a scale	Standard Deviation 24
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Emotional Health Week 40	8.3 Units on a scale	Standard Deviation 19.94
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Fatigue Week 52	4.5 Units on a scale	Standard Deviation 24.78
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Burden to Others Week 12	6.7 Units on a scale	Standard Deviation 28
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Planning Week 40	7.8 Units on a scale	Standard Deviation 23.19
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Emotional Health Week 32	4.3 Units on a scale	Standard Deviation 23.55
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Fatigue Week 16	6.6 Units on a scale	Standard Deviation 21.39
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Burden to Others Week 16	8.1 Units on a scale	Standard Deviation 23.32
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Pain Week 52	12.9 Units on a scale	Standard Deviation 22.64
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Emotional Health Week 24	5.6 Units on a scale	Standard Deviation 24.02
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Fatigue Week 40	6.1 Units on a scale	Standard Deviation 25.28
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Burden to Others Week 24	9.0 Units on a scale	Standard Deviation 24.12
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Pain Week 8	9.9 Units on a scale	Standard Deviation 24.65
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Emotional Health Week 16	7.5 Units on a scale	Standard Deviation 19.59
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Fatigue Week 8	7.1 Units on a scale	Standard Deviation 21.31
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Burden to Others Week 32	6.8 Units on a scale	Standard Deviation 24.09
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Body Image Week 12	7.1 Units on a scale	Standard Deviation 21.07
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Emotional Health Week 12	7.6 Units on a scale	Standard Deviation 21.08
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Planning Week 52	7.0 Units on a scale	Standard Deviation 23.12
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Burden to Others Week 40	12.4 Units on a scale	Standard Deviation 21.91
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Planning Week 12	5.8 Units on a scale	Standard Deviation 23.39
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Emotional Health Week 8	7.0 Units on a scale	Standard Deviation 19.26
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Fatigue Week 12	5.8 Units on a scale	Standard Deviation 21.3
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Burden to Others Week 52	10.7 Units on a scale	Standard Deviation 22.13
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Pain Week 4	6.7 Units on a scale	Standard Deviation 21.81
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Emotional Health Week 4	4.7 Units on a scale	Standard Deviation 18.48
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Body Image Week 24	10.2 Units on a scale	Standard Deviation 20.47
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Intimate Relationship Week 4	1.6 Units on a scale	Standard Deviation 28.29
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Pain Week 32	9.2 Units on a scale	Standard Deviation 24.6
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Physical Health Week 52	9.0 Units on a scale	Standard Deviation 18.44
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Body Image Week 40	8.2 Units on a scale	Standard Deviation 23.99
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Intimate Relationship Week 8	4.2 Units on a scale	Standard Deviation 28.44
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Body Image Week 16	7.6 Units on a scale	Standard Deviation 23.11
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Physical Health Week 40	8.2 Units on a scale	Standard Deviation 17.38
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Planning Week 16	5.3 Units on a scale	Standard Deviation 24.12
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Intimate Relationship Week 12	4.7 Units on a scale	Standard Deviation 25.65
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Planning Week 8	8.4 Units on a scale	Standard Deviation 23.25
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Physical Health Week 32	6.7 Units on a scale	Standard Deviation 19.45
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Body Image Week 8	7.5 Units on a scale	Standard Deviation 23.4
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Intimate Relationship Week 16	1.6 Units on a scale	Standard Deviation 30.76
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Pain Week 24	9.3 Units on a scale	Standard Deviation 24.31
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Physical Health Week 24	7.2 Units on a scale	Standard Deviation 18.59
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Fatigue Week 24	4.8 Units on a scale	Standard Deviation 23.34
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Intimate Relationship Week 24	2.1 Units on a scale	Standard Deviation 28.79
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Fatigue Week 32	3.7 Units on a scale	Standard Deviation 22.71
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Physical Health Week 16	6.1 Units on a scale	Standard Deviation 18.71
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Body Image Week 52	9.8 Units on a scale	Standard Deviation 21.46
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Intimate Relationship Week 32	1.3 Units on a scale	Standard Deviation 31.78
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Planning Week 24	8.1 Units on a scale	Standard Deviation 23.55
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Physical Health Week 12	6.7 Units on a scale	Standard Deviation 19.78
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Planning Week 4	4.9 Units on a scale	Standard Deviation 19.64
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Intimate Relationship Week 40	6.6 Units on a scale	Standard Deviation 27.91
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Pain Week 16	8.3 Units on a scale	Standard Deviation 25.6
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Physical Health Week 8	6.3 Units on a scale	Standard Deviation 19.94
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Body Image Week 4	8.4 Units on a scale	Standard Deviation 24.41
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Intimate Relationship Week 52	4.4 Units on a scale	Standard Deviation 28.36
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Body Image Week 32	8.1 Units on a scale	Standard Deviation 23.71
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Physical Health Week 4	4.7 Units on a scale	Standard Deviation 17.68
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Body Image Week 32	3.3 Units on a scale	Standard Deviation 24.99
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Planning Week 4	5.4 Units on a scale	Standard Deviation 24.3
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Planning Week 8	5.8 Units on a scale	Standard Deviation 25.14
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Body Image Week 24	5.8 Units on a scale	Standard Deviation 27.31
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Planning Week 12	6.8 Units on a scale	Standard Deviation 25.74
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Planning Week 16	6.5 Units on a scale	Standard Deviation 28
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Planning Week 24	11.5 Units on a scale	Standard Deviation 29.08
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Planning Week 32	9.9 Units on a scale	Standard Deviation 25.9
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Planning Week 40	11.6 Units on a scale	Standard Deviation 26.17
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Planning Week 52	9.9 Units on a scale	Standard Deviation 28.29
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Fatigue Week 32	8.5 Units on a scale	Standard Deviation 22.96
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Intimate Relationship Week 4	4.7 Units on a scale	Standard Deviation 24.06
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Intimate Relationship Week 8	9.7 Units on a scale	Standard Deviation 29.1
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Body Image Week 40	4.6 Units on a scale	Standard Deviation 26.67
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Intimate Relationship Week 12	2.3 Units on a scale	Standard Deviation 30.37
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Intimate Relationship Week 16	3.8 Units on a scale	Standard Deviation 32.46
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Intimate Relationship Week 24	6.7 Units on a scale	Standard Deviation 30.76
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Intimate Relationship Week 32	6.5 Units on a scale	Standard Deviation 29.41
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Body Image Week 52	5.1 Units on a scale	Standard Deviation 27.3
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Intimate Relationship Week 40	6.4 Units on a scale	Standard Deviation 32.53
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Intimate Relationship Week 52	8.4 Units on a scale	Standard Deviation 29.58
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Fatigue Week 52	11.2 Units on a scale	Standard Deviation 22.56
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Burden to Others Week 4	6.8 Units on a scale	Standard Deviation 24.85
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Burden to Others Week 8	5.7 Units on a scale	Standard Deviation 25.8
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Fatigue Week 4	6.2 Units on a scale	Standard Deviation 19.91
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Burden to Others Week 12	7.4 Units on a scale	Standard Deviation 25.93
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Burden to Others Week 16	6.7 Units on a scale	Standard Deviation 25.8
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Burden to Others Week 24	11.8 Units on a scale	Standard Deviation 27.15
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Burden to Others Week 32	9.6 Units on a scale	Standard Deviation 27.14
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Fatigue Week 8	4.9 Units on a scale	Standard Deviation 20.61
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Burden to Others Week 40	12.4 Units on a scale	Standard Deviation 28.74
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Burden to Others Week 52	13.0 Units on a scale	Standard Deviation 30.04
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Fatigue Week 40	11.0 Units on a scale	Standard Deviation 25.18
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Emotional Health Week 4	4.2 Units on a scale	Standard Deviation 18.45
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Emotional Health Week 8	2.3 Units on a scale	Standard Deviation 19.51
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Fatigue Week 12	7.3 Units on a scale	Standard Deviation 23.11
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Emotional Health Week 12	4.9 Units on a scale	Standard Deviation 20.99
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Emotional Health Week 16	7.4 Units on a scale	Standard Deviation 18.56
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Emotional Health Week 24	8.9 Units on a scale	Standard Deviation 20.97
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Emotional Health Week 32	9.0 Units on a scale	Standard Deviation 22.66
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Fatigue Week 16	7.1 Units on a scale	Standard Deviation 24.16
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Emotional Health Week 40	7.6 Units on a scale	Standard Deviation 21.52
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Emotional Health Week 52	8.2 Units on a scale	Standard Deviation 22.77
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Physical Health Week 4	4.0 Units on a scale	Standard Deviation 14.04
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Physical Health Week 8	3.8 Units on a scale	Standard Deviation 17.64
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Body Image Week 4	2.5 Units on a scale	Standard Deviation 24.6
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Physical Health Week 12	5.6 Units on a scale	Standard Deviation 15.95
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Physical Health Week 16	7.4 Units on a scale	Standard Deviation 17.61
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Physical Health Week 24	8.4 Units on a scale	Standard Deviation 20.47
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Physical Health Week 32	9.4 Units on a scale	Standard Deviation 17.21
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Body Image Week 8	-1.3 Units on a scale	Standard Deviation 27.06
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Physical Health Week 40	9.6 Units on a scale	Standard Deviation 19.1
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Physical Health Week 52	11.6 Units on a scale	Standard Deviation 19.88
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Fatigue Week 24	9.0 Units on a scale	Standard Deviation 26
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Pain Week 4	9.0 Units on a scale	Standard Deviation 20.9
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Pain Week 8	7.3 Units on a scale	Standard Deviation 21.76
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Body Image Week 12	2.3 Units on a scale	Standard Deviation 26.86
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Pain Week 12	9.8 Units on a scale	Standard Deviation 23.35
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Pain Week 16	10.5 Units on a scale	Standard Deviation 26.33
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Pain Week 24	13.0 Units on a scale	Standard Deviation 28.18
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Pain Week 32	12.8 Units on a scale	Standard Deviation 22.87
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Body Image Week 16	-0.4 Units on a scale	Standard Deviation 25.31
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Pain Week 40	15.3 Units on a scale	Standard Deviation 23.81
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Pain Week 52	14.9 Units on a scale	Standard Deviation 26.11
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Fatigue Week 52	6.7 Units on a scale	Standard Deviation 17.89
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Intimate Relationship Week 52	8.9 Units on a scale	Standard Deviation 24.52
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Pain Week 12	5.5 Units on a scale	Standard Deviation 14.73
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Physical Health Week 4	3.5 Units on a scale	Standard Deviation 13.43
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Body Image Week 52	7.8 Units on a scale	Standard Deviation 21.56
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Intimate Relationship Week 40	7.8 Units on a scale	Standard Deviation 22.72
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Body Image Week 12	6.6 Units on a scale	Standard Deviation 16.53
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Physical Health Week 8	4.6 Units on a scale	Standard Deviation 14.69
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Planning Week 24	5.6 Units on a scale	Standard Deviation 21.79
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Intimate Relationship Week 32	1.4 Units on a scale	Standard Deviation 27.86
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Pain Week 52	9.6 Units on a scale	Standard Deviation 19.99
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Physical Health Week 12	5.7 Units on a scale	Standard Deviation 14.94
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Body Image Week 4	4.0 Units on a scale	Standard Deviation 18.79
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Intimate Relationship Week 24	5.3 Units on a scale	Standard Deviation 26.29
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Pain Week 16	6.9 Units on a scale	Standard Deviation 15.47
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Physical Health Week 16	6.2 Units on a scale	Standard Deviation 15.59
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Fatigue Week 32	4.1 Units on a scale	Standard Deviation 17.24
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Intimate Relationship Week 16	4.2 Units on a scale	Standard Deviation 22.99
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Fatigue Week 24	3.6 Units on a scale	Standard Deviation 14.2
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Physical Health Week 24	6.1 Units on a scale	Standard Deviation 13.63
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Body Image Week 40	9.0 Units on a scale	Standard Deviation 18.31
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Intimate Relationship Week 12	6.4 Units on a scale	Standard Deviation 21.32
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Planning Week 16	6.3 Units on a scale	Standard Deviation 22.91
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Physical Health Week 32	7.0 Units on a scale	Standard Deviation 16.21
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Pain Week 40	9.6 Units on a scale	Standard Deviation 20.51
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Intimate Relationship Week 8	3.7 Units on a scale	Standard Deviation 18.73
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Pain Week 24	6.2 Units on a scale	Standard Deviation 17.02
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Physical Health Week 40	7.1 Units on a scale	Standard Deviation 17.98
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Body Image Week 8	6.5 Units on a scale	Standard Deviation 17.3
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Intimate Relationship Week 4	3.2 Units on a scale	Standard Deviation 24.06
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Body Image Week 24	6.7 Units on a scale	Standard Deviation 21.8
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Physical Health Week 52	7.9 Units on a scale	Standard Deviation 18.73
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Planning Week 12	5.1 Units on a scale	Standard Deviation 20.55
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Burden to Others Week 52	10.5 Units on a scale	Standard Deviation 25.89
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Planning Week 52	10.5 Units on a scale	Standard Deviation 21.59
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Emotional Health Week 4	1.8 Units on a scale	Standard Deviation 16.73
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Fatigue Week 8	4.5 Units on a scale	Standard Deviation 16.78
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Burden to Others Week 40	12.1 Units on a scale	Standard Deviation 25.78
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Body Image Week 16	5.7 Units on a scale	Standard Deviation 20.39
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Emotional Health Week 8	5.3 Units on a scale	Standard Deviation 15.53
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Pain Week 4	5.7 Units on a scale	Standard Deviation 16.26
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Burden to Others Week 32	8.4 Units on a scale	Standard Deviation 28.21
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Body Image Week 32	5.8 Units on a scale	Standard Deviation 21.54
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Emotional Health Week 12	4.7 Units on a scale	Standard Deviation 16.39
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Fatigue Week 12	5.0 Units on a scale	Standard Deviation 16.08
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Burden to Others Week 24	5.8 Units on a scale	Standard Deviation 26.21
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Planning Week 40	8.0 Units on a scale	Standard Deviation 23.52
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Emotional Health Week 16	6.2 Units on a scale	Standard Deviation 18.32
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Fatigue Week 40	5.3 Units on a scale	Standard Deviation 16.73
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Burden to Others Week 16	7.4 Units on a scale	Standard Deviation 24.3
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Pain Week 32	8.7 Units on a scale	Standard Deviation 17.18
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Emotional Health Week 24	4.3 Units on a scale	Standard Deviation 20.04
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Fatigue Week 4	3.9 Units on a scale	Standard Deviation 17.08
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Burden to Others Week 12	7.3 Units on a scale	Standard Deviation 24.74
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Pain Week 8	6.7 Units on a scale	Standard Deviation 18.31
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Emotional Health Week 32	6.0 Units on a scale	Standard Deviation 20.56
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Planning Week 4	4.6 Units on a scale	Standard Deviation 18.73
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Burden to Others Week 8	8.0 Units on a scale	Standard Deviation 25.79
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Planning Week 32	6.9 Units on a scale	Standard Deviation 22.07
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Emotional Health Week 40	6.7 Units on a scale	Standard Deviation 19.14
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Fatigue Week 16	4.1 Units on a scale	Standard Deviation 15.81
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Burden to Others Week 4	2.2 Units on a scale	Standard Deviation 24.24
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Planning Week 8	3.9 Units on a scale	Standard Deviation 22.98
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52	Emotional Health Week 52	7.6 Units on a scale	Standard Deviation 18.8

Secondary

DBPC Period: Change From Baseline in Physician's Global Assessment (PGA) Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

The Physician's Global Assessment of Disease Activity was recorded using the 100 millimeter horizontal Visual Analog Scale (VAS). Physician rated participant's disease activity on a scale ranged from 0-100 millimeter (mm), where 0 indicated no disease activity and 100 represented maximum disease activity.

Time frame: Baseline, Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

Arm	Measure	Group	Value (MEAN)	Dispersion
DBPC Period: Placebo	DBPC Period: Change From Baseline in Physician's Global Assessment (PGA) Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 4	-8 Millimeter	Standard Deviation 11.7
DBPC Period: Placebo	DBPC Period: Change From Baseline in Physician's Global Assessment (PGA) Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 8	-13 Millimeter	Standard Deviation 16.2
DBPC Period: Placebo	DBPC Period: Change From Baseline in Physician's Global Assessment (PGA) Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 12	-18 Millimeter	Standard Deviation 17.4
DBPC Period: Placebo	DBPC Period: Change From Baseline in Physician's Global Assessment (PGA) Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 16	-21 Millimeter	Standard Deviation 17.6
DBPC Period: Placebo	DBPC Period: Change From Baseline in Physician's Global Assessment (PGA) Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 20	-23 Millimeter	Standard Deviation 19.2
DBPC Period: Placebo	DBPC Period: Change From Baseline in Physician's Global Assessment (PGA) Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 24	-24 Millimeter	Standard Deviation 17.8
DBPC Period: Placebo	DBPC Period: Change From Baseline in Physician's Global Assessment (PGA) Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 28	-26 Millimeter	Standard Deviation 17.6
DBPC Period: Placebo	DBPC Period: Change From Baseline in Physician's Global Assessment (PGA) Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 32	-26 Millimeter	Standard Deviation 17.8
DBPC Period: Placebo	DBPC Period: Change From Baseline in Physician's Global Assessment (PGA) Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 36	-26 Millimeter	Standard Deviation 17.9
DBPC Period: Placebo	DBPC Period: Change From Baseline in Physician's Global Assessment (PGA) Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 40	-27 Millimeter	Standard Deviation 16.9
DBPC Period: Placebo	DBPC Period: Change From Baseline in Physician's Global Assessment (PGA) Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 44	-28 Millimeter	Standard Deviation 16.6
DBPC Period: Placebo	DBPC Period: Change From Baseline in Physician's Global Assessment (PGA) Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 48	-29 Millimeter	Standard Deviation 16.5
DBPC Period: Placebo	DBPC Period: Change From Baseline in Physician's Global Assessment (PGA) Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 52	-29 Millimeter	Standard Deviation 16.2
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Physician's Global Assessment (PGA) Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 16	-20 Millimeter	Standard Deviation 19.7
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Physician's Global Assessment (PGA) Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 52	-31 Millimeter	Standard Deviation 20.7
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Physician's Global Assessment (PGA) Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 44	-28 Millimeter	Standard Deviation 20.1
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Physician's Global Assessment (PGA) Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 32	-26 Millimeter	Standard Deviation 20.8
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Physician's Global Assessment (PGA) Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 12	-18 Millimeter	Standard Deviation 18.8
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Physician's Global Assessment (PGA) Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 4	-8 Millimeter	Standard Deviation 14.1
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Physician's Global Assessment (PGA) Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 40	-27 Millimeter	Standard Deviation 19.1
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Physician's Global Assessment (PGA) Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 36	-26 Millimeter	Standard Deviation 20.9
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Physician's Global Assessment (PGA) Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 24	-24 Millimeter	Standard Deviation 20
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Physician's Global Assessment (PGA) Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 20	-21 Millimeter	Standard Deviation 19.5
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Physician's Global Assessment (PGA) Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 8	-14 Millimeter	Standard Deviation 16.5
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Physician's Global Assessment (PGA) Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 48	-29 Millimeter	Standard Deviation 19.5
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Physician's Global Assessment (PGA) Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 28	-26 Millimeter	Standard Deviation 20.3
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Physician's Global Assessment (PGA) Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 44	-30 Millimeter	Standard Deviation 20.7
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Physician's Global Assessment (PGA) Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 16	-21 Millimeter	Standard Deviation 18.7
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Physician's Global Assessment (PGA) Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 20	-24 Millimeter	Standard Deviation 17.9
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Physician's Global Assessment (PGA) Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 52	-33 Millimeter	Standard Deviation 19.2
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Physician's Global Assessment (PGA) Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 24	-25 Millimeter	Standard Deviation 19.2
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Physician's Global Assessment (PGA) Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 28	-26 Millimeter	Standard Deviation 18.6
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Physician's Global Assessment (PGA) Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 48	-32 Millimeter	Standard Deviation 18.8
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Physician's Global Assessment (PGA) Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 32	-26 Millimeter	Standard Deviation 19
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Physician's Global Assessment (PGA) Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 36	-29 Millimeter	Standard Deviation 18.3
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Physician's Global Assessment (PGA) Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 40	-30 Millimeter	Standard Deviation 19.7
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Physician's Global Assessment (PGA) Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 4	-9 Millimeter	Standard Deviation 13.4
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Physician's Global Assessment (PGA) Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 8	-13 Millimeter	Standard Deviation 15.5
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Physician's Global Assessment (PGA) Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 12	-19 Millimeter	Standard Deviation 18.3
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Physician's Global Assessment (PGA) Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 40	-25 Millimeter	Standard Deviation 18.1
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Physician's Global Assessment (PGA) Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 32	-26 Millimeter	Standard Deviation 17.5
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Physician's Global Assessment (PGA) Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 16	-19 Millimeter	Standard Deviation 18
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Physician's Global Assessment (PGA) Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 4	-9 Millimeter	Standard Deviation 12.1
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Physician's Global Assessment (PGA) Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 28	-24 Millimeter	Standard Deviation 17.8
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Physician's Global Assessment (PGA) Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 24	-21 Millimeter	Standard Deviation 18
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Physician's Global Assessment (PGA) Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 12	-18 Millimeter	Standard Deviation 16.9
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Physician's Global Assessment (PGA) Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 8	-14 Millimeter	Standard Deviation 15.9
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Physician's Global Assessment (PGA) Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 20	-20 Millimeter	Standard Deviation 18.6
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Physician's Global Assessment (PGA) Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 36	-26 Millimeter	Standard Deviation 18.3
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Physician's Global Assessment (PGA) Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 52	-27 Millimeter	Standard Deviation 18.1
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Physician's Global Assessment (PGA) Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 48	-28 Millimeter	Standard Deviation 18.3
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Physician's Global Assessment (PGA) Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 44	-26 Millimeter	Standard Deviation 16.6

Secondary

DBPC Period: Change From Baseline in Study 36-Item Short Form Health Survey Version 2 (SF-36v2) Physical Component Summary Score and Mental Component Summary Scores at Week 4, 8, 12, 16, 24, 32, 40 and 52

The 36-Item Short-Form Health Survey (SF-36) was a standardized survey evaluating 8 aspects of functional health and well-being. These eight subscales were summarized as relating to either physical health or mental health. Physical component summary (PCS) was based primarily on physical functioning, role-physical, bodily pain, and general health scales and mental component summary (MCS) encompasses vitality, social functioning, role-emotional, and mental health scales. Score from mental health, role emotional, social functioning, and vitality domains were averaged to calculate MCS. Total score range for MCS was 0 - 100 (100 = highest level of mental functioning). Score from physical function, role physical, bodily pain, and general health domains were averaged to calculate PCS. Total score range for PCS was 0-100 (100 = highest level of physical functioning).

Time frame: Baseline, Week 4, 8, 12, 16, 24, 32, 40 and 52

Arm	Measure	Group	Value (MEAN)	Dispersion
DBPC Period: Placebo	DBPC Period: Change From Baseline in Study 36-Item Short Form Health Survey Version 2 (SF-36v2) Physical Component Summary Score and Mental Component Summary Scores at Week 4, 8, 12, 16, 24, 32, 40 and 52	Physical Component Summary Score at Week 24	3.4 Units on a Scale	Standard Deviation 7.08
DBPC Period: Placebo	DBPC Period: Change From Baseline in Study 36-Item Short Form Health Survey Version 2 (SF-36v2) Physical Component Summary Score and Mental Component Summary Scores at Week 4, 8, 12, 16, 24, 32, 40 and 52	Physical Component Summary Score at Week 8	1.8 Units on a Scale	Standard Deviation 6.35
DBPC Period: Placebo	DBPC Period: Change From Baseline in Study 36-Item Short Form Health Survey Version 2 (SF-36v2) Physical Component Summary Score and Mental Component Summary Scores at Week 4, 8, 12, 16, 24, 32, 40 and 52	Physical Component Summary Score at Week 12	2.4 Units on a Scale	Standard Deviation 6.44
DBPC Period: Placebo	DBPC Period: Change From Baseline in Study 36-Item Short Form Health Survey Version 2 (SF-36v2) Physical Component Summary Score and Mental Component Summary Scores at Week 4, 8, 12, 16, 24, 32, 40 and 52	Physical Component Summary Score at Week 16	3.3 Units on a Scale	Standard Deviation 7.04
DBPC Period: Placebo	DBPC Period: Change From Baseline in Study 36-Item Short Form Health Survey Version 2 (SF-36v2) Physical Component Summary Score and Mental Component Summary Scores at Week 4, 8, 12, 16, 24, 32, 40 and 52	Physical Component Summary Score at Week 4	1.2 Units on a Scale	Standard Deviation 5.42
DBPC Period: Placebo	DBPC Period: Change From Baseline in Study 36-Item Short Form Health Survey Version 2 (SF-36v2) Physical Component Summary Score and Mental Component Summary Scores at Week 4, 8, 12, 16, 24, 32, 40 and 52	Physical Component Summary Score at Week 32	3.5 Units on a Scale	Standard Deviation 8.03
DBPC Period: Placebo	DBPC Period: Change From Baseline in Study 36-Item Short Form Health Survey Version 2 (SF-36v2) Physical Component Summary Score and Mental Component Summary Scores at Week 4, 8, 12, 16, 24, 32, 40 and 52	Physical Component Summary Score at Week 40	4.2 Units on a Scale	Standard Deviation 7.11
DBPC Period: Placebo	DBPC Period: Change From Baseline in Study 36-Item Short Form Health Survey Version 2 (SF-36v2) Physical Component Summary Score and Mental Component Summary Scores at Week 4, 8, 12, 16, 24, 32, 40 and 52	Physical Component Summary Score at Week 52	3.7 Units on a Scale	Standard Deviation 8.32
DBPC Period: Placebo	DBPC Period: Change From Baseline in Study 36-Item Short Form Health Survey Version 2 (SF-36v2) Physical Component Summary Score and Mental Component Summary Scores at Week 4, 8, 12, 16, 24, 32, 40 and 52	Mental Component Summary Score at Week 4	3.9 Units on a Scale	Standard Deviation 9.38
DBPC Period: Placebo	DBPC Period: Change From Baseline in Study 36-Item Short Form Health Survey Version 2 (SF-36v2) Physical Component Summary Score and Mental Component Summary Scores at Week 4, 8, 12, 16, 24, 32, 40 and 52	Mental Component Summary Score at Week 8	2.5 Units on a Scale	Standard Deviation 8.59
DBPC Period: Placebo	DBPC Period: Change From Baseline in Study 36-Item Short Form Health Survey Version 2 (SF-36v2) Physical Component Summary Score and Mental Component Summary Scores at Week 4, 8, 12, 16, 24, 32, 40 and 52	Mental Component Summary Score at Week 12	3.1 Units on a Scale	Standard Deviation 10.07
DBPC Period: Placebo	DBPC Period: Change From Baseline in Study 36-Item Short Form Health Survey Version 2 (SF-36v2) Physical Component Summary Score and Mental Component Summary Scores at Week 4, 8, 12, 16, 24, 32, 40 and 52	Mental Component Summary Score at Week 16	3.6 Units on a Scale	Standard Deviation 9.84
DBPC Period: Placebo	DBPC Period: Change From Baseline in Study 36-Item Short Form Health Survey Version 2 (SF-36v2) Physical Component Summary Score and Mental Component Summary Scores at Week 4, 8, 12, 16, 24, 32, 40 and 52	Mental Component Summary Score at Week 24	2.9 Units on a Scale	Standard Deviation 9.75
DBPC Period: Placebo	DBPC Period: Change From Baseline in Study 36-Item Short Form Health Survey Version 2 (SF-36v2) Physical Component Summary Score and Mental Component Summary Scores at Week 4, 8, 12, 16, 24, 32, 40 and 52	Mental Component Summary Score at Week 32	3.5 Units on a Scale	Standard Deviation 8.55
DBPC Period: Placebo	DBPC Period: Change From Baseline in Study 36-Item Short Form Health Survey Version 2 (SF-36v2) Physical Component Summary Score and Mental Component Summary Scores at Week 4, 8, 12, 16, 24, 32, 40 and 52	Mental Component Summary Score at Week 40	4.5 Units on a Scale	Standard Deviation 8.81
DBPC Period: Placebo	DBPC Period: Change From Baseline in Study 36-Item Short Form Health Survey Version 2 (SF-36v2) Physical Component Summary Score and Mental Component Summary Scores at Week 4, 8, 12, 16, 24, 32, 40 and 52	Mental Component Summary Score at Week 52	3.8 Units on a Scale	Standard Deviation 9.45
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Study 36-Item Short Form Health Survey Version 2 (SF-36v2) Physical Component Summary Score and Mental Component Summary Scores at Week 4, 8, 12, 16, 24, 32, 40 and 52	Physical Component Summary Score at Week 32	3.8 Units on a Scale	Standard Deviation 7.36
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Study 36-Item Short Form Health Survey Version 2 (SF-36v2) Physical Component Summary Score and Mental Component Summary Scores at Week 4, 8, 12, 16, 24, 32, 40 and 52	Mental Component Summary Score at Week 4	1.7 Units on a Scale	Standard Deviation 9.25
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Study 36-Item Short Form Health Survey Version 2 (SF-36v2) Physical Component Summary Score and Mental Component Summary Scores at Week 4, 8, 12, 16, 24, 32, 40 and 52	Mental Component Summary Score at Week 52	1.7 Units on a Scale	Standard Deviation 9.91
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Study 36-Item Short Form Health Survey Version 2 (SF-36v2) Physical Component Summary Score and Mental Component Summary Scores at Week 4, 8, 12, 16, 24, 32, 40 and 52	Mental Component Summary Score at Week 16	2.5 Units on a Scale	Standard Deviation 8.39
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Study 36-Item Short Form Health Survey Version 2 (SF-36v2) Physical Component Summary Score and Mental Component Summary Scores at Week 4, 8, 12, 16, 24, 32, 40 and 52	Mental Component Summary Score at Week 40	1.5 Units on a Scale	Standard Deviation 10.55
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Study 36-Item Short Form Health Survey Version 2 (SF-36v2) Physical Component Summary Score and Mental Component Summary Scores at Week 4, 8, 12, 16, 24, 32, 40 and 52	Mental Component Summary Score at Week 8	2.2 Units on a Scale	Standard Deviation 8.81
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Study 36-Item Short Form Health Survey Version 2 (SF-36v2) Physical Component Summary Score and Mental Component Summary Scores at Week 4, 8, 12, 16, 24, 32, 40 and 52	Physical Component Summary Score at Week 12	3.7 Units on a Scale	Standard Deviation 7.71
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Study 36-Item Short Form Health Survey Version 2 (SF-36v2) Physical Component Summary Score and Mental Component Summary Scores at Week 4, 8, 12, 16, 24, 32, 40 and 52	Mental Component Summary Score at Week 12	3.1 Units on a Scale	Standard Deviation 8.45
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Study 36-Item Short Form Health Survey Version 2 (SF-36v2) Physical Component Summary Score and Mental Component Summary Scores at Week 4, 8, 12, 16, 24, 32, 40 and 52	Physical Component Summary Score at Week 24	4.6 Units on a Scale	Standard Deviation 7.57
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Study 36-Item Short Form Health Survey Version 2 (SF-36v2) Physical Component Summary Score and Mental Component Summary Scores at Week 4, 8, 12, 16, 24, 32, 40 and 52	Physical Component Summary Score at Week 40	4.6 Units on a Scale	Standard Deviation 7.97
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Study 36-Item Short Form Health Survey Version 2 (SF-36v2) Physical Component Summary Score and Mental Component Summary Scores at Week 4, 8, 12, 16, 24, 32, 40 and 52	Physical Component Summary Score at Week 16	4.0 Units on a Scale	Standard Deviation 7.56
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Study 36-Item Short Form Health Survey Version 2 (SF-36v2) Physical Component Summary Score and Mental Component Summary Scores at Week 4, 8, 12, 16, 24, 32, 40 and 52	Physical Component Summary Score at Week 8	3.5 Units on a Scale	Standard Deviation 7.69
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Study 36-Item Short Form Health Survey Version 2 (SF-36v2) Physical Component Summary Score and Mental Component Summary Scores at Week 4, 8, 12, 16, 24, 32, 40 and 52	Mental Component Summary Score at Week 24	2.4 Units on a Scale	Standard Deviation 8.41
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Study 36-Item Short Form Health Survey Version 2 (SF-36v2) Physical Component Summary Score and Mental Component Summary Scores at Week 4, 8, 12, 16, 24, 32, 40 and 52	Physical Component Summary Score at Week 52	5.4 Units on a Scale	Standard Deviation 7.05
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Study 36-Item Short Form Health Survey Version 2 (SF-36v2) Physical Component Summary Score and Mental Component Summary Scores at Week 4, 8, 12, 16, 24, 32, 40 and 52	Mental Component Summary Score at Week 32	1.8 Units on a Scale	Standard Deviation 9.51
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Study 36-Item Short Form Health Survey Version 2 (SF-36v2) Physical Component Summary Score and Mental Component Summary Scores at Week 4, 8, 12, 16, 24, 32, 40 and 52	Physical Component Summary Score at Week 4	2.5 Units on a Scale	Standard Deviation 7.4
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Study 36-Item Short Form Health Survey Version 2 (SF-36v2) Physical Component Summary Score and Mental Component Summary Scores at Week 4, 8, 12, 16, 24, 32, 40 and 52	Physical Component Summary Score at Week 32	5.4 Units on a Scale	Standard Deviation 7.24
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Study 36-Item Short Form Health Survey Version 2 (SF-36v2) Physical Component Summary Score and Mental Component Summary Scores at Week 4, 8, 12, 16, 24, 32, 40 and 52	Physical Component Summary Score at Week 24	5.4 Units on a Scale	Standard Deviation 7.63
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Study 36-Item Short Form Health Survey Version 2 (SF-36v2) Physical Component Summary Score and Mental Component Summary Scores at Week 4, 8, 12, 16, 24, 32, 40 and 52	Mental Component Summary Score at Week 32	2.8 Units on a Scale	Standard Deviation 9.71
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Study 36-Item Short Form Health Survey Version 2 (SF-36v2) Physical Component Summary Score and Mental Component Summary Scores at Week 4, 8, 12, 16, 24, 32, 40 and 52	Physical Component Summary Score at Week 40	5.7 Units on a Scale	Standard Deviation 7.76
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Study 36-Item Short Form Health Survey Version 2 (SF-36v2) Physical Component Summary Score and Mental Component Summary Scores at Week 4, 8, 12, 16, 24, 32, 40 and 52	Physical Component Summary Score at Week 52	6.5 Units on a Scale	Standard Deviation 8.58
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Study 36-Item Short Form Health Survey Version 2 (SF-36v2) Physical Component Summary Score and Mental Component Summary Scores at Week 4, 8, 12, 16, 24, 32, 40 and 52	Mental Component Summary Score at Week 52	3.9 Units on a Scale	Standard Deviation 11.21
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Study 36-Item Short Form Health Survey Version 2 (SF-36v2) Physical Component Summary Score and Mental Component Summary Scores at Week 4, 8, 12, 16, 24, 32, 40 and 52	Mental Component Summary Score at Week 4	1.9 Units on a Scale	Standard Deviation 7.93
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Study 36-Item Short Form Health Survey Version 2 (SF-36v2) Physical Component Summary Score and Mental Component Summary Scores at Week 4, 8, 12, 16, 24, 32, 40 and 52	Mental Component Summary Score at Week 8	1.6 Units on a Scale	Standard Deviation 8.48
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Study 36-Item Short Form Health Survey Version 2 (SF-36v2) Physical Component Summary Score and Mental Component Summary Scores at Week 4, 8, 12, 16, 24, 32, 40 and 52	Mental Component Summary Score at Week 40	3.2 Units on a Scale	Standard Deviation 9.81
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Study 36-Item Short Form Health Survey Version 2 (SF-36v2) Physical Component Summary Score and Mental Component Summary Scores at Week 4, 8, 12, 16, 24, 32, 40 and 52	Mental Component Summary Score at Week 12	0.8 Units on a Scale	Standard Deviation 10.39
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Study 36-Item Short Form Health Survey Version 2 (SF-36v2) Physical Component Summary Score and Mental Component Summary Scores at Week 4, 8, 12, 16, 24, 32, 40 and 52	Mental Component Summary Score at Week 16	2.8 Units on a Scale	Standard Deviation 9.39
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Study 36-Item Short Form Health Survey Version 2 (SF-36v2) Physical Component Summary Score and Mental Component Summary Scores at Week 4, 8, 12, 16, 24, 32, 40 and 52	Physical Component Summary Score at Week 4	3.5 Units on a Scale	Standard Deviation 6.01
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Study 36-Item Short Form Health Survey Version 2 (SF-36v2) Physical Component Summary Score and Mental Component Summary Scores at Week 4, 8, 12, 16, 24, 32, 40 and 52	Physical Component Summary Score at Week 8	3.0 Units on a Scale	Standard Deviation 6.61
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Study 36-Item Short Form Health Survey Version 2 (SF-36v2) Physical Component Summary Score and Mental Component Summary Scores at Week 4, 8, 12, 16, 24, 32, 40 and 52	Mental Component Summary Score at Week 24	3.4 Units on a Scale	Standard Deviation 9.68
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Study 36-Item Short Form Health Survey Version 2 (SF-36v2) Physical Component Summary Score and Mental Component Summary Scores at Week 4, 8, 12, 16, 24, 32, 40 and 52	Physical Component Summary Score at Week 12	4.2 Units on a Scale	Standard Deviation 6.68
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Study 36-Item Short Form Health Survey Version 2 (SF-36v2) Physical Component Summary Score and Mental Component Summary Scores at Week 4, 8, 12, 16, 24, 32, 40 and 52	Physical Component Summary Score at Week 16	4.4 Units on a Scale	Standard Deviation 5.81
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Study 36-Item Short Form Health Survey Version 2 (SF-36v2) Physical Component Summary Score and Mental Component Summary Scores at Week 4, 8, 12, 16, 24, 32, 40 and 52	Mental Component Summary Score at Week 52	4.6 Units on a Scale	Standard Deviation 9.8
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Study 36-Item Short Form Health Survey Version 2 (SF-36v2) Physical Component Summary Score and Mental Component Summary Scores at Week 4, 8, 12, 16, 24, 32, 40 and 52	Physical Component Summary Score at Week 52	4.8 Units on a Scale	Standard Deviation 7.76
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Study 36-Item Short Form Health Survey Version 2 (SF-36v2) Physical Component Summary Score and Mental Component Summary Scores at Week 4, 8, 12, 16, 24, 32, 40 and 52	Physical Component Summary Score at Week 12	3.0 Units on a Scale	Standard Deviation 6.99
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Study 36-Item Short Form Health Survey Version 2 (SF-36v2) Physical Component Summary Score and Mental Component Summary Scores at Week 4, 8, 12, 16, 24, 32, 40 and 52	Physical Component Summary Score at Week 4	2.2 Units on a Scale	Standard Deviation 5.86
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Study 36-Item Short Form Health Survey Version 2 (SF-36v2) Physical Component Summary Score and Mental Component Summary Scores at Week 4, 8, 12, 16, 24, 32, 40 and 52	Mental Component Summary Score at Week 32	4.3 Units on a Scale	Standard Deviation 9.03
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Study 36-Item Short Form Health Survey Version 2 (SF-36v2) Physical Component Summary Score and Mental Component Summary Scores at Week 4, 8, 12, 16, 24, 32, 40 and 52	Physical Component Summary Score at Week 40	4.1 Units on a Scale	Standard Deviation 8.59
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Study 36-Item Short Form Health Survey Version 2 (SF-36v2) Physical Component Summary Score and Mental Component Summary Scores at Week 4, 8, 12, 16, 24, 32, 40 and 52	Mental Component Summary Score at Week 24	2.7 Units on a Scale	Standard Deviation 8.87
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Study 36-Item Short Form Health Survey Version 2 (SF-36v2) Physical Component Summary Score and Mental Component Summary Scores at Week 4, 8, 12, 16, 24, 32, 40 and 52	Physical Component Summary Score at Week 8	2.2 Units on a Scale	Standard Deviation 6.63
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Study 36-Item Short Form Health Survey Version 2 (SF-36v2) Physical Component Summary Score and Mental Component Summary Scores at Week 4, 8, 12, 16, 24, 32, 40 and 52	Physical Component Summary Score at Week 24	2.8 Units on a Scale	Standard Deviation 7.15
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Study 36-Item Short Form Health Survey Version 2 (SF-36v2) Physical Component Summary Score and Mental Component Summary Scores at Week 4, 8, 12, 16, 24, 32, 40 and 52	Mental Component Summary Score at Week 8	3.6 Units on a Scale	Standard Deviation 9.04
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Study 36-Item Short Form Health Survey Version 2 (SF-36v2) Physical Component Summary Score and Mental Component Summary Scores at Week 4, 8, 12, 16, 24, 32, 40 and 52	Physical Component Summary Score at Week 32	3.8 Units on a Scale	Standard Deviation 6.89
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Study 36-Item Short Form Health Survey Version 2 (SF-36v2) Physical Component Summary Score and Mental Component Summary Scores at Week 4, 8, 12, 16, 24, 32, 40 and 52	Mental Component Summary Score at Week 12	2.9 Units on a Scale	Standard Deviation 8.89
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Study 36-Item Short Form Health Survey Version 2 (SF-36v2) Physical Component Summary Score and Mental Component Summary Scores at Week 4, 8, 12, 16, 24, 32, 40 and 52	Mental Component Summary Score at Week 40	4.0 Units on a Scale	Standard Deviation 9.85
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Study 36-Item Short Form Health Survey Version 2 (SF-36v2) Physical Component Summary Score and Mental Component Summary Scores at Week 4, 8, 12, 16, 24, 32, 40 and 52	Mental Component Summary Score at Week 4	2.4 Units on a Scale	Standard Deviation 7.68
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Study 36-Item Short Form Health Survey Version 2 (SF-36v2) Physical Component Summary Score and Mental Component Summary Scores at Week 4, 8, 12, 16, 24, 32, 40 and 52	Physical Component Summary Score at Week 16	3.4 Units on a Scale	Standard Deviation 6.77
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Study 36-Item Short Form Health Survey Version 2 (SF-36v2) Physical Component Summary Score and Mental Component Summary Scores at Week 4, 8, 12, 16, 24, 32, 40 and 52	Mental Component Summary Score at Week 16	2.9 Units on a Scale	Standard Deviation 9.13

Secondary

DBPC Period: Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

SLEDAI-2K is an activity index that measures disease activity and records feature of active lupus as present or not present. SLEDAI-2K uses a weighted checklist to assign a numerical score based on the presence or absence of 24 symptoms at the time of assessment or during the previous 30 days. Each symptom present is assigned between 1 and 8 points based on its usual clinical importance, yielding a total score that ranges from 0 points (no symptoms) to 105 points (presence of all defined symptoms).

Time frame: Baseline, Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

Arm	Measure	Group	Value (MEAN)	Dispersion
DBPC Period: Placebo	DBPC Period: Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 4	-1 Units on a Scale	Standard Deviation 1.9
DBPC Period: Placebo	DBPC Period: Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 8	-2 Units on a Scale	Standard Deviation 3.1
DBPC Period: Placebo	DBPC Period: Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 12	-3 Units on a Scale	Standard Deviation 3.8
DBPC Period: Placebo	DBPC Period: Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 16	-4 Units on a Scale	Standard Deviation 3.7
DBPC Period: Placebo	DBPC Period: Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 20	-4 Units on a Scale	Standard Deviation 4.1
DBPC Period: Placebo	DBPC Period: Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 24	-4 Units on a Scale	Standard Deviation 4
DBPC Period: Placebo	DBPC Period: Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 28	-4 Units on a Scale	Standard Deviation 3.9
DBPC Period: Placebo	DBPC Period: Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 32	-4 Units on a Scale	Standard Deviation 4
DBPC Period: Placebo	DBPC Period: Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 36	-4 Units on a Scale	Standard Deviation 4.3
DBPC Period: Placebo	DBPC Period: Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 40	-5 Units on a Scale	Standard Deviation 4.1
DBPC Period: Placebo	DBPC Period: Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 44	-4 Units on a Scale	Standard Deviation 4
DBPC Period: Placebo	DBPC Period: Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 48	-4 Units on a Scale	Standard Deviation 4.1
DBPC Period: Placebo	DBPC Period: Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 52	-5 Units on a Scale	Standard Deviation 4
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 16	-3 Units on a Scale	Standard Deviation 3.4
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 52	-5 Units on a Scale	Standard Deviation 3.7
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 44	-5 Units on a Scale	Standard Deviation 3.7
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 32	-4 Units on a Scale	Standard Deviation 3.5
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 12	-3 Units on a Scale	Standard Deviation 3.3
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 4	-1 Units on a Scale	Standard Deviation 2.1
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 40	-5 Units on a Scale	Standard Deviation 3.6
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 36	-5 Units on a Scale	Standard Deviation 3.5
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 24	-4 Units on a Scale	Standard Deviation 3.7
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 20	-4 Units on a Scale	Standard Deviation 3.8
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 8	-2 Units on a Scale	Standard Deviation 3.2
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 48	-5 Units on a Scale	Standard Deviation 3.7
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 28	-4 Units on a Scale	Standard Deviation 3.6
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 44	-5 Units on a Scale	Standard Deviation 3.9
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 16	-3 Units on a Scale	Standard Deviation 3.4
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 20	-4 Units on a Scale	Standard Deviation 3.4
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 52	-5 Units on a Scale	Standard Deviation 3.7
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 24	-4 Units on a Scale	Standard Deviation 3.6
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 28	-4 Units on a Scale	Standard Deviation 3.5
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 48	-5 Units on a Scale	Standard Deviation 3.8
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 32	-4 Units on a Scale	Standard Deviation 3.7
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 36	-5 Units on a Scale	Standard Deviation 3.6
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 40	-5 Units on a Scale	Standard Deviation 3.8
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 4	0 Units on a Scale	Standard Deviation 1.9
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 8	-2 Units on a Scale	Standard Deviation 3
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 12	-3 Units on a Scale	Standard Deviation 3.2
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 40	-4 Units on a Scale	Standard Deviation 3.3
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 32	-4 Units on a Scale	Standard Deviation 3.4
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 16	-3 Units on a Scale	Standard Deviation 3.6
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 4	-1 Units on a Scale	Standard Deviation 2.2
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 28	-4 Units on a Scale	Standard Deviation 3.5
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 24	-3 Units on a Scale	Standard Deviation 3.4
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 12	-3 Units on a Scale	Standard Deviation 3.4
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 8	-2 Units on a Scale	Standard Deviation 3.2
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 20	-4 Units on a Scale	Standard Deviation 3.4
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 36	-4 Units on a Scale	Standard Deviation 3.5
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 52	-5 Units on a Scale	Standard Deviation 3.9
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 48	-5 Units on a Scale	Standard Deviation 3.3
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 44	-4 Units on a Scale	Standard Deviation 3.5

Secondary

DBPC Period: Change From Baseline to Week 52 in Prednisone Equivalent Corticosteroid (CS) Daily Dose at at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

Change From Baseline in Prednisone-equivalent CS Daily Dose at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 were reported.

Time frame: Baseline, Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

Population: The mITT analysis set included all randomized participants who had received at least one dose of IMP (Evobrutinib or placebo) and have at least one Baseline and one post Baseline disease assessment among the following: SFI, SLEDAI 2K, PGA, BILAG 2004, CLASI. . Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure and Number Analyzed signified those participants who were evaluable for the specified category at given time points.

Arm	Measure	Group	Value (MEAN)	Dispersion
DBPC Period: Placebo	DBPC Period: Change From Baseline to Week 52 in Prednisone Equivalent Corticosteroid (CS) Daily Dose at at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 20	-1.94 Milligram (mg)	Standard Deviation 4.054
DBPC Period: Placebo	DBPC Period: Change From Baseline to Week 52 in Prednisone Equivalent Corticosteroid (CS) Daily Dose at at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 16	-1.67 Milligram (mg)	Standard Deviation 4.427
DBPC Period: Placebo	DBPC Period: Change From Baseline to Week 52 in Prednisone Equivalent Corticosteroid (CS) Daily Dose at at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 10	-1.43 Milligram (mg)	Standard Deviation 3.985
DBPC Period: Placebo	DBPC Period: Change From Baseline to Week 52 in Prednisone Equivalent Corticosteroid (CS) Daily Dose at at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 52	-1.70 Milligram (mg)	Standard Deviation 5.47
DBPC Period: Placebo	DBPC Period: Change From Baseline to Week 52 in Prednisone Equivalent Corticosteroid (CS) Daily Dose at at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 14	-2.00 Milligram (mg)	Standard Deviation 4.569
DBPC Period: Placebo	DBPC Period: Change From Baseline to Week 52 in Prednisone Equivalent Corticosteroid (CS) Daily Dose at at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 12	-1.26 Milligram (mg)	Standard Deviation 3.26
DBPC Period: Placebo	DBPC Period: Change From Baseline to Week 52 in Prednisone Equivalent Corticosteroid (CS) Daily Dose at at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 44	-2.42 Milligram (mg)	Standard Deviation 4.833
DBPC Period: Placebo	DBPC Period: Change From Baseline to Week 52 in Prednisone Equivalent Corticosteroid (CS) Daily Dose at at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 40	-2.08 Milligram (mg)	Standard Deviation 6.149
DBPC Period: Placebo	DBPC Period: Change From Baseline to Week 52 in Prednisone Equivalent Corticosteroid (CS) Daily Dose at at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 4	0.01 Milligram (mg)	Standard Deviation 1.267
DBPC Period: Placebo	DBPC Period: Change From Baseline to Week 52 in Prednisone Equivalent Corticosteroid (CS) Daily Dose at at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 1	0.21 Milligram (mg)	Standard Deviation 1.443
DBPC Period: Placebo	DBPC Period: Change From Baseline to Week 52 in Prednisone Equivalent Corticosteroid (CS) Daily Dose at at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 36	-2.42 Milligram (mg)	Standard Deviation 4.835
DBPC Period: Placebo	DBPC Period: Change From Baseline to Week 52 in Prednisone Equivalent Corticosteroid (CS) Daily Dose at at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 32	-2.45 Milligram (mg)	Standard Deviation 4.584
DBPC Period: Placebo	DBPC Period: Change From Baseline to Week 52 in Prednisone Equivalent Corticosteroid (CS) Daily Dose at at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 6	-1.07 Milligram (mg)	Standard Deviation 3.563
DBPC Period: Placebo	DBPC Period: Change From Baseline to Week 52 in Prednisone Equivalent Corticosteroid (CS) Daily Dose at at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 48	-2.38 Milligram (mg)	Standard Deviation 4.895
DBPC Period: Placebo	DBPC Period: Change From Baseline to Week 52 in Prednisone Equivalent Corticosteroid (CS) Daily Dose at at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 28	-2.23 Milligram (mg)	Standard Deviation 4.439
DBPC Period: Placebo	DBPC Period: Change From Baseline to Week 52 in Prednisone Equivalent Corticosteroid (CS) Daily Dose at at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 24	-1.99 Milligram (mg)	Standard Deviation 4.228
DBPC Period: Placebo	DBPC Period: Change From Baseline to Week 52 in Prednisone Equivalent Corticosteroid (CS) Daily Dose at at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 8	-0.57 Milligram (mg)	Standard Deviation 2.588
DBPC Period: Placebo	DBPC Period: Change From Baseline to Week 52 in Prednisone Equivalent Corticosteroid (CS) Daily Dose at at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 2	0.10 Milligram (mg)	Standard Deviation 1.206
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline to Week 52 in Prednisone Equivalent Corticosteroid (CS) Daily Dose at at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 4	-0.45 Milligram (mg)	Standard Deviation 2.879
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline to Week 52 in Prednisone Equivalent Corticosteroid (CS) Daily Dose at at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 1	0.00 Milligram (mg)	Standard Deviation 0
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline to Week 52 in Prednisone Equivalent Corticosteroid (CS) Daily Dose at at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 2	-0.07 Milligram (mg)	Standard Deviation 0.524
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline to Week 52 in Prednisone Equivalent Corticosteroid (CS) Daily Dose at at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 6	-0.64 Milligram (mg)	Standard Deviation 3.275
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline to Week 52 in Prednisone Equivalent Corticosteroid (CS) Daily Dose at at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 8	-1.24 Milligram (mg)	Standard Deviation 3.915
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline to Week 52 in Prednisone Equivalent Corticosteroid (CS) Daily Dose at at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 10	-2.04 Milligram (mg)	Standard Deviation 5.146
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline to Week 52 in Prednisone Equivalent Corticosteroid (CS) Daily Dose at at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 12	-1.85 Milligram (mg)	Standard Deviation 4.158
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline to Week 52 in Prednisone Equivalent Corticosteroid (CS) Daily Dose at at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 14	-2.70 Milligram (mg)	Standard Deviation 5.428
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline to Week 52 in Prednisone Equivalent Corticosteroid (CS) Daily Dose at at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 16	-2.70 Milligram (mg)	Standard Deviation 4.955
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline to Week 52 in Prednisone Equivalent Corticosteroid (CS) Daily Dose at at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 20	-2.82 Milligram (mg)	Standard Deviation 4.905
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline to Week 52 in Prednisone Equivalent Corticosteroid (CS) Daily Dose at at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 24	-2.64 Milligram (mg)	Standard Deviation 5.066
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline to Week 52 in Prednisone Equivalent Corticosteroid (CS) Daily Dose at at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 28	-2.97 Milligram (mg)	Standard Deviation 4.981
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline to Week 52 in Prednisone Equivalent Corticosteroid (CS) Daily Dose at at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 32	-3.13 Milligram (mg)	Standard Deviation 5.193
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline to Week 52 in Prednisone Equivalent Corticosteroid (CS) Daily Dose at at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 36	-3.31 Milligram (mg)	Standard Deviation 5.327
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline to Week 52 in Prednisone Equivalent Corticosteroid (CS) Daily Dose at at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 40	-3.21 Milligram (mg)	Standard Deviation 5.28
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline to Week 52 in Prednisone Equivalent Corticosteroid (CS) Daily Dose at at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 44	-3.21 Milligram (mg)	Standard Deviation 5.28
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline to Week 52 in Prednisone Equivalent Corticosteroid (CS) Daily Dose at at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 48	-3.22 Milligram (mg)	Standard Deviation 5.31
DBPC Period: M2951 25 mg QD	DBPC Period: Change From Baseline to Week 52 in Prednisone Equivalent Corticosteroid (CS) Daily Dose at at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 52	-2.94 Milligram (mg)	Standard Deviation 5.534
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline to Week 52 in Prednisone Equivalent Corticosteroid (CS) Daily Dose at at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 8	-1.09 Milligram (mg)	Standard Deviation 3.64
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline to Week 52 in Prednisone Equivalent Corticosteroid (CS) Daily Dose at at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 20	-2.64 Milligram (mg)	Standard Deviation 5.489
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline to Week 52 in Prednisone Equivalent Corticosteroid (CS) Daily Dose at at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 24	-2.61 Milligram (mg)	Standard Deviation 5.568
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline to Week 52 in Prednisone Equivalent Corticosteroid (CS) Daily Dose at at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 6	-0.59 Milligram (mg)	Standard Deviation 2.095
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline to Week 52 in Prednisone Equivalent Corticosteroid (CS) Daily Dose at at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 52	-3.09 Milligram (mg)	Standard Deviation 5.981
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline to Week 52 in Prednisone Equivalent Corticosteroid (CS) Daily Dose at at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 28	-3.07 Milligram (mg)	Standard Deviation 6.068
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline to Week 52 in Prednisone Equivalent Corticosteroid (CS) Daily Dose at at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 48	-3.37 Milligram (mg)	Standard Deviation 6.265
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline to Week 52 in Prednisone Equivalent Corticosteroid (CS) Daily Dose at at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 32	-3.18 Milligram (mg)	Standard Deviation 6.161
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline to Week 52 in Prednisone Equivalent Corticosteroid (CS) Daily Dose at at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 4	-0.04 Milligram (mg)	Standard Deviation 0.739
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline to Week 52 in Prednisone Equivalent Corticosteroid (CS) Daily Dose at at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 36	-3.18 Milligram (mg)	Standard Deviation 6.136
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline to Week 52 in Prednisone Equivalent Corticosteroid (CS) Daily Dose at at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 1	0.00 Milligram (mg)	Standard Deviation 0
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline to Week 52 in Prednisone Equivalent Corticosteroid (CS) Daily Dose at at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 40	-3.24 Milligram (mg)	Standard Deviation 6.218
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline to Week 52 in Prednisone Equivalent Corticosteroid (CS) Daily Dose at at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 2	0.00 Milligram (mg)	Standard Deviation 0
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline to Week 52 in Prednisone Equivalent Corticosteroid (CS) Daily Dose at at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 12	-1.73 Milligram (mg)	Standard Deviation 4.574
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline to Week 52 in Prednisone Equivalent Corticosteroid (CS) Daily Dose at at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 10	-1.56 Milligram (mg)	Standard Deviation 4.137
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline to Week 52 in Prednisone Equivalent Corticosteroid (CS) Daily Dose at at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 14	-1.87 Milligram (mg)	Standard Deviation 4.489
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline to Week 52 in Prednisone Equivalent Corticosteroid (CS) Daily Dose at at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 44	-3.27 Milligram (mg)	Standard Deviation 6.254
DBPC Period: M2951 75 mg QD	DBPC Period: Change From Baseline to Week 52 in Prednisone Equivalent Corticosteroid (CS) Daily Dose at at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 16	-2.47 Milligram (mg)	Standard Deviation 5.365
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline to Week 52 in Prednisone Equivalent Corticosteroid (CS) Daily Dose at at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 12	-1.97 Milligram (mg)	Standard Deviation 4.15
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline to Week 52 in Prednisone Equivalent Corticosteroid (CS) Daily Dose at at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 44	-2.56 Milligram (mg)	Standard Deviation 5.121
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline to Week 52 in Prednisone Equivalent Corticosteroid (CS) Daily Dose at at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 36	-2.37 Milligram (mg)	Standard Deviation 5.445
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline to Week 52 in Prednisone Equivalent Corticosteroid (CS) Daily Dose at at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 20	-2.53 Milligram (mg)	Standard Deviation 4.727
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline to Week 52 in Prednisone Equivalent Corticosteroid (CS) Daily Dose at at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 6	-0.70 Milligram (mg)	Standard Deviation 3.484
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline to Week 52 in Prednisone Equivalent Corticosteroid (CS) Daily Dose at at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 1	0.00 Milligram (mg)	Standard Deviation 0
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline to Week 52 in Prednisone Equivalent Corticosteroid (CS) Daily Dose at at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 2	-0.13 Milligram (mg)	Standard Deviation 1.405
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline to Week 52 in Prednisone Equivalent Corticosteroid (CS) Daily Dose at at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 24	-2.34 Milligram (mg)	Standard Deviation 5.33
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline to Week 52 in Prednisone Equivalent Corticosteroid (CS) Daily Dose at at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 8	-1.02 Milligram (mg)	Standard Deviation 3.422
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline to Week 52 in Prednisone Equivalent Corticosteroid (CS) Daily Dose at at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 52	-2.63 Milligram (mg)	Standard Deviation 5.673
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline to Week 52 in Prednisone Equivalent Corticosteroid (CS) Daily Dose at at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 40	-2.67 Milligram (mg)	Standard Deviation 5.202
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline to Week 52 in Prednisone Equivalent Corticosteroid (CS) Daily Dose at at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 28	-2.46 Milligram (mg)	Standard Deviation 5.371
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline to Week 52 in Prednisone Equivalent Corticosteroid (CS) Daily Dose at at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 4	-0.15 Milligram (mg)	Standard Deviation 1.428
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline to Week 52 in Prednisone Equivalent Corticosteroid (CS) Daily Dose at at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 10	-2.50 Milligram (mg)	Standard Deviation 4.971
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline to Week 52 in Prednisone Equivalent Corticosteroid (CS) Daily Dose at at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 16	-2.40 Milligram (mg)	Standard Deviation 4.535
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline to Week 52 in Prednisone Equivalent Corticosteroid (CS) Daily Dose at at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 32	-2.44 Milligram (mg)	Standard Deviation 5.347
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline to Week 52 in Prednisone Equivalent Corticosteroid (CS) Daily Dose at at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 14	-2.76 Milligram (mg)	Standard Deviation 5.125
DBPC Period: M2951 50 mg BID	DBPC Period: Change From Baseline to Week 52 in Prednisone Equivalent Corticosteroid (CS) Daily Dose at at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Week 48	-2.62 Milligram (mg)	Standard Deviation 5.136

Secondary

DBPC Period: Cumulative Prednisone Equivalent Corticosteroid (CS) Dose at Week 52

Cumulative Prednisone-equivalent Corticosteroid (CS) Dose was calculated at Week 52.

Time frame: Week 52

Arm	Measure	Value (MEAN)	Dispersion
DBPC Period: Placebo	DBPC Period: Cumulative Prednisone Equivalent Corticosteroid (CS) Dose at Week 52	2267.66 Milligrams	Standard Deviation 1507.652
DBPC Period: M2951 25 mg QD	DBPC Period: Cumulative Prednisone Equivalent Corticosteroid (CS) Dose at Week 52	2209.46 Milligrams	Standard Deviation 1922.557
DBPC Period: M2951 75 mg QD	DBPC Period: Cumulative Prednisone Equivalent Corticosteroid (CS) Dose at Week 52	2137.70 Milligrams	Standard Deviation 1618.688
DBPC Period: M2951 50 mg BID	DBPC Period: Cumulative Prednisone Equivalent Corticosteroid (CS) Dose at Week 52	2205.56 Milligrams	Standard Deviation 1737.092

Secondary

DBPC Period: Number of Participants With a Sustained Reduction of Oral Corticosteroids (OCS) Dose to 7.5 mg Prednisone Equivalent Per Day or Less With Response Based on SRI-4 at Week 52 in Serologically Active Subgroup

SRI-4 response was defined as greater than or equal to (\>=) 4-point reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) total score, no new British Isles Lupus Assessment Group (BILAG) A and no more than 1 new BILAG B domain score, no worsening (less than 10 percent increase) from baseline in Physician's Global Assessment of Disease Activity (PGA) and no treatment failure. SLEDAI-2K assessment consists of 24 items with total score of 0(no symptoms) to 105 (presence of all defined symptoms) with higher scores representing increased disease activity. BILAG Index: assessing clinical signs, symptoms, or laboratory parameters related to Systemic Lupus Erythematosus (SLE), divided into 9 organ systems. For each organ system A=severe disease, B=moderate disease, C=mild stable disease, D=inactive, but previously active, E=inactive and never affected. The PGA assess disease activity on a visual analogue scale = from very well(0)-very poor(100).

Time frame: Week 52

Population: The mITT analysis set included all randomized participants who had received at least one dose of IMP (Evobrutinib or placebo) and have at least one Baseline and one post Baseline disease assessment among the following: SFI, SLEDAI 2K, PGA, BILAG 2004, CLASI. Here, Overall Number of Participants Analyzed signifies those participants with positive antidsDNA and/or low complement levels at screening (Serologically active subgroup) and evaluable for this outcome measure.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
DBPC Period: Placebo	DBPC Period: Number of Participants With a Sustained Reduction of Oral Corticosteroids (OCS) Dose to 7.5 mg Prednisone Equivalent Per Day or Less With Response Based on SRI-4 at Week 52 in Serologically Active Subgroup	21 Participants
DBPC Period: M2951 25 mg QD	DBPC Period: Number of Participants With a Sustained Reduction of Oral Corticosteroids (OCS) Dose to 7.5 mg Prednisone Equivalent Per Day or Less With Response Based on SRI-4 at Week 52 in Serologically Active Subgroup	25 Participants
DBPC Period: M2951 75 mg QD	DBPC Period: Number of Participants With a Sustained Reduction of Oral Corticosteroids (OCS) Dose to 7.5 mg Prednisone Equivalent Per Day or Less With Response Based on SRI-4 at Week 52 in Serologically Active Subgroup	22 Participants
DBPC Period: M2951 50 mg BID	DBPC Period: Number of Participants With a Sustained Reduction of Oral Corticosteroids (OCS) Dose to 7.5 mg Prednisone Equivalent Per Day or Less With Response Based on SRI-4 at Week 52 in Serologically Active Subgroup	25 Participants

p-value: 0.846495% CI: [0.23, 3.31]Regression, Logistic

p-value: 0.41795% CI: [0.16, 2.12]Regression, Logistic

p-value: 0.998895% CI: [0.27, 3.74]Regression, Logistic

Secondary

DBPC Period: Number of Participants With a Sustained Reduction of Oral Corticosteroids (OCS) Dose to 7.5 mg Prednisone Equivalent Per Day or Less With Response Based on Systemic Lupus Erythematosus Responder Index 4 (SRI-4) at Week 52

SRI-4 response was defined as greater than or equal to (\>=) 4-point reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) total score, no new British Isles Lupus Assessment Group (BILAG) A and no more than 1 new BILAG B domain score, no worsening (less than 10 percent increase) from baseline in Physician's Global Assessment of Disease Activity (PGA) and no treatment failure. SLEDAI-2K assessment consists of 24 items with total score of 0(no symptoms) to 105 (presence of all defined symptoms) with higher scores representing increased disease activity. BILAG Index: assessing clinical signs, symptoms, or laboratory parameters related to Systemic Lupus Erythematosus (SLE), divided into 9 organ systems. For each organ system A=severe disease, B=moderate disease, C=mild stable disease, D=inactive, but previously active, E=inactive and never affected. The PGA assess disease activity on a visual analogue scale =from 0(very well) to 100(very poor).

Time frame: Week 52

Population: The mITT analysis set included all randomized participants who had received at least one dose of IMP (Evobrutinib or placebo) and have at least one Baseline and one post Baseline disease assessment among the following: SFI, SLEDAI 2K, PGA, BILAG 2004, CLASI. Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
DBPC Period: Placebo	DBPC Period: Number of Participants With a Sustained Reduction of Oral Corticosteroids (OCS) Dose to 7.5 mg Prednisone Equivalent Per Day or Less With Response Based on Systemic Lupus Erythematosus Responder Index 4 (SRI-4) at Week 52	43 Participants
DBPC Period: M2951 25 mg QD	DBPC Period: Number of Participants With a Sustained Reduction of Oral Corticosteroids (OCS) Dose to 7.5 mg Prednisone Equivalent Per Day or Less With Response Based on Systemic Lupus Erythematosus Responder Index 4 (SRI-4) at Week 52	45 Participants
DBPC Period: M2951 75 mg QD	DBPC Period: Number of Participants With a Sustained Reduction of Oral Corticosteroids (OCS) Dose to 7.5 mg Prednisone Equivalent Per Day or Less With Response Based on Systemic Lupus Erythematosus Responder Index 4 (SRI-4) at Week 52	43 Participants
DBPC Period: M2951 50 mg BID	DBPC Period: Number of Participants With a Sustained Reduction of Oral Corticosteroids (OCS) Dose to 7.5 mg Prednisone Equivalent Per Day or Less With Response Based on Systemic Lupus Erythematosus Responder Index 4 (SRI-4) at Week 52	41 Participants

p-value: 0.772895% CI: [0.46, 2.82]Regression, Logistic

p-value: 0.331495% CI: [0.28, 1.54]Regression, Logistic

p-value: 0.720595% CI: [0.36, 2.04]Regression, Logistic

Secondary

DBPC Period: Number of Participants With a Sustained Reduction of Oral Corticosteroids (OCS) Dose to 7.5 mg Prednisone Equivalent Per Day or Less With Response Based on Systemic Lupus Erythematosus Responder Index 6 (SRI-6) at Week 52

Time frame: Week 52

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
DBPC Period: Placebo	DBPC Period: Number of Participants With a Sustained Reduction of Oral Corticosteroids (OCS) Dose to 7.5 mg Prednisone Equivalent Per Day or Less With Response Based on Systemic Lupus Erythematosus Responder Index 6 (SRI-6) at Week 52	18 Participants
DBPC Period: M2951 25 mg QD	DBPC Period: Number of Participants With a Sustained Reduction of Oral Corticosteroids (OCS) Dose to 7.5 mg Prednisone Equivalent Per Day or Less With Response Based on Systemic Lupus Erythematosus Responder Index 6 (SRI-6) at Week 52	19 Participants
DBPC Period: M2951 75 mg QD	DBPC Period: Number of Participants With a Sustained Reduction of Oral Corticosteroids (OCS) Dose to 7.5 mg Prednisone Equivalent Per Day or Less With Response Based on Systemic Lupus Erythematosus Responder Index 6 (SRI-6) at Week 52	23 Participants
DBPC Period: M2951 50 mg BID	DBPC Period: Number of Participants With a Sustained Reduction of Oral Corticosteroids (OCS) Dose to 7.5 mg Prednisone Equivalent Per Day or Less With Response Based on Systemic Lupus Erythematosus Responder Index 6 (SRI-6) at Week 52	15 Participants

p-value: 0.836495% CI: [0.35, 3.71]Regression, Logistic

p-value: 0.828795% CI: [0.37, 3.45]Regression, Logistic

p-value: 0.762195% CI: [0.35, 4.16]Regression, Logistic

Secondary

DBPC Period: Number of Participants With British Isles Lupus Assessment Group (BILAG) 2004 Flare-Free Status During the 52-Week Treatment Period

A participant has a flare-free status if no flare has been reported during the 52-week treatment period. Participants who discontinued treatment prior to Week 52, without having a flare are counted as not being flare free at Week 52. A flare was defined as either 1 or more new BILAG-2004 A (severe disease activity) or 2 or more new BILAG-2004 B (moderate disease activity) items compared to the previous visit. BILAG Index: assessing clinical signs, symptoms, or laboratory parameters related to SLE, divided into 9 organ systems. For each organ system based on alphabetic score: A=severe disease, B=moderate disease, C=mild stable disease, D=inactive, but previously active, E=inactive and never affected.

Time frame: up to Week 52

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
DBPC Period: Placebo	DBPC Period: Number of Participants With British Isles Lupus Assessment Group (BILAG) 2004 Flare-Free Status During the 52-Week Treatment Period	41 Participants
DBPC Period: M2951 25 mg QD	DBPC Period: Number of Participants With British Isles Lupus Assessment Group (BILAG) 2004 Flare-Free Status During the 52-Week Treatment Period	35 Participants
DBPC Period: M2951 75 mg QD	DBPC Period: Number of Participants With British Isles Lupus Assessment Group (BILAG) 2004 Flare-Free Status During the 52-Week Treatment Period	37 Participants
DBPC Period: M2951 50 mg BID	DBPC Period: Number of Participants With British Isles Lupus Assessment Group (BILAG) 2004 Flare-Free Status During the 52-Week Treatment Period	33 Participants

p-value: 0.374395% CI: [0.44, 1.37]Regression, Logistic

p-value: 0.644595% CI: [0.5, 1.54]Regression, Logistic

p-value: 0.263495% CI: [0.41, 1.28]Regression, Logistic

Secondary

DBPC Period: Number of Participants With Change From Baseline in Prednisone Equivalent Corticosteroid (CS) Dose by >=25% to a Dose of <=7.5 Milligram Per Day (mg/Day), With no BILAG A or 2B Flare in Disease Activity at Week 52

BILAG A or 2B flare is defined as at least one BILAG A grade or two BILAG B grade in any organ system due to items that are new or worse, compared to the BILAG evaluation at the previous visit, during the 52 week treatment period. BILAG Index: assessing clinical signs, symptoms, or laboratory parameters related to systemic lupus erythematosus (SLE), divided into 9 organ systems. For each organ system based on alphabetic score: A=severe disease, B=moderate disease, C=mild stable disease, D=inactive, but previously active, E=inactive and never affected.

Time frame: Baseline and Week 52

Population: The mITT analysis set included all randomized participants who had received at least one dose of IMP (Evobrutinib or placebo) and have at least one Baseline and one post Baseline disease assessment among the following: SFI, SLEDAI 2K, PGA, BILAG 2004, CLASI. Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
DBPC Period: Placebo	DBPC Period: Number of Participants With Change From Baseline in Prednisone Equivalent Corticosteroid (CS) Dose by >=25% to a Dose of <=7.5 Milligram Per Day (mg/Day), With no BILAG A or 2B Flare in Disease Activity at Week 52	19 Participants
DBPC Period: M2951 25 mg QD	DBPC Period: Number of Participants With Change From Baseline in Prednisone Equivalent Corticosteroid (CS) Dose by >=25% to a Dose of <=7.5 Milligram Per Day (mg/Day), With no BILAG A or 2B Flare in Disease Activity at Week 52	23 Participants
DBPC Period: M2951 75 mg QD	DBPC Period: Number of Participants With Change From Baseline in Prednisone Equivalent Corticosteroid (CS) Dose by >=25% to a Dose of <=7.5 Milligram Per Day (mg/Day), With no BILAG A or 2B Flare in Disease Activity at Week 52	20 Participants
DBPC Period: M2951 50 mg BID	DBPC Period: Number of Participants With Change From Baseline in Prednisone Equivalent Corticosteroid (CS) Dose by >=25% to a Dose of <=7.5 Milligram Per Day (mg/Day), With no BILAG A or 2B Flare in Disease Activity at Week 52	21 Participants

95% CI: [-9.7, 21.2]

95% CI: [-14.5, 15.6]

95% CI: [-13.5, 16.6]

Secondary

DBPC Period: Number of Participants With Low Disease Activity Status, Defined by Clinical Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) Score of Less Than or Equal (<= ) 2 at Week 52

Low disease activity is defined as SLEDAI-2K score \<=2. SLEDAI-2K is an activity index that measures disease activity and records feature of active lupus as present or not present. SLEDAI-2K uses a weighted checklist to assign a numerical score based on the presence or absence of 24 symptoms at the time of assessment or during the previous 30 days. Each symptom present is assigned between 1 and 8 points based on its usual clinical importance, yielding a total score that ranges from 0 points (no symptoms) to 105 points (presence of all defined symptoms). Clinical SLEDAI-2K score is equal to the SLEDAI-2K score from electronic case report form (eCRF) excluding the components 'Increased Deoxyribonucleic acid (DNA) Binding' and 'Low Complement'.

Time frame: Week 52

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
DBPC Period: Placebo	DBPC Period: Number of Participants With Low Disease Activity Status, Defined by Clinical Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) Score of Less Than or Equal (<= ) 2 at Week 52	42 Participants
DBPC Period: M2951 25 mg QD	DBPC Period: Number of Participants With Low Disease Activity Status, Defined by Clinical Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) Score of Less Than or Equal (<= ) 2 at Week 52	50 Participants
DBPC Period: M2951 75 mg QD	DBPC Period: Number of Participants With Low Disease Activity Status, Defined by Clinical Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) Score of Less Than or Equal (<= ) 2 at Week 52	52 Participants
DBPC Period: M2951 50 mg BID	DBPC Period: Number of Participants With Low Disease Activity Status, Defined by Clinical Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) Score of Less Than or Equal (<= ) 2 at Week 52	41 Participants

p-value: 0.264295% CI: [0.79, 2.35]Regression, Logistic

p-value: 0.148995% CI: [0.87, 2.57]Regression, Logistic

p-value: 0.928595% CI: [0.56, 1.7]Regression, Logistic

Secondary

DBPC Period: Number of Participants With Low Disease Activity Status, Defined by Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) Score of Less Than or Equal (<= ) 2 at Week 52

Time frame: Week 52

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
DBPC Period: Placebo	DBPC Period: Number of Participants With Low Disease Activity Status, Defined by Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) Score of Less Than or Equal (<= ) 2 at Week 52	26 Participants
DBPC Period: M2951 25 mg QD	DBPC Period: Number of Participants With Low Disease Activity Status, Defined by Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) Score of Less Than or Equal (<= ) 2 at Week 52	32 Participants
DBPC Period: M2951 75 mg QD	DBPC Period: Number of Participants With Low Disease Activity Status, Defined by Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) Score of Less Than or Equal (<= ) 2 at Week 52	39 Participants
DBPC Period: M2951 50 mg BID	DBPC Period: Number of Participants With Low Disease Activity Status, Defined by Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) Score of Less Than or Equal (<= ) 2 at Week 52	28 Participants

p-value: 0.363595% CI: [0.72, 2.47]Regression, Logistic

p-value: 0.032995% CI: [1.06, 3.56]Regression, Logistic

p-value: 0.761995% CI: [0.59, 2.07]Regression, Logistic

Secondary

DBPC Period: Number of Participants With Lupus Low Disease Activity State (LLDAS) at Week 52

Lupus low disease activity state will be measured as: SLEDAI-2K \<= 4; No activity in any major organ systems (renal, central nervous system, cardiopulmonary, vasculitis, fever); No new features of disease activity compared with the previous assessment; Prednisone-equivalent \<= 7.5 milligram per day; Unchanged background immunosuppressive therapy.

Time frame: Week 52

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
DBPC Period: Placebo	DBPC Period: Number of Participants With Lupus Low Disease Activity State (LLDAS) at Week 52	29 Participants
DBPC Period: M2951 25 mg QD	DBPC Period: Number of Participants With Lupus Low Disease Activity State (LLDAS) at Week 52	32 Participants
DBPC Period: M2951 75 mg QD	DBPC Period: Number of Participants With Lupus Low Disease Activity State (LLDAS) at Week 52	35 Participants
DBPC Period: M2951 50 mg BID	DBPC Period: Number of Participants With Lupus Low Disease Activity State (LLDAS) at Week 52	29 Participants

p-value: 0.69795% CI: [0.62, 2.04]Regression, Logistic

p-value: 0.323495% CI: [0.75, 2.42]Regression, Logistic

p-value: 0.984695% CI: [0.54, 1.82]Regression, Logistic

Secondary

DBPC Period: Number of Participants With Patient Global Impression of Change (PGIC) Scale Score of Any Improvement, no Change and Any Worsening

The PGIC is a self-rated scale that asks the participant to describe the change in activity limitations, symptoms, emotions, and overall quality of life (QoL) related to the participants painful condition on the following scale: 1 (very much improved), 2 (much improved), 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (much worse) and 7 (very much worse). Number of participants in the PGIC categories of any improvement (that is PGIC scale score 1, 2 or 3), no change (that is PGIC scale score 4) and any worsening (that is PGIC scale score 5, 6 or 7) are reported.

Time frame: Week 4, 8, 12, 16, 24, 32, 40, and 52

Arm	Measure	Group	Category	Value (COUNT_OF_PARTICIPANTS)
DBPC Period: Placebo	DBPC Period: Number of Participants With Patient Global Impression of Change (PGIC) Scale Score of Any Improvement, no Change and Any Worsening	Week 12	Any Improvement	78 Participants
DBPC Period: Placebo	DBPC Period: Number of Participants With Patient Global Impression of Change (PGIC) Scale Score of Any Improvement, no Change and Any Worsening	Week 4	No Change	33 Participants
DBPC Period: Placebo	DBPC Period: Number of Participants With Patient Global Impression of Change (PGIC) Scale Score of Any Improvement, no Change and Any Worsening	Week 4	Any Worsening	8 Participants
DBPC Period: Placebo	DBPC Period: Number of Participants With Patient Global Impression of Change (PGIC) Scale Score of Any Improvement, no Change and Any Worsening	Week 4	Missing	2 Participants
DBPC Period: Placebo	DBPC Period: Number of Participants With Patient Global Impression of Change (PGIC) Scale Score of Any Improvement, no Change and Any Worsening	Week 8	Any Improvement	80 Participants
DBPC Period: Placebo	DBPC Period: Number of Participants With Patient Global Impression of Change (PGIC) Scale Score of Any Improvement, no Change and Any Worsening	Week 8	No Change	22 Participants
DBPC Period: Placebo	DBPC Period: Number of Participants With Patient Global Impression of Change (PGIC) Scale Score of Any Improvement, no Change and Any Worsening	Week 8	Any Worsening	5 Participants
DBPC Period: Placebo	DBPC Period: Number of Participants With Patient Global Impression of Change (PGIC) Scale Score of Any Improvement, no Change and Any Worsening	Week 8	Missing	3 Participants
DBPC Period: Placebo	DBPC Period: Number of Participants With Patient Global Impression of Change (PGIC) Scale Score of Any Improvement, no Change and Any Worsening	Week 4	Any Improvement	69 Participants
DBPC Period: Placebo	DBPC Period: Number of Participants With Patient Global Impression of Change (PGIC) Scale Score of Any Improvement, no Change and Any Worsening	Week 12	No Change	23 Participants
DBPC Period: Placebo	DBPC Period: Number of Participants With Patient Global Impression of Change (PGIC) Scale Score of Any Improvement, no Change and Any Worsening	Week 12	Any Worsening	5 Participants
DBPC Period: Placebo	DBPC Period: Number of Participants With Patient Global Impression of Change (PGIC) Scale Score of Any Improvement, no Change and Any Worsening	Week 12	Missing	2 Participants
DBPC Period: Placebo	DBPC Period: Number of Participants With Patient Global Impression of Change (PGIC) Scale Score of Any Improvement, no Change and Any Worsening	Week 16	Any Improvement	75 Participants
DBPC Period: Placebo	DBPC Period: Number of Participants With Patient Global Impression of Change (PGIC) Scale Score of Any Improvement, no Change and Any Worsening	Week 16	No Change	23 Participants
DBPC Period: Placebo	DBPC Period: Number of Participants With Patient Global Impression of Change (PGIC) Scale Score of Any Improvement, no Change and Any Worsening	Week 16	Any Worsening	3 Participants
DBPC Period: Placebo	DBPC Period: Number of Participants With Patient Global Impression of Change (PGIC) Scale Score of Any Improvement, no Change and Any Worsening	Week 16	Missing	3 Participants
DBPC Period: Placebo	DBPC Period: Number of Participants With Patient Global Impression of Change (PGIC) Scale Score of Any Improvement, no Change and Any Worsening	Week 24	Any Improvement	67 Participants
DBPC Period: Placebo	DBPC Period: Number of Participants With Patient Global Impression of Change (PGIC) Scale Score of Any Improvement, no Change and Any Worsening	Week 24	No Change	23 Participants
DBPC Period: Placebo	DBPC Period: Number of Participants With Patient Global Impression of Change (PGIC) Scale Score of Any Improvement, no Change and Any Worsening	Week 24	Any Worsening	6 Participants
DBPC Period: Placebo	DBPC Period: Number of Participants With Patient Global Impression of Change (PGIC) Scale Score of Any Improvement, no Change and Any Worsening	Week 24	Missing	2 Participants
DBPC Period: Placebo	DBPC Period: Number of Participants With Patient Global Impression of Change (PGIC) Scale Score of Any Improvement, no Change and Any Worsening	Week 32	Any Improvement	70 Participants
DBPC Period: Placebo	DBPC Period: Number of Participants With Patient Global Impression of Change (PGIC) Scale Score of Any Improvement, no Change and Any Worsening	Week 32	No Change	16 Participants
DBPC Period: Placebo	DBPC Period: Number of Participants With Patient Global Impression of Change (PGIC) Scale Score of Any Improvement, no Change and Any Worsening	Week 32	Any Worsening	4 Participants
DBPC Period: Placebo	DBPC Period: Number of Participants With Patient Global Impression of Change (PGIC) Scale Score of Any Improvement, no Change and Any Worsening	Week 32	Missing	1 Participants
DBPC Period: Placebo	DBPC Period: Number of Participants With Patient Global Impression of Change (PGIC) Scale Score of Any Improvement, no Change and Any Worsening	Week 40	Any Improvement	67 Participants
DBPC Period: Placebo	DBPC Period: Number of Participants With Patient Global Impression of Change (PGIC) Scale Score of Any Improvement, no Change and Any Worsening	Week 40	No Change	19 Participants
DBPC Period: Placebo	DBPC Period: Number of Participants With Patient Global Impression of Change (PGIC) Scale Score of Any Improvement, no Change and Any Worsening	Week 40	Any Worsening	2 Participants
DBPC Period: Placebo	DBPC Period: Number of Participants With Patient Global Impression of Change (PGIC) Scale Score of Any Improvement, no Change and Any Worsening	Week 40	Missing	1 Participants
DBPC Period: Placebo	DBPC Period: Number of Participants With Patient Global Impression of Change (PGIC) Scale Score of Any Improvement, no Change and Any Worsening	Week 52	Any Improvement	66 Participants
DBPC Period: Placebo	DBPC Period: Number of Participants With Patient Global Impression of Change (PGIC) Scale Score of Any Improvement, no Change and Any Worsening	Week 52	No Change	14 Participants
DBPC Period: Placebo	DBPC Period: Number of Participants With Patient Global Impression of Change (PGIC) Scale Score of Any Improvement, no Change and Any Worsening	Week 52	Any Worsening	6 Participants
DBPC Period: Placebo	DBPC Period: Number of Participants With Patient Global Impression of Change (PGIC) Scale Score of Any Improvement, no Change and Any Worsening	Week 52	Missing	2 Participants
DBPC Period: M2951 25 mg QD	DBPC Period: Number of Participants With Patient Global Impression of Change (PGIC) Scale Score of Any Improvement, no Change and Any Worsening	Week 32	Missing	0 Participants
DBPC Period: M2951 25 mg QD	DBPC Period: Number of Participants With Patient Global Impression of Change (PGIC) Scale Score of Any Improvement, no Change and Any Worsening	Week 24	Any Improvement	77 Participants
DBPC Period: M2951 25 mg QD	DBPC Period: Number of Participants With Patient Global Impression of Change (PGIC) Scale Score of Any Improvement, no Change and Any Worsening	Week 8	No Change	18 Participants
DBPC Period: M2951 25 mg QD	DBPC Period: Number of Participants With Patient Global Impression of Change (PGIC) Scale Score of Any Improvement, no Change and Any Worsening	Week 32	Any Worsening	6 Participants
DBPC Period: M2951 25 mg QD	DBPC Period: Number of Participants With Patient Global Impression of Change (PGIC) Scale Score of Any Improvement, no Change and Any Worsening	Week 52	Any Improvement	64 Participants
DBPC Period: M2951 25 mg QD	DBPC Period: Number of Participants With Patient Global Impression of Change (PGIC) Scale Score of Any Improvement, no Change and Any Worsening	Week 24	No Change	12 Participants
DBPC Period: M2951 25 mg QD	DBPC Period: Number of Participants With Patient Global Impression of Change (PGIC) Scale Score of Any Improvement, no Change and Any Worsening	Week 40	No Change	12 Participants
DBPC Period: M2951 25 mg QD	DBPC Period: Number of Participants With Patient Global Impression of Change (PGIC) Scale Score of Any Improvement, no Change and Any Worsening	Week 32	No Change	15 Participants
DBPC Period: M2951 25 mg QD	DBPC Period: Number of Participants With Patient Global Impression of Change (PGIC) Scale Score of Any Improvement, no Change and Any Worsening	Week 12	Missing	3 Participants
DBPC Period: M2951 25 mg QD	DBPC Period: Number of Participants With Patient Global Impression of Change (PGIC) Scale Score of Any Improvement, no Change and Any Worsening	Week 24	Any Worsening	6 Participants
DBPC Period: M2951 25 mg QD	DBPC Period: Number of Participants With Patient Global Impression of Change (PGIC) Scale Score of Any Improvement, no Change and Any Worsening	Week 12	No Change	13 Participants
DBPC Period: M2951 25 mg QD	DBPC Period: Number of Participants With Patient Global Impression of Change (PGIC) Scale Score of Any Improvement, no Change and Any Worsening	Week 52	No Change	18 Participants
DBPC Period: M2951 25 mg QD	DBPC Period: Number of Participants With Patient Global Impression of Change (PGIC) Scale Score of Any Improvement, no Change and Any Worsening	Week 32	Any Improvement	70 Participants
DBPC Period: M2951 25 mg QD	DBPC Period: Number of Participants With Patient Global Impression of Change (PGIC) Scale Score of Any Improvement, no Change and Any Worsening	Week 24	Missing	0 Participants
DBPC Period: M2951 25 mg QD	DBPC Period: Number of Participants With Patient Global Impression of Change (PGIC) Scale Score of Any Improvement, no Change and Any Worsening	Week 8	Any Improvement	81 Participants
DBPC Period: M2951 25 mg QD	DBPC Period: Number of Participants With Patient Global Impression of Change (PGIC) Scale Score of Any Improvement, no Change and Any Worsening	Week 52	Missing	6 Participants
DBPC Period: M2951 25 mg QD	DBPC Period: Number of Participants With Patient Global Impression of Change (PGIC) Scale Score of Any Improvement, no Change and Any Worsening	Week 52	Any Worsening	1 Participants
DBPC Period: M2951 25 mg QD	DBPC Period: Number of Participants With Patient Global Impression of Change (PGIC) Scale Score of Any Improvement, no Change and Any Worsening	Week 16	Any Improvement	81 Participants
DBPC Period: M2951 25 mg QD	DBPC Period: Number of Participants With Patient Global Impression of Change (PGIC) Scale Score of Any Improvement, no Change and Any Worsening	Week 12	Any Improvement	82 Participants
DBPC Period: M2951 25 mg QD	DBPC Period: Number of Participants With Patient Global Impression of Change (PGIC) Scale Score of Any Improvement, no Change and Any Worsening	Week 4	Missing	0 Participants
DBPC Period: M2951 25 mg QD	DBPC Period: Number of Participants With Patient Global Impression of Change (PGIC) Scale Score of Any Improvement, no Change and Any Worsening	Week 40	Missing	0 Participants
DBPC Period: M2951 25 mg QD	DBPC Period: Number of Participants With Patient Global Impression of Change (PGIC) Scale Score of Any Improvement, no Change and Any Worsening	Week 16	No Change	13 Participants
DBPC Period: M2951 25 mg QD	DBPC Period: Number of Participants With Patient Global Impression of Change (PGIC) Scale Score of Any Improvement, no Change and Any Worsening	Week 8	Any Worsening	9 Participants
DBPC Period: M2951 25 mg QD	DBPC Period: Number of Participants With Patient Global Impression of Change (PGIC) Scale Score of Any Improvement, no Change and Any Worsening	Week 4	Any Worsening	9 Participants
DBPC Period: M2951 25 mg QD	DBPC Period: Number of Participants With Patient Global Impression of Change (PGIC) Scale Score of Any Improvement, no Change and Any Worsening	Week 8	Missing	2 Participants
DBPC Period: M2951 25 mg QD	DBPC Period: Number of Participants With Patient Global Impression of Change (PGIC) Scale Score of Any Improvement, no Change and Any Worsening	Week 16	Any Worsening	7 Participants
DBPC Period: M2951 25 mg QD	DBPC Period: Number of Participants With Patient Global Impression of Change (PGIC) Scale Score of Any Improvement, no Change and Any Worsening	Week 12	Any Worsening	7 Participants
DBPC Period: M2951 25 mg QD	DBPC Period: Number of Participants With Patient Global Impression of Change (PGIC) Scale Score of Any Improvement, no Change and Any Worsening	Week 4	No Change	27 Participants
DBPC Period: M2951 25 mg QD	DBPC Period: Number of Participants With Patient Global Impression of Change (PGIC) Scale Score of Any Improvement, no Change and Any Worsening	Week 40	Any Improvement	69 Participants
DBPC Period: M2951 25 mg QD	DBPC Period: Number of Participants With Patient Global Impression of Change (PGIC) Scale Score of Any Improvement, no Change and Any Worsening	Week 16	Missing	0 Participants
DBPC Period: M2951 25 mg QD	DBPC Period: Number of Participants With Patient Global Impression of Change (PGIC) Scale Score of Any Improvement, no Change and Any Worsening	Week 40	Any Worsening	8 Participants
DBPC Period: M2951 25 mg QD	DBPC Period: Number of Participants With Patient Global Impression of Change (PGIC) Scale Score of Any Improvement, no Change and Any Worsening	Week 4	Any Improvement	78 Participants
DBPC Period: M2951 75 mg QD	DBPC Period: Number of Participants With Patient Global Impression of Change (PGIC) Scale Score of Any Improvement, no Change and Any Worsening	Week 52	Any Worsening	5 Participants
DBPC Period: M2951 75 mg QD	DBPC Period: Number of Participants With Patient Global Impression of Change (PGIC) Scale Score of Any Improvement, no Change and Any Worsening	Week 12	Any Improvement	81 Participants
DBPC Period: M2951 75 mg QD	DBPC Period: Number of Participants With Patient Global Impression of Change (PGIC) Scale Score of Any Improvement, no Change and Any Worsening	Week 12	No Change	15 Participants
DBPC Period: M2951 75 mg QD	DBPC Period: Number of Participants With Patient Global Impression of Change (PGIC) Scale Score of Any Improvement, no Change and Any Worsening	Week 40	Any Worsening	4 Participants
DBPC Period: M2951 75 mg QD	DBPC Period: Number of Participants With Patient Global Impression of Change (PGIC) Scale Score of Any Improvement, no Change and Any Worsening	Week 12	Any Worsening	7 Participants
DBPC Period: M2951 75 mg QD	DBPC Period: Number of Participants With Patient Global Impression of Change (PGIC) Scale Score of Any Improvement, no Change and Any Worsening	Week 12	Missing	4 Participants
DBPC Period: M2951 75 mg QD	DBPC Period: Number of Participants With Patient Global Impression of Change (PGIC) Scale Score of Any Improvement, no Change and Any Worsening	Week 16	Any Improvement	87 Participants
DBPC Period: M2951 75 mg QD	DBPC Period: Number of Participants With Patient Global Impression of Change (PGIC) Scale Score of Any Improvement, no Change and Any Worsening	Week 16	No Change	16 Participants
DBPC Period: M2951 75 mg QD	DBPC Period: Number of Participants With Patient Global Impression of Change (PGIC) Scale Score of Any Improvement, no Change and Any Worsening	Week 40	Missing	2 Participants
DBPC Period: M2951 75 mg QD	DBPC Period: Number of Participants With Patient Global Impression of Change (PGIC) Scale Score of Any Improvement, no Change and Any Worsening	Week 16	Any Worsening	2 Participants
DBPC Period: M2951 75 mg QD	DBPC Period: Number of Participants With Patient Global Impression of Change (PGIC) Scale Score of Any Improvement, no Change and Any Worsening	Week 16	Missing	0 Participants
DBPC Period: M2951 75 mg QD	DBPC Period: Number of Participants With Patient Global Impression of Change (PGIC) Scale Score of Any Improvement, no Change and Any Worsening	Week 24	Any Improvement	87 Participants
DBPC Period: M2951 75 mg QD	DBPC Period: Number of Participants With Patient Global Impression of Change (PGIC) Scale Score of Any Improvement, no Change and Any Worsening	Week 24	No Change	7 Participants
DBPC Period: M2951 75 mg QD	DBPC Period: Number of Participants With Patient Global Impression of Change (PGIC) Scale Score of Any Improvement, no Change and Any Worsening	Week 52	Any Improvement	76 Participants
DBPC Period: M2951 75 mg QD	DBPC Period: Number of Participants With Patient Global Impression of Change (PGIC) Scale Score of Any Improvement, no Change and Any Worsening	Week 24	Any Worsening	5 Participants
DBPC Period: M2951 75 mg QD	DBPC Period: Number of Participants With Patient Global Impression of Change (PGIC) Scale Score of Any Improvement, no Change and Any Worsening	Week 24	Missing	2 Participants
DBPC Period: M2951 75 mg QD	DBPC Period: Number of Participants With Patient Global Impression of Change (PGIC) Scale Score of Any Improvement, no Change and Any Worsening	Week 32	Any Improvement	80 Participants
DBPC Period: M2951 75 mg QD	DBPC Period: Number of Participants With Patient Global Impression of Change (PGIC) Scale Score of Any Improvement, no Change and Any Worsening	Week 32	No Change	8 Participants
DBPC Period: M2951 75 mg QD	DBPC Period: Number of Participants With Patient Global Impression of Change (PGIC) Scale Score of Any Improvement, no Change and Any Worsening	Week 52	No Change	6 Participants
DBPC Period: M2951 75 mg QD	DBPC Period: Number of Participants With Patient Global Impression of Change (PGIC) Scale Score of Any Improvement, no Change and Any Worsening	Week 32	Any Worsening	5 Participants
DBPC Period: M2951 75 mg QD	DBPC Period: Number of Participants With Patient Global Impression of Change (PGIC) Scale Score of Any Improvement, no Change and Any Worsening	Week 32	Missing	2 Participants
DBPC Period: M2951 75 mg QD	DBPC Period: Number of Participants With Patient Global Impression of Change (PGIC) Scale Score of Any Improvement, no Change and Any Worsening	Week 52	Missing	3 Participants
DBPC Period: M2951 75 mg QD	DBPC Period: Number of Participants With Patient Global Impression of Change (PGIC) Scale Score of Any Improvement, no Change and Any Worsening	Week 4	Any Improvement	81 Participants
DBPC Period: M2951 75 mg QD	DBPC Period: Number of Participants With Patient Global Impression of Change (PGIC) Scale Score of Any Improvement, no Change and Any Worsening	Week 4	No Change	23 Participants
DBPC Period: M2951 75 mg QD	DBPC Period: Number of Participants With Patient Global Impression of Change (PGIC) Scale Score of Any Improvement, no Change and Any Worsening	Week 40	Any Improvement	80 Participants
DBPC Period: M2951 75 mg QD	DBPC Period: Number of Participants With Patient Global Impression of Change (PGIC) Scale Score of Any Improvement, no Change and Any Worsening	Week 4	Any Worsening	8 Participants
DBPC Period: M2951 75 mg QD	DBPC Period: Number of Participants With Patient Global Impression of Change (PGIC) Scale Score of Any Improvement, no Change and Any Worsening	Week 4	Missing	1 Participants
DBPC Period: M2951 75 mg QD	DBPC Period: Number of Participants With Patient Global Impression of Change (PGIC) Scale Score of Any Improvement, no Change and Any Worsening	Week 8	Any Improvement	85 Participants
DBPC Period: M2951 75 mg QD	DBPC Period: Number of Participants With Patient Global Impression of Change (PGIC) Scale Score of Any Improvement, no Change and Any Worsening	Week 8	No Change	19 Participants
DBPC Period: M2951 75 mg QD	DBPC Period: Number of Participants With Patient Global Impression of Change (PGIC) Scale Score of Any Improvement, no Change and Any Worsening	Week 40	No Change	7 Participants
DBPC Period: M2951 75 mg QD	DBPC Period: Number of Participants With Patient Global Impression of Change (PGIC) Scale Score of Any Improvement, no Change and Any Worsening	Week 8	Any Worsening	5 Participants
DBPC Period: M2951 75 mg QD	DBPC Period: Number of Participants With Patient Global Impression of Change (PGIC) Scale Score of Any Improvement, no Change and Any Worsening	Week 8	Missing	1 Participants
DBPC Period: M2951 50 mg BID	DBPC Period: Number of Participants With Patient Global Impression of Change (PGIC) Scale Score of Any Improvement, no Change and Any Worsening	Week 12	Any Worsening	4 Participants
DBPC Period: M2951 50 mg BID	DBPC Period: Number of Participants With Patient Global Impression of Change (PGIC) Scale Score of Any Improvement, no Change and Any Worsening	Week 16	Missing	2 Participants
DBPC Period: M2951 50 mg BID	DBPC Period: Number of Participants With Patient Global Impression of Change (PGIC) Scale Score of Any Improvement, no Change and Any Worsening	Week 40	No Change	9 Participants
DBPC Period: M2951 50 mg BID	DBPC Period: Number of Participants With Patient Global Impression of Change (PGIC) Scale Score of Any Improvement, no Change and Any Worsening	Week 4	Any Improvement	71 Participants
DBPC Period: M2951 50 mg BID	DBPC Period: Number of Participants With Patient Global Impression of Change (PGIC) Scale Score of Any Improvement, no Change and Any Worsening	Week 40	Missing	1 Participants
DBPC Period: M2951 50 mg BID	DBPC Period: Number of Participants With Patient Global Impression of Change (PGIC) Scale Score of Any Improvement, no Change and Any Worsening	Week 16	Any Worsening	2 Participants
DBPC Period: M2951 50 mg BID	DBPC Period: Number of Participants With Patient Global Impression of Change (PGIC) Scale Score of Any Improvement, no Change and Any Worsening	Week 8	No Change	28 Participants
DBPC Period: M2951 50 mg BID	DBPC Period: Number of Participants With Patient Global Impression of Change (PGIC) Scale Score of Any Improvement, no Change and Any Worsening	Week 4	No Change	34 Participants
DBPC Period: M2951 50 mg BID	DBPC Period: Number of Participants With Patient Global Impression of Change (PGIC) Scale Score of Any Improvement, no Change and Any Worsening	Week 12	Any Improvement	77 Participants
DBPC Period: M2951 50 mg BID	DBPC Period: Number of Participants With Patient Global Impression of Change (PGIC) Scale Score of Any Improvement, no Change and Any Worsening	Week 16	No Change	15 Participants
DBPC Period: M2951 50 mg BID	DBPC Period: Number of Participants With Patient Global Impression of Change (PGIC) Scale Score of Any Improvement, no Change and Any Worsening	Week 12	No Change	20 Participants
DBPC Period: M2951 50 mg BID	DBPC Period: Number of Participants With Patient Global Impression of Change (PGIC) Scale Score of Any Improvement, no Change and Any Worsening	Week 4	Any Worsening	8 Participants
DBPC Period: M2951 50 mg BID	DBPC Period: Number of Participants With Patient Global Impression of Change (PGIC) Scale Score of Any Improvement, no Change and Any Worsening	Week 40	Any Improvement	73 Participants
DBPC Period: M2951 50 mg BID	DBPC Period: Number of Participants With Patient Global Impression of Change (PGIC) Scale Score of Any Improvement, no Change and Any Worsening	Week 16	Any Improvement	79 Participants
DBPC Period: M2951 50 mg BID	DBPC Period: Number of Participants With Patient Global Impression of Change (PGIC) Scale Score of Any Improvement, no Change and Any Worsening	Week 8	Missing	3 Participants
DBPC Period: M2951 50 mg BID	DBPC Period: Number of Participants With Patient Global Impression of Change (PGIC) Scale Score of Any Improvement, no Change and Any Worsening	Week 4	Missing	0 Participants
DBPC Period: M2951 50 mg BID	DBPC Period: Number of Participants With Patient Global Impression of Change (PGIC) Scale Score of Any Improvement, no Change and Any Worsening	Week 24	Missing	0 Participants
DBPC Period: M2951 50 mg BID	DBPC Period: Number of Participants With Patient Global Impression of Change (PGIC) Scale Score of Any Improvement, no Change and Any Worsening	Week 52	Any Improvement	64 Participants
DBPC Period: M2951 50 mg BID	DBPC Period: Number of Participants With Patient Global Impression of Change (PGIC) Scale Score of Any Improvement, no Change and Any Worsening	Week 52	Any Worsening	4 Participants
DBPC Period: M2951 50 mg BID	DBPC Period: Number of Participants With Patient Global Impression of Change (PGIC) Scale Score of Any Improvement, no Change and Any Worsening	Week 32	Any Improvement	72 Participants
DBPC Period: M2951 50 mg BID	DBPC Period: Number of Participants With Patient Global Impression of Change (PGIC) Scale Score of Any Improvement, no Change and Any Worsening	Week 24	Any Worsening	5 Participants
DBPC Period: M2951 50 mg BID	DBPC Period: Number of Participants With Patient Global Impression of Change (PGIC) Scale Score of Any Improvement, no Change and Any Worsening	Week 24	No Change	17 Participants
DBPC Period: M2951 50 mg BID	DBPC Period: Number of Participants With Patient Global Impression of Change (PGIC) Scale Score of Any Improvement, no Change and Any Worsening	Week 12	Missing	3 Participants
DBPC Period: M2951 50 mg BID	DBPC Period: Number of Participants With Patient Global Impression of Change (PGIC) Scale Score of Any Improvement, no Change and Any Worsening	Week 32	No Change	13 Participants
DBPC Period: M2951 50 mg BID	DBPC Period: Number of Participants With Patient Global Impression of Change (PGIC) Scale Score of Any Improvement, no Change and Any Worsening	Week 8	Any Worsening	3 Participants
DBPC Period: M2951 50 mg BID	DBPC Period: Number of Participants With Patient Global Impression of Change (PGIC) Scale Score of Any Improvement, no Change and Any Worsening	Week 24	Any Improvement	73 Participants
DBPC Period: M2951 50 mg BID	DBPC Period: Number of Participants With Patient Global Impression of Change (PGIC) Scale Score of Any Improvement, no Change and Any Worsening	Week 8	Any Improvement	75 Participants
DBPC Period: M2951 50 mg BID	DBPC Period: Number of Participants With Patient Global Impression of Change (PGIC) Scale Score of Any Improvement, no Change and Any Worsening	Week 32	Any Worsening	3 Participants
DBPC Period: M2951 50 mg BID	DBPC Period: Number of Participants With Patient Global Impression of Change (PGIC) Scale Score of Any Improvement, no Change and Any Worsening	Week 52	No Change	13 Participants
DBPC Period: M2951 50 mg BID	DBPC Period: Number of Participants With Patient Global Impression of Change (PGIC) Scale Score of Any Improvement, no Change and Any Worsening	Week 52	Missing	4 Participants
DBPC Period: M2951 50 mg BID	DBPC Period: Number of Participants With Patient Global Impression of Change (PGIC) Scale Score of Any Improvement, no Change and Any Worsening	Week 40	Any Worsening	4 Participants
DBPC Period: M2951 50 mg BID	DBPC Period: Number of Participants With Patient Global Impression of Change (PGIC) Scale Score of Any Improvement, no Change and Any Worsening	Week 32	Missing	1 Participants

Secondary

DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

Number of Participants With Reduction From Baseline in Prednisone-equivalent Corticosteroid (CS) Daily Dose by \> 0 to 25%, \>25% to 50%, \>50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 were reported.

Time frame: Baseline, Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
DBPC Period: Placebo	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >0-25% Week 4	1 Participants
DBPC Period: Placebo	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >50-100% Week 1	0 Participants
DBPC Period: Placebo	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >0-25% Week 20	5 Participants
DBPC Period: Placebo	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >50-100% Week 2	0 Participants
DBPC Period: Placebo	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Increased from Baseline Week 8	2 Participants
DBPC Period: Placebo	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >50-100% Week 4	0 Participants
DBPC Period: Placebo	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Increased from Baseline Week 36	0 Participants
DBPC Period: Placebo	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >50-100% Week 6	1 Participants
DBPC Period: Placebo	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >50-100% Week 8	1 Participants
DBPC Period: Placebo	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >0-25% Week 24	4 Participants
DBPC Period: Placebo	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >50-100% Week 10	2 Participants
DBPC Period: Placebo	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >50-100% Week 12	1 Participants
DBPC Period: Placebo	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Increased from Baseline Week 40	1 Participants
DBPC Period: Placebo	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >50-100% Week 14	5 Participants
DBPC Period: Placebo	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Increased from Baseline Week 1	1 Participants
DBPC Period: Placebo	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >0-25% Week 8	6 Participants
DBPC Period: Placebo	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >50-100% Week 16	5 Participants
DBPC Period: Placebo	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Increased from Baseline Week 44	0 Participants
DBPC Period: Placebo	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >0-25% Week 28	2 Participants
DBPC Period: Placebo	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >50-100% Week 20	7 Participants
DBPC Period: Placebo	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >50-100% Week 24	7 Participants
DBPC Period: Placebo	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Increased from Baseline Week 10	1 Participants
DBPC Period: Placebo	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >0-25% Week 52	1 Participants
DBPC Period: Placebo	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >50-100% Week 28	9 Participants
DBPC Period: Placebo	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Increased from Baseline Week 48	0 Participants
DBPC Period: Placebo	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >50-100% Week 32	11 Participants
DBPC Period: Placebo	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >0-25% Week 32	1 Participants
DBPC Period: Placebo	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >50-100% Week 36	10 Participants
DBPC Period: Placebo	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >50-100% Week 40	10 Participants
DBPC Period: Placebo	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Increased from Baseline Week 52	2 Participants
DBPC Period: Placebo	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >50-100% Week 44	10 Participants
DBPC Period: Placebo	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >0-25% Week 6	3 Participants
DBPC Period: Placebo	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >50-100% Week 48	9 Participants
DBPC Period: Placebo	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Increased from Baseline Week 4	2 Participants
DBPC Period: Placebo	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >0-25% Week 36	1 Participants
DBPC Period: Placebo	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >50-100% Week 52	9 Participants
DBPC Period: Placebo	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >25- 50% Week 1	0 Participants
DBPC Period: Placebo	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Increased from Baseline Week 12	1 Participants
DBPC Period: Placebo	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >25- 50% Week 2	0 Participants
DBPC Period: Placebo	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >0-25% Week 2	1 Participants
DBPC Period: Placebo	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >25- 50% Week 4	1 Participants
DBPC Period: Placebo	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >0-25% Week 44	1 Participants
DBPC Period: Placebo	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >0-25% Week 10	0 Participants
DBPC Period: Placebo	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >25- 50% Week 6	4 Participants
DBPC Period: Placebo	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Increased from Baseline Week 14	1 Participants
DBPC Period: Placebo	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >25- 50% Week 8	5 Participants
DBPC Period: Placebo	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >25- 50% Week 10	7 Participants
DBPC Period: Placebo	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >25- 50% Week 12	14 Participants
DBPC Period: Placebo	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Increased from Baseline Week 16	1 Participants
DBPC Period: Placebo	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >0-25% Week 12	5 Participants
DBPC Period: Placebo	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >25- 50% Week 14	7 Participants
DBPC Period: Placebo	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >25- 50% Week 16	16 Participants
DBPC Period: Placebo	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >0-25% Week 40	1 Participants
DBPC Period: Placebo	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Increased from Baseline Week 6	1 Participants
DBPC Period: Placebo	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >25- 50% Week 20	13 Participants
DBPC Period: Placebo	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Increased from Baseline Week 20	0 Participants
DBPC Period: Placebo	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >25- 50% Week 24	12 Participants
DBPC Period: Placebo	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >0-25% Week 14	2 Participants
DBPC Period: Placebo	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >25- 50% Week 28	14 Participants
DBPC Period: Placebo	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >0-25% Week 1	0 Participants
DBPC Period: Placebo	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >25- 50% Week 32	15 Participants
DBPC Period: Placebo	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Increased from Baseline Week 24	0 Participants
DBPC Period: Placebo	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >25- 50% Week 36	15 Participants
DBPC Period: Placebo	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Increased from Baseline Week 2	2 Participants
DBPC Period: Placebo	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >25- 50% Week 40	15 Participants
DBPC Period: Placebo	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Increased from Baseline Week 28	0 Participants
DBPC Period: Placebo	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >0-25% Week 16	5 Participants
DBPC Period: Placebo	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >25- 50% Week 44	15 Participants
DBPC Period: Placebo	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >25- 50% Week 48	15 Participants
DBPC Period: Placebo	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >0-25% Week 48	0 Participants
DBPC Period: Placebo	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >25- 50% Week 52	16 Participants
DBPC Period: Placebo	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Increased from Baseline Week 32	0 Participants
DBPC Period: M2951 25 mg QD	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >0-25% Week 8	6 Participants
DBPC Period: M2951 25 mg QD	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >25- 50% Week 44	15 Participants
DBPC Period: M2951 25 mg QD	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >50-100% Week 1	0 Participants
DBPC Period: M2951 25 mg QD	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Increased from Baseline Week 32	0 Participants
DBPC Period: M2951 25 mg QD	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >25- 50% Week 1	0 Participants
DBPC Period: M2951 25 mg QD	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >25- 50% Week 36	13 Participants
DBPC Period: M2951 25 mg QD	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >50-100% Week 2	0 Participants
DBPC Period: M2951 25 mg QD	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Increased from Baseline Week 12	1 Participants
DBPC Period: M2951 25 mg QD	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >0-25% Week 20	10 Participants
DBPC Period: M2951 25 mg QD	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >25- 50% Week 20	11 Participants
DBPC Period: M2951 25 mg QD	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >50-100% Week 4	1 Participants
DBPC Period: M2951 25 mg QD	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >0-25% Week 48	5 Participants
DBPC Period: M2951 25 mg QD	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >25- 50% Week 2	0 Participants
DBPC Period: M2951 25 mg QD	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Increased from Baseline Week 4	1 Participants
DBPC Period: M2951 25 mg QD	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >50-100% Week 6	1 Participants
DBPC Period: M2951 25 mg QD	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Increased from Baseline Week 36	0 Participants
DBPC Period: M2951 25 mg QD	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >0-25% Week 4	5 Participants
DBPC Period: M2951 25 mg QD	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Increased from Baseline Week 28	0 Participants
DBPC Period: M2951 25 mg QD	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >50-100% Week 8	3 Participants
DBPC Period: M2951 25 mg QD	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Increased from Baseline Week 8	1 Participants
DBPC Period: M2951 25 mg QD	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Increased from Baseline Week 20	0 Participants
DBPC Period: M2951 25 mg QD	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >25- 50% Week 4	2 Participants
DBPC Period: M2951 25 mg QD	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >50-100% Week 10	3 Participants
DBPC Period: M2951 25 mg QD	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Increased from Baseline Week 2	0 Participants
DBPC Period: M2951 25 mg QD	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >0-25% Week 24	10 Participants
DBPC Period: M2951 25 mg QD	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >0-25% Week 1	0 Participants
DBPC Period: M2951 25 mg QD	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >50-100% Week 12	6 Participants
DBPC Period: M2951 25 mg QD	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >25- 50% Week 24	9 Participants
DBPC Period: M2951 25 mg QD	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Increased from Baseline Week 40	0 Participants
DBPC Period: M2951 25 mg QD	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Increased from Baseline Week 6	1 Participants
DBPC Period: M2951 25 mg QD	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >50-100% Week 14	6 Participants
DBPC Period: M2951 25 mg QD	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >25- 50% Week 6	1 Participants
DBPC Period: M2951 25 mg QD	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >0-25% Week 16	10 Participants
DBPC Period: M2951 25 mg QD	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >0-25% Week 10	3 Participants
DBPC Period: M2951 25 mg QD	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >50-100% Week 16	13 Participants
DBPC Period: M2951 25 mg QD	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >25- 50% Week 40	15 Participants
DBPC Period: M2951 25 mg QD	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >25- 50% Week 8	9 Participants
DBPC Period: M2951 25 mg QD	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Increased from Baseline Week 14	0 Participants
DBPC Period: M2951 25 mg QD	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >50-100% Week 20	13 Participants
DBPC Period: M2951 25 mg QD	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Increased from Baseline Week 44	0 Participants
DBPC Period: M2951 25 mg QD	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >0-25% Week 28	8 Participants
DBPC Period: M2951 25 mg QD	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Increased from Baseline Week 1	0 Participants
DBPC Period: M2951 25 mg QD	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >50-100% Week 24	14 Participants
DBPC Period: M2951 25 mg QD	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >25- 50% Week 28	12 Participants
DBPC Period: M2951 25 mg QD	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >25- 50% Week 10	6 Participants
DBPC Period: M2951 25 mg QD	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >0-25% Week 44	5 Participants
DBPC Period: M2951 25 mg QD	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >50-100% Week 28	14 Participants
DBPC Period: M2951 25 mg QD	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >0-25% Week 2	2 Participants
DBPC Period: M2951 25 mg QD	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Increased from Baseline Week 48	0 Participants
DBPC Period: M2951 25 mg QD	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >25- 50% Week 52	12 Participants
DBPC Period: M2951 25 mg QD	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >50-100% Week 32	16 Participants
DBPC Period: M2951 25 mg QD	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Increased from Baseline Week 10	1 Participants
DBPC Period: M2951 25 mg QD	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >25- 50% Week 12	9 Participants
DBPC Period: M2951 25 mg QD	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >0-25% Week 14	2 Participants
DBPC Period: M2951 25 mg QD	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >50-100% Week 36	17 Participants
DBPC Period: M2951 25 mg QD	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >0-25% Week 52	5 Participants
DBPC Period: M2951 25 mg QD	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >0-25% Week 32	7 Participants
DBPC Period: M2951 25 mg QD	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >25- 50% Week 48	14 Participants
DBPC Period: M2951 25 mg QD	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >50-100% Week 40	15 Participants
DBPC Period: M2951 25 mg QD	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >25- 50% Week 32	11 Participants
DBPC Period: M2951 25 mg QD	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Increased from Baseline Week 52	0 Participants
DBPC Period: M2951 25 mg QD	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >25- 50% Week 14	6 Participants
DBPC Period: M2951 25 mg QD	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >50-100% Week 44	15 Participants
DBPC Period: M2951 25 mg QD	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >0-25% Week 6	4 Participants
DBPC Period: M2951 25 mg QD	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Increased from Baseline Week 16	1 Participants
DBPC Period: M2951 25 mg QD	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >0-25% Week 12	11 Participants
DBPC Period: M2951 25 mg QD	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >50-100% Week 48	15 Participants
DBPC Period: M2951 25 mg QD	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >0-25% Week 40	5 Participants
DBPC Period: M2951 25 mg QD	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >25- 50% Week 16	12 Participants
DBPC Period: M2951 25 mg QD	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Increased from Baseline Week 24	0 Participants
DBPC Period: M2951 25 mg QD	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >50-100% Week 52	17 Participants
DBPC Period: M2951 25 mg QD	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >0-25% Week 36	5 Participants
DBPC Period: M2951 75 mg QD	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >50-100% Week 52	19 Participants
DBPC Period: M2951 75 mg QD	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Increased from Baseline Week 1	0 Participants
DBPC Period: M2951 75 mg QD	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >0-25% Week 36	4 Participants
DBPC Period: M2951 75 mg QD	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Increased from Baseline Week 2	0 Participants
DBPC Period: M2951 75 mg QD	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Increased from Baseline Week 4	1 Participants
DBPC Period: M2951 75 mg QD	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Increased from Baseline Week 6	0 Participants
DBPC Period: M2951 75 mg QD	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Increased from Baseline Week 8	1 Participants
DBPC Period: M2951 75 mg QD	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >0-25% Week 40	3 Participants
DBPC Period: M2951 75 mg QD	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Increased from Baseline Week 10	0 Participants
DBPC Period: M2951 75 mg QD	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >0-25% Week 6	3 Participants
DBPC Period: M2951 75 mg QD	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Increased from Baseline Week 12	1 Participants
DBPC Period: M2951 75 mg QD	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Increased from Baseline Week 14	0 Participants
DBPC Period: M2951 75 mg QD	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Increased from Baseline Week 16	1 Participants
DBPC Period: M2951 75 mg QD	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >0-25% Week 44	3 Participants
DBPC Period: M2951 75 mg QD	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Increased from Baseline Week 20	0 Participants
DBPC Period: M2951 75 mg QD	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Increased from Baseline Week 24	0 Participants
DBPC Period: M2951 75 mg QD	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Increased from Baseline Week 28	0 Participants
DBPC Period: M2951 75 mg QD	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Increased from Baseline Week 32	0 Participants
DBPC Period: M2951 75 mg QD	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Increased from Baseline Week 36	0 Participants
DBPC Period: M2951 75 mg QD	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >0-25% Week 48	4 Participants
DBPC Period: M2951 75 mg QD	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Increased from Baseline Week 40	0 Participants
DBPC Period: M2951 75 mg QD	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Increased from Baseline Week 44	0 Participants
DBPC Period: M2951 75 mg QD	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Increased from Baseline Week 48	0 Participants
DBPC Period: M2951 75 mg QD	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Increased from Baseline Week 52	0 Participants
DBPC Period: M2951 75 mg QD	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >0-25% Week 52	4 Participants
DBPC Period: M2951 75 mg QD	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >25- 50% Week 1	0 Participants
DBPC Period: M2951 75 mg QD	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >0-25% Week 8	5 Participants
DBPC Period: M2951 75 mg QD	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >25- 50% Week 2	0 Participants
DBPC Period: M2951 75 mg QD	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >25- 50% Week 4	1 Participants
DBPC Period: M2951 75 mg QD	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >25- 50% Week 6	2 Participants
DBPC Period: M2951 75 mg QD	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >25- 50% Week 8	6 Participants
DBPC Period: M2951 75 mg QD	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >0-25% Week 10	4 Participants
DBPC Period: M2951 75 mg QD	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >25- 50% Week 10	4 Participants
DBPC Period: M2951 75 mg QD	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >25- 50% Week 12	10 Participants
DBPC Period: M2951 75 mg QD	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >25- 50% Week 14	2 Participants
DBPC Period: M2951 75 mg QD	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >25- 50% Week 16	9 Participants
DBPC Period: M2951 75 mg QD	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >0-25% Week 12	8 Participants
DBPC Period: M2951 75 mg QD	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >25- 50% Week 20	8 Participants
DBPC Period: M2951 75 mg QD	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >0-25% Week 2	0 Participants
DBPC Period: M2951 75 mg QD	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >25- 50% Week 24	8 Participants
DBPC Period: M2951 75 mg QD	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >25- 50% Week 28	9 Participants
DBPC Period: M2951 75 mg QD	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >25- 50% Week 32	8 Participants
DBPC Period: M2951 75 mg QD	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >0-25% Week 14	4 Participants
DBPC Period: M2951 75 mg QD	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >25- 50% Week 36	6 Participants
DBPC Period: M2951 75 mg QD	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >25- 50% Week 40	6 Participants
DBPC Period: M2951 75 mg QD	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >25- 50% Week 44	6 Participants
DBPC Period: M2951 75 mg QD	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >25- 50% Week 48	6 Participants
DBPC Period: M2951 75 mg QD	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >0-25% Week 16	5 Participants
DBPC Period: M2951 75 mg QD	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >25- 50% Week 52	7 Participants
DBPC Period: M2951 75 mg QD	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >50-100% Week 1	0 Participants
DBPC Period: M2951 75 mg QD	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >50-100% Week 2	0 Participants
DBPC Period: M2951 75 mg QD	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >50-100% Week 4	0 Participants
DBPC Period: M2951 75 mg QD	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >0-25% Week 20	5 Participants
DBPC Period: M2951 75 mg QD	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >50-100% Week 6	0 Participants
DBPC Period: M2951 75 mg QD	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >50-100% Week 8	4 Participants
DBPC Period: M2951 75 mg QD	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >50-100% Week 10	3 Participants
DBPC Period: M2951 75 mg QD	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >50-100% Week 12	6 Participants
DBPC Period: M2951 75 mg QD	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >0-25% Week 24	5 Participants
DBPC Period: M2951 75 mg QD	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >50-100% Week 14	7 Participants
DBPC Period: M2951 75 mg QD	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >0-25% Week 4	2 Participants
DBPC Period: M2951 75 mg QD	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >50-100% Week 16	13 Participants
DBPC Period: M2951 75 mg QD	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >50-100% Week 20	14 Participants
DBPC Period: M2951 75 mg QD	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >50-100% Week 24	13 Participants
DBPC Period: M2951 75 mg QD	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >0-25% Week 28	5 Participants
DBPC Period: M2951 75 mg QD	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >50-100% Week 28	15 Participants
DBPC Period: M2951 75 mg QD	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >0-25% Week 1	0 Participants
DBPC Period: M2951 75 mg QD	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >50-100% Week 32	16 Participants
DBPC Period: M2951 75 mg QD	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >50-100% Week 36	18 Participants
DBPC Period: M2951 75 mg QD	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >50-100% Week 40	18 Participants
DBPC Period: M2951 75 mg QD	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >0-25% Week 32	4 Participants
DBPC Period: M2951 75 mg QD	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >50-100% Week 44	18 Participants
DBPC Period: M2951 75 mg QD	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >50-100% Week 48	19 Participants
DBPC Period: M2951 50 mg BID	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >50-100% Week 16	9 Participants
DBPC Period: M2951 50 mg BID	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >0-25% Week 1	0 Participants
DBPC Period: M2951 50 mg BID	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >0-25% Week 2	0 Participants
DBPC Period: M2951 50 mg BID	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >0-25% Week 4	1 Participants
DBPC Period: M2951 50 mg BID	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >0-25% Week 6	4 Participants
DBPC Period: M2951 50 mg BID	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >0-25% Week 8	6 Participants
DBPC Period: M2951 50 mg BID	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >0-25% Week 10	5 Participants
DBPC Period: M2951 50 mg BID	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >0-25% Week 12	6 Participants
DBPC Period: M2951 50 mg BID	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >0-25% Week 14	5 Participants
DBPC Period: M2951 50 mg BID	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >0-25% Week 16	6 Participants
DBPC Period: M2951 50 mg BID	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >0-25% Week 20	5 Participants
DBPC Period: M2951 50 mg BID	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >0-25% Week 24	5 Participants
DBPC Period: M2951 50 mg BID	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >0-25% Week 28	4 Participants
DBPC Period: M2951 50 mg BID	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >0-25% Week 32	3 Participants
DBPC Period: M2951 50 mg BID	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >0-25% Week 36	3 Participants
DBPC Period: M2951 50 mg BID	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >0-25% Week 40	3 Participants
DBPC Period: M2951 50 mg BID	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >0-25% Week 44	3 Participants
DBPC Period: M2951 50 mg BID	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >0-25% Week 48	3 Participants
DBPC Period: M2951 50 mg BID	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >0-25% Week 52	4 Participants
DBPC Period: M2951 50 mg BID	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >25- 50% Week 1	0 Participants
DBPC Period: M2951 50 mg BID	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >25- 50% Week 2	0 Participants
DBPC Period: M2951 50 mg BID	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >25- 50% Week 4	0 Participants
DBPC Period: M2951 50 mg BID	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >25- 50% Week 6	0 Participants
DBPC Period: M2951 50 mg BID	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >25- 50% Week 8	5 Participants
DBPC Period: M2951 50 mg BID	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >25- 50% Week 10	10 Participants
DBPC Period: M2951 50 mg BID	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >25- 50% Week 12	15 Participants
DBPC Period: M2951 50 mg BID	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >25- 50% Week 14	8 Participants
DBPC Period: M2951 50 mg BID	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >25- 50% Week 16	16 Participants
DBPC Period: M2951 50 mg BID	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >25- 50% Week 20	14 Participants
DBPC Period: M2951 50 mg BID	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >25- 50% Week 24	13 Participants
DBPC Period: M2951 50 mg BID	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >25- 50% Week 28	16 Participants
DBPC Period: M2951 50 mg BID	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >25- 50% Week 32	16 Participants
DBPC Period: M2951 50 mg BID	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >25- 50% Week 36	15 Participants
DBPC Period: M2951 50 mg BID	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >25- 50% Week 40	16 Participants
DBPC Period: M2951 50 mg BID	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >25- 50% Week 44	16 Participants
DBPC Period: M2951 50 mg BID	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >25- 50% Week 48	17 Participants
DBPC Period: M2951 50 mg BID	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >25- 50% Week 52	17 Participants
DBPC Period: M2951 50 mg BID	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >50-100% Week 1	0 Participants
DBPC Period: M2951 50 mg BID	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >50-100% Week 2	1 Participants
DBPC Period: M2951 50 mg BID	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >50-100% Week 4	1 Participants
DBPC Period: M2951 50 mg BID	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >50-100% Week 6	1 Participants
DBPC Period: M2951 50 mg BID	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >50-100% Week 8	3 Participants
DBPC Period: M2951 50 mg BID	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >50-100% Week 10	4 Participants
DBPC Period: M2951 50 mg BID	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >50-100% Week 12	6 Participants
DBPC Period: M2951 50 mg BID	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >50-100% Week 14	7 Participants
DBPC Period: M2951 50 mg BID	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Increased from Baseline Week 24	0 Participants
DBPC Period: M2951 50 mg BID	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >50-100% Week 20	11 Participants
DBPC Period: M2951 50 mg BID	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >50-100% Week 24	11 Participants
DBPC Period: M2951 50 mg BID	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >50-100% Week 28	11 Participants
DBPC Period: M2951 50 mg BID	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >50-100% Week 32	12 Participants
DBPC Period: M2951 50 mg BID	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >50-100% Week 36	11 Participants
DBPC Period: M2951 50 mg BID	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >50-100% Week 40	11 Participants
DBPC Period: M2951 50 mg BID	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >50-100% Week 44	10 Participants
DBPC Period: M2951 50 mg BID	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >50-100% Week 48	10 Participants
DBPC Period: M2951 50 mg BID	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Reduction of dose by >50-100% Week 52	12 Participants
DBPC Period: M2951 50 mg BID	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Increased from Baseline Week 1	0 Participants
DBPC Period: M2951 50 mg BID	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Increased from Baseline Week 2	0 Participants
DBPC Period: M2951 50 mg BID	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Increased from Baseline Week 4	0 Participants
DBPC Period: M2951 50 mg BID	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Increased from Baseline Week 6	0 Participants
DBPC Period: M2951 50 mg BID	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Increased from Baseline Week 8	0 Participants
DBPC Period: M2951 50 mg BID	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Increased from Baseline Week 10	0 Participants
DBPC Period: M2951 50 mg BID	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Increased from Baseline Week 12	0 Participants
DBPC Period: M2951 50 mg BID	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Increased from Baseline Week 14	0 Participants
DBPC Period: M2951 50 mg BID	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Increased from Baseline Week 16	0 Participants
DBPC Period: M2951 50 mg BID	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Increased from Baseline Week 20	0 Participants
DBPC Period: M2951 50 mg BID	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Increased from Baseline Week 28	1 Participants
DBPC Period: M2951 50 mg BID	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Increased from Baseline Week 32	1 Participants
DBPC Period: M2951 50 mg BID	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Increased from Baseline Week 36	1 Participants
DBPC Period: M2951 50 mg BID	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Increased from Baseline Week 40	1 Participants
DBPC Period: M2951 50 mg BID	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Increased from Baseline Week 44	1 Participants
DBPC Period: M2951 50 mg BID	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Increased from Baseline Week 48	1 Participants
DBPC Period: M2951 50 mg BID	DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Increased from Baseline Week 52	2 Participants

Secondary

DBPC Period: Number of Participants With Response Based on BILAG-Based Composite Lupus Assessment (BICLA) at Week 52

BICLA response defined as participants meeting following criteria: \[1\] At least one gradation of improvement in baseline BILAG scores in all body systems with moderate or severe disease activity at entry (example: all A (severe disease) scores falling to B (moderate), C (mild), or D (no activity) and all B scores falling to C or D; \[2\] No new BILAG A or more than one new BILAG B scores; \[3\] No worsening of total SLEDAI-2K score from baseline; \[4\] No significant deterioration (=\<10%) in physician's global assessment and \[5\] No treatment failure (initiation of non-protocol treatment).

Time frame: Week 52

Population: The mITT analysis set included all randomized participants who had received at least one dose of IMP (Evobrutinib or placebo) and have at least one Baseline and one post Baseline disease assessment among the following: SFI, SLEDAI 2K, PGA, BILAG 2004, CLASI. Here, Overall Number of Participants Analyzed signifies those participants who have at least 1 BILAG A or 2 BILAG B grades at Baseline (BICLA Subpopulation).

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
DBPC Period: Placebo	DBPC Period: Number of Participants With Response Based on BILAG-Based Composite Lupus Assessment (BICLA) at Week 52	30 Participants
DBPC Period: M2951 25 mg QD	DBPC Period: Number of Participants With Response Based on BILAG-Based Composite Lupus Assessment (BICLA) at Week 52	29 Participants
DBPC Period: M2951 75 mg QD	DBPC Period: Number of Participants With Response Based on BILAG-Based Composite Lupus Assessment (BICLA) at Week 52	33 Participants
DBPC Period: M2951 50 mg BID	DBPC Period: Number of Participants With Response Based on BILAG-Based Composite Lupus Assessment (BICLA) at Week 52	24 Participants

p-value: 0.906195% CI: [0.49, 1.88]Regression, Logistic

p-value: 0.605395% CI: [0.61, 2.31]Regression, Logistic

p-value: 0.5295% CI: [0.4, 1.59]Regression, Logistic

Secondary

DBPC Period: Number of Participants With Response Based on Systemic Lupus Erythematosus Responder Index 4 (SRI-4) at Week 52 in Serologically Active (SA) Subgroup

SRI-4 response was defined as greater than or equal to (\>=) 4-point reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) total score, no new British Isles Lupus Assessment Group (BILAG) A and no more than 1 new BILAG B domain score, no worsening (less than 10 percent increase) from baseline in Physician's Global Assessment of Disease Activity (PGA) and no treatment failure. SLEDAI-2K assessment consists of 24 items with total score of 0(no symptoms) to 105 (presence of all defined symptoms) with higher scores representing increased disease activity. BILAG Index: assessing clinical signs, symptoms, or laboratory parameters related to Systemic Lupus Erythematosus (SLE), divided into 9 organ systems. For each organ system A=severe disease, B=moderate disease, C=mild stable disease, D=inactive, but previously active, E=inactive and never affected. The PGA assess disease activity on a visual analogue scale =from 0(very well) to 100(very poor).

Time frame: Week 52

Population: The mITT analysis set included all randomized participants who had received at least one dose of IMP (Evobrutinib or placebo) and have at least one Baseline and one post Baseline disease assessment among the following: SFI, SLEDAI 2K, PGA, BILAG 2004, CLASI. Here, Overall Number of Participants Analyzed signifies those participants with positive anti-double-stranded deoxyribonucleic acid (antidsDNA) and/or low complement levels at screening (Serologically active subgroup).

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
DBPC Period: Placebo	DBPC Period: Number of Participants With Response Based on Systemic Lupus Erythematosus Responder Index 4 (SRI-4) at Week 52 in Serologically Active (SA) Subgroup	28 Participants
DBPC Period: M2951 25 mg QD	DBPC Period: Number of Participants With Response Based on Systemic Lupus Erythematosus Responder Index 4 (SRI-4) at Week 52 in Serologically Active (SA) Subgroup	38 Participants
DBPC Period: M2951 75 mg QD	DBPC Period: Number of Participants With Response Based on Systemic Lupus Erythematosus Responder Index 4 (SRI-4) at Week 52 in Serologically Active (SA) Subgroup	29 Participants
DBPC Period: M2951 50 mg BID	DBPC Period: Number of Participants With Response Based on Systemic Lupus Erythematosus Responder Index 4 (SRI-4) at Week 52 in Serologically Active (SA) Subgroup	34 Participants

p-value: 0.546295% CI: [0.74, 3.15]Regression, Logistic

p-value: 0.546295% CI: [0.49, 2.13]Regression, Logistic

p-value: 0.546295% CI: [0.65, 2.81]Regression, Logistic

Secondary

DBPC Period: Number of Participants With Response Based on Systemic Lupus Erythematosus Responder Index 6 (SRI-6) at Week 52 in Serologically Active Subgroup

Time frame: Week 52

Population: The mITT analysis set included all randomized participants who had received at least one dose of IMP (Evobrutinib or placebo) and have at least one Baseline and one post Baseline disease assessment among the following: SFI, SLEDAI 2K, PGA, BILAG 2004, CLASI. Here, Overall Number of Participants Analyzed signifies those participants with positive anti-double-stranded deoxyribonucleic acid (antidsDNA) and/or low complement levels at screening (Serologically active subgroup).

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
DBPC Period: Placebo	DBPC Period: Number of Participants With Response Based on Systemic Lupus Erythematosus Responder Index 6 (SRI-6) at Week 52 in Serologically Active Subgroup	17 Participants
DBPC Period: M2951 25 mg QD	DBPC Period: Number of Participants With Response Based on Systemic Lupus Erythematosus Responder Index 6 (SRI-6) at Week 52 in Serologically Active Subgroup	25 Participants
DBPC Period: M2951 75 mg QD	DBPC Period: Number of Participants With Response Based on Systemic Lupus Erythematosus Responder Index 6 (SRI-6) at Week 52 in Serologically Active Subgroup	23 Participants
DBPC Period: M2951 50 mg BID	DBPC Period: Number of Participants With Response Based on Systemic Lupus Erythematosus Responder Index 6 (SRI-6) at Week 52 in Serologically Active Subgroup	23 Participants

p-value: 0.243495% CI: [0.73, 3.54]Regression, Logistic

p-value: 0.238995% CI: [0.73, 3.63]Regression, Logistic

p-value: 0.195295% CI: [0.76, 3.85]Regression, Logistic

Secondary

DBPC Period: Time to First British Isles Lupus Assessment Group (BILAG) A or 2B Moderate to Severe Flare

BILAG Index: assessing clinical signs, symptoms, or laboratory parameters related to SLE, divided into 9 organ systems. For each organ system based on alphabetic score: A=severe disease, B=moderate disease, C=mild stable disease, D=inactive, but previously active, E=inactive and never affected. BILAG evaluated by scoring each of a list of signs and symptoms as: improving (1); same (2); worse (3); new (4); not present (0); not done (ND). Total BILAG score is sum of scores of 9 domains where A=12, B=8, C=1, D=0, and E=0. Total score ranges from 0 to 108 with a higher score indicating greater lupus activity. A Moderate to Severe (BILAG A or 2B) flare is defined as at least one BILAG A (severe disease activity) grade or two BILAG B (moderate disease activity) grade in any organ system due to items that are new or worse, compared to the BILAG evaluation at the previous visit, during the 52 week treatment. It was measured using Kaplan-Meier (KM) estimates.

Time frame: Baseline up to Week 56

Population: The mITT analysis set included all randomized participants who had received at least one dose of IMP (Evobrutinib or placebo) and have at least one Baseline and one post Baseline disease assessment among the following: SFI, SLEDAI 2K, PGA, BILAG 2004, CLASI. Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure.

Arm	Measure	Value (MEDIAN)
DBPC Period: Placebo	DBPC Period: Time to First British Isles Lupus Assessment Group (BILAG) A or 2B Moderate to Severe Flare	NA Days
DBPC Period: M2951 25 mg QD	DBPC Period: Time to First British Isles Lupus Assessment Group (BILAG) A or 2B Moderate to Severe Flare	NA Days
DBPC Period: M2951 75 mg QD	DBPC Period: Time to First British Isles Lupus Assessment Group (BILAG) A or 2B Moderate to Severe Flare	NA Days
DBPC Period: M2951 50 mg BID	DBPC Period: Time to First British Isles Lupus Assessment Group (BILAG) A or 2B Moderate to Severe Flare	NA Days

p-value: 0.098795% CI: [0.87, 2.89]Cox proportional hazards model

p-value: 0.920195% CI: [0.51, 1.85]Cox proportional hazards model

p-value: 0.564595% CI: [0.6, 2.2]Cox proportional hazards model

Secondary

DBPC Period: Time to First Severe British Isles Lupus Assessment Group (BILAG) A Flare

BILAG Index: assessing clinical signs, symptoms, or laboratory parameters related to SLE, divided into 9 organ systems. For each organ system based on alphabetic score: A=severe disease, B=moderate disease, C=mild stable disease, D=inactive, but previously active, E=inactive and never affected. BILAG evaluated by scoring each of a list of signs and symptoms as: improving (1); same (2); worse (3); new (4); not present (0); not done (ND). Total BILAG score is sum of scores of 9 domains where A=12, B=8, C=1, D=0, and E=0. Total score ranges from 0 to 108 with a higher score indicating greater lupus activity. Time to first severe flare, where a severe flare is defined as at least one BILAG A (Severe disease activity) score in any organ system due to items that are new or worse, compared to the BILAG evaluation at the previous visit, during the 52-Week Treatment. It was measured using Kaplan-Meier (KM) estimates.

Time frame: Baseline up to Week 56

Population: The mITT analysis set included all randomized participants who had received at least one dose of IMP (Evobrutinib or placebo) and have at least one Baseline and one post Baseline disease assessment among the following: SFI, SLEDAI 2K, PGA, BILAG 2004, CLASI. Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure.

Arm	Measure	Value (MEDIAN)
DBPC Period: Placebo	DBPC Period: Time to First Severe British Isles Lupus Assessment Group (BILAG) A Flare	NA Days
DBPC Period: M2951 25 mg QD	DBPC Period: Time to First Severe British Isles Lupus Assessment Group (BILAG) A Flare	NA Days
DBPC Period: M2951 75 mg QD	DBPC Period: Time to First Severe British Isles Lupus Assessment Group (BILAG) A Flare	NA Days
DBPC Period: M2951 50 mg BID	DBPC Period: Time to First Severe British Isles Lupus Assessment Group (BILAG) A Flare	NA Days

p-value: 0.703495% CI: [0.57, 2.4]Cox proportional hazards model

p-value: 0.546295% CI: [0.31, 1.52]Cox proportional hazards model

p-value: 0.546295% CI: [0.42, 1.97]Cox proportional hazards model

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026

A Phase II Study of M2951 in SLE

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Brief summary

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Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

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Participant flow

Recruitment details

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 12

DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 2

DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 24

DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 36

DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 4

DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 52

DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 56

DBPC Period: Change From Baseline in Total B Cell Count at Week 24

DBPC Period: Change From Baseline in Total B Cell Count at Week 4

DBPC Period: Change From Baseline in Total B Cell Count at Week 52

DBPC Period: Change From Baseline in Total B Cell Count at Week 56

DBPC Period: Mean Absolute Total B Cell Count at Week 24

DBPC Period: Mean Absolute Total B Cell Count at Week 4

DBPC Period: Mean Absolute Total B Cell Count at Week 52

DBPC Period: Mean Absolute Total B Cell Count at Week 56

DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 12

DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 2

DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 24

DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 36

DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 4

DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 52

DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 56

DBPC Period: Number of Participants With Clinically Significant Change From Baseline in Vital Signs

DBPC Period: Number of Participants With Clinically Significant Changes From Baseline in 12-Lead Electrocardiogram (ECG) Findings

DBPC Period: Number of Participants With Clinically Significant Changes From Baseline in Laboratory Parameters

DBPC Period: Number of Participants With Response Based on Systemic Lupus Erythematosus Responder Index 4 (SRI-4) at Week 52

DBPC Period: Number of Participants With Response Based on Systemic Lupus Erythematosus Responder Index 6 (SRI-6) at Week 52

DBPC Period: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs According to National Cancer Institute-Common Terminology Criteria for Adverse Events Version 4.03 (NCI-CTCAE v4.03)

DBPC Period: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) by Severity According to National Cancer Institute-Common Terminology Criteria for Adverse Events Version 4.03 (NCI-CTCAE v4.03)

DBPC Period: Annualized Flare Rate

DBPC Period: Change From Baseline in British Isles Lupus Assessment Group (BILAG)-2004 Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

DBPC Period: Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

DBPC Period: Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Health Outcome Questionnaire at Week 4, 8, 12, 16, 24, 32, 40 and 52

DBPC Period: Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Visual Analog Scale (VAS) at Week 4, 8, 12, 16, 24, 32, 40 and 52

DBPC Period: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 4, 8, 12, 16, 24, 32, 40 and 52

DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52

DBPC Period: Change From Baseline in Physician's Global Assessment (PGA) Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

DBPC Period: Change From Baseline in Study 36-Item Short Form Health Survey Version 2 (SF-36v2) Physical Component Summary Score and Mental Component Summary Scores at Week 4, 8, 12, 16, 24, 32, 40 and 52

DBPC Period: Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

DBPC Period: Change From Baseline to Week 52 in Prednisone Equivalent Corticosteroid (CS) Daily Dose at at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

DBPC Period: Cumulative Prednisone Equivalent Corticosteroid (CS) Dose at Week 52

DBPC Period: Number of Participants With a Sustained Reduction of Oral Corticosteroids (OCS) Dose to 7.5 mg Prednisone Equivalent Per Day or Less With Response Based on SRI-4 at Week 52 in Serologically Active Subgroup

DBPC Period: Number of Participants With a Sustained Reduction of Oral Corticosteroids (OCS) Dose to 7.5 mg Prednisone Equivalent Per Day or Less With Response Based on Systemic Lupus Erythematosus Responder Index 4 (SRI-4) at Week 52

DBPC Period: Number of Participants With a Sustained Reduction of Oral Corticosteroids (OCS) Dose to 7.5 mg Prednisone Equivalent Per Day or Less With Response Based on Systemic Lupus Erythematosus Responder Index 6 (SRI-6) at Week 52

DBPC Period: Number of Participants With British Isles Lupus Assessment Group (BILAG) 2004 Flare-Free Status During the 52-Week Treatment Period

DBPC Period: Number of Participants With Change From Baseline in Prednisone Equivalent Corticosteroid (CS) Dose by >=25% to a Dose of <=7.5 Milligram Per Day (mg/Day), With no BILAG A or 2B Flare in Disease Activity at Week 52

DBPC Period: Number of Participants With Low Disease Activity Status, Defined by Clinical Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) Score of Less Than or Equal (<= ) 2 at Week 52

DBPC Period: Number of Participants With Low Disease Activity Status, Defined by Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) Score of Less Than or Equal (<= ) 2 at Week 52

DBPC Period: Number of Participants With Lupus Low Disease Activity State (LLDAS) at Week 52

DBPC Period: Number of Participants With Patient Global Impression of Change (PGIC) Scale Score of Any Improvement, no Change and Any Worsening

DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

DBPC Period: Number of Participants With Response Based on BILAG-Based Composite Lupus Assessment (BICLA) at Week 52

DBPC Period: Number of Participants With Response Based on Systemic Lupus Erythematosus Responder Index 4 (SRI-4) at Week 52 in Serologically Active (SA) Subgroup

DBPC Period: Number of Participants With Response Based on Systemic Lupus Erythematosus Responder Index 6 (SRI-6) at Week 52 in Serologically Active Subgroup

DBPC Period: Time to First British Isles Lupus Assessment Group (BILAG) A or 2B Moderate to Severe Flare

DBPC Period: Time to First Severe British Isles Lupus Assessment Group (BILAG) A Flare