Systemic Lupus Erythematosus
Conditions
Keywords
SLE, Systemic Lupus Erythematosus, Sifalimumab, MEDI-545
Brief summary
To evaluate the efficacy and safety of sifalimumab compared to placebo in subjects with moderately to severely active Systemic Lupus Erythematosus (SLE).
Detailed description
This is a Phase 2b, multinational, multicenter, randomized, double-blind, placebo controlled, parallel group study to evaluate the efficacy and safety of three intravenous (IV) treatment regimens of sifalimumab (200, 600, or 1,200 mg) in adult subjects with chronic moderately-to-severely active SLE with an inadequate response to standard of care (SOC) for SLE.
Interventions
BIOLOGICALSifalimumab 200 mg
Sifalimumab 200 mg intravenously every 2 weeks for 4 weeks and then monthly for 44 weeks for a total of 14 doses.
BIOLOGICALSifalimumab 600 mg
Sifalimumab 600 mg intravenously every 2 weeks for 4 weeks and then monthly for 44 weeks for a total of 14 doses.
BIOLOGICALSifalimumab 1,200 mg
Sifalimumab 1,200 mg intravenously every 2 weeks for 4 weeks and then monthly for 44 weeks for a total of 14 doses.
OTHERPlacebo
IV Placebo every 2 weeks for 4 weeks and then monthly for 44 weeks
Sponsors
MedImmune LLC
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
No
Inclusion criteria
- Fulfills at least 4 of American College of Rheumatology (ACR) criteria for systemic lupus erythematosus (SLE) including a positive antinuclear antibody (ANA) or elevated ds-deoxyribonucleic acid (DNA) or Sm antibody at screening - Disease history of SLE greater than or equal to (\>=) 24 weeks at screening - Weight more than (\>) 40 kilogram (kg) - Currently receiving stable dose of oral prednisone and/or antimalarials/immunosuppressives - Active moderate to severe SLE disease based on SLE disease activity score (SLEDAI) and British Isles Lupus Assessment Group Index (BILAG) and Physicians Global Assessment - No evidence of cervical malignancy on PAP within 6 months of randomization - Female subjects must be willing to avoid pregnancy - Negative TB test or newly positive TB test due to latent TB for which treatment must be initiated at or before randomization.
Exclusion criteria
- Active severe SLE-driven renal disease or unstable renal disease prior to screening - Active severe or unstable neuropsychiatric SLE - Clinically significant active infection including ongoing and chronic infections - History of human immunodeficiency virus (HIV) - Confirmed Positive tests for Hepatitis B or positive test for hepatitis C - History of severe herpes infection such as herpes encephalitis, ophthalmic herpes, disseminated herpes - Herpes Zoster within 3 months of screening - History of cancer other than basal cancer or cervical cancer treated with apparent success \>=1 year prior to randomization - Receipt of a biologic agent within 5 half-lives or prior to loss of pharmacodynamic and/or clinical effect (whichever is longer) prior to screening - Live or attenuated vaccine within 4 weeks prior to screening - Subjects with substance abuse - Subjects with significant hematologic abnormalities.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving a Response in Systemic Lupus Erythematosus Responder Index 4 (SRI [4]) | Day 365 | SRI (4) responder is defined as: 1) a reduction in baseline Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) disease activity score of greater than or equal to (\>=) 4 points (with increased deoxyribonucleic acid \[DNA\] binding item of SLEDAI-2K score based on the ANA Multi-Lyte® ANA-II Plus Test System); 2) no worsening in Physician Global Assessment (MDGA) (worsening is defined as an increase of \>=0.3 from baseline on a 0-3 visual analogue scale) and 3) no worsening in British Isles Lupus Assessment Group (BILAG-2004) (worsening is defined as at least 1 new 'A' score or 2 new 'B' scores on the BILAG-2004 compared with baseline). |
| Percentage of Participants Achieving a Positive Response in SRI (4) in 4-Gene Interferon Test High Participants | Day 365 | SRI (4) responder is defined as: 1) a reduction in baseline SLEDAI-2K disease activity score of \>=4 points (with increased DNA binding item of SLEDAI-2K score based on the ANA Multi-Lyte® ANA-II Plus Test System); 2) no worsening in Physician Global Assessment (MDGA) (worsening is defined as an increase of \>=0.3 from baseline on a 0-3 visual analogue scale) and 3) no worsening in BILAG-2004 (worsening is defined as at least 1 new 'A' score or 2 new 'B' scores on the BILAG-2004 compared with baseline). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Achieved a Greater Than 3-Point Improvement in the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale | Day 365 | FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (not at all) to 4 (very much). Larger the participant's response to the questions (with the exception of 2 negatively stated), greater was the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (TESAEs) | Day 1 up to Week 74 | An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent defined as events present at baseline that worsened in intensity after administration of investigational product or events absent at baseline that emerged after administration of investigational product, for the period extending until the end of participant participation in the study. |
| Percentage of Participants on Greater Than or Equal to 10 mg/Day Oral Prednisone (or Equivalent) at Baseline Who Were Able to Reduce to Less Than or Equal to (<=) 7.5 mg/Day | Day 365 | Percentage of participants on \>=10 mg/day oral corticosteroids (OCS) at baseline who were able to taper it to \<=7.5 mg/day by Day 365 were recorded. |
| Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs) | Day 1 up to Week 61 | Vital sign assessments included blood pressure, pulse rate, temperature, weight and respiratory rate. Vital signs abnormalities recorded as TEAEs were reported. |
| Number of Participants With Abnormal Electrocardiogram (ECG) Findings Reported as TEAEs | Day 1 up to Week 56 | The 12-lead ECG data were summarized and evaluated. Number of participants with clinically significant abnormal ECG findings as assessed by cardiologist were recorded and reported as TEAEs. |
| Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Day 1 up to Week 61 | Laboratory investigations included hematology, serum chemistries and urinalysis parameters. Participants with clinically significant abnormalities in these laboratory investigations recorded as TEAEs were reported. |
| Percentage of Participants With a Cutaneous Lupus Erythematosus Disease Activity and Severity Index (CLASI) Activity Score Greater Than or Equal to (>=) 10 at Baseline Who Achieved a >= 4-point Reduction | Day 365 | The CLASI consists of two scores, the first summarizes the activity of the disease while the second is a measure of the damage done by the disease. Activity is scored on the basis of erythema, scale/hyperkeratosis, mucous membrane involvement, acute hair loss and non-scarring alopecia. Damage is scored in terms of dyspigmentation and scarring, including scarring alopecia. The percentage of participants with a CLASI activity score \>=10 at baseline who achieved a clinically significant (\>=4-point) reduction at Day 365 were reported. |
Countries
Argentina, Brazil, Bulgaria, Canada, Chile, France, Germany, Hungary, India, Italy, Jamaica, Mexico, Netherlands, Peru, Philippines, Poland, Romania, South Africa, Spain, Thailand, United Kingdom, United States
Participant flow
Pre-assignment details
A total of 834 participants were screened out of which 402 participants did not meet eligibility criteria and were considered screen failures, and 432 participants were randomized into the study.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Placebo matching to sifalimumab administered by intravenous infusion at a fixed dose of every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses. | 108 |
| Sifalimumab 200 Milligram (mg) Sifalimumab 200 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses. | 108 |
| Sifalimumab 600 mg Sifalimumab 600 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses. | 109 |
| Sifalimumab 1,200 mg Sifalimumab 1,200 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses. | 107 |
| Total | 432 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Death | 2 | 0 | 2 | 2 |
| Overall Study | Early termination due to AE/SAE | 1 | 1 | 0 | 0 |
| Overall Study | Lack of Efficacy | 1 | 2 | 2 | 1 |
| Overall Study | Lost to Follow-up | 5 | 2 | 3 | 1 |
| Overall Study | Missed follow-up visit | 0 | 1 | 2 | 2 |
| Overall Study | Participant randomized in error | 0 | 0 | 1 | 0 |
| Overall Study | Participant's refusal to continue | 0 | 3 | 1 | 1 |
| Overall Study | Pregnancy | 0 | 1 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 8 | 8 | 6 | 8 |
Baseline characteristics
| Characteristic | Placebo | Sifalimumab 200 Milligram (mg) | Sifalimumab 600 mg | Sifalimumab 1,200 mg | Total |
|---|---|---|---|---|---|
| Age, Continuous | 38.4 years STANDARD_DEVIATION 12.3 | 39.9 years STANDARD_DEVIATION 11.4 | 40.1 years STANDARD_DEVIATION 11.3 | 39.4 years STANDARD_DEVIATION 12.1 | 39.4 years STANDARD_DEVIATION 11.7 |
| Sex: Female, Male Female | 101 Participants | 103 Participants | 98 Participants | 97 Participants | 399 Participants |
| Sex: Female, Male Male | 7 Participants | 5 Participants | 11 Participants | 10 Participants | 33 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 93 / 108 | 94 / 108 | 96 / 108 | 92 / 107 |
| serious Total, serious adverse events | 19 / 108 | 16 / 108 | 22 / 108 | 21 / 107 |
Outcome results
Primary
Percentage of Participants Achieving a Positive Response in SRI (4) in 4-Gene Interferon Test High Participants
SRI (4) responder is defined as: 1) a reduction in baseline SLEDAI-2K disease activity score of \>=4 points (with increased DNA binding item of SLEDAI-2K score based on the ANA Multi-Lyte® ANA-II Plus Test System); 2) no worsening in Physician Global Assessment (MDGA) (worsening is defined as an increase of \>=0.3 from baseline on a 0-3 visual analogue scale) and 3) no worsening in BILAG-2004 (worsening is defined as at least 1 new 'A' score or 2 new 'B' scores on the BILAG-2004 compared with baseline).
Time frame: Day 365
Population: The mITT population included all randomized participants who received any investigational product and had a baseline primary efficacy measurement. Here, N signifies number of participants with positive diagnostic test.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants Achieving a Positive Response in SRI (4) in 4-Gene Interferon Test High Participants | 42.0 percentage of participants |
| Sifalimumab 200 Milligram (mg) | Percentage of Participants Achieving a Positive Response in SRI (4) in 4-Gene Interferon Test High Participants | 57.5 percentage of participants |
| Sifalimumab 600 mg | Percentage of Participants Achieving a Positive Response in SRI (4) in 4-Gene Interferon Test High Participants | 50.0 percentage of participants |
| Sifalimumab 1,200 mg | Percentage of Participants Achieving a Positive Response in SRI (4) in 4-Gene Interferon Test High Participants | 57.5 percentage of participants |
p-value: 0.04290% CI: [1.13, 3.14]Regression, Logistic
p-value: 0.26490% CI: [0.85, 2.35]Regression, Logistic
p-value: 0.03890% CI: [1.14, 3.19]Regression, Logistic
Primary
Percentage of Participants Achieving a Response in Systemic Lupus Erythematosus Responder Index 4 (SRI [4])
SRI (4) responder is defined as: 1) a reduction in baseline Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) disease activity score of greater than or equal to (\>=) 4 points (with increased deoxyribonucleic acid \[DNA\] binding item of SLEDAI-2K score based on the ANA Multi-Lyte® ANA-II Plus Test System); 2) no worsening in Physician Global Assessment (MDGA) (worsening is defined as an increase of \>=0.3 from baseline on a 0-3 visual analogue scale) and 3) no worsening in British Isles Lupus Assessment Group (BILAG-2004) (worsening is defined as at least 1 new 'A' score or 2 new 'B' scores on the BILAG-2004 compared with baseline).
Time frame: Day 365
Population: The modified intent-to-treat (mITT) population included all randomized participants who received any investigational product and had a baseline primary efficacy measurement.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants Achieving a Response in Systemic Lupus Erythematosus Responder Index 4 (SRI [4]) | 45.4 percentage of participants |
| Sifalimumab 200 Milligram (mg) | Percentage of Participants Achieving a Response in Systemic Lupus Erythematosus Responder Index 4 (SRI [4]) | 58.3 percentage of participants |
| Sifalimumab 600 mg | Percentage of Participants Achieving a Response in Systemic Lupus Erythematosus Responder Index 4 (SRI [4]) | 56.5 percentage of participants |
| Sifalimumab 1,200 mg | Percentage of Participants Achieving a Response in Systemic Lupus Erythematosus Responder Index 4 (SRI [4]) | 59.8 percentage of participants |
p-value: 0.05790% CI: [1.03, 2.71]Regression, Logistic
p-value: 0.09490% CI: [1.01, 2.54]Regression, Logistic
p-value: 0.03190% CI: [1.16, 2.94]Regression, Logistic
Secondary
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs)
Laboratory investigations included hematology, serum chemistries and urinalysis parameters. Participants with clinically significant abnormalities in these laboratory investigations recorded as TEAEs were reported.
Time frame: Day 1 up to Week 61
Population: The safety population included all participants who received any investigational product.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Lymphopenia | 1 participants |
| Placebo | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | White blood cell count increased | 3 participants |
| Placebo | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Neutrophil count increased | 3 participants |
| Placebo | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Iron deficiency anaemia | 1 participants |
| Placebo | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Haemoglobin decreased | 0 participants |
| Placebo | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Lymphocyte count decreased | 2 participants |
| Placebo | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | White blood cell count decreased | 1 participants |
| Placebo | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Autoimmune haemolytic anaemia | 1 participants |
| Placebo | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Eosinophilia | 0 participants |
| Placebo | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Haematocrit increased | 0 participants |
| Placebo | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Haemoglobin increased | 0 participants |
| Placebo | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Leukopenia | 0 participants |
| Placebo | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Anaemia | 1 participants |
| Placebo | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Neutropenia | 3 participants |
| Placebo | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Neutrophil count decreased | 1 participants |
| Placebo | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Platelet count increased | 0 participants |
| Placebo | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Red blood cell count decreased | 0 participants |
| Placebo | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Thrombocytopenia | 0 participants |
| Placebo | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Platelet count decreased | 2 participants |
| Placebo | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Monocyte count increased | 1 participants |
| Placebo | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Hypokalaemia | 4 participants |
| Placebo | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Alanine aminotransferase increased | 5 participants |
| Placebo | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Gamma-glutamyltransferase increased | 5 participants |
| Placebo | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Hypertriglyceridaemia | 2 participants |
| Placebo | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Dyslipidaemia | 2 participants |
| Placebo | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Hepatic enzyme increased | 2 participants |
| Placebo | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Aspartate aminotransferase increased | 2 participants |
| Placebo | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Blood creatine phosphokinase increased | 2 participants |
| Placebo | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Blood creatinine increased | 0 participants |
| Placebo | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Blood glucose increased | 1 participants |
| Placebo | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Hyperglycaemia | 1 participants |
| Placebo | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Transaminases increased | 1 participants |
| Placebo | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Blood potassium decreased | 0 participants |
| Placebo | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Low density lipoprotein increased | 0 participants |
| Placebo | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Blood albumin decreased | 0 participants |
| Placebo | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Blood alkaline phosphatase decreased | 1 participants |
| Placebo | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Blood calcium increased | 1 participants |
| Placebo | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Blood cholesterol increased | 0 participants |
| Placebo | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Blood homocysteine increased | 0 participants |
| Placebo | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Liver function test abnormal | 1 participants |
| Placebo | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Hyperlipidaemia | 0 participants |
| Placebo | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Hypoalbuminaemia | 2 participants |
| Placebo | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Hypoglycaemia | 0 participants |
| Placebo | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Blood bilirubin increased | 1 participants |
| Placebo | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Hypocalcaemia | 1 participants |
| Placebo | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Blood triglycerides increased | 1 participants |
| Placebo | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Hyperbilirubinaemia | 0 participants |
| Placebo | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Hypertransaminasaemia | 0 participants |
| Sifalimumab 200 Milligram (mg) | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Lymphopenia | 1 participants |
| Sifalimumab 200 Milligram (mg) | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Dyslipidaemia | 0 participants |
| Sifalimumab 200 Milligram (mg) | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Red blood cell count decreased | 0 participants |
| Sifalimumab 200 Milligram (mg) | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Hypertransaminasaemia | 0 participants |
| Sifalimumab 200 Milligram (mg) | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Hypoglycaemia | 0 participants |
| Sifalimumab 200 Milligram (mg) | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Hepatic enzyme increased | 2 participants |
| Sifalimumab 200 Milligram (mg) | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Autoimmune haemolytic anaemia | 1 participants |
| Sifalimumab 200 Milligram (mg) | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Blood alkaline phosphatase decreased | 0 participants |
| Sifalimumab 200 Milligram (mg) | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | White blood cell count decreased | 0 participants |
| Sifalimumab 200 Milligram (mg) | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Aspartate aminotransferase increased | 1 participants |
| Sifalimumab 200 Milligram (mg) | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Hyperlipidaemia | 0 participants |
| Sifalimumab 200 Milligram (mg) | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Blood albumin decreased | 0 participants |
| Sifalimumab 200 Milligram (mg) | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Low density lipoprotein increased | 1 participants |
| Sifalimumab 200 Milligram (mg) | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Blood creatine phosphokinase increased | 0 participants |
| Sifalimumab 200 Milligram (mg) | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Thrombocytopenia | 1 participants |
| Sifalimumab 200 Milligram (mg) | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Hypocalcaemia | 0 participants |
| Sifalimumab 200 Milligram (mg) | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Blood potassium decreased | 1 participants |
| Sifalimumab 200 Milligram (mg) | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Blood creatinine increased | 1 participants |
| Sifalimumab 200 Milligram (mg) | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Haemoglobin increased | 0 participants |
| Sifalimumab 200 Milligram (mg) | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Transaminases increased | 0 participants |
| Sifalimumab 200 Milligram (mg) | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Blood bilirubin increased | 0 participants |
| Sifalimumab 200 Milligram (mg) | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Blood glucose increased | 0 participants |
| Sifalimumab 200 Milligram (mg) | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Lymphocyte count decreased | 1 participants |
| Sifalimumab 200 Milligram (mg) | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Hyperglycaemia | 0 participants |
| Sifalimumab 200 Milligram (mg) | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Leukopenia | 1 participants |
| Sifalimumab 200 Milligram (mg) | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Platelet count decreased | 0 participants |
| Sifalimumab 200 Milligram (mg) | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Neutrophil count decreased | 0 participants |
| Sifalimumab 200 Milligram (mg) | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Blood cholesterol increased | 0 participants |
| Sifalimumab 200 Milligram (mg) | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Haemoglobin decreased | 1 participants |
| Sifalimumab 200 Milligram (mg) | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Monocyte count increased | 0 participants |
| Sifalimumab 200 Milligram (mg) | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Liver function test abnormal | 0 participants |
| Sifalimumab 200 Milligram (mg) | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Blood triglycerides increased | 0 participants |
| Sifalimumab 200 Milligram (mg) | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Hyperbilirubinaemia | 0 participants |
| Sifalimumab 200 Milligram (mg) | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Hypokalaemia | 1 participants |
| Sifalimumab 200 Milligram (mg) | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Haematocrit increased | 0 participants |
| Sifalimumab 200 Milligram (mg) | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Iron deficiency anaemia | 2 participants |
| Sifalimumab 200 Milligram (mg) | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Hypoalbuminaemia | 0 participants |
| Sifalimumab 200 Milligram (mg) | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Alanine aminotransferase increased | 1 participants |
| Sifalimumab 200 Milligram (mg) | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Blood homocysteine increased | 0 participants |
| Sifalimumab 200 Milligram (mg) | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Neutrophil count increased | 1 participants |
| Sifalimumab 200 Milligram (mg) | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Platelet count increased | 0 participants |
| Sifalimumab 200 Milligram (mg) | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Gamma-glutamyltransferase increased | 0 participants |
| Sifalimumab 200 Milligram (mg) | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Neutropenia | 0 participants |
| Sifalimumab 200 Milligram (mg) | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | White blood cell count increased | 1 participants |
| Sifalimumab 200 Milligram (mg) | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Blood calcium increased | 0 participants |
| Sifalimumab 200 Milligram (mg) | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Hypertriglyceridaemia | 1 participants |
| Sifalimumab 200 Milligram (mg) | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Eosinophilia | 0 participants |
| Sifalimumab 200 Milligram (mg) | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Anaemia | 4 participants |
| Sifalimumab 600 mg | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Red blood cell count decreased | 0 participants |
| Sifalimumab 600 mg | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Lymphopenia | 0 participants |
| Sifalimumab 600 mg | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Neutropenia | 0 participants |
| Sifalimumab 600 mg | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Liver function test abnormal | 1 participants |
| Sifalimumab 600 mg | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Neutrophil count decreased | 0 participants |
| Sifalimumab 600 mg | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Platelet count increased | 1 participants |
| Sifalimumab 600 mg | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Hypertransaminasaemia | 1 participants |
| Sifalimumab 600 mg | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Thrombocytopenia | 0 participants |
| Sifalimumab 600 mg | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Hyperlipidaemia | 0 participants |
| Sifalimumab 600 mg | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Platelet count decreased | 0 participants |
| Sifalimumab 600 mg | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Monocyte count increased | 0 participants |
| Sifalimumab 600 mg | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Hypokalaemia | 4 participants |
| Sifalimumab 600 mg | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Alanine aminotransferase increased | 1 participants |
| Sifalimumab 600 mg | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Hypoalbuminaemia | 1 participants |
| Sifalimumab 600 mg | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Gamma-glutamyltransferase increased | 1 participants |
| Sifalimumab 600 mg | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Hypertriglyceridaemia | 1 participants |
| Sifalimumab 600 mg | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Hyperbilirubinaemia | 1 participants |
| Sifalimumab 600 mg | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Dyslipidaemia | 2 participants |
| Sifalimumab 600 mg | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Hepatic enzyme increased | 2 participants |
| Sifalimumab 600 mg | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Hypoglycaemia | 0 participants |
| Sifalimumab 600 mg | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Aspartate aminotransferase increased | 0 participants |
| Sifalimumab 600 mg | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Blood creatine phosphokinase increased | 2 participants |
| Sifalimumab 600 mg | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Blood creatinine increased | 0 participants |
| Sifalimumab 600 mg | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Blood glucose increased | 0 participants |
| Sifalimumab 600 mg | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Blood bilirubin increased | 0 participants |
| Sifalimumab 600 mg | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Hyperglycaemia | 0 participants |
| Sifalimumab 600 mg | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Transaminases increased | 1 participants |
| Sifalimumab 600 mg | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Blood potassium decreased | 1 participants |
| Sifalimumab 600 mg | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Low density lipoprotein increased | 1 participants |
| Sifalimumab 600 mg | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Hypocalcaemia | 0 participants |
| Sifalimumab 600 mg | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Blood albumin decreased | 1 participants |
| Sifalimumab 600 mg | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Blood alkaline phosphatase decreased | 0 participants |
| Sifalimumab 600 mg | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Anaemia | 4 participants |
| Sifalimumab 600 mg | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | White blood cell count increased | 2 participants |
| Sifalimumab 600 mg | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Blood calcium increased | 1 participants |
| Sifalimumab 600 mg | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Neutrophil count increased | 2 participants |
| Sifalimumab 600 mg | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Iron deficiency anaemia | 0 participants |
| Sifalimumab 600 mg | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Haemoglobin decreased | 0 participants |
| Sifalimumab 600 mg | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Lymphocyte count decreased | 1 participants |
| Sifalimumab 600 mg | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Blood cholesterol increased | 1 participants |
| Sifalimumab 600 mg | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | White blood cell count decreased | 1 participants |
| Sifalimumab 600 mg | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Autoimmune haemolytic anaemia | 0 participants |
| Sifalimumab 600 mg | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Blood triglycerides increased | 1 participants |
| Sifalimumab 600 mg | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Eosinophilia | 0 participants |
| Sifalimumab 600 mg | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Haematocrit increased | 1 participants |
| Sifalimumab 600 mg | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Blood homocysteine increased | 1 participants |
| Sifalimumab 600 mg | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Haemoglobin increased | 1 participants |
| Sifalimumab 600 mg | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Leukopenia | 0 participants |
| Sifalimumab 1,200 mg | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Dyslipidaemia | 2 participants |
| Sifalimumab 1,200 mg | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Hypertriglyceridaemia | 3 participants |
| Sifalimumab 1,200 mg | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Leukopenia | 0 participants |
| Sifalimumab 1,200 mg | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Anaemia | 2 participants |
| Sifalimumab 1,200 mg | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Hypoalbuminaemia | 0 participants |
| Sifalimumab 1,200 mg | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Gamma-glutamyltransferase increased | 4 participants |
| Sifalimumab 1,200 mg | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Platelet count increased | 0 participants |
| Sifalimumab 1,200 mg | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | White blood cell count increased | 3 participants |
| Sifalimumab 1,200 mg | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Haemoglobin increased | 0 participants |
| Sifalimumab 1,200 mg | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Alanine aminotransferase increased | 3 participants |
| Sifalimumab 1,200 mg | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Eosinophilia | 1 participants |
| Sifalimumab 1,200 mg | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Neutrophil count increased | 2 participants |
| Sifalimumab 1,200 mg | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Blood calcium increased | 0 participants |
| Sifalimumab 1,200 mg | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Hypokalaemia | 5 participants |
| Sifalimumab 1,200 mg | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Liver function test abnormal | 0 participants |
| Sifalimumab 1,200 mg | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Iron deficiency anaemia | 2 participants |
| Sifalimumab 1,200 mg | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Monocyte count increased | 0 participants |
| Sifalimumab 1,200 mg | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Hyperlipidaemia | 1 participants |
| Sifalimumab 1,200 mg | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Neutrophil count decreased | 1 participants |
| Sifalimumab 1,200 mg | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Haemoglobin decreased | 1 participants |
| Sifalimumab 1,200 mg | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Platelet count decreased | 0 participants |
| Sifalimumab 1,200 mg | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Thrombocytopenia | 0 participants |
| Sifalimumab 1,200 mg | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Blood homocysteine increased | 0 participants |
| Sifalimumab 1,200 mg | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Lymphocyte count decreased | 0 participants |
| Sifalimumab 1,200 mg | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Haematocrit increased | 0 participants |
| Sifalimumab 1,200 mg | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Blood glucose increased | 2 participants |
| Sifalimumab 1,200 mg | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Red blood cell count decreased | 1 participants |
| Sifalimumab 1,200 mg | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Hyperglycaemia | 2 participants |
| Sifalimumab 1,200 mg | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Blood bilirubin increased | 0 participants |
| Sifalimumab 1,200 mg | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Blood creatinine increased | 1 participants |
| Sifalimumab 1,200 mg | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Lymphopenia | 0 participants |
| Sifalimumab 1,200 mg | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Transaminases increased | 1 participants |
| Sifalimumab 1,200 mg | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Hypertransaminasaemia | 0 participants |
| Sifalimumab 1,200 mg | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Hyperbilirubinaemia | 0 participants |
| Sifalimumab 1,200 mg | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | White blood cell count decreased | 1 participants |
| Sifalimumab 1,200 mg | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Blood potassium decreased | 0 participants |
| Sifalimumab 1,200 mg | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Blood creatine phosphokinase increased | 0 participants |
| Sifalimumab 1,200 mg | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Hypoglycaemia | 1 participants |
| Sifalimumab 1,200 mg | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Blood cholesterol increased | 0 participants |
| Sifalimumab 1,200 mg | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Low density lipoprotein increased | 0 participants |
| Sifalimumab 1,200 mg | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Blood triglycerides increased | 0 participants |
| Sifalimumab 1,200 mg | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Aspartate aminotransferase increased | 2 participants |
| Sifalimumab 1,200 mg | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Neutropenia | 1 participants |
| Sifalimumab 1,200 mg | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Blood albumin decreased | 0 participants |
| Sifalimumab 1,200 mg | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Hypocalcaemia | 0 participants |
| Sifalimumab 1,200 mg | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Hepatic enzyme increased | 0 participants |
| Sifalimumab 1,200 mg | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Autoimmune haemolytic anaemia | 0 participants |
| Sifalimumab 1,200 mg | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Blood alkaline phosphatase decreased | 1 participants |
Secondary
Number of Participants With Abnormal Electrocardiogram (ECG) Findings Reported as TEAEs
The 12-lead ECG data were summarized and evaluated. Number of participants with clinically significant abnormal ECG findings as assessed by cardiologist were recorded and reported as TEAEs.
Time frame: Day 1 up to Week 56
Population: The safety population included all participants who received any investigational product.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Participants With Abnormal Electrocardiogram (ECG) Findings Reported as TEAEs | 2 participants |
| Sifalimumab 200 Milligram (mg) | Number of Participants With Abnormal Electrocardiogram (ECG) Findings Reported as TEAEs | 0 participants |
| Sifalimumab 600 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings Reported as TEAEs | 1 participants |
| Sifalimumab 1,200 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings Reported as TEAEs | 0 participants |
Secondary
Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs)
Vital sign assessments included blood pressure, pulse rate, temperature, weight and respiratory rate. Vital signs abnormalities recorded as TEAEs were reported.
Time frame: Day 1 up to Week 61
Population: The safety population included all participants who received any investigational product.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs) | Orthostatic hypotension | 1 participants |
| Placebo | Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs) | Hypertensive crisis | 0 participants |
| Placebo | Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs) | Hypotension | 1 participants |
| Placebo | Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs) | Blood pressure increased | 1 participants |
| Placebo | Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs) | Weight increased | 0 participants |
| Placebo | Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs) | Hypertension | 7 participants |
| Placebo | Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs) | Weight decreased | 1 participants |
| Placebo | Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs) | Chills | 1 participants |
| Placebo | Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs) | Pyrexia | 3 participants |
| Sifalimumab 200 Milligram (mg) | Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs) | Chills | 2 participants |
| Sifalimumab 200 Milligram (mg) | Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs) | Orthostatic hypotension | 0 participants |
| Sifalimumab 200 Milligram (mg) | Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs) | Hypertensive crisis | 0 participants |
| Sifalimumab 200 Milligram (mg) | Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs) | Hypertension | 4 participants |
| Sifalimumab 200 Milligram (mg) | Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs) | Pyrexia | 2 participants |
| Sifalimumab 200 Milligram (mg) | Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs) | Weight increased | 1 participants |
| Sifalimumab 200 Milligram (mg) | Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs) | Hypotension | 0 participants |
| Sifalimumab 200 Milligram (mg) | Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs) | Weight decreased | 0 participants |
| Sifalimumab 200 Milligram (mg) | Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs) | Blood pressure increased | 2 participants |
| Sifalimumab 600 mg | Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs) | Chills | 0 participants |
| Sifalimumab 600 mg | Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs) | Pyrexia | 6 participants |
| Sifalimumab 600 mg | Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs) | Hypertension | 5 participants |
| Sifalimumab 600 mg | Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs) | Weight increased | 2 participants |
| Sifalimumab 600 mg | Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs) | Blood pressure increased | 1 participants |
| Sifalimumab 600 mg | Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs) | Hypertensive crisis | 0 participants |
| Sifalimumab 600 mg | Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs) | Orthostatic hypotension | 0 participants |
| Sifalimumab 600 mg | Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs) | Weight decreased | 0 participants |
| Sifalimumab 600 mg | Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs) | Hypotension | 0 participants |
| Sifalimumab 1,200 mg | Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs) | Orthostatic hypotension | 1 participants |
| Sifalimumab 1,200 mg | Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs) | Blood pressure increased | 0 participants |
| Sifalimumab 1,200 mg | Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs) | Weight increased | 2 participants |
| Sifalimumab 1,200 mg | Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs) | Hypotension | 0 participants |
| Sifalimumab 1,200 mg | Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs) | Weight decreased | 1 participants |
| Sifalimumab 1,200 mg | Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs) | Hypertension | 4 participants |
| Sifalimumab 1,200 mg | Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs) | Hypertensive crisis | 1 participants |
| Sifalimumab 1,200 mg | Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs) | Chills | 1 participants |
| Sifalimumab 1,200 mg | Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs) | Pyrexia | 7 participants |
Secondary
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (TESAEs)
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent defined as events present at baseline that worsened in intensity after administration of investigational product or events absent at baseline that emerged after administration of investigational product, for the period extending until the end of participant participation in the study.
Time frame: Day 1 up to Week 74
Population: The safety population included all participants who received any investigational product.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (TESAEs) | TESAE | 19 participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (TESAEs) | TEAE | 94 participants |
| Sifalimumab 200 Milligram (mg) | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (TESAEs) | TESAE | 16 participants |
| Sifalimumab 200 Milligram (mg) | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (TESAEs) | TEAE | 97 participants |
| Sifalimumab 600 mg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (TESAEs) | TEAE | 97 participants |
| Sifalimumab 600 mg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (TESAEs) | TESAE | 22 participants |
| Sifalimumab 1,200 mg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (TESAEs) | TESAE | 21 participants |
| Sifalimumab 1,200 mg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (TESAEs) | TEAE | 93 participants |
Secondary
Percentage of Participants on Greater Than or Equal to 10 mg/Day Oral Prednisone (or Equivalent) at Baseline Who Were Able to Reduce to Less Than or Equal to (<=) 7.5 mg/Day
Percentage of participants on \>=10 mg/day oral corticosteroids (OCS) at baseline who were able to taper it to \<=7.5 mg/day by Day 365 were recorded.
Time frame: Day 365
Population: The mITT population included all randomized participants who received any investigational product and had a baseline primary efficacy measurement. Here, N signifies number of participants on \>=10 mg/day oral prednisone (or equivalent) at baseline.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants on Greater Than or Equal to 10 mg/Day Oral Prednisone (or Equivalent) at Baseline Who Were Able to Reduce to Less Than or Equal to (<=) 7.5 mg/Day | Reduce OCS to <=7.5 mg/day: Yes | 6.5 percentage of participants |
| Placebo | Percentage of Participants on Greater Than or Equal to 10 mg/Day Oral Prednisone (or Equivalent) at Baseline Who Were Able to Reduce to Less Than or Equal to (<=) 7.5 mg/Day | Reduce OCS to <=7.5 mg/day: No | 93.5 percentage of participants |
| Sifalimumab 200 Milligram (mg) | Percentage of Participants on Greater Than or Equal to 10 mg/Day Oral Prednisone (or Equivalent) at Baseline Who Were Able to Reduce to Less Than or Equal to (<=) 7.5 mg/Day | Reduce OCS to <=7.5 mg/day: No | 91.8 percentage of participants |
| Sifalimumab 200 Milligram (mg) | Percentage of Participants on Greater Than or Equal to 10 mg/Day Oral Prednisone (or Equivalent) at Baseline Who Were Able to Reduce to Less Than or Equal to (<=) 7.5 mg/Day | Reduce OCS to <=7.5 mg/day: Yes | 8.2 percentage of participants |
| Sifalimumab 600 mg | Percentage of Participants on Greater Than or Equal to 10 mg/Day Oral Prednisone (or Equivalent) at Baseline Who Were Able to Reduce to Less Than or Equal to (<=) 7.5 mg/Day | Reduce OCS to <=7.5 mg/day: Yes | 9.4 percentage of participants |
| Sifalimumab 600 mg | Percentage of Participants on Greater Than or Equal to 10 mg/Day Oral Prednisone (or Equivalent) at Baseline Who Were Able to Reduce to Less Than or Equal to (<=) 7.5 mg/Day | Reduce OCS to <=7.5 mg/day: No | 90.6 percentage of participants |
| Sifalimumab 1,200 mg | Percentage of Participants on Greater Than or Equal to 10 mg/Day Oral Prednisone (or Equivalent) at Baseline Who Were Able to Reduce to Less Than or Equal to (<=) 7.5 mg/Day | Reduce OCS to <=7.5 mg/day: Yes | 6.2 percentage of participants |
| Sifalimumab 1,200 mg | Percentage of Participants on Greater Than or Equal to 10 mg/Day Oral Prednisone (or Equivalent) at Baseline Who Were Able to Reduce to Less Than or Equal to (<=) 7.5 mg/Day | Reduce OCS to <=7.5 mg/day: No | 93.8 percentage of participants |
p-value: 0.80890% CI: [0.37, 3.81]Regression, Logistic
p-value: 0.59890% CI: [0.45, 4.66]Regression, Logistic
p-value: 0.88490% CI: [0.27, 3.02]Regression, Logistic
Secondary
Percentage of Participants Who Achieved a Greater Than 3-Point Improvement in the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale
FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (not at all) to 4 (very much). Larger the participant's response to the questions (with the exception of 2 negatively stated), greater was the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score).
Time frame: Day 365
Population: The mITT population included all randomized participants who received any investigational product and had a baseline primary efficacy measurement. Here, N signifies number of participants with a FACIT-fatigue score \<49 at baseline.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants Who Achieved a Greater Than 3-Point Improvement in the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale | Achieved > 3-point improvement: Yes | 30.5 percentage of participants |
| Placebo | Percentage of Participants Who Achieved a Greater Than 3-Point Improvement in the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale | Achieved > 3-point improvement: No | 69.5 percentage of participants |
| Sifalimumab 200 Milligram (mg) | Percentage of Participants Who Achieved a Greater Than 3-Point Improvement in the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale | Achieved > 3-point improvement: No | 61.9 percentage of participants |
| Sifalimumab 200 Milligram (mg) | Percentage of Participants Who Achieved a Greater Than 3-Point Improvement in the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale | Achieved > 3-point improvement: Yes | 38.1 percentage of participants |
| Sifalimumab 600 mg | Percentage of Participants Who Achieved a Greater Than 3-Point Improvement in the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale | Achieved > 3-point improvement: Yes | 42.2 percentage of participants |
| Sifalimumab 600 mg | Percentage of Participants Who Achieved a Greater Than 3-Point Improvement in the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale | Achieved > 3-point improvement: No | 57.8 percentage of participants |
| Sifalimumab 1,200 mg | Percentage of Participants Who Achieved a Greater Than 3-Point Improvement in the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale | Achieved > 3-point improvement: Yes | 35.6 percentage of participants |
| Sifalimumab 1,200 mg | Percentage of Participants Who Achieved a Greater Than 3-Point Improvement in the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale | Achieved > 3-point improvement: No | 64.4 percentage of participants |
p-value: 0.2790% CI: [0.85, 2.25]Regression, Logistic
p-value: 0.07790% CI: [1.04, 2.74]Regression, Logistic
p-value: 0.45390% CI: [0.76, 2.05]Regression, Logistic
Secondary
Percentage of Participants With a Cutaneous Lupus Erythematosus Disease Activity and Severity Index (CLASI) Activity Score Greater Than or Equal to (>=) 10 at Baseline Who Achieved a >= 4-point Reduction
The CLASI consists of two scores, the first summarizes the activity of the disease while the second is a measure of the damage done by the disease. Activity is scored on the basis of erythema, scale/hyperkeratosis, mucous membrane involvement, acute hair loss and non-scarring alopecia. Damage is scored in terms of dyspigmentation and scarring, including scarring alopecia. The percentage of participants with a CLASI activity score \>=10 at baseline who achieved a clinically significant (\>=4-point) reduction at Day 365 were reported.
Time frame: Day 365
Population: The mITT population included all randomized participants who received any investigational product and had a baseline primary efficacy measurement. Here, N signifies number of participants with a CLASI activity score \>=10 at baseline.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants With a Cutaneous Lupus Erythematosus Disease Activity and Severity Index (CLASI) Activity Score Greater Than or Equal to (>=) 10 at Baseline Who Achieved a >= 4-point Reduction | Achieved >=4-point reduction: Yes | 48.6 percentage of participants |
| Placebo | Percentage of Participants With a Cutaneous Lupus Erythematosus Disease Activity and Severity Index (CLASI) Activity Score Greater Than or Equal to (>=) 10 at Baseline Who Achieved a >= 4-point Reduction | Achieved >=4-point reduction: No | 51.4 percentage of participants |
| Sifalimumab 200 Milligram (mg) | Percentage of Participants With a Cutaneous Lupus Erythematosus Disease Activity and Severity Index (CLASI) Activity Score Greater Than or Equal to (>=) 10 at Baseline Who Achieved a >= 4-point Reduction | Achieved >=4-point reduction: No | 27.3 percentage of participants |
| Sifalimumab 200 Milligram (mg) | Percentage of Participants With a Cutaneous Lupus Erythematosus Disease Activity and Severity Index (CLASI) Activity Score Greater Than or Equal to (>=) 10 at Baseline Who Achieved a >= 4-point Reduction | Achieved >=4-point reduction: Yes | 72.7 percentage of participants |
| Sifalimumab 600 mg | Percentage of Participants With a Cutaneous Lupus Erythematosus Disease Activity and Severity Index (CLASI) Activity Score Greater Than or Equal to (>=) 10 at Baseline Who Achieved a >= 4-point Reduction | Achieved >=4-point reduction: Yes | 57.6 percentage of participants |
| Sifalimumab 600 mg | Percentage of Participants With a Cutaneous Lupus Erythematosus Disease Activity and Severity Index (CLASI) Activity Score Greater Than or Equal to (>=) 10 at Baseline Who Achieved a >= 4-point Reduction | Achieved >=4-point reduction: No | 42.4 percentage of participants |
| Sifalimumab 1,200 mg | Percentage of Participants With a Cutaneous Lupus Erythematosus Disease Activity and Severity Index (CLASI) Activity Score Greater Than or Equal to (>=) 10 at Baseline Who Achieved a >= 4-point Reduction | Achieved >=4-point reduction: Yes | 73.1 percentage of participants |
| Sifalimumab 1,200 mg | Percentage of Participants With a Cutaneous Lupus Erythematosus Disease Activity and Severity Index (CLASI) Activity Score Greater Than or Equal to (>=) 10 at Baseline Who Achieved a >= 4-point Reduction | Achieved >=4-point reduction: No | 26.9 percentage of participants |
p-value: 0.04490% CI: [1.22, 7.01]Regression, Logistic
p-value: 0.49890% CI: [0.62, 3.19]Regression, Logistic
p-value: 0.04990% CI: [1.2, 7.68]Regression, Logistic