Systemic Lupus Erythematosus
Conditions
Keywords
Lupus, SLE
Brief summary
The primary objective of this study is to evaluate the long term safety and tolerability of repeated administration of subcutaneous (SC) CEP-33457 for injection every 4 weeks over 72 weeks (18 doses) in participants with systemic lupus erythematosus (SLE) who have participated in a previous Cephalon sponsored clinical study of CEP-33457, and completed at least Visit 8 (Week 24 of that study).
Interventions
DRUGCEP-33457
CEP-33457 will be administered subcutaneously per dose specified in the arm description.
Sponsors
Cephalon, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* The participant has an established diagnosis of SLE as defined by ACR Classification Revised Criteria. The diagnosis is fulfilled provided that at least 4 criteria are met. * The participant previously participated in and completed at least Visit 8 (Week 24) the Cephalon sponsored clinical study with CEP-33457 (study C33457/2047) and, in the investigator's opinion, would benefit from continued participation in a clinical study. * Women must be surgically sterile, 2 years postmenopausal, or, if of childbearing potential, using a medically accepted method of contraception, and must agree to continued use of this method for the duration of the study and for 30 days after discontinuation of study drug treatment.
Exclusion criteria
* The participant has New York Heart Association (NYHA) Class III or IV congestive heart failure. * The participant has an estimated glomerular filtration rate (eGFR) of less than 30 milliliters (mL)/minute (min)/1.73 square meter (m\^2) (via Modification of Diet in Renal Disease \[MDRD\] equation). * The participant has an aspartate aminotransferase (AST) or alanine aminotransferase (ALT) value greater than 2 times the upper limit of normal (ULN) or a total bilirubin level greater than 1.5 times ULN. * The participant has a planned immunization with a live or live attenuated vaccine within 3 months prior to administration of the first dose of study drug and for 3 months after administration of the last dose of study drug. * The participant has any clinically significant abnormalities on electrocardiogram (ECG) that are not related to SLE, as determined by the investigator. Participants with stable ECG changes without evidence of active cardiovascular disease may participate at the discretion of the investigator and medical monitor. * The participant has an ongoing active systemic infection requiring treatment or a history of severe infection, such as hepatitis or pneumonia, in the 3 months prior to administration of the first dose of study drug. Less severe infections in the 3 months prior to administration of the first dose of study drug are permitted at the discretion of the investigator and medical monitor. * The participant has any concomitant medical condition unrelated to SLE that may interfere with his or her safety or with evaluation of the study drug, as determined by the investigator. * The participant has a history of a positive test result for hepatitis B surface antigen (HBsAg) or hepatitis C virus antibody (HCV Ab). * The participant has a known positive history of antibodies to human immunodeficiency virus (HIV) or HIV disease. * The participant has a history of alcohol or substance dependence or abuse (with the exception of nicotine), according to the Diagnostic and Statistical Manual of Mental Disorders of the American Psychiatric Association, Fourth Edition, Text Revision (DSM-IV-TR), within 3 months of the screening visit for study C33457/2047, or has current substance abuse. * The participant has a history of severe allergic reactions to or hypersensitivity to any component of the study drug. * The participant is a pregnant or lactating woman. (Any women becoming pregnant during the study will be withdrawn from the study.) * The participant has undergone or is undergoing treatment with another investigational drug for the treatment of lupus within 6 months prior to the 1st dose of study drug or has received any other investigational drug for any other condition within 30 days prior to the 1st dose of study drug, except for treatment with CEP-33457 or placebo in study C33457/2047. * The participant has a known history of antibodies to CEP-33457. * The participant is unlikely to comply with the study protocol or is unsuitable for any other reason, as judged by the investigator or medical monitor.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events (AEs) | Baseline up to Week 72 | An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AEs included clinically significant vitals, labs, and physical examination findings. Serious adverse events (SAEs) were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section. |
| Number of Participants Who Received Concomitant Medications | Baseline up to Week 72 | Any concomitant therapy or medication taken while the participant received study drug. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With British Isles Lupus Assessment Group 2004 (BILAG-2004) Response | Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 | The BILAG-2004 is a validated objective and subjective global measure of the SLE disease activity, based on the physician's intention to treat, and refers to disease activity within the last 4 weeks before completion of the index. It includes 97 clinical and laboratory components to evaluate SLE disease activity in 9 different body systems (constitutional, mucocutaneous, neuropsychiatric, musculoskeletal, cardiorespiratory, gastrointestinal, ophthalmic, renal, and hematological). Each body system is assigned a score displayed as a grade from A to E, as follows: A=very active disease; B=participant needs increase in treatment for moderately active disease; C=stab1e or mild disease; D=previous system involvement but no current disease activity; and E=no current disease activity and the body system has never been involved. BILAG 2004 response was defined as no new BILAG A body system score and no more than 1 new BILAG B body system score from baseline. |
| Number of Participants Showing No Worsening on Physician's Global Assessment (PhGA) Scale | Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 | The PhGA was completed by the physician using a 3-inch visual analog scale (VAS) labeled from 0=none to 3=severe. A change of greater than 0.3 point on the VAS indicates worsening. The number of participants showing no worsening are presented. |
| Number of Participants Showing No Worsening on Patient's Global Assessment (PtGA) Scale | Week 12, 24, 36, 48, 60, and 72 | The PtGA was completed by the participant, using a 3-inch VAS labeled from 0=none to 3=severe. A change of greater than 0.3 point on the VAS indicated worsening. The number of participants showing no worsening are presented. |
| Change From Baseline in Short-Form 36 (SF-36) Domain Scores | Baseline, Week 12, 24, 36, 48, 60 and final assessment (or early termination [up to Week 72]) | The SF-36 questionnaire has 36 questions composing the scale that represent 8 domains: 1) physical functioning, 2) physical role functioning, 3) bodily pain, 4) general health, 5) vitality, 6) social functioning, 7) emotional role functioning, and 8) mental health. All domains are scored on a scale from 0 (worst) to 100 (best), with higher scores representing the best possible health state. Change from baseline scores in the following individual standardized domains: Bodily pain, physical functioning, social functioning and vitality were presented. |
| Change From Baseline in the Biomarker: Anti-U1 Ribonucleoprotein Antibody (Anti-UI RNP Ab) | Baseline, Week 12, 24, 36, 48, 60 and final assessment (or early termination [up to Week 72]) | Anti-UI RNP Ab was measured from blood serum collected at specified time points. |
| Change From Baseline in the Biomarker: C-Reactive Protein (CRP) | Baseline, Week 12, 24, 36, 48, 60, and Final Assessment (or Early Termination [up to Week 72]) | CRP was measured from blood serum samples at specified time points. |
| Number of Participants Achieving a Clinical Response Using the Systemic Lupus Erythematosus (SLE) Responder Index (SRI) | Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 | An SRI response was defined as a reduction from baseline in SLE Disease Activity Index 2000 (SLEDAI-2K) score of ≥4 points, no worsening in Physician Global Assessment (PhGA), no new British Isles Lupus Assessment Group (BILAG) A body system score, and ≤1 new BILAG B body system score from baseline. SLEDAI 2K includes 24 weighted clinical and laboratory variables. Total score = 0 to 105. A score of 6 to 10 = moderate disease activity, and a reduction of \>3 points = improvement. PhGA was completed by physician using a visual analog scale (VAS) from 0=none to 3=severe. A change of \>0.3 points = worsening. BILAG includes 97 clinical and laboratory items. Each organ system is assigned a score displayed as a grade from A to E: A=very active disease; B=participant needs increase in treatment for moderately active disease; C=stable or mild disease; D=previous organ involvement but no current disease activity; and E=no current disease activity and organ system has never been involved. |
| Number of Participants With Mild to Moderate Flare, Severe Flare, and No Flare, Based on the Safety of Estrogens in Lupus Erythematosus: National Assessment (SELENA) Flare Index | Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64 and Final Assessment (or Early Termination [up to Week 72]) | The SELENA Flare Index divides flares into 2 categories: mild/moderate and severe. A severe flare would lead to early withdrawal. The number of participants with mild to moderate flare, severe flare, and no flare at each visit during the treatment period were reported. |
| Change From Baseline in Total Damage Score as Assessed by the Systemic Lupus International Collaborative Clinics/American College of Rheumatology (SLICC/ACR) Damage Index | Baseline, Week 24, 48 and Final Assessment (or Early Termination [up to Week 72]) | The SLICC/ACR damage index assesses specific comorbidities associated with SLE. It consists of 41 items and covers 12 body systems. Total damage scores were calculated using the 41 items. The total damage score ranges from 0 (no damage) to 47 (maximum disease damage severity) with higher scores indicating increasing disease damage severity. |
| Number of Participants Achieving Remission of Disease | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64 and Final Assessment (or Early Termination [up to Week 72]) | Remission of disease was defined as a reduction of SLEDAI-2K score to 0. The SLEDAI-2K is a validated objective measure that assesses disease activity within the last 28 days before completion of the index. It is a global index and includes 24 weighted clinical and laboratory variables. The total score (sum of all 24 scores) ranges from 0 to 105, with higher scores representing increased disease activity. |
| Number of Participants With Change in Steroid Dose | From Baseline up to Final Assessment (or Early Termination [up to Week 72]) | Number of participants with change in steroid dose (prednisone equivalent/day) were reported. The change in steroid dose was evaluated to determine the number of participants taking a dose less than 7.5 mg of prednisone equivalent/day, a dose of 7.5 mg prednisone equivalent/day or more, and none per day. |
| Number of Participants With Reactive and Non-Reactive Anti-CEP-33457 Antibodies | Week 24, 48 and Final Assessment (or Early Termination [up to Week 72]) | Immunogenicity was assessed by detection of the presence of specific anti-CEP-33457 antibodies in blood serum samples collected at the specified time points. |
| Number of Participants With Anti-nuclear Antibodies (ANA) | Week 12, 24, 36, 48, 60, and Final Assessment (or Early Termination [up to Week 72]) | Anti-nuclear antibodies (ANA) were measured from blood serum samples at specified time points. |
| Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Total Score | Baseline, Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64 and Final Assessment (or Early Termination [up to Week 72]) | The SLEDAI-2K is a validated objective measure that assesses disease activity within the last 28 days before completion of the index. It is a global index and includes 24 weighted clinical and laboratory variables. The total score (sum of all 24 scores) ranges from 0 to 105, with higher scores representing increased disease activity. |
Countries
Belgium, Czechia, France, Germany, Hungary, Poland, Portugal, Spain, Ukraine, United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CEP-33457 Participants received 200 mcg of CEP-33457 SC every 4 weeks for a maximum of 17 doses (64 weeks). | 136 |
| Total | 136 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 9 |
| Overall Study | Lack of Efficacy | 6 |
| Overall Study | Lost to Follow-up | 2 |
| Overall Study | Other than specified | 3 |
| Overall Study | Protocol Violation | 2 |
| Overall Study | Withdrawal by Subject | 6 |
| Overall Study | Withdrawn due to early study termination | 107 |
Baseline characteristics
| Characteristic | CEP-33457 |
|---|---|
| Age, Continuous | 40.6 years STANDARD_DEVIATION 11.44 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 16 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 120 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race/Ethnicity, Customized Race Asian | 5 Participants |
| Race/Ethnicity, Customized Race Black | 22 Participants |
| Race/Ethnicity, Customized Race Other | 8 Participants |
| Race/Ethnicity, Customized Race White | 101 Participants |
| Sex: Female, Male Female | 124 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 136 |
| other Total, other adverse events | 89 / 136 |
| serious Total, serious adverse events | 11 / 136 |
Outcome results
Primary
Number of Participants Who Received Concomitant Medications
Any concomitant therapy or medication taken while the participant received study drug.
Time frame: Baseline up to Week 72
Population: Safety analysis set included all enrolled participants who took at least 1 dose of study drug.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CEP-33457 | Number of Participants Who Received Concomitant Medications | 136 Participants |
Primary
Number of Participants With Adverse Events (AEs)
An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AEs included clinically significant vitals, labs, and physical examination findings. Serious adverse events (SAEs) were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
Time frame: Baseline up to Week 72
Population: Safety analysis set included all enrolled participants who took at least 1 dose of study drug.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CEP-33457 | Number of Participants With Adverse Events (AEs) | 117 Participants |
Secondary
Change From Baseline in Short-Form 36 (SF-36) Domain Scores
The SF-36 questionnaire has 36 questions composing the scale that represent 8 domains: 1) physical functioning, 2) physical role functioning, 3) bodily pain, 4) general health, 5) vitality, 6) social functioning, 7) emotional role functioning, and 8) mental health. All domains are scored on a scale from 0 (worst) to 100 (best), with higher scores representing the best possible health state. Change from baseline scores in the following individual standardized domains: Bodily pain, physical functioning, social functioning and vitality were presented.
Time frame: Baseline, Week 12, 24, 36, 48, 60 and final assessment (or early termination [up to Week 72])
Population: ITT analysis set included all enrolled participants who took at least 1 dose of study drug. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure and 'number analyzed' signifies participants evaluable for specified category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CEP-33457 | Change From Baseline in Short-Form 36 (SF-36) Domain Scores | Bodily pain: Change at Week 12 | 2.8 units on a scale | Standard Deviation 16.43 |
| CEP-33457 | Change From Baseline in Short-Form 36 (SF-36) Domain Scores | Bodily pain: Change at Week 24 | 1.5 units on a scale | Standard Deviation 20.68 |
| CEP-33457 | Change From Baseline in Short-Form 36 (SF-36) Domain Scores | Bodily pain: Change at Week 36 | 5.5 units on a scale | Standard Deviation 23.09 |
| CEP-33457 | Change From Baseline in Short-Form 36 (SF-36) Domain Scores | Bodily pain: Change at Week 48 | 8.8 units on a scale | Standard Deviation 16.18 |
| CEP-33457 | Change From Baseline in Short-Form 36 (SF-36) Domain Scores | Bodily pain: Change at Week 60 | 9.0 units on a scale | Standard Deviation 28.59 |
| CEP-33457 | Change From Baseline in Short-Form 36 (SF-36) Domain Scores | Bodily pain: Change at Final Assessment (or Early Termination [up to Week 72]) | 2.7 units on a scale | Standard Deviation 20.26 |
| CEP-33457 | Change From Baseline in Short-Form 36 (SF-36) Domain Scores | Physical functioning: Change at Week 12 | 1.7 units on a scale | Standard Deviation 12.28 |
| CEP-33457 | Change From Baseline in Short-Form 36 (SF-36) Domain Scores | Physical functioning: Change at Week 24 | -0.4 units on a scale | Standard Deviation 15.57 |
| CEP-33457 | Change From Baseline in Short-Form 36 (SF-36) Domain Scores | Physical functioning: Change at Week 36 | -0.5 units on a scale | Standard Deviation 17.2 |
| CEP-33457 | Change From Baseline in Short-Form 36 (SF-36) Domain Scores | Physical functioning: Change at Week 48 | 3.0 units on a scale | Standard Deviation 14.36 |
| CEP-33457 | Change From Baseline in Short-Form 36 (SF-36) Domain Scores | Physical functioning: Change at Week 60 | 4.4 units on a scale | Standard Deviation 15.45 |
| CEP-33457 | Change From Baseline in Short-Form 36 (SF-36) Domain Scores | Physical functioning: Change at Final Assessment (or Early Termination [up to Week 72]) | 1.1 units on a scale | Standard Deviation 17.04 |
| CEP-33457 | Change From Baseline in Short-Form 36 (SF-36) Domain Scores | Social functioning: Change at Week 12 | 0.7 units on a scale | Standard Deviation 15.18 |
| CEP-33457 | Change From Baseline in Short-Form 36 (SF-36) Domain Scores | Social functioning: Change at Week 24 | 3.6 units on a scale | Standard Deviation 19.43 |
| CEP-33457 | Change From Baseline in Short-Form 36 (SF-36) Domain Scores | Social functioning: Change at Week 36 | 2.3 units on a scale | Standard Deviation 21.87 |
| CEP-33457 | Change From Baseline in Short-Form 36 (SF-36) Domain Scores | Social functioning: Change at Week 48 | -0.6 units on a scale | Standard Deviation 22.75 |
| CEP-33457 | Change From Baseline in Short-Form 36 (SF-36) Domain Scores | Social functioning: Change at Week 60 | 7.8 units on a scale | Standard Deviation 21.06 |
| CEP-33457 | Change From Baseline in Short-Form 36 (SF-36) Domain Scores | Social functioning: Change at Final Assessment (or Early Termination [up to Week 72]) | -0.1 units on a scale | Standard Deviation 20.56 |
| CEP-33457 | Change From Baseline in Short-Form 36 (SF-36) Domain Scores | Vitality: Change at Week 12 | 3.4 units on a scale | Standard Deviation 15.28 |
| CEP-33457 | Change From Baseline in Short-Form 36 (SF-36) Domain Scores | Vitality: Change at Week 24 | 2.1 units on a scale | Standard Deviation 18.04 |
| CEP-33457 | Change From Baseline in Short-Form 36 (SF-36) Domain Scores | Vitality: Change at Week 36 | 3.9 units on a scale | Standard Deviation 19.03 |
| CEP-33457 | Change From Baseline in Short-Form 36 (SF-36) Domain Scores | Vitality: Change at Week 48 | 4.7 units on a scale | Standard Deviation 17.78 |
| CEP-33457 | Change From Baseline in Short-Form 36 (SF-36) Domain Scores | Vitality: Change at Week 60 | 7.0 units on a scale | Standard Deviation 23.25 |
| CEP-33457 | Change From Baseline in Short-Form 36 (SF-36) Domain Scores | Vitality: Change at Final Assessment (or Early Termination [up to Week 72]) | 2.6 units on a scale | Standard Deviation 15.94 |
Secondary
Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Total Score
The SLEDAI-2K is a validated objective measure that assesses disease activity within the last 28 days before completion of the index. It is a global index and includes 24 weighted clinical and laboratory variables. The total score (sum of all 24 scores) ranges from 0 to 105, with higher scores representing increased disease activity.
Time frame: Baseline, Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64 and Final Assessment (or Early Termination [up to Week 72])
Population: ITT analysis set included all enrolled participants who took at least 1 dose of study drug. Here, 'number analyzed' signifies participants evaluable at specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CEP-33457 | Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Total Score | Change at Week 40 | -1.9 units on a scale | Standard Deviation 3.34 |
| CEP-33457 | Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Total Score | Change at Week 44 | -2.3 units on a scale | Standard Deviation 3.84 |
| CEP-33457 | Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Total Score | Change at Week 48 | -2.2 units on a scale | Standard Deviation 3.86 |
| CEP-33457 | Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Total Score | Change at Week 52 | -3.0 units on a scale | Standard Deviation 3.94 |
| CEP-33457 | Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Total Score | Change at Week 56 | -3.6 units on a scale | Standard Deviation 4.41 |
| CEP-33457 | Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Total Score | Change at Week 60 | -2.3 units on a scale | Standard Deviation 5.52 |
| CEP-33457 | Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Total Score | Change at Week 64 | -3.3 units on a scale | Standard Deviation 6.5 |
| CEP-33457 | Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Total Score | Change at Final Assessment (or Early Termination [up to Week 72]) | -0.9 units on a scale | Standard Deviation 3.62 |
| CEP-33457 | Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Total Score | Change at Week 4 | -0.4 units on a scale | Standard Deviation 2.48 |
| CEP-33457 | Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Total Score | Change at Week 8 | -0.9 units on a scale | Standard Deviation 2.36 |
| CEP-33457 | Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Total Score | Change at Week 12 | -0.9 units on a scale | Standard Deviation 2.71 |
| CEP-33457 | Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Total Score | Change at Week 16 | -0.7 units on a scale | Standard Deviation 2.74 |
| CEP-33457 | Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Total Score | Change at Week 20 | -1.3 units on a scale | Standard Deviation 3.1 |
| CEP-33457 | Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Total Score | Change at Week 24 | -1.5 units on a scale | Standard Deviation 3.4 |
| CEP-33457 | Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Total Score | Change at Week 28 | -2.0 units on a scale | Standard Deviation 3.8 |
| CEP-33457 | Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Total Score | Change at Week 32 | -1.9 units on a scale | Standard Deviation 3.48 |
| CEP-33457 | Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Total Score | Change at Week 36 | -2.1 units on a scale | Standard Deviation 3.39 |
Secondary
Change From Baseline in the Biomarker: Anti-U1 Ribonucleoprotein Antibody (Anti-UI RNP Ab)
Anti-UI RNP Ab was measured from blood serum collected at specified time points.
Time frame: Baseline, Week 12, 24, 36, 48, 60 and final assessment (or early termination [up to Week 72])
Population: ITT analysis set included all enrolled participants who took at least 1 dose of study drug. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure and 'number analyzed' signifies participants evaluable at specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CEP-33457 | Change From Baseline in the Biomarker: Anti-U1 Ribonucleoprotein Antibody (Anti-UI RNP Ab) | Change at Week 12 | 193.0 units (U)/milliliter (mL) | Standard Deviation 505.2 |
| CEP-33457 | Change From Baseline in the Biomarker: Anti-U1 Ribonucleoprotein Antibody (Anti-UI RNP Ab) | Change at Week 24 | 313.6 units (U)/milliliter (mL) | Standard Deviation 642.69 |
| CEP-33457 | Change From Baseline in the Biomarker: Anti-U1 Ribonucleoprotein Antibody (Anti-UI RNP Ab) | Change at Week 36 | 199.2 units (U)/milliliter (mL) | Standard Deviation 497.79 |
| CEP-33457 | Change From Baseline in the Biomarker: Anti-U1 Ribonucleoprotein Antibody (Anti-UI RNP Ab) | Change at Week 48 | 327.7 units (U)/milliliter (mL) | Standard Deviation 643.54 |
| CEP-33457 | Change From Baseline in the Biomarker: Anti-U1 Ribonucleoprotein Antibody (Anti-UI RNP Ab) | Change at Week 60 | 480.1 units (U)/milliliter (mL) | Standard Deviation 723.53 |
| CEP-33457 | Change From Baseline in the Biomarker: Anti-U1 Ribonucleoprotein Antibody (Anti-UI RNP Ab) | Change at Final Assessment (or Early Termination [up to Week 72]) | 154.7 units (U)/milliliter (mL) | Standard Deviation 470.23 |
Secondary
Change From Baseline in the Biomarker: C-Reactive Protein (CRP)
CRP was measured from blood serum samples at specified time points.
Time frame: Baseline, Week 12, 24, 36, 48, 60, and Final Assessment (or Early Termination [up to Week 72])
Population: ITT analysis set included all enrolled participants who took at least 1 dose of study drug. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure and 'number analyzed' signifies participants evaluable at specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CEP-33457 | Change From Baseline in the Biomarker: C-Reactive Protein (CRP) | Change at Week 12 | 0 milligrams (mg)/deciliter (dL) | Standard Deviation 0.68 |
| CEP-33457 | Change From Baseline in the Biomarker: C-Reactive Protein (CRP) | Change at Week 24 | 0 milligrams (mg)/deciliter (dL) | Standard Deviation 0.48 |
| CEP-33457 | Change From Baseline in the Biomarker: C-Reactive Protein (CRP) | Change at Week 36 | -0.1 milligrams (mg)/deciliter (dL) | Standard Deviation 0.41 |
| CEP-33457 | Change From Baseline in the Biomarker: C-Reactive Protein (CRP) | Change at Week 48 | 0 milligrams (mg)/deciliter (dL) | Standard Deviation 0.46 |
| CEP-33457 | Change From Baseline in the Biomarker: C-Reactive Protein (CRP) | Change at Week 60 | -0.1 milligrams (mg)/deciliter (dL) | Standard Deviation 0.3 |
| CEP-33457 | Change From Baseline in the Biomarker: C-Reactive Protein (CRP) | Change at Final Assessment (or Early Termination [up to Week 72]) | 0 milligrams (mg)/deciliter (dL) | Standard Deviation 0.82 |
Secondary
Change From Baseline in Total Damage Score as Assessed by the Systemic Lupus International Collaborative Clinics/American College of Rheumatology (SLICC/ACR) Damage Index
The SLICC/ACR damage index assesses specific comorbidities associated with SLE. It consists of 41 items and covers 12 body systems. Total damage scores were calculated using the 41 items. The total damage score ranges from 0 (no damage) to 47 (maximum disease damage severity) with higher scores indicating increasing disease damage severity.
Time frame: Baseline, Week 24, 48 and Final Assessment (or Early Termination [up to Week 72])
Population: ITT analysis set included all enrolled participants who took at least 1 dose of study drug. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure and 'number analyzed' signifies participants evaluable at specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CEP-33457 | Change From Baseline in Total Damage Score as Assessed by the Systemic Lupus International Collaborative Clinics/American College of Rheumatology (SLICC/ACR) Damage Index | Change at Week 24 | 0 units on a scale | Standard Deviation 0.42 |
| CEP-33457 | Change From Baseline in Total Damage Score as Assessed by the Systemic Lupus International Collaborative Clinics/American College of Rheumatology (SLICC/ACR) Damage Index | Change at Week 48 | -0.1 units on a scale | Standard Deviation 0.48 |
| CEP-33457 | Change From Baseline in Total Damage Score as Assessed by the Systemic Lupus International Collaborative Clinics/American College of Rheumatology (SLICC/ACR) Damage Index | Change at Final Assessment (or Early Termination [up to Week 72]) | -0.1 units on a scale | Standard Deviation 0.44 |
Secondary
Number of Participants Achieving a Clinical Response Using the Systemic Lupus Erythematosus (SLE) Responder Index (SRI)
An SRI response was defined as a reduction from baseline in SLE Disease Activity Index 2000 (SLEDAI-2K) score of ≥4 points, no worsening in Physician Global Assessment (PhGA), no new British Isles Lupus Assessment Group (BILAG) A body system score, and ≤1 new BILAG B body system score from baseline. SLEDAI 2K includes 24 weighted clinical and laboratory variables. Total score = 0 to 105. A score of 6 to 10 = moderate disease activity, and a reduction of \>3 points = improvement. PhGA was completed by physician using a visual analog scale (VAS) from 0=none to 3=severe. A change of \>0.3 points = worsening. BILAG includes 97 clinical and laboratory items. Each organ system is assigned a score displayed as a grade from A to E: A=very active disease; B=participant needs increase in treatment for moderately active disease; C=stable or mild disease; D=previous organ involvement but no current disease activity; and E=no current disease activity and organ system has never been involved.
Time frame: Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72
Population: Intent-to-treat (ITT) analysis set included all enrolled participants who took at least 1 dose of study drug.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CEP-33457 | Number of Participants Achieving a Clinical Response Using the Systemic Lupus Erythematosus (SLE) Responder Index (SRI) | Week 4 | 10 Participants |
| CEP-33457 | Number of Participants Achieving a Clinical Response Using the Systemic Lupus Erythematosus (SLE) Responder Index (SRI) | Week 8 | 18 Participants |
| CEP-33457 | Number of Participants Achieving a Clinical Response Using the Systemic Lupus Erythematosus (SLE) Responder Index (SRI) | Week 12 | 19 Participants |
| CEP-33457 | Number of Participants Achieving a Clinical Response Using the Systemic Lupus Erythematosus (SLE) Responder Index (SRI) | Week 16 | 19 Participants |
| CEP-33457 | Number of Participants Achieving a Clinical Response Using the Systemic Lupus Erythematosus (SLE) Responder Index (SRI) | Week 20 | 21 Participants |
| CEP-33457 | Number of Participants Achieving a Clinical Response Using the Systemic Lupus Erythematosus (SLE) Responder Index (SRI) | Week 24 | 18 Participants |
| CEP-33457 | Number of Participants Achieving a Clinical Response Using the Systemic Lupus Erythematosus (SLE) Responder Index (SRI) | Week 28 | 17 Participants |
| CEP-33457 | Number of Participants Achieving a Clinical Response Using the Systemic Lupus Erythematosus (SLE) Responder Index (SRI) | Week 32 | 11 Participants |
| CEP-33457 | Number of Participants Achieving a Clinical Response Using the Systemic Lupus Erythematosus (SLE) Responder Index (SRI) | Week 36 | 12 Participants |
| CEP-33457 | Number of Participants Achieving a Clinical Response Using the Systemic Lupus Erythematosus (SLE) Responder Index (SRI) | Week 40 | 10 Participants |
| CEP-33457 | Number of Participants Achieving a Clinical Response Using the Systemic Lupus Erythematosus (SLE) Responder Index (SRI) | Week 44 | 6 Participants |
| CEP-33457 | Number of Participants Achieving a Clinical Response Using the Systemic Lupus Erythematosus (SLE) Responder Index (SRI) | Week 48 | 5 Participants |
| CEP-33457 | Number of Participants Achieving a Clinical Response Using the Systemic Lupus Erythematosus (SLE) Responder Index (SRI) | Week 52 | 5 Participants |
| CEP-33457 | Number of Participants Achieving a Clinical Response Using the Systemic Lupus Erythematosus (SLE) Responder Index (SRI) | Week 56 | 6 Participants |
| CEP-33457 | Number of Participants Achieving a Clinical Response Using the Systemic Lupus Erythematosus (SLE) Responder Index (SRI) | Week 60 | 2 Participants |
| CEP-33457 | Number of Participants Achieving a Clinical Response Using the Systemic Lupus Erythematosus (SLE) Responder Index (SRI) | Week 64 | 1 Participants |
| CEP-33457 | Number of Participants Achieving a Clinical Response Using the Systemic Lupus Erythematosus (SLE) Responder Index (SRI) | Week 68 | 0 Participants |
| CEP-33457 | Number of Participants Achieving a Clinical Response Using the Systemic Lupus Erythematosus (SLE) Responder Index (SRI) | Week 72 | 0 Participants |
Secondary
Number of Participants Achieving Remission of Disease
Remission of disease was defined as a reduction of SLEDAI-2K score to 0. The SLEDAI-2K is a validated objective measure that assesses disease activity within the last 28 days before completion of the index. It is a global index and includes 24 weighted clinical and laboratory variables. The total score (sum of all 24 scores) ranges from 0 to 105, with higher scores representing increased disease activity.
Time frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64 and Final Assessment (or Early Termination [up to Week 72])
Population: ITT analysis set included all enrolled participants who took at least 1 dose of study drug. Here 'number analyzed' signifies participants evaluable at specified timepoint.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CEP-33457 | Number of Participants Achieving Remission of Disease | Week 52 | 1 Participants |
| CEP-33457 | Number of Participants Achieving Remission of Disease | Week 56 | 1 Participants |
| CEP-33457 | Number of Participants Achieving Remission of Disease | Week 4 | 8 Participants |
| CEP-33457 | Number of Participants Achieving Remission of Disease | Week 8 | 9 Participants |
| CEP-33457 | Number of Participants Achieving Remission of Disease | Week 12 | 11 Participants |
| CEP-33457 | Number of Participants Achieving Remission of Disease | Week 16 | 10 Participants |
| CEP-33457 | Number of Participants Achieving Remission of Disease | Week 20 | 10 Participants |
| CEP-33457 | Number of Participants Achieving Remission of Disease | Week 24 | 4 Participants |
| CEP-33457 | Number of Participants Achieving Remission of Disease | Week 28 | 2 Participants |
| CEP-33457 | Number of Participants Achieving Remission of Disease | Week 32 | 1 Participants |
| CEP-33457 | Number of Participants Achieving Remission of Disease | Week 36 | 1 Participants |
| CEP-33457 | Number of Participants Achieving Remission of Disease | Week 40 | 1 Participants |
| CEP-33457 | Number of Participants Achieving Remission of Disease | Week 44 | 1 Participants |
| CEP-33457 | Number of Participants Achieving Remission of Disease | Week 48 | 1 Participants |
| CEP-33457 | Number of Participants Achieving Remission of Disease | Week 60 | 0 Participants |
| CEP-33457 | Number of Participants Achieving Remission of Disease | Week 64 | 0 Participants |
| CEP-33457 | Number of Participants Achieving Remission of Disease | Final Assessment (or Early Termination [up to Week 72]) | 8 Participants |
Secondary
Number of Participants Showing No Worsening on Patient's Global Assessment (PtGA) Scale
The PtGA was completed by the participant, using a 3-inch VAS labeled from 0=none to 3=severe. A change of greater than 0.3 point on the VAS indicated worsening. The number of participants showing no worsening are presented.
Time frame: Week 12, 24, 36, 48, 60, and 72
Population: ITT analysis set included all enrolled participants who took at least 1 dose of study drug.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CEP-33457 | Number of Participants Showing No Worsening on Patient's Global Assessment (PtGA) Scale | Week 12 | 90 Participants |
| CEP-33457 | Number of Participants Showing No Worsening on Patient's Global Assessment (PtGA) Scale | Week 24 | 43 Participants |
| CEP-33457 | Number of Participants Showing No Worsening on Patient's Global Assessment (PtGA) Scale | Week 36 | 23 Participants |
| CEP-33457 | Number of Participants Showing No Worsening on Patient's Global Assessment (PtGA) Scale | Week 48 | 17 Participants |
| CEP-33457 | Number of Participants Showing No Worsening on Patient's Global Assessment (PtGA) Scale | Week 60 | 6 Participants |
| CEP-33457 | Number of Participants Showing No Worsening on Patient's Global Assessment (PtGA) Scale | Week 72 | 0 Participants |
Secondary
Number of Participants Showing No Worsening on Physician's Global Assessment (PhGA) Scale
The PhGA was completed by the physician using a 3-inch visual analog scale (VAS) labeled from 0=none to 3=severe. A change of greater than 0.3 point on the VAS indicates worsening. The number of participants showing no worsening are presented.
Time frame: Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72
Population: ITT analysis set included all enrolled participants who took at least 1 dose of study drug.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CEP-33457 | Number of Participants Showing No Worsening on Physician's Global Assessment (PhGA) Scale | Week 4 | 113 Participants |
| CEP-33457 | Number of Participants Showing No Worsening on Physician's Global Assessment (PhGA) Scale | Week 8 | 111 Participants |
| CEP-33457 | Number of Participants Showing No Worsening on Physician's Global Assessment (PhGA) Scale | Week 12 | 105 Participants |
| CEP-33457 | Number of Participants Showing No Worsening on Physician's Global Assessment (PhGA) Scale | Week 16 | 100 Participants |
| CEP-33457 | Number of Participants Showing No Worsening on Physician's Global Assessment (PhGA) Scale | Week 20 | 76 Participants |
| CEP-33457 | Number of Participants Showing No Worsening on Physician's Global Assessment (PhGA) Scale | Week 24 | 48 Participants |
| CEP-33457 | Number of Participants Showing No Worsening on Physician's Global Assessment (PhGA) Scale | Week 28 | 41 Participants |
| CEP-33457 | Number of Participants Showing No Worsening on Physician's Global Assessment (PhGA) Scale | Week 32 | 34 Participants |
| CEP-33457 | Number of Participants Showing No Worsening on Physician's Global Assessment (PhGA) Scale | Week 36 | 28 Participants |
| CEP-33457 | Number of Participants Showing No Worsening on Physician's Global Assessment (PhGA) Scale | Week 40 | 25 Participants |
| CEP-33457 | Number of Participants Showing No Worsening on Physician's Global Assessment (PhGA) Scale | Week 44 | 20 Participants |
| CEP-33457 | Number of Participants Showing No Worsening on Physician's Global Assessment (PhGA) Scale | Week 48 | 19 Participants |
| CEP-33457 | Number of Participants Showing No Worsening on Physician's Global Assessment (PhGA) Scale | Week 52 | 15 Participants |
| CEP-33457 | Number of Participants Showing No Worsening on Physician's Global Assessment (PhGA) Scale | Week 56 | 10 Participants |
| CEP-33457 | Number of Participants Showing No Worsening on Physician's Global Assessment (PhGA) Scale | Week 60 | 8 Participants |
| CEP-33457 | Number of Participants Showing No Worsening on Physician's Global Assessment (PhGA) Scale | Week 64 | 3 Participants |
| CEP-33457 | Number of Participants Showing No Worsening on Physician's Global Assessment (PhGA) Scale | Week 68 | 0 Participants |
| CEP-33457 | Number of Participants Showing No Worsening on Physician's Global Assessment (PhGA) Scale | Week 72 | 0 Participants |
Secondary
Number of Participants With Anti-nuclear Antibodies (ANA)
Anti-nuclear antibodies (ANA) were measured from blood serum samples at specified time points.
Time frame: Week 12, 24, 36, 48, 60, and Final Assessment (or Early Termination [up to Week 72])
Population: ITT analysis set included all enrolled participants who took at least 1 dose of study drug. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure and 'number analyzed' signifies participants evaluable at specified timepoint.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| CEP-33457 | Number of Participants With Anti-nuclear Antibodies (ANA) | Week 60 | >=1:1280 | 1 Participants |
| CEP-33457 | Number of Participants With Anti-nuclear Antibodies (ANA) | Week 60 | 1:1280 | 0 Participants |
| CEP-33457 | Number of Participants With Anti-nuclear Antibodies (ANA) | Week 12 | None detected | 0 Participants |
| CEP-33457 | Number of Participants With Anti-nuclear Antibodies (ANA) | Week 12 | <1:40 | 0 Participants |
| CEP-33457 | Number of Participants With Anti-nuclear Antibodies (ANA) | Week 12 | 1:40 | 16 Participants |
| CEP-33457 | Number of Participants With Anti-nuclear Antibodies (ANA) | Week 12 | 1:80 | 17 Participants |
| CEP-33457 | Number of Participants With Anti-nuclear Antibodies (ANA) | Week 12 | 1:160 | 20 Participants |
| CEP-33457 | Number of Participants With Anti-nuclear Antibodies (ANA) | Week 12 | 1:320 | 30 Participants |
| CEP-33457 | Number of Participants With Anti-nuclear Antibodies (ANA) | Week 12 | 1:640 | 7 Participants |
| CEP-33457 | Number of Participants With Anti-nuclear Antibodies (ANA) | Week 12 | 1:1280 | 0 Participants |
| CEP-33457 | Number of Participants With Anti-nuclear Antibodies (ANA) | Week 12 | >=1:1280 | 22 Participants |
| CEP-33457 | Number of Participants With Anti-nuclear Antibodies (ANA) | Week 24 | None detected | 0 Participants |
| CEP-33457 | Number of Participants With Anti-nuclear Antibodies (ANA) | Week 24 | <1:40 | 0 Participants |
| CEP-33457 | Number of Participants With Anti-nuclear Antibodies (ANA) | Week 24 | 1:40 | 3 Participants |
| CEP-33457 | Number of Participants With Anti-nuclear Antibodies (ANA) | Week 24 | 1:80 | 11 Participants |
| CEP-33457 | Number of Participants With Anti-nuclear Antibodies (ANA) | Week 24 | 1:160 | 12 Participants |
| CEP-33457 | Number of Participants With Anti-nuclear Antibodies (ANA) | Week 24 | 1:320 | 11 Participants |
| CEP-33457 | Number of Participants With Anti-nuclear Antibodies (ANA) | Week 24 | 1:640 | 4 Participants |
| CEP-33457 | Number of Participants With Anti-nuclear Antibodies (ANA) | Week 24 | 1:1280 | 0 Participants |
| CEP-33457 | Number of Participants With Anti-nuclear Antibodies (ANA) | Week 24 | >=1:1280 | 16 Participants |
| CEP-33457 | Number of Participants With Anti-nuclear Antibodies (ANA) | Week 36 | None detected | 0 Participants |
| CEP-33457 | Number of Participants With Anti-nuclear Antibodies (ANA) | Week 36 | <1:40 | 0 Participants |
| CEP-33457 | Number of Participants With Anti-nuclear Antibodies (ANA) | Week 36 | 1:40 | 5 Participants |
| CEP-33457 | Number of Participants With Anti-nuclear Antibodies (ANA) | Week 36 | 1:80 | 6 Participants |
| CEP-33457 | Number of Participants With Anti-nuclear Antibodies (ANA) | Week 36 | 1:160 | 7 Participants |
| CEP-33457 | Number of Participants With Anti-nuclear Antibodies (ANA) | Week 36 | 1:320 | 4 Participants |
| CEP-33457 | Number of Participants With Anti-nuclear Antibodies (ANA) | Week 36 | 1:640 | 2 Participants |
| CEP-33457 | Number of Participants With Anti-nuclear Antibodies (ANA) | Week 36 | 1:1280 | 0 Participants |
| CEP-33457 | Number of Participants With Anti-nuclear Antibodies (ANA) | Week 36 | >=1:1280 | 6 Participants |
| CEP-33457 | Number of Participants With Anti-nuclear Antibodies (ANA) | Week 48 | None detected | 0 Participants |
| CEP-33457 | Number of Participants With Anti-nuclear Antibodies (ANA) | Week 48 | <1:40 | 0 Participants |
| CEP-33457 | Number of Participants With Anti-nuclear Antibodies (ANA) | Week 48 | 1:40 | 4 Participants |
| CEP-33457 | Number of Participants With Anti-nuclear Antibodies (ANA) | Week 48 | 1:80 | 4 Participants |
| CEP-33457 | Number of Participants With Anti-nuclear Antibodies (ANA) | Week 48 | 1:160 | 3 Participants |
| CEP-33457 | Number of Participants With Anti-nuclear Antibodies (ANA) | Week 48 | 1:320 | 2 Participants |
| CEP-33457 | Number of Participants With Anti-nuclear Antibodies (ANA) | Week 48 | 1:640 | 2 Participants |
| CEP-33457 | Number of Participants With Anti-nuclear Antibodies (ANA) | Week 48 | 1:1280 | 0 Participants |
| CEP-33457 | Number of Participants With Anti-nuclear Antibodies (ANA) | Week 48 | >=1:1280 | 5 Participants |
| CEP-33457 | Number of Participants With Anti-nuclear Antibodies (ANA) | Week 60 | None detected | 0 Participants |
| CEP-33457 | Number of Participants With Anti-nuclear Antibodies (ANA) | Week 60 | <1:40 | 0 Participants |
| CEP-33457 | Number of Participants With Anti-nuclear Antibodies (ANA) | Week 60 | 1:40 | 1 Participants |
| CEP-33457 | Number of Participants With Anti-nuclear Antibodies (ANA) | Week 60 | 1:80 | 2 Participants |
| CEP-33457 | Number of Participants With Anti-nuclear Antibodies (ANA) | Week 60 | 1:160 | 2 Participants |
| CEP-33457 | Number of Participants With Anti-nuclear Antibodies (ANA) | Week 60 | 1:320 | 1 Participants |
| CEP-33457 | Number of Participants With Anti-nuclear Antibodies (ANA) | Week 60 | 1:640 | 1 Participants |
| CEP-33457 | Number of Participants With Anti-nuclear Antibodies (ANA) | Final Assessment (or Early Termination [up to Week 72]) | None detected | 0 Participants |
| CEP-33457 | Number of Participants With Anti-nuclear Antibodies (ANA) | Final Assessment (or Early Termination [up to Week 72]) | <1:40 | 0 Participants |
| CEP-33457 | Number of Participants With Anti-nuclear Antibodies (ANA) | Final Assessment (or Early Termination [up to Week 72]) | 1:40 | 16 Participants |
| CEP-33457 | Number of Participants With Anti-nuclear Antibodies (ANA) | Final Assessment (or Early Termination [up to Week 72]) | 1:80 | 16 Participants |
| CEP-33457 | Number of Participants With Anti-nuclear Antibodies (ANA) | Final Assessment (or Early Termination [up to Week 72]) | 1:160 | 18 Participants |
| CEP-33457 | Number of Participants With Anti-nuclear Antibodies (ANA) | Final Assessment (or Early Termination [up to Week 72]) | 1:320 | 28 Participants |
| CEP-33457 | Number of Participants With Anti-nuclear Antibodies (ANA) | Final Assessment (or Early Termination [up to Week 72]) | 1:640 | 18 Participants |
| CEP-33457 | Number of Participants With Anti-nuclear Antibodies (ANA) | Final Assessment (or Early Termination [up to Week 72]) | 1:1280 | 0 Participants |
| CEP-33457 | Number of Participants With Anti-nuclear Antibodies (ANA) | Final Assessment (or Early Termination [up to Week 72]) | >=1:1280 | 30 Participants |
Secondary
Number of Participants With British Isles Lupus Assessment Group 2004 (BILAG-2004) Response
The BILAG-2004 is a validated objective and subjective global measure of the SLE disease activity, based on the physician's intention to treat, and refers to disease activity within the last 4 weeks before completion of the index. It includes 97 clinical and laboratory components to evaluate SLE disease activity in 9 different body systems (constitutional, mucocutaneous, neuropsychiatric, musculoskeletal, cardiorespiratory, gastrointestinal, ophthalmic, renal, and hematological). Each body system is assigned a score displayed as a grade from A to E, as follows: A=very active disease; B=participant needs increase in treatment for moderately active disease; C=stab1e or mild disease; D=previous system involvement but no current disease activity; and E=no current disease activity and the body system has never been involved. BILAG 2004 response was defined as no new BILAG A body system score and no more than 1 new BILAG B body system score from baseline.
Time frame: Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72
Population: ITT analysis set included all enrolled participants who took at least 1 dose of study drug.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CEP-33457 | Number of Participants With British Isles Lupus Assessment Group 2004 (BILAG-2004) Response | Week 4 | 126 Participants |
| CEP-33457 | Number of Participants With British Isles Lupus Assessment Group 2004 (BILAG-2004) Response | Week 8 | 118 Participants |
| CEP-33457 | Number of Participants With British Isles Lupus Assessment Group 2004 (BILAG-2004) Response | Week 12 | 111 Participants |
| CEP-33457 | Number of Participants With British Isles Lupus Assessment Group 2004 (BILAG-2004) Response | Week 16 | 110 Participants |
| CEP-33457 | Number of Participants With British Isles Lupus Assessment Group 2004 (BILAG-2004) Response | Week 20 | 88 Participants |
| CEP-33457 | Number of Participants With British Isles Lupus Assessment Group 2004 (BILAG-2004) Response | Week 24 | 56 Participants |
| CEP-33457 | Number of Participants With British Isles Lupus Assessment Group 2004 (BILAG-2004) Response | Week 28 | 47 Participants |
| CEP-33457 | Number of Participants With British Isles Lupus Assessment Group 2004 (BILAG-2004) Response | Week 32 | 34 Participants |
| CEP-33457 | Number of Participants With British Isles Lupus Assessment Group 2004 (BILAG-2004) Response | Week 36 | 30 Participants |
| CEP-33457 | Number of Participants With British Isles Lupus Assessment Group 2004 (BILAG-2004) Response | Week 40 | 28 Participants |
| CEP-33457 | Number of Participants With British Isles Lupus Assessment Group 2004 (BILAG-2004) Response | Week 44 | 22 Participants |
| CEP-33457 | Number of Participants With British Isles Lupus Assessment Group 2004 (BILAG-2004) Response | Week 48 | 19 Participants |
| CEP-33457 | Number of Participants With British Isles Lupus Assessment Group 2004 (BILAG-2004) Response | Week 52 | 15 Participants |
| CEP-33457 | Number of Participants With British Isles Lupus Assessment Group 2004 (BILAG-2004) Response | Week 56 | 12 Participants |
| CEP-33457 | Number of Participants With British Isles Lupus Assessment Group 2004 (BILAG-2004) Response | Week 60 | 7 Participants |
| CEP-33457 | Number of Participants With British Isles Lupus Assessment Group 2004 (BILAG-2004) Response | Week 64 | 3 Participants |
| CEP-33457 | Number of Participants With British Isles Lupus Assessment Group 2004 (BILAG-2004) Response | Week 68 | 0 Participants |
| CEP-33457 | Number of Participants With British Isles Lupus Assessment Group 2004 (BILAG-2004) Response | Week 72 | 0 Participants |
Secondary
Number of Participants With Change in Steroid Dose
Number of participants with change in steroid dose (prednisone equivalent/day) were reported. The change in steroid dose was evaluated to determine the number of participants taking a dose less than 7.5 mg of prednisone equivalent/day, a dose of 7.5 mg prednisone equivalent/day or more, and none per day.
Time frame: From Baseline up to Final Assessment (or Early Termination [up to Week 72])
Population: ITT analysis set included all enrolled participants who took at least 1 dose of study drug.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CEP-33457 | Number of Participants With Change in Steroid Dose | <7.5 mg at Baseline to <7.5 mg at Final Assessment | 37 Participants |
| CEP-33457 | Number of Participants With Change in Steroid Dose | <7.5 mg at Baseline to >=7.5 mg at Final Assessment | 1 Participants |
| CEP-33457 | Number of Participants With Change in Steroid Dose | <7.5 mg at Baseline to None at Final Assessment | 0 Participants |
| CEP-33457 | Number of Participants With Change in Steroid Dose | >=7.5 mg at Baseline to <7.5 mg at Final Assessment | 5 Participants |
| CEP-33457 | Number of Participants With Change in Steroid Dose | >=7.5 mg at Baseline to >=7.5 mg at Final Assessment | 49 Participants |
| CEP-33457 | Number of Participants With Change in Steroid Dose | >=7.5 mg at Baseline to None at Final Assessment | 3 Participants |
| CEP-33457 | Number of Participants With Change in Steroid Dose | None at Baseline to <7.5 mg at Final Assessment | 3 Participants |
| CEP-33457 | Number of Participants With Change in Steroid Dose | None at Baseline to >=7.5 mg at Final Assessment | 2 Participants |
| CEP-33457 | Number of Participants With Change in Steroid Dose | None at Baseline to None at Final Assessment | 36 Participants |
Secondary
Number of Participants With Mild to Moderate Flare, Severe Flare, and No Flare, Based on the Safety of Estrogens in Lupus Erythematosus: National Assessment (SELENA) Flare Index
The SELENA Flare Index divides flares into 2 categories: mild/moderate and severe. A severe flare would lead to early withdrawal. The number of participants with mild to moderate flare, severe flare, and no flare at each visit during the treatment period were reported.
Time frame: Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64 and Final Assessment (or Early Termination [up to Week 72])
Population: ITT analysis set included all enrolled participants who took at least 1 dose of study drug. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure and 'number analyzed' signifies participants evaluable at specified timepoint.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| CEP-33457 | Number of Participants With Mild to Moderate Flare, Severe Flare, and No Flare, Based on the Safety of Estrogens in Lupus Erythematosus: National Assessment (SELENA) Flare Index | Week 4 | Mild/moderate flare | 15 Participants |
| CEP-33457 | Number of Participants With Mild to Moderate Flare, Severe Flare, and No Flare, Based on the Safety of Estrogens in Lupus Erythematosus: National Assessment (SELENA) Flare Index | Week 4 | Severe flare | 1 Participants |
| CEP-33457 | Number of Participants With Mild to Moderate Flare, Severe Flare, and No Flare, Based on the Safety of Estrogens in Lupus Erythematosus: National Assessment (SELENA) Flare Index | Week 4 | No flare | 114 Participants |
| CEP-33457 | Number of Participants With Mild to Moderate Flare, Severe Flare, and No Flare, Based on the Safety of Estrogens in Lupus Erythematosus: National Assessment (SELENA) Flare Index | Week 8 | Mild/moderate flare | 13 Participants |
| CEP-33457 | Number of Participants With Mild to Moderate Flare, Severe Flare, and No Flare, Based on the Safety of Estrogens in Lupus Erythematosus: National Assessment (SELENA) Flare Index | Week 8 | Severe flare | 0 Participants |
| CEP-33457 | Number of Participants With Mild to Moderate Flare, Severe Flare, and No Flare, Based on the Safety of Estrogens in Lupus Erythematosus: National Assessment (SELENA) Flare Index | Week 8 | No flare | 109 Participants |
| CEP-33457 | Number of Participants With Mild to Moderate Flare, Severe Flare, and No Flare, Based on the Safety of Estrogens in Lupus Erythematosus: National Assessment (SELENA) Flare Index | Week 12 | Mild/moderate flare | 21 Participants |
| CEP-33457 | Number of Participants With Mild to Moderate Flare, Severe Flare, and No Flare, Based on the Safety of Estrogens in Lupus Erythematosus: National Assessment (SELENA) Flare Index | Week 12 | Severe flare | 0 Participants |
| CEP-33457 | Number of Participants With Mild to Moderate Flare, Severe Flare, and No Flare, Based on the Safety of Estrogens in Lupus Erythematosus: National Assessment (SELENA) Flare Index | Week 12 | No flare | 97 Participants |
| CEP-33457 | Number of Participants With Mild to Moderate Flare, Severe Flare, and No Flare, Based on the Safety of Estrogens in Lupus Erythematosus: National Assessment (SELENA) Flare Index | Week 16 | Mild/moderate flare | 14 Participants |
| CEP-33457 | Number of Participants With Mild to Moderate Flare, Severe Flare, and No Flare, Based on the Safety of Estrogens in Lupus Erythematosus: National Assessment (SELENA) Flare Index | Week 16 | Severe flare | 0 Participants |
| CEP-33457 | Number of Participants With Mild to Moderate Flare, Severe Flare, and No Flare, Based on the Safety of Estrogens in Lupus Erythematosus: National Assessment (SELENA) Flare Index | Week 16 | No flare | 99 Participants |
| CEP-33457 | Number of Participants With Mild to Moderate Flare, Severe Flare, and No Flare, Based on the Safety of Estrogens in Lupus Erythematosus: National Assessment (SELENA) Flare Index | Week 20 | Mild/moderate flare | 9 Participants |
| CEP-33457 | Number of Participants With Mild to Moderate Flare, Severe Flare, and No Flare, Based on the Safety of Estrogens in Lupus Erythematosus: National Assessment (SELENA) Flare Index | Week 20 | Severe flare | 0 Participants |
| CEP-33457 | Number of Participants With Mild to Moderate Flare, Severe Flare, and No Flare, Based on the Safety of Estrogens in Lupus Erythematosus: National Assessment (SELENA) Flare Index | Week 20 | No flare | 82 Participants |
| CEP-33457 | Number of Participants With Mild to Moderate Flare, Severe Flare, and No Flare, Based on the Safety of Estrogens in Lupus Erythematosus: National Assessment (SELENA) Flare Index | Week 24 | Mild/moderate flare | 8 Participants |
| CEP-33457 | Number of Participants With Mild to Moderate Flare, Severe Flare, and No Flare, Based on the Safety of Estrogens in Lupus Erythematosus: National Assessment (SELENA) Flare Index | Week 24 | Severe flare | 0 Participants |
| CEP-33457 | Number of Participants With Mild to Moderate Flare, Severe Flare, and No Flare, Based on the Safety of Estrogens in Lupus Erythematosus: National Assessment (SELENA) Flare Index | Week 24 | No flare | 51 Participants |
| CEP-33457 | Number of Participants With Mild to Moderate Flare, Severe Flare, and No Flare, Based on the Safety of Estrogens in Lupus Erythematosus: National Assessment (SELENA) Flare Index | Week 28 | Mild/moderate flare | 8 Participants |
| CEP-33457 | Number of Participants With Mild to Moderate Flare, Severe Flare, and No Flare, Based on the Safety of Estrogens in Lupus Erythematosus: National Assessment (SELENA) Flare Index | Week 28 | Severe flare | 0 Participants |
| CEP-33457 | Number of Participants With Mild to Moderate Flare, Severe Flare, and No Flare, Based on the Safety of Estrogens in Lupus Erythematosus: National Assessment (SELENA) Flare Index | Week 28 | No flare | 39 Participants |
| CEP-33457 | Number of Participants With Mild to Moderate Flare, Severe Flare, and No Flare, Based on the Safety of Estrogens in Lupus Erythematosus: National Assessment (SELENA) Flare Index | Week 32 | Mild/moderate flare | 5 Participants |
| CEP-33457 | Number of Participants With Mild to Moderate Flare, Severe Flare, and No Flare, Based on the Safety of Estrogens in Lupus Erythematosus: National Assessment (SELENA) Flare Index | Week 32 | Severe flare | 0 Participants |
| CEP-33457 | Number of Participants With Mild to Moderate Flare, Severe Flare, and No Flare, Based on the Safety of Estrogens in Lupus Erythematosus: National Assessment (SELENA) Flare Index | Week 32 | No flare | 32 Participants |
| CEP-33457 | Number of Participants With Mild to Moderate Flare, Severe Flare, and No Flare, Based on the Safety of Estrogens in Lupus Erythematosus: National Assessment (SELENA) Flare Index | Week 36 | Mild/moderate flare | 4 Participants |
| CEP-33457 | Number of Participants With Mild to Moderate Flare, Severe Flare, and No Flare, Based on the Safety of Estrogens in Lupus Erythematosus: National Assessment (SELENA) Flare Index | Week 36 | Severe flare | 0 Participants |
| CEP-33457 | Number of Participants With Mild to Moderate Flare, Severe Flare, and No Flare, Based on the Safety of Estrogens in Lupus Erythematosus: National Assessment (SELENA) Flare Index | Week 36 | No flare | 28 Participants |
| CEP-33457 | Number of Participants With Mild to Moderate Flare, Severe Flare, and No Flare, Based on the Safety of Estrogens in Lupus Erythematosus: National Assessment (SELENA) Flare Index | Week 40 | Mild/moderate flare | 4 Participants |
| CEP-33457 | Number of Participants With Mild to Moderate Flare, Severe Flare, and No Flare, Based on the Safety of Estrogens in Lupus Erythematosus: National Assessment (SELENA) Flare Index | Week 40 | Severe flare | 0 Participants |
| CEP-33457 | Number of Participants With Mild to Moderate Flare, Severe Flare, and No Flare, Based on the Safety of Estrogens in Lupus Erythematosus: National Assessment (SELENA) Flare Index | Week 40 | No flare | 25 Participants |
| CEP-33457 | Number of Participants With Mild to Moderate Flare, Severe Flare, and No Flare, Based on the Safety of Estrogens in Lupus Erythematosus: National Assessment (SELENA) Flare Index | Week 44 | Mild/moderate flare | 4 Participants |
| CEP-33457 | Number of Participants With Mild to Moderate Flare, Severe Flare, and No Flare, Based on the Safety of Estrogens in Lupus Erythematosus: National Assessment (SELENA) Flare Index | Week 44 | Severe flare | 0 Participants |
| CEP-33457 | Number of Participants With Mild to Moderate Flare, Severe Flare, and No Flare, Based on the Safety of Estrogens in Lupus Erythematosus: National Assessment (SELENA) Flare Index | Week 44 | No flare | 21 Participants |
| CEP-33457 | Number of Participants With Mild to Moderate Flare, Severe Flare, and No Flare, Based on the Safety of Estrogens in Lupus Erythematosus: National Assessment (SELENA) Flare Index | Week 48 | Mild/moderate flare | 2 Participants |
| CEP-33457 | Number of Participants With Mild to Moderate Flare, Severe Flare, and No Flare, Based on the Safety of Estrogens in Lupus Erythematosus: National Assessment (SELENA) Flare Index | Week 48 | Severe flare | 0 Participants |
| CEP-33457 | Number of Participants With Mild to Moderate Flare, Severe Flare, and No Flare, Based on the Safety of Estrogens in Lupus Erythematosus: National Assessment (SELENA) Flare Index | Week 48 | No flare | 19 Participants |
| CEP-33457 | Number of Participants With Mild to Moderate Flare, Severe Flare, and No Flare, Based on the Safety of Estrogens in Lupus Erythematosus: National Assessment (SELENA) Flare Index | Week 52 | Mild/moderate flare | 2 Participants |
| CEP-33457 | Number of Participants With Mild to Moderate Flare, Severe Flare, and No Flare, Based on the Safety of Estrogens in Lupus Erythematosus: National Assessment (SELENA) Flare Index | Week 52 | Severe flare | 0 Participants |
| CEP-33457 | Number of Participants With Mild to Moderate Flare, Severe Flare, and No Flare, Based on the Safety of Estrogens in Lupus Erythematosus: National Assessment (SELENA) Flare Index | Week 52 | No flare | 15 Participants |
| CEP-33457 | Number of Participants With Mild to Moderate Flare, Severe Flare, and No Flare, Based on the Safety of Estrogens in Lupus Erythematosus: National Assessment (SELENA) Flare Index | Week 56 | Mild/moderate flare | 3 Participants |
| CEP-33457 | Number of Participants With Mild to Moderate Flare, Severe Flare, and No Flare, Based on the Safety of Estrogens in Lupus Erythematosus: National Assessment (SELENA) Flare Index | Week 56 | Severe flare | 0 Participants |
| CEP-33457 | Number of Participants With Mild to Moderate Flare, Severe Flare, and No Flare, Based on the Safety of Estrogens in Lupus Erythematosus: National Assessment (SELENA) Flare Index | Week 56 | No flare | 10 Participants |
| CEP-33457 | Number of Participants With Mild to Moderate Flare, Severe Flare, and No Flare, Based on the Safety of Estrogens in Lupus Erythematosus: National Assessment (SELENA) Flare Index | Week 60 | Mild/moderate flare | 2 Participants |
| CEP-33457 | Number of Participants With Mild to Moderate Flare, Severe Flare, and No Flare, Based on the Safety of Estrogens in Lupus Erythematosus: National Assessment (SELENA) Flare Index | Week 60 | Severe flare | 0 Participants |
| CEP-33457 | Number of Participants With Mild to Moderate Flare, Severe Flare, and No Flare, Based on the Safety of Estrogens in Lupus Erythematosus: National Assessment (SELENA) Flare Index | Week 60 | No flare | 6 Participants |
| CEP-33457 | Number of Participants With Mild to Moderate Flare, Severe Flare, and No Flare, Based on the Safety of Estrogens in Lupus Erythematosus: National Assessment (SELENA) Flare Index | Week 64 | Mild/moderate flare | 1 Participants |
| CEP-33457 | Number of Participants With Mild to Moderate Flare, Severe Flare, and No Flare, Based on the Safety of Estrogens in Lupus Erythematosus: National Assessment (SELENA) Flare Index | Week 64 | Severe flare | 0 Participants |
| CEP-33457 | Number of Participants With Mild to Moderate Flare, Severe Flare, and No Flare, Based on the Safety of Estrogens in Lupus Erythematosus: National Assessment (SELENA) Flare Index | Week 64 | No flare | 3 Participants |
| CEP-33457 | Number of Participants With Mild to Moderate Flare, Severe Flare, and No Flare, Based on the Safety of Estrogens in Lupus Erythematosus: National Assessment (SELENA) Flare Index | Final Assessment (or Early Termination [up to Week 72]) | Mild/moderate flare | 24 Participants |
| CEP-33457 | Number of Participants With Mild to Moderate Flare, Severe Flare, and No Flare, Based on the Safety of Estrogens in Lupus Erythematosus: National Assessment (SELENA) Flare Index | Final Assessment (or Early Termination [up to Week 72]) | Severe flare | 4 Participants |
| CEP-33457 | Number of Participants With Mild to Moderate Flare, Severe Flare, and No Flare, Based on the Safety of Estrogens in Lupus Erythematosus: National Assessment (SELENA) Flare Index | Final Assessment (or Early Termination [up to Week 72]) | No flare | 107 Participants |
Secondary
Number of Participants With Reactive and Non-Reactive Anti-CEP-33457 Antibodies
Immunogenicity was assessed by detection of the presence of specific anti-CEP-33457 antibodies in blood serum samples collected at the specified time points.
Time frame: Week 24, 48 and Final Assessment (or Early Termination [up to Week 72])
Population: ITT analysis set included all enrolled participants who took at least 1 dose of study drug. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure and 'number analyzed' signifies participants evaluable at specified timepoint.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| CEP-33457 | Number of Participants With Reactive and Non-Reactive Anti-CEP-33457 Antibodies | Week 24 | Reactive | 4 Participants |
| CEP-33457 | Number of Participants With Reactive and Non-Reactive Anti-CEP-33457 Antibodies | Week 24 | Non-reactive | 53 Participants |
| CEP-33457 | Number of Participants With Reactive and Non-Reactive Anti-CEP-33457 Antibodies | Week 48 | Reactive | 1 Participants |
| CEP-33457 | Number of Participants With Reactive and Non-Reactive Anti-CEP-33457 Antibodies | Week 48 | Non-reactive | 21 Participants |
| CEP-33457 | Number of Participants With Reactive and Non-Reactive Anti-CEP-33457 Antibodies | Final Assessment (or Early Termination [up to Week 72]) | Reactive | 7 Participants |
| CEP-33457 | Number of Participants With Reactive and Non-Reactive Anti-CEP-33457 Antibodies | Final Assessment (or Early Termination [up to Week 72]) | Non-reactive | 119 Participants |