A Phase II Study of M2951 in SLE

• ClinicalTrials.gov Identifier: NCT02975336
• Recruitment Status: Terminated
• First Posted: November 29, 2016
• Results First Posted: December 17, 2020
• Last Update Posted: April 12, 2021
• Sponsor: EMD Serono Research & Development Institute, Inc.
• Collaborator: Merck KGaA, Darmstadt, Germany
• Information provided by (Responsible Party): EMD Serono ( EMD Serono Research & Development Institute, Inc. )

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Systemic Lupus Erythematosus	Drug: Placebo; Drug: M2951	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 469 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Phase II, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study To Evaluate the Safety and Efficacy of M2951 in Subjects With SLE
• Actual Study Start Date: January 4, 2017
• Actual Primary Completion Date: November 27, 2019
• Actual Study Completion Date: March 23, 2020

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: Double-Blind Placebo-Controlled (DBPC) Period: Placebo	Drug: Placebo; Participants received placebo matched to M2951 orally for 52 weeks.
Experimental: DBPC Period: M2951 25 mg QD	Drug: M2951; Participants received 25 milligrams (mg) of M2951 orally once daily (QD) for 52 weeks.; Other Name: Evobrutinib
Experimental: DBPC Period: M2951 75 mg QD	Drug: M2951; Participants received 75 mg of M2951 orally QD for 52 weeks.; Other Name: Evobrutinib
Experimental: DBPC Period: M2951 50 mg BID	Drug: M2951; Participants received 50 mg of M2951 orally twice daily (BID) for 52 weeks.; Other Name: Evobrutinib
Experimental: Long-Term Extension (LTE) Period: Placebo/ M2951 50 mg BID	Drug: M2951; Participants who had received Placebo or M2951 (25 mg QD, 75 mg QD or 50 mg BID) during DBPC period were switched to receive 50 mg M2951 orally BID in LTE period for 104 weeks.; Other Name: Evobrutinib
Experimental: LTE Period: M2951 25 mg QD/ M2951 50 mg BID	Drug: M2951; Participants who had received Placebo or M2951 (25 mg QD, 75 mg QD or 50 mg BID) during DBPC period were switched to receive 50 mg M2951 orally BID in LTE period for 104 weeks.; Other Name: Evobrutinib
Experimental: LTE Period: M2951 75 mg QD/ M2951 50 mg BID	Drug: M2951; Participants who had received Placebo or M2951 (25 mg QD, 75 mg QD or 50 mg BID) during DBPC period were switched to receive 50 mg M2951 orally BID in LTE period for 104 weeks.; Other Name: Evobrutinib
Experimental: LTE Period: M2951 50 mg BID/ M2951 50 mg BID	Drug: M2951; Participants who had received Placebo or M2951 (25 mg QD, 75 mg QD or 50 mg BID) during DBPC period were switched to receive 50 mg M2951 orally BID in LTE period for 104 weeks.; Other Name: Evobrutinib

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

United States, Alabama

Pinnacle Research Group LLC

Anniston, Alabama, United States, 36207

United States, Arizona

Arizona Arthritis & Rheumatology Associates, P.C.

Mesa, Arizona, United States, 85210

Arizona Arthritis & Rheumatology Associates, P.C.

Phoenix, Arizona, United States, 85032

United States, California

Advanced Research Center, Inc.

Anaheim, California, United States, 92805

Wallace Rheumatic Study Center

Beverly Hills, California, United States, 90211

Medvin Clinical Research

Covina, California, United States, 91722

Southern California Permanent Medical Group

Fontana, California, United States, 92335

Global Research Management

Glendale, California, United States, 91204

University of Southern California

Los Angeles, California, United States, 90033

East Bay Rheumatology Medical Group, Inc.

San Leandro, California, United States, 94578

Inland Rheumatology Clinical Trials, Inc.

Upland, California, United States, 91786

Nazanin Firooz, MD Inc.

West Hills, California, United States, 91307

United States, Colorado

University of Colorado Denver Anschutz Medical Campus

Aurora, Colorado, United States, 80045

United States, Connecticut

Yale School Of Medicine

New Haven, Connecticut, United States, 06519

United States, Florida

Clinical Research of West Florida - Corporate

Clearwater, Florida, United States, 33765

Omega Research Consultants

DeBary, Florida, United States, 32713

Center for Rheumatology, Immunology & Arthritis

Fort Lauderdale, Florida, United States, 33309

Hope Clinical Trials

Miami, Florida, United States, 33165

IRIS Research and Development

Plantation, Florida, United States, 33324

McIlwain Medical Group, PA

Tampa, Florida, United States, 33614

Meridien Research, Inc.

Tampa, Florida, United States, 33634

United States, Georgia

Marietta Rheumatology Associates, PC

Marietta, Georgia, United States, 30060

United States, Illinois

The University of Chicago Medicine

Chicago, Illinois, United States, 60637

United States, Louisiana

LSU Health Sciences Center Gastroenterology

Shreveport, Louisiana, United States, 71103

United States, Massachusetts

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States, 02215

United States, Michigan

Henry Ford Health System

Detroit, Michigan, United States, 48202

AA MRC LLC Ahmed Arif Medical Research Center

Flint, Michigan, United States, 48439

United States, Mississippi

University of Mississippi Medical Center

Jackson, Mississippi, United States, 39216

United States, Missouri

Washington University in St. Louis

Saint Louis, Missouri, United States, 63110

United States, New York

Montefiore Medical Center PRIME

Bronx, New York, United States, 10461

Hospital for Special Surgery

New York, New York, United States, 10021

SUNY Upstate Medical Center

Syracuse, New York, United States, 13210

United States, North Carolina

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States, 27599

Medication Management, LLC

Greensboro, North Carolina, United States, 27408

United States, Pennsylvania

Allegheny-Singer Research Institute

Pittsburgh, Pennsylvania, United States, 15224

United States, South Carolina

Innovative Clinical Research, LLC

Greenville, South Carolina, United States, 29601

United States, Texas

Metroplex Clinical Research Center, LLC

Dallas, Texas, United States, 75231

Accurate Clinical Research, Inc.

Houston, Texas, United States, 77034

Accurate Clinical Management - Brionez

Houston, Texas, United States, 77084

Medical Center Research, LLC Webster Office

Pearland, Texas, United States, 77584

DM Clinical Research

Tomball, Texas, United States, 77375

United States, Washington

FSAEI HE " First Moscow State Medical University n.a. I.M. Sechenov" of the MoH of the RF

Seattle, Washington, United States

Argentina

Instituto de Investigaciones Clinicas

Mar del Plata, Buenos Aires, Argentina

Instituto de Investigaciones Clinicas Quilmes

Quilmes, Buenos Aires, Argentina

Centro Medico Privado de Reumatologia

San Miguel de Tucuman, Tucuman, Argentina

Investigaciones Clinicas Tucuman

San Miguel de Tucuman, Tucuman, Argentina

Centro Integral de Reumatologia

San Miguel de Tucumán, Tucuman, Argentina

APRILLUS

Ciudad Autonoma Buenos aires, Argentina

Centro Medico Dra Laura Maffei Investigacion Clinica Aplicada

Ciudad Autonoma Buenos Aires, Argentina

Clinica Adventista Belgrano

Ciudad Autonoma Buenos Aires, Argentina

Hospital Britanico de Buenos Aires

Ciudad Autonoma Buenos Aires, Argentina

Hospital General de Agudos Dr. J. M. Ramos Mejia

Ciudad Autonoma Buenos Aires, Argentina

Sanatorio Allende

Cordoba, Argentina

Instituto de Reumatologia

Mendoza, Argentina

Cordis S.A.

Salta, Argentina

Centro Polivalente de Asistencia e Inv. Clinica CER

San Juan, Argentina

Bulgaria

UMHAT "Pulmed" OOD

Plovdiv, Bulgaria

MHAT - Ruse, AD

Ruse, Bulgaria

Medizinski Zentar-1-Sevlievo EOOD

Sevlievo, Bulgaria

Medical Center "Excelsior", OOD

Sofia, Bulgaria

Medical Center Comac Medical EOOD

Sofia, Bulgaria

UMHAT "SofiaMed", OOD

Sofia, Bulgaria

UMHAT "Sv. Ivan Rilski", EAD

Sofia, Bulgaria

Chile

Corporacion de Beneficencia Osorno

Osorno, Chile

Centro de Estudios Reumatologicos

Santiago, Chile

Centro Medico Prosalud

Santiago, Chile

Interin

Santiago, Chile

Psicomedica Clinical and Research Group

Santiago, Chile

Quantum Research Santiago

Santiago, Chile

Colombia

Centro de Reumatologia y Ortopedia SAS

Barranquilla, Colombia

Clínica de la Costa Ltda.

Barranquilla, Colombia

Fundacion Instituto de Reumatologia Fernando Chalem

Bogota, Colombia

Simedics Ips Sas

Bogotá, Colombia

Servimed S.A.S.

Bucaramanga, Colombia

Germany

Charite Universitaetsmedizin Berlin - Campus Charite Mitte

Berlin, Germany

Italy

Humanitas Research Hospital

Rozzano, Milano, Italy

Ospedale San Raffaele

Milano, Italy

Azienda Ospedaliera Universitaria- Università degli Studi della Campania "Luigi Vanvitelli"

Napoli, Italy

Arcispedale S. Maria Nuova Azienda Ospedaliera di Reggio Emilia

Reggio Emilia, Italy

Policlinico Universitario Agostino Gemelli

Roma, Italy

Japan

Ehime University Hospital

Toon-shi, Ehime-Ken, Japan

Tobata General Hospital

Kitakyushu-shi, Fukuoka-Ken, Japan

University of Occupational and Environmental Health Hospital

Kitakyushu-shi, Fukuoka-Ken, Japan

NHO Asahikawa Medical Center

Asahikawa-shi, Hokkaido, Japan

Kanazawa University Hospital

Kanazawa-shi, Ishikawa-Ken, Japan

Kagawa University Hospital

Kita-gun, Kagawa-Ken, Japan

Eiraku Clinic

Kagoshima-shi, Kagoshima-Ken, Japan

Tohoku University Hospital

Sendai-shi, Miyagi-Ken, Japan

Seirei Hamamatsu General Hospital

Hamamatsu-shi, Shizuoka-Ken, Japan

Dokkyo Medical University Hospital

Shimotsuga-gun, Tochigi-Ken, Japan

St. Luke's International Hospital

Chuo-ku, Tokyo-To, Japan

Tokyo Metropolitan Tama Medical Center

Fuchu-shi, Tokyo-To, Japan

Nihon University Itabashi Hospital

Itabashi-ku, Tokyo-To, Japan

Keio University Hospital

Shinjuku-ku, Tokyo-To, Japan

Tottori University Hospital

Yonago-shi, Tottori-Ken, Japan

Korea, Republic of

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, Korea, Republic of

Ajou University Hospital

Suwon-si, Gyeonggi-do, Korea, Republic of

Dong-A University Hospital

Busan, Korea, Republic of

Kyungpook National University Hospital

Daegu, Korea, Republic of

Konkuk University Medical Center

Seoul, Korea, Republic of

Severance Hospital, Yonsei University

Seoul, Korea, Republic of

The Catholic University of Korea, Yeouido St. Mary's Hospital

Seoul, Korea, Republic of

Malaysia

Hospital Pakar Sultanah Fatimah

Muar, Johor, Malaysia

Hospital Umum Sarawak

Kuching, Sarawak, Malaysia

Hospital Selayang

Batu Caves, Selangor, Malaysia

International Medical University (IMU) Healthcare

Bukit Jalil, Selangor, Malaysia

Hospital Kuala Lumpur

Kuala Lumpur, Malaysia

Mauritius

CAP Research

Solferino-Phoenix, Mauritius

Mexico

Unidad de Investigacion de las Enfermedades Reumaticas

Cuauhtemoc, Distrito Federal, Mexico

Clinstile, S.A. de C.V.

Mexico, Distrito Federal, Mexico

Clinical Research Institute S.C.

Tlalnepantla, Estado De Mexico, Mexico

Morales Vargas Centro de Investigacion, S.C.

Leon, Guanajuato, Mexico

Clinica de Investigacion en Reumatologia y Obesidad S.C.

Guadalajara, Jalisco, Mexico

Unidad de Investigacion en Enfermedades Cronico Degenerativas SC

Guadalajara, Jalisco, Mexico

Accelerium S. de R.L. de C.V.

Monterrey, Nuevo León, Mexico

Hospital Central Dr Ignacio Morones Prieto

San Luis Potosi, San Luis Potos, Mexico

Investigacion y Biomedicina de Chihuahua, S.C.

Chihuahua, Mexico

Peru

Hogar Clínica San Juan de Dios - Arequipa

Arequipa, Peru

Clinica El Golf

Lima, Peru

Clinica Medica Cayetano Heredia

Lima, Peru

Clinica San Juan Bautista

Lima, Peru

Clinica Vesalio

Lima, Peru

GINOBS SA. Instituto de Ginecologia y Reproduccion

Lima, Peru

Hospital Nacional Cayetano Heredia

Lima, Peru

University of Washington Medical Center

Lima, Peru

ICCV Research Instituto del Cerebro y la Columna Vertebral

Miraflores, Peru

Philippines

Angeles University Foundation Medical Center

Angeles City, Pampanga, Philippines

Mary Mediatrix Medical Center

Batangas, Philippines

De La Salle University Medical Center

Dasmariñas City, Cavite, Philippines

Davao Doctors Hospital

Davao City, Philippines

Southern Philippines Medical Center

Davao City, Philippines

Iloilo Doctors Hospital

Iloilo City, Philippines

St. Luke's Medical Center

Quezon City, Philippines

Poland

CERMED

Bialystok, Poland

Szpital Uniwersytecki nr 2 im.dr J. Biziela

Bydgoszcz, Poland

Centrum Reumatologiczne Indywidualna Specjalistyczna Praktyka Lekarska lek. Barbara Bazela

Elblag, Poland

Centrum Medyczne Plejady

Krakow, Poland

Nzoz Atopia

Krakow, Poland

Rheuma Medicus Zaklad

Warsawa, Poland

Romania

Spitalul Clinic "Dr.I. Cantacuzino"

Bucuresti, Romania

Spitalul Clinic "Sf. Maria"

Bucuresti, Romania

S.C Mediab S.R.L

Tirgu Mures, Romania

Russian Federation

LLC "Alliance Biomedical - Ural Group"

Izhevsk, Russian Federation

TSBIH "Krasnoyarsk Interdistrict Clinical Hospital of Emergency Medical Care n.a. N.S. Karpovich

Krasnoyarsk, Russian Federation

HMA - Hospital Maria Auxiliadora

Moscow, Russian Federation

Ultramed

Omsk, Russian Federation

LLC Medical Sanitary Unit#157

Saint-Petersburg, Russian Federation

SPb SBIH "Clinical Rheumatological Hospital # 25"

Saint-Petersburg, Russian Federation

SIH "Saratov City Clinical Hospital # 12"

Saratov, Russian Federation

Research Institute of Emergency Medical Care

St. Petersburg, Russian Federation

Nebbiolo LLC

Tomsk, Russian Federation

South Africa

Wits Clinical Research

Johannesburg, Gauteng, South Africa

Winelands Medical Research Centre

Stellenbosch, Western Cape, South Africa

Naidoo, A - Netcare Umhlanga Hospital

Durban, South Africa, 4319

Taiwan

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung, Taiwan

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung, Taiwan

Taichung Veterans General Hospital

Taichung, Taiwan

Sponsors and Collaborators

EMD Serono Research & Development Institute, Inc.

Merck KGaA, Darmstadt, Germany

Investigators

• Study Director: Medical Responsible; EMD Serono Research & Development Institute, Inc., a business of Merck KGaA, Darmstadt, Germany

  Study Documents (Full-Text)

Documents provided by EMD Serono ( EMD Serono Research & Development Institute, Inc. ):

Study Protocol  [PDF] May 22, 2018

Statistical Analysis Plan  [PDF] June 11, 2020

More Information

Additional Information:

Trial Awareness and Transparency website 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Hannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3(3):CD007478. doi: 10.1002/14651858.CD007478.pub2.

• Responsible Party: EMD Serono Research & Development Institute, Inc.
• ClinicalTrials.gov Identifier: NCT02975336
• Other Study ID Numbers: MS200527-0018; 2016-002950-19 ( EudraCT Number )
• First Posted: November 29, 2016
• Results First Posted: December 17, 2020
• Last Update Posted: April 12, 2021
• Last Verified: March 2021

Keywords provided by EMD Serono ( EMD Serono Research & Development Institute, Inc. ):

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

Additional relevant MeSH terms:

Lupus Erythematosus, Systemic; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases