Adults 18 to 75, any sex, with Systemic Lupus Erythematosus. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
DBPC Period: Number of Participants With Response Based on Systemic Lupus Erythematosus Responder Index 4 (SRI-4) at Week 52Primary· 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: a
Group
Value
95% CI
DBPC Period: Placebo
52
DBPC Period: M2951 25 mg QD
64
DBPC Period: M2951 75 mg QD
60
DBPC Period: M2951 50 mg BID
55
DBPC Period: Number of Participants With Response Based on Systemic Lupus Erythematosus Responder Index 6 (SRI-6) at Week 52Primary· 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 sys
Group
Value
95% CI
DBPC Period: Placebo
22
DBPC Period: M2951 25 mg QD
27
DBPC Period: M2951 75 mg QD
30
DBPC Period: M2951 50 mg BID
24
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)Primary· 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 bot
Any TEAEs
Group
Value
95% CI
DBPC Period: Placebo
96
DBPC Period: M2951 25 mg QD
103
DBPC Period: M2951 75 mg QD
100
DBPC Period: M2951 50 mg BID
99
Any serious TEAE
Group
Value
95% CI
DBPC Period: Placebo
10
DBPC Period: M2951 25 mg QD
13
DBPC Period: M2951 75 mg QD
11
DBPC Period: M2951 50 mg BID
9
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)Primary· 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.
Grade 1
Group
Value
95% CI
DBPC Period: Placebo
76
DBPC Period: M2951 25 mg QD
80
DBPC Period: M2951 75 mg QD
79
DBPC Period: M2951 50 mg BID
76
Grade 2
Group
Value
95% CI
DBPC Period: Placebo
63
DBPC Period: M2951 25 mg QD
77
DBPC Period: M2951 75 mg QD
72
DBPC Period: M2951 50 mg BID
78
Grade 3
Group
Value
95% CI
DBPC Period: Placebo
24
DBPC Period: M2951 25 mg QD
29
DBPC Period: M2951 75 mg QD
24
DBPC Period: M2951 50 mg BID
21
Grade 4
Group
Value
95% CI
DBPC Period: Placebo
1
DBPC Period: M2951 25 mg QD
1
DBPC Period: M2951 75 mg QD
0
DBPC Period: M2951 50 mg BID
2
Grade 5
Group
Value
95% CI
DBPC Period: Placebo
0
DBPC Period: M2951 25 mg QD
1
DBPC Period: M2951 75 mg QD
1
DBPC Period: M2951 50 mg BID
0
DBPC Period: Number of Participants With Clinically Significant Change From Baseline in Vital SignsPrimary· 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.
Group
Value
95% CI
DBPC Period: Placebo
0
DBPC Period: M2951 25 mg QD
0
DBPC Period: M2951 75 mg QD
0
DBPC Period: M2951 50 mg BID
0
DBPC Period: Number of Participants With Clinically Significant Changes From Baseline in 12-Lead Electrocardiogram (ECG) FindingsPrimary· 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.
Group
Value
95% CI
DBPC Period: Placebo
0
DBPC Period: M2951 25 mg QD
0
DBPC Period: M2951 75 mg QD
0
DBPC Period: M2951 50 mg BID
0
DBPC Period: Number of Participants With Clinically Significant Changes From Baseline in Laboratory ParametersPrimary· 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.
Group
Value
95% CI
DBPC Period: Placebo
0
DBPC Period: M2951 25 mg QD
0
DBPC Period: M2951 75 mg QD
0
DBPC Period: M2951 50 mg BID
0
DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 2Primary· Week 2
Mean absolute value of serum levels of IgG, IgA, IgM were assessed at Week 2.
IgG
Group
Value
95% CI
DBPC Period: Placebo
14.56
± 5.367
DBPC Period: M2951 25 mg QD
13.75
± 4.652
DBPC Period: M2951 75 mg QD
14.37
± 5.536
DBPC Period: M2951 50 mg BID
12.81
± 3.847
IgA
Group
Value
95% CI
DBPC Period: Placebo
2.62
± 1.207
DBPC Period: M2951 25 mg QD
2.75
± 1.374
DBPC Period: M2951 75 mg QD
2.78
± 1.328
DBPC Period: M2951 50 mg BID
2.66
± 1.137
IgM
Group
Value
95% CI
DBPC Period: Placebo
1.12
± 0.662
DBPC Period: M2951 25 mg QD
1.22
± 0.890
DBPC Period: M2951 75 mg QD
1.09
± 0.697
DBPC Period: M2951 50 mg BID
1.18
± 0.776
DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 4Primary· Week 4
Mean absolute value of serum levels of IgG, IgA, IgM were assessed at Week 4.
IgG
Group
Value
95% CI
DBPC Period: Placebo
14.92
± 5.497
DBPC Period: M2951 25 mg QD
13.60
± 4.590
DBPC Period: M2951 75 mg QD
14.21
± 4.828
DBPC Period: M2951 50 mg BID
12.73
± 3.771
IgA
Group
Value
95% CI
DBPC Period: Placebo
2.71
± 1.284
DBPC Period: M2951 25 mg QD
2.73
± 1.349
DBPC Period: M2951 75 mg QD
2.82
± 1.293
DBPC Period: M2951 50 mg BID
2.64
± 1.109
IgM
Group
Value
95% CI
DBPC Period: Placebo
1.12
± 0.699
DBPC Period: M2951 25 mg QD
1.18
± 0.824
DBPC Period: M2951 75 mg QD
1.06
± 0.676
DBPC Period: M2951 50 mg BID
1.16
± 0.745
DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 12Primary· Week 12
Mean absolute value of serum levels of IgG, IgA, IgM were assessed at Week 12.
IgG:
Group
Value
95% CI
DBPC Period: Placebo
14.91
± 5.312
DBPC Period: M2951 25 mg QD
12.92
± 4.332
DBPC Period: M2951 75 mg QD
13.64
± 4.035
DBPC Period: M2951 50 mg BID
12.38
± 3.520
IgA
Group
Value
95% CI
DBPC Period: Placebo
2.72
± 1.321
DBPC Period: M2951 25 mg QD
2.73
± 1.340
DBPC Period: M2951 75 mg QD
2.88
± 1.363
DBPC Period: M2951 50 mg BID
2.68
± 1.021
IgM
Group
Value
95% CI
DBPC Period: Placebo
1.11
± 0.683
DBPC Period: M2951 25 mg QD
1.05
± 0.700
DBPC Period: M2951 75 mg QD
0.95
± 0.610
DBPC Period: M2951 50 mg BID
1.02
± 0.695
DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 24Primary· Week 24
Mean absolute value of serum levels of IgG, IgA, IgM were assessed at Week 24.
IgG
Group
Value
95% CI
DBPC Period: Placebo
15.01
± 5.190
DBPC Period: M2951 25 mg QD
13.75
± 4.783
DBPC Period: M2951 75 mg QD
13.79
± 4.165
DBPC Period: M2951 50 mg BID
12.86
± 3.725
IgA
Group
Value
95% CI
DBPC Period: Placebo
2.79
± 1.430
DBPC Period: M2951 25 mg QD
2.89
± 1.460
DBPC Period: M2951 75 mg QD
2.98
± 1.391
DBPC Period: M2951 50 mg BID
2.78
± 1.091
IgM
Group
Value
95% CI
DBPC Period: Placebo
1.07
± 0.609
DBPC Period: M2951 25 mg QD
1.01
± 0.686
DBPC Period: M2951 75 mg QD
0.89
± 0.583
DBPC Period: M2951 50 mg BID
0.98
± 0.656
DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 36Primary· Week 36
Mean absolute value of serum levels of IgG, IgA, IgM were assessed at Week 36.
IgG
Group
Value
95% CI
DBPC Period: Placebo
14.81
± 5.217
DBPC Period: M2951 25 mg QD
13.54
± 4.242
DBPC Period: M2951 75 mg QD
13.67
± 3.934
DBPC Period: M2951 50 mg BID
12.65
± 3.480
IgA
Group
Value
95% CI
DBPC Period: Placebo
2.72
± 1.378
DBPC Period: M2951 25 mg QD
2.89
± 1.418
DBPC Period: M2951 75 mg QD
3.01
± 1.420
DBPC Period: M2951 50 mg BID
2.86
± 1.073
IgM
Group
Value
95% CI
DBPC Period: Placebo
1.06
± 0.630
DBPC Period: M2951 25 mg QD
1.01
± 0.669
DBPC Period: M2951 75 mg QD
0.85
± 0.541
DBPC Period: M2951 50 mg BID
0.95
± 0.656
Adverse events — posted to ClinicalTrials.gov
Time frame: Double-Blind Placebo-Controlled: Baseline up to Week 56 Long-Term Extension: Up to Week 108.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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).
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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NCT02784106 — Safety and Efficacy Study of M2951 in Participants With Rheumatoid Arthritis
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by EMD Serono Research & Development Institute, Inc.
Last refreshed: 12 April 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02975336.