A Phase II Study of M2951 in Systemic Lupus Erythematosus (SLE)

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223900

Enrollment

480

Registered

2018-05-14

Start date

2017-01-20

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Systemic Lupus Erythematosus

Interventions

investigational material(s) Generic name etc : M2951 (Other Name: Evobrutinib) INN of investigational material : - Therapeutic category code : 399 Agents affecting metabolism, n.e.c. Dosage and Admini

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - 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

Exclusion criteria: - Subjects 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 or equal to (>=) 30 mg daily prednisone equivalent - Use of injectable corticosteroids, or change in dose of corticosteroids. - Other protocol defined exclusion criteria could apply.

Design outcomes

Primary

Measure	Time frame
safety efficacy exploratory - Number of Subjects With Response Based on Systemic Lupus Erythematosus Responder Index 4 (SRI-4): All Subjects [ Time Frame: Week 52 ] - Number of Subjects With Response Based on Systemic Lupus Erythematosus Responder Index 6 (SRI-6): High Disease Activity (HDA) Subgroup Subjects [ Time Frame: Week 52 ] - Occurrences of Subjects With Treatment-emergent Serious Adverse Events (SAEs) and Adverse Events (AEs) [ Time Frame: Baseline up to Week 56 ] - Occurrences of Treatment-emergent Adverse Events (TEAEs) According to Severity [ Time Frame: Baseline up to Week 56 ] - Number of Subjects With Clinically Significant Vital signs, Electrocardiogram (ECG) and Laboratory Abnormalities [ Time Frame: Baseline up to Week 56 ] - Serum Total Immunoglobulin (Ig) levels [ Time Frame: up to Week 56 ] - Total B Cell Counts [ Time Frame: up to Week 56 ] - Change From Baseline to Week 56 in Serum total Immunoglobulin (Ig) levels [ Time Frame: Baseline, up to Week 56 ] - Change From Baseline to Week 56 in Total B Cell Counts [ Time Frame: Baseline, up to Week 56 ]	—

Measure

Time frame

safety efficacy exploratory - Number of Subjects With Response Based on Systemic Lupus Erythematosus Responder Index 4 (SRI-4): All Subjects [ Time Frame: Week 52 ] - Number of Subjects With Response Based on Systemic Lupus Erythematosus Responder Index 6 (SRI-6): High Disease Activity (HDA) Subgroup Subjects [ Time Frame: Week 52 ] - Occurrences of Subjects With Treatment-emergent Serious Adverse Events (SAEs) and Adverse Events (AEs) [ Time Frame: Baseline up to Week 56 ] - Occurrences of Treatment-emergent Adverse Events (TEAEs) According to Severity [ Time Frame: Baseline up to Week 56 ] - Number of Subjects With Clinically Significant Vital signs, Electrocardiogram (ECG) and Laboratory Abnormalities [ Time Frame: Baseline up to Week 56 ] - Serum Total Immunoglobulin (Ig) levels [ Time Frame: up to Week 56 ] - Total B Cell Counts [ Time Frame: up to Week 56 ] - Change From Baseline to Week 56 in Serum total Immunoglobulin (Ig) levels [ Time Frame: Baseline, up to Week 56 ] - Change From Baseline to Week 56 in Total B Cell Counts [ Time Frame: Baseline, up to Week 56 ]

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Secondary

Measure	Time frame
efficacy exploratory - Time to First Severe Flare [Time Frame: Baseline up to Week 52] - Number of Subjects With Response Based on Systemic Lupus Erythematosus Responder Index 4 (SRI-4): Serologically Active Subgroup [Time Frame: Week 52] - Number of Subjects With Response Based on Systemic Lupus Erythematosus Responder Index 6 (SRI-6): Serologically Active Subgroup [Time Frame: Week 52] - Time to First Flare [Time Frame: Baseline up to Week 52] - Flare-free Status [Time Frame: Week 52] - Annualized Flare Rate [Time Frame: Baseline up to Week 52] - Low Disease Activity Status, Defined by Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) Score of =25% to a dose of 50%, or an increase [Time Frame: Baseline, up to Week 52] - Cumulative Prednisone-equivalent CS dose [Time Frame: Baseline up to Week 52] - Clinically Meaningful Change in CS Dose From Baseline [Time Frame: up to Week 52] - Number of Subjects with a Sustained Reduction of Oral Corticosteroids (OCS) Dose to 7.5 milligrams prednisone equivalent per day or less With Response Based on Systemic Lupus Erythematosus Responder Index 4 (SRI-4): all subject [Time Frame: Week 52] - Number of Subjects with a Sustained Reduction of OCS Dose less than or equal to (<=) Day 1 dose With Response Based on Systemic Lupus Erythematosus Responder Index 4 (SRI-4): all subject [Time Frame: Week 52] - Number of Subjects with a Sustained Reduction of OCS Dose to 7.5 milligrams prednisone equivalent per day or less With Response Based on Systemic Lupus Erythematosus Responder Index 6 (SRI-6): HDA subgroup [Time Frame: Week 52] - Number of Subjects with a Sustained Reduction of OCS Dose less than or equal to (<=) Day 1 dose Response Based on Systemic Lupus Erythematosus Responder Index 6 (SRI-6): HDA subgroup [Time Frame: Week 52] - Number of Subjects with a Sustained Reduction of OCS Dose to 7.5 milligrams prednisone equivalent per day or less With Response Based on Systemic Lupus Erythematosus Responder Index 4	—

Measure

Time frame

efficacy exploratory - Time to First Severe Flare [Time Frame: Baseline up to Week 52] - Number of Subjects With Response Based on Systemic Lupus Erythematosus Responder Index 4 (SRI-4): Serologically Active Subgroup [Time Frame: Week 52] - Number of Subjects With Response Based on Systemic Lupus Erythematosus Responder Index 6 (SRI-6): Serologically Active Subgroup [Time Frame: Week 52] - Time to First Flare [Time Frame: Baseline up to Week 52] - Flare-free Status [Time Frame: Week 52] - Annualized Flare Rate [Time Frame: Baseline up to Week 52] - Low Disease Activity Status, Defined by Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) Score of =25% to a dose of 50%, or an increase [Time Frame: Baseline, up to Week 52] - Cumulative Prednisone-equivalent CS dose [Time Frame: Baseline up to Week 52] - Clinically Meaningful Change in CS Dose From Baseline [Time Frame: up to Week 52] - Number of Subjects with a Sustained Reduction of Oral Corticosteroids (OCS) Dose to 7.5 milligrams prednisone equivalent per day or less With Response Based on Systemic Lupus Erythematosus Responder Index 4 (SRI-4): all subject [Time Frame: Week 52] - Number of Subjects with a Sustained Reduction of OCS Dose less than or equal to (<=) Day 1 dose With Response Based on Systemic Lupus Erythematosus Responder Index 4 (SRI-4): all subject [Time Frame: Week 52] - Number of Subjects with a Sustained Reduction of OCS Dose to 7.5 milligrams prednisone equivalent per day or less With Response Based on Systemic Lupus Erythematosus Responder Index 6 (SRI-6): HDA subgroup [Time Frame: Week 52] - Number of Subjects with a Sustained Reduction of OCS Dose less than or equal to (<=) Day 1 dose Response Based on Systemic Lupus Erythematosus Responder Index 6 (SRI-6): HDA subgroup [Time Frame: Week 52] - Number of Subjects with a Sustained Reduction of OCS Dose to 7.5 milligrams prednisone equivalent per day or less With Response Based on Systemic Lupus Erythematosus Responder Index 4

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Countries

Africa, Asia except Japan, Europe, Japan, North America, South America

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026