A Phase II Study of M2951 in 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) - N/A

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-002950-19-BG

Enrollment

468

Registered

2017-03-27

Start date

2017-04-27

Completion date

Unknown

Last updated

2021-04-05

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

Conditions

Systemic Lupus Erythematosus (SLE) MedDRA version: 20.0 Level: PT Classification code 10042945 Term: Systemic lupus erythematosus System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Interventions

Product Name: Evobrutinib Product Code: M2951 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Evobrutinib CAS Number: 1415823-73-2 Current Sponsor code: M2951 Other descriptive name: M295

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Eligible male and female subjects, aged 18 to 75 years; must have diagnosis of SLE with either the SLICC criteria for SLE, or at least four of the 11 ACR classification criteria for SLE, of at least six months duration prior to Screening; SLEDAI-2K total score = 6 (including clinical SLEDAI = 4) at Screening Visit; and have positive test results for anti double-stranded DNA (anti-dsDNA) antibody and/or anti nuclear antibody (human epithelial cell-2 ANA = 1:80) and/or anti-Smith (anti Sm) antibody at the time of Screening Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 464 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 4

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; active central nervous system SLE (to be severe or progressive including history of transverse myelitis, seizures, and/or associated with significant cognitive impairment); or within two weeks prior to Screening or during Screening: use of oral corticosteroids > 30 mg daily prednisone equivalent; use of injectable corticosteroids, or change in dose of corticosteroids.

Design outcomes

Primary

Measure	Time frame
Main Objective: - To evaluate the efficacy and dose response of M2951 compared to placebo in reducing disease activity in adult subjects with active, autoantibody-positive SLE who are receiving SoC therapy based on SRI-4 response at Week 52 in all subjects, or on SRI-6 response at Week 52 in the HDA subgroup, defined as SLEDAI-2K = 10. - To evaluate the safety of M2951 in subjects with SLE on SoC therapy. The objective of the LTE Period is: - To evaluate the long-term safety, efficacy, and HRQoL of M2951 at an initial dose of 50 mg twice daily or the eventual Phase III dose when decided for an additional two years.;Secondary Objective: Key secondary objectives: •To evaluate the efficacy and dose response of M2951 compared to placebo in delaying time to first severe flare during the Treatment Period,in subjects with SLE on SoC therapy,where a severe flare is defined as at least one BILAG 2004 A in any organ system due to items that are new or worse,compared to the BILAG evaluation at the previous visit •To evaluate the efficacy and dose response of M2951 compared to placebo in reducing disease activity,based on the SRI-4 response at W52,in the serologically active subgroup,which is defined as subjects with positive anti-dsDNA and/or low complement levels Other secondary objectives: •To evaluate the efficacy of M2951 compared to placebo on changes in disease activity and in organ-specific disease activity over52W •To evaluate the effect of M2951 compared to placebo on the annualized flare rate and on CS usage over52W •To evaluate the impact of M2951 treatment compared to placebo on subject reported HRQoL over52W;Primary end point(s): 1) Number of Subjects With Response Based on Systemic Lupus Erythematosus Responder Index 4 (SRI-4): All Subjects 2) Number of Subjects With Response Based on Systemic Lupus Erythematosus Responder Index 6 (SRI-6): High Disease Activity (HDA) Subgroup Subjects 3) Occurrences of Subjects With Treatment-emergent Serious Adverse Events (SA	—

Measure

Time frame

Main Objective: - To evaluate the efficacy and dose response of M2951 compared to placebo in reducing disease activity in adult subjects with active, autoantibody-positive SLE who are receiving SoC therapy based on SRI-4 response at Week 52 in all subjects, or on SRI-6 response at Week 52 in the HDA subgroup, defined as SLEDAI-2K = 10. - To evaluate the safety of M2951 in subjects with SLE on SoC therapy. The objective of the LTE Period is: - To evaluate the long-term safety, efficacy, and HRQoL of M2951 at an initial dose of 50 mg twice daily or the eventual Phase III dose when decided for an additional two years.;Secondary Objective: Key secondary objectives: •To evaluate the efficacy and dose response of M2951 compared to placebo in delaying time to first severe flare during the Treatment Period,in subjects with SLE on SoC therapy,where a severe flare is defined as at least one BILAG 2004 A in any organ system due to items that are new or worse,compared to the BILAG evaluation at the previous visit •To evaluate the efficacy and dose response of M2951 compared to placebo in reducing disease activity,based on the SRI-4 response at W52,in the serologically active subgroup,which is defined as subjects with positive anti-dsDNA and/or low complement levels Other secondary objectives: •To evaluate the efficacy of M2951 compared to placebo on changes in disease activity and in organ-specific disease activity over52W •To evaluate the effect of M2951 compared to placebo on the annualized flare rate and on CS usage over52W •To evaluate the impact of M2951 treatment compared to placebo on subject reported HRQoL over52W;Primary end point(s): 1) Number of Subjects With Response Based on Systemic Lupus Erythematosus Responder Index 4 (SRI-4): All Subjects 2) Number of Subjects With Response Based on Systemic Lupus Erythematosus Responder Index 6 (SRI-6): High Disease Activity (HDA) Subgroup Subjects 3) Occurrences of Subjects With Treatment-emergent Serious Adverse Events (SA

—

Secondary

Measure	Time frame
Secondary end point(s): 1) Time to First Severe Flare 2) Number of Subjects With Response Based on Systemic Lupus Erythematosus Responder Index 4 (SRI-4): Serologically Active Subgroup;Timepoint(s) of evaluation of this end point: 1: Baseline up to Week 52 2: Week 52	—

Countries

Argentina, Brazil, Bulgaria, Chile, Colombia, Germany, Italy, Japan, Korea, Republic of, Malaysia, Mauritius, Mexico, Peru, Philippines, Poland, Romania, Russian Federation, South Africa, Taiwan, United States

Contacts

Public ContactCommunication Center

Merck KGaA

service@merckgroup.com+496151725200

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026