A Phase II Study of M2951 in SLE

• Status: Terminated
• Trial end date: 2020-03-23
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: EMD Serono Research & Development Institute, Inc.
• Collaborators: Merck KGaA; Merck KGaA, Darmstadt, Germany

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