A Phase II Study of M2951 in SLE

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Systemic Lupus Erythematosus

In brief

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).

Key facts

Study ID

NCT02975336

Run by

EMD Serono Research & Development Institute, Inc.

People needed

469

Starts

2017-01-04

Expected to finish

2020-03-23

Last updated by the study team

2021-04-12

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Arizona Arthritis & Rheumatology Associates, P.C. — Mesa, Arizona, United States
• Arizona Arthritis & Rheumatology Associates, P.C. — Phoenix, Arizona, United States
• Advanced Research Center, Inc. — Anaheim, California, United States
• Wallace Rheumatic Study Center — Beverly Hills, California, United States
• Medvin Clinical Research — Covina, California, United States
• Southern California Permanent Medical Group — Fontana, California, United States
• Global Research Management — Glendale, California, United States
• University of Southern California — Los Angeles, California, United States
• East Bay Rheumatology Medical Group, Inc. — San Leandro, California, United States
• Inland Rheumatology Clinical Trials, Inc. — Upland, California, United States
• Nazanin Firooz, MD Inc. — West Hills, California, United States
• University of Colorado Denver Anschutz Medical Campus — Aurora, Colorado, United States
• Yale School Of Medicine — New Haven, Connecticut, United States
• Clinical Research of West Florida - Corporate — Clearwater, Florida, United States
• Omega Research Consultants — DeBary, Florida, United States
• Center for Rheumatology, Immunology & Arthritis — Fort Lauderdale, Florida, United States
• Hope Clinical Trials — Miami, Florida, United States
• IRIS Research and Development — Plantation, Florida, United States
• McIlwain Medical Group, PA — Tampa, Florida, United States
• Meridien Research, Inc. — Tampa, Florida, United States
• Marietta Rheumatology Associates, PC — Marietta, Georgia, United States
• The University of Chicago Medicine — Chicago, Illinois, United States
• LSU Health Sciences Center Gastroenterology — Shreveport, Louisiana, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Pinnacle Research Group LLC — Anniston, Alabama, United States

Full record on ClinicalTrials.gov

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