Active Clinical Trials
A Phase II Study of M2951 in Systemic Lupus Erythematosus (SLE)
West Penn Hospital
EMD Serono Research & Development Institute, Inc.
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)
M2951 is an investigational drug under evaluation for treatment of autoimmune and inflammatory disorders. The purpose of the study is to assess the Safety and Efficacy of M2951 in Subjects with Systemic Lupus Erythematosus (SLE).
- Eligible male and female subjects, 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) at the time of Screening
- 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.
|Ages Eligible for Study:||18 Years to 75 Years (Adult, Senior)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|