Clinical Trial 43592

Tampa, FL 33606


Summary:

Idorsia Pharmaceuticals, Ltd / “A Phase 2b multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy, safety and tolerability of cenerimod in subjects with moderate to severe systemic lupus erythematosus (SLE)”



Criteria:

1. Have a diagnosis of SLE made at least 6 months prior to Screening,

2. ale and female subjects, age 18 to 75 years old(both inclusive).

3. At least 2 points for musculoskeletal or mucocutaneous manifestations (i.e., myositis, arthritis, rash, alopecia, mucosal ulcers).

4. History or presence of positive ANA or anti-dsDNA antibodies.

5.Currently treated with stable doses of one or more of the following background medications: NSAIDs, Anti-malarials (≤ 400 mg/day hydroxychloroquine, ≤ 500 mg/day chloroquine, ≤100 mg/day quinacrine), Mycophenolate mofetil (≤ 2 g/day), Mycophenolic acid(≤1440mg/day), Azathioprine (≤ 2 mg/kg/day), Methotrexate (≤ 20 mg/week), Corticosteroids (≤ 40 mg/day prednisone or equivalent), Belimumab (≤10 mg/kg every 4 weeksintravenously [i.v.], or 200 mg/week subcutaneously [s.c.])


Qualified Participants May Receive:

1. Compensation for time and travel

2. Study-related medication at no cost

3. Study-related care and assessments at no cost

4. Local Rheumatologist oversite of study


Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.