Study of GS-0272 in Participants With Rheumatoid Arthritis or Systemic Lupus Erythematosus (MARASLE)
Rheumatoid Arthritis, Systemic Lupus Erythematosus
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis
Eligibility Criteria
Key Inclusion Criteria: Part A (Rheumatoid Arthritis (RA) Cohorts)-Specific Inclusion Criteria: Diagnosis of RA at least 3 months prior to screening fulfilling the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria. Ongoing treatment with 1 or 2 conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) for at least 12 weeks prior to the first dose of study drug, with a stable dose for at least 4 weeks prior to the first dose of study drug, as follows: Individuals must not be on a biologic disease-modifying antirheumatic drugs (bDMARD)/targeted synthetic disease-modifying antirheumatic drug (tsDMARD) at Day 1 or during the study and must discontinue b/tsDMARD use for at least 4 weeks (with the exception of rituximab, which must be discontinued for at least 16 weeks) prior to the first dose of study drug. Part B (Systemic Lupus Erythematosus (SLE) Cohort)-Specific Inclusion Criteria: Fulfill EULAR/ACR 2019 classification criteria for SLE at least 24 weeks prior to the first dose of study drug. Individuals using protocol-permitted nonbiologic immunosuppressive/immunomodulatory agents (antimalarials, methotrexate (MTX), azathioprine, cyclosporine, leflunomide, minocycline, mycophenolate mofetil, mycophenolic acid, dapsone, and oral [not topical] tacrolimus) for the treatment of SLE must maintain stable dose(s) for at least 4 weeks prior to the first dose of study drug and through the end of study. Key Exclusion Criteria: Meet any of the protocol-specified infection criteria (hepatitis C, Hepatitis B, HIV, tuberculosis, others). Highly active SLE (including but not limited to lupus nephritis (with significant increases in urine protein/creatinine ratio over clinical baseline, recent worsening or creatinine clearance, and/or pyuria/hematuria), neuropsychiatric SLE, and/or vasculitis) that could put the individual at risk per investigator's judgment. Exposure to cyclophosphamide or any biologic lupus therapy within 8 weeks prior to the first dose of study drug. Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Sites / Locations
- Altoona Center for Clinical ResearchRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Part A: Rheumatoid Arthritis (RA) Cohorts: GS-0272 or Placebo
Part B: Systemic Lupus Erythematosus (SLE) Cohort: GS-0272 or Placebo
Part A will include participants with RA. Part A will have 3 cohorts. Each cohort in Part A will be randomized in a 3:1 ratio to receive either ascending doses of GS-0272 or placebo for 12 weeks. Dosing will begin in Cohort 1. Cohorts 2 and 3 will be initiated upon review of blinded safety data from the preceding cohort.
Part B will include participants with SLE. Part B will have only 1 cohort (Cohort 4). Participants in Cohort 4 will be randomized in a 3:1 ratio to receive either GS-0272 or placebo for 12 weeks.