Study Details

OVERVIEW

A Multicenter, Randomized, Placebo-Controlled Phase 1b Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Pharmacodynamics of Multiple Ascending Subcutaneous Doses of GS-0272 in Adult Participants With Rheumatoid Arthritis or Systemic Lupus Erythematosus (MARASLE) (MARASLE)

PROTOCOL SUMMARY

The goals of this clinical study are to learn more about the study drug, GS-0272, and its safety and tolerability following multiple doses in participants with rheumatoid arthritis (RA) and systemic lupus erythematosus (SLE). The primary objectives of this study are to assess the safety and tolerability of multiple ascending subcutaneous (SC) doses of GS-0272 and to characterize the pharmacokinetics of GS-0272 following multiple SC doses of GS-0272, in participants with RA or SLE.

Participation Requirements

Age

18 Years - 75 Years

Sex

All

Healthy Volunteers

Medical Condition

Rheumatoid Arthritis, Systemic Lupus Erythematosus

Gender

N/A

Date

September 2023 - June 2025

Study Type

Interventional

Study Phase

Phase 1

Product

GS-0272, Placebo

Eligibility Information

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.

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.

Locations

Locations (5)

Clinical Research of West Florida, Inc.

Clearwater, Florida, United States, 33765

Altoona Center for Clinical Research

Duncansville, Pennsylvania, United States, 16635

ARENSIA Exploratory Medicine LLC

Tbilisi, Georgia, 0112

IMSP Republican Clinical Hospital "Timofei Mosneaga", ARENSIA E.M.

Chisinau, Moldova, Republic of, MD-2025

Kings College Hospital

London, United Kingdom, SE5 9RS

Study of GS-0272 in Participants With Rheumatoid Arthritis or Systemic Lupus Erythematosus (MARASLE)