Study Details

OVERVIEW

A Multicenter, Randomized, Placebo-Controlled Phase 1b Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Pharmacodynamics of Multiple Ascending Doses of GS-0272 in Adult Participants With Rheumatoid Arthritis (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). The primary objectives of this study are to assess the safety and tolerability of multiple ascending doses of GS-0272 and to characterize the pharmacokinetics of GS-0272 following multiple doses of GS-0272, in participants with RA.

Participation Requirements

Age

18 Years - 75 Years

Sex

ALL

Healthy Volunteers

Medical Condition

Rheumatoid Arthritis

Gender

N/A

Date

September 2023 - June 2025

Study Type

INTERVENTIONAL

Study Phase

PHASE1

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 (Active RA Cohort)-Specific Inclusion Criteria:
Participant is seropositive as demonstrated by a positive anti-cyclic citrullinated peptide (anti-CCP) antibody and/or positive rheumatoid factor at screening.
Participant has an elevated high-sensitivity C-reactive protein (hsCRP) ≥ 1.2 x upper limit of normal (ULN).
Participant has 6 or more swollen and tender joints as assessed on the SJC66/TJC68. Distal interphalangeal joints will not be counted towards the 6 joint eligibility.
Participant has had inadequate response or intolerance to at least 1 but not more than 2 bDMARD/tsDMARD therapeutics. A lack of efficacy is defined as documented continued or recurrent disease activity after at least 12 weeks of treatment of RA.

Exclusion Criteria

Meet any of the protocol-specified infection criteria (hepatitis C, Hepatitis B, HIV, tuberculosis, others).
Inadequate response or intolerance to more than 2 bDMARDs/tsDMARDs.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Locations

Locations (9)

1238 E. Arrow Hwy

Upland, California, United States, 91786

Clinical Research of West Florida, Inc.

Clearwater, Florida, United States, 33765

Jacksonville Center for Clinical Research

Jacksonville, Florida, United States, 32216

Altoona Center for Clinical Research

Duncansville, Pennsylvania, United States, 16635

1600 Republic Parkway

Mesquite, Texas, United States, 75150

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

NIHR Wellcome Trust Clinical Research Facility, University Hospital Southampton NHS Foundation Trust

Southampton, United Kingdom, SO16 6YD

Study of GS-0272 in Participants With Rheumatoid Arthritis (MARASLE)