Study of GS-0272 in Participants With Rheumatoid Arthritis
About the study
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.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION 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 (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
Key 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.
Study Locations
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How to Apply
Contact the study center to learn if this study is a good match for you.
Study Details
Contition
Rheumatoid Arthritis
Age
18 - 75
Phase
PHASE1
Participants Needed
87
Est. Completion Date
Jun 30, 2025
Treatment Type
INTERVENTIONAL
Sponsor
Gilead Sciences
ClinicalTrials.gov NCT Identifier
NCT06031415
Study Number
GS-US-666-6692
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