Status:
RECRUITING
Study of GS-0272 in Participants With Rheumatoid Arthritis
Lead Sponsor:
Gilead Sciences
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief 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 ...
Eligibility Criteria
Inclusion
- Key
- Age limit for the Republic of Korea for male or nonpregnant female is between 19 and 75 years of age.
- Part A (Rheumatoid Arthritis (RA) Cohorts)-Specific
- 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
- 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) greater than upper limit of normal (ULN).
- Participant has 6 or more swollen and 6 or more 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 3 bDMARD/tsDMARD therapeutics with no more than 2 MOAs. A lack of response is defined as documented continued or recurrent disease activity after at least 12 weeks of treatment of RA.
- Key
Exclusion
- Meet any of the protocol-specified infection criteria (hepatitis C, Hepatitis B, HIV, tuberculosis, others).
- Inadequate response or intolerance to more than 3 bDMARDs/tsDMARDs with more than 2 MOAs.
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Key Trial Info
Start Date :
September 28 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
87 Patients enrolled
Trial Details
Trial ID
NCT06031415
Start Date
September 28 2023
End Date
March 1 2026
Last Update
December 22 2025
Active Locations (24)
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1
Arizona Arthritis & Rheumatology Associates P.C.
Glendale, California, United States, 85306
2
Stanford School of Medicine, Division of Immunology & Rheumatology
Palo Alto, California, United States, 94304
3
1238 E. Arrow Hwy
Upland, California, United States, 91786
4
Clinical Research of West Florida, Inc.
Clearwater, Florida, United States, 33765