Study of GS-0272 in Participants With Rheumatoid Arthritis

Launched by GILEAD SCIENCES · Sep 4, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called GS-0272 to see how safe it is and how well it works in people with rheumatoid arthritis (RA). The researchers want to understand how the drug behaves in the body after giving it in increasing doses to participants. This study is currently looking for individuals aged 18 to 75 who have been diagnosed with RA for at least three months and are already taking certain other RA treatments. To be eligible, participants should not have used specific types of RA medications (known as biologics) for at least four weeks before starting the study.

If you decide to participate, you'll receive the study drug and will be monitored closely for any side effects or reactions to the medication. The study aims to gather important information that could help improve treatments for RA in the future. Remember, you will need to meet certain health criteria, so it’s essential to discuss your medical history with the study team to see if you qualify.

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ALL

Eligibility criteria

• Key Inclusion Criteria:
• • 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 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) 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 Criteria:
• • 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.