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NCT06031415 | RECRUITING | Rheumatoid Arthritis

Study of GS-0272 in Participants With Rheumatoid Arthritis
Sponsor:

Gilead Sciences

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 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.

Condition or disease

Rheumatoid Arthritis

Intervention/treatment

GS-0272

Placebo

Phase

PHASE1

Study Type : INTERVENTIONAL
Estimated Enrollment : 87 participants
Masking : DOUBLE
Primary Purpose : TREATMENT
Official Title : 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
Actual Study Start Date : 2023-09-28
Estimated Primary Completion Date : 2025-06
Estimated Study Completion Date : 2025-06

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 75 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.
      • 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 of GS-0272 in Participants With Rheumatoid Arthritis

Location Details

NCT06031415

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

NOT YET RECRUITING

United States, Florida

Clinical Research of West Florida, Inc.

Clearwater, Florida, United States, 33765

NOT YET RECRUITING

United States, Florida

Jacksonville Center for Clinical Research

Jacksonville, Florida, United States, 32216

RECRUITING

United States, Pennsylvania

Altoona Center for Clinical Research

Duncansville, Pennsylvania, United States, 16635

RECRUITING

Georgia,

ARENSIA Exploratory Medicine LLC

Tbilisi, Georgia, 0112

RECRUITING

Moldova, Republic of,

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

Chisinau, Moldova, Republic of, MD-2025

RECRUITING

United Kingdom,

Kings College Hospital

London, United Kingdom, SE5 9RS

RECRUITING

United Kingdom,

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

Southampton, United Kingdom, SO16 6YD