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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 : 2026-03
Estimated Study Completion Date : 2026-03

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
  • * 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.
Study of GS-0272 in Participants With Rheumatoid Arthritis

Location Details

NCT06031415

Please Choose a site

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

RECRUITING

United States, California

Arizona Arthritis & Rheumatology Associates P.C.

Glendale, California, United States, 85306

RECRUITING

United States, California

Stanford School of Medicine, Division of Immunology & Rheumatology

Palo Alto, California, United States, 94304

RECRUITING

United States, California

1238 E. Arrow Hwy

Upland, California, United States, 91786

RECRUITING

United States, Florida

Clinical Research of West Florida, Inc.

Clearwater, florida, United States, 33765

RECRUITING

United States, Florida

Jacksonville Center for Clinical Research

Jacksonville, florida, United States, 32216

RECRUITING

United States, Illinois

Greater Chicago Specialty Physicians/ Clinical Investigation Specialists

Niles, Illinois, United States, 60714

RECRUITING

United States, Illinois

Greater Chicago Specialty Physicians/Clinical Investigation Specialists, Inc.

Schaumburg, Illinois, United States, 60195

RECRUITING

United States, Oregon

Summit Headlands LLC

Portland, Oregon, United States, 97210

COMPLETED

United States, Pennsylvania

Altoona Center for Clinical Research

Duncansville, Pennsylvania, United States, 16635

RECRUITING

United States, Pennsylvania

PA Regional Center for Arthritis and Osteoporosis Research

Wyomissing, Pennsylvania, United States, 19610

RECRUITING

United States, Texas

Precision Comprehensive Clinical Research Solutions

Colleyville, Texas, United States, 76034

RECRUITING

United States, Texas

Accurate Clinical Research, Inc.

Houston, Texas, United States, 77089

RECRUITING

United States, Texas

Precision Comprehensive Clinical Research Solutions

Irving, Texas, United States, 75061

RECRUITING

United States, Texas

1600 Republic Parkway

Mesquite, Texas, United States, 75150

RECRUITING

Georgia,

ARENSIA Exploratory Medicine LLC

Tbilisi, Georgia, 0112

RECRUITING

Moldova,

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

Chisinau, Moldova, MD-2025

RECRUITING

South Korea,

Chungnam National University Hospital

Daejeon, South Korea, 35015

RECRUITING

South Korea,

Seoul National University Hospital

Seoul, South Korea, 110 744

RECRUITING

South Korea,

University Hospital Update

Suwon, South Korea, 16499

RECRUITING

United Kingdom,

Cambridge Clinical Research Centre, Rheumatology Research Unit - E6, Addenbrookes Hospital

Cambridge, United Kingdom, CB2 0QQ

RECRUITING

United Kingdom,

University Hospitals Coventry & Warwickshire NHS Trust

Coventry, United Kingdom, CV2 2DX

RECRUITING

United Kingdom,

Kings College Hospital

London, United Kingdom, SE5 9RS

RECRUITING

United Kingdom,

Simbec Research Limited

Merthyr Tydfil, United Kingdom, CF48 4DR

RECRUITING

United Kingdom,

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

Southampton, United Kingdom, SO16 6YD