Study of GS-0272 in Participants With Rheumatoid Arthritis

Last updated: December 19, 2025
Sponsor: Gilead Sciences
Overall Status: Active - Recruiting

Phase

1

Condition

Cutaneous Lupus Erythematosus

Arthritis And Arthritic Pain

Musculoskeletal Diseases

Treatment

Placebo

GS-0272

Clinical Study ID

NCT06031415
GS-US-666-6692
  • Ages 18-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 AmericanCollege of Rheumatology (ACR)/European League Against Rheumatism (EULAR)classification criteria.

  • Ongoing treatment with 1 or 2 conventional synthetic disease-modifying antirheumaticdrugs (csDMARDs) for at least 12 weeks prior to the first dose of study drug, with astable 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 1or during the study and must discontinue b/tsDMARD use for at least 4 weeks (withthe exception of rituximab, which must be discontinued for at least 16 weeks) priorto the first dose of study drug.

Part B (Active RA Cohort)-Specific Inclusion Criteria:

  • Participant is seropositive as demonstrated by a positive anti-cyclic citrullinatedpeptide (anti-CCP) antibody and/or positive rheumatoid factor at screening.

  • Participant has an elevated high-sensitivity C-reactive protein (hsCRP) greater thanupper limit of normal (ULN).

  • Participant has 6 or more swollen and 6 or more tender joints as assessed on theSJC66/TJC68. Distal interphalangeal joints will not be counted towards the 6 jointeligibility.

  • Participant has had inadequate response or intolerance to at least 1 but not morethan 3 bDMARD/tsDMARD therapeutics with no more than 2 MOAs. A lack of response isdefined as documented continued or recurrent disease activity after at least 12weeks of treatment of RA.

Exclusion

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 2MOAs.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Design

Total Participants: 87
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 1
Study Start date:
September 28, 2023
Estimated Completion Date:
March 31, 2026

Connect with a study center

  • ARENSIA Exploratory Medicine LLC

    Tbilisi, 0112
    Georgia

    Site Not Available

  • ARENSIA Exploratory Medicine LLC

    Tbilisi 611717, 0112
    Georgia

    Active - Recruiting

  • Chungnam National University Hospital

    Daejeon, 35015
    Korea, Republic of

    Site Not Available

  • Seoul National University Hospital

    Seoul, 110 744
    Korea, Republic of

    Site Not Available

  • Ajou University Hospital

    Suwon, 16499
    Korea, Republic of

    Site Not Available

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

    Chisinau 618426, MD-2025
    Moldova

    Active - Recruiting

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

    Chisinau, MD-2025
    Moldova, Republic of

    Site Not Available

  • Chungnam National University Hospital

    Daejeon 1835235, 35015
    South Korea

    Active - Recruiting

  • Seoul National University Hospital

    Seoul 1835848, 110 744
    South Korea

    Active - Recruiting

  • Ajou University Hospital

    Suwon 1835553, 16499
    South Korea

    Active - Recruiting

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

    Cambridge, CB2 0QQ
    United Kingdom

    Site Not Available

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

    Cambridge 2653941, CB2 0QQ
    United Kingdom

    Active - Recruiting

  • University Hospitals Coventry & Warwickshire NHS Trust

    Coventry 2652221, CV2 2DX
    United Kingdom

    Active - Recruiting

  • Kings College Hospital

    London, SE5 9RS
    United Kingdom

    Site Not Available

  • Kings College Hospital

    London 2643743, SE5 9RS
    United Kingdom

    Active - Recruiting

  • Simbec Research Limited

    Merthyr Tydfil, CF48 4DR
    United Kingdom

    Site Not Available

  • Simbec Research Limited

    Merthyr Tydfil 2642705, CF48 4DR
    United Kingdom

    Active - Recruiting

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

    Southampton, SO16 6YD
    United Kingdom

    Site Not Available

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

    Southampton 2637487, SO16 6YD
    United Kingdom

    Active - Recruiting

  • Arizona Arthritis & Rheumatology Associates P.C.

    Glendale, California 85306
    United States

    Site Not Available

  • Arizona Arthritis & Rheumatology Associates PC

    Glendale, California 85306
    United States

    Active - Recruiting

  • Stanford School of Medicine, Division of Immunology & Rheumatology

    Palo Alto, California 94304
    United States

    Site Not Available

  • 1238 E. Arrow Hwy

    Upland, California 91786
    United States

    Site Not Available

  • Arizona Arthritis & Rheumatology Associates P.C.

    Glendale 5352423, California 5332921 85306
    United States

    Active - Recruiting

  • Stanford School of Medicine, Division of Immunology & Rheumatology

    Palo Alto 5380748, California 5332921 94304
    United States

    Active - Recruiting

  • 1238 E. Arrow Hwy

    Upland 5404915, California 5332921 91786
    United States

    Active - Recruiting

  • Clinical Research of West Florida, Inc.

    Clearwater, Florida 33765
    United States

    Site Not Available

  • Jacksonville Center for Clinical Research

    Jacksonville, Florida 32216
    United States

    Site Not Available

  • Clinical Research of West Florida, Inc.

    Clearwater 4151316, Florida 4155751 33765
    United States

    Active - Recruiting

  • Jacksonville Center for Clinical Research

    Jacksonville 4160021, Florida 4155751 32216
    United States

    Active - Recruiting

  • Greater Chicago Specialty Physicians/ Clinical Investigation Specialists

    Niles 4903730, Illinois 4896861 60714
    United States

    Active - Recruiting

  • Greater Chicago Specialty Physicians/Clinical Investigation Specialists, Inc.

    Schaumburg 4910713, Illinois 4896861 60195
    United States

    Active - Recruiting

  • Summit Headlands LLC

    Portland, Oregon 97210
    United States

    Site Not Available

  • Summit Headlands LLC

    Portland 5746545, Oregon 5744337 97210
    United States

    Active - Recruiting

  • Altoona Center for Clinical Research

    Duncansville, Pennsylvania 16635
    United States

    Site Not Available

  • PA Regional Center for Arthritis and Osteoporosis Research

    Wyomissing, Pennsylvania 19610
    United States

    Site Not Available

  • Altoona Center for Clinical Research

    Duncansville 5187508, Pennsylvania 6254927 16635
    United States

    Completed

  • PA Regional Center for Arthritis and Osteoporosis Research

    Wyomissing 5220248, Pennsylvania 6254927 19610
    United States

    Active - Recruiting

  • Precision Comprehensive Clinical Research Solutions

    Colleyville, Texas 76034
    United States

    Site Not Available

  • Accurate Clinical Research, Inc.

    Houston, Texas 77089
    United States

    Site Not Available

  • 1600 Republic Parkway

    Mesquite, Texas 75150
    United States

    Site Not Available

  • Precision Comprehensive Clinical Research Solutions

    Colleyville 4682478, Texas 4736286 76034
    United States

    Active - Recruiting

  • Accurate Clinical Research, Inc.

    Houston 4699066, Texas 4736286 77089
    United States

    Active - Recruiting

  • Precision Comprehensive Clinical Research Solutions

    Irving 4700168, Texas 4736286 75061
    United States

    Active - Recruiting

  • 1600 Republic Parkway

    Mesquite 4710826, Texas 4736286 75150
    United States

    Active - Recruiting

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