Study of GS-0272 in Participants With Rheumatoid Arthritis

Last updated: April 7, 2025
Sponsor: Gilead Sciences
Overall Status: Active - Recruiting

Phase

1

Condition

Systemic Lupus Erythematosus

Rheumatoid Arthritis

Cutaneous Lupus Erythematosus

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:
June 30, 2025

Connect with a study center

  • ARENSIA Exploratory Medicine LLC

    Tbilisi, 0112
    Georgia

    Active - Recruiting

  • Seoul National University Hospital

    Seoul, 110 744
    Korea, Republic of

    Active - Recruiting

  • Ajou University Hospital

    Suwon, 16499
    Korea, Republic of

    Active - Recruiting

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

    Chisinau, MD-2025
    Moldova, Republic of

    Active - Recruiting

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

    Cambridge, CB2 0QQ
    United Kingdom

    Active - Recruiting

  • Kings College Hospital

    London, SE5 9RS
    United Kingdom

    Active - Recruiting

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

    Southampton, SO16 6YD
    United Kingdom

    Active - Recruiting

  • 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

    Active - Recruiting

  • 1238 E. Arrow Hwy

    Upland, California 91786
    United States

    Active - Recruiting

  • Clinical Research of West Florida, Inc.

    Clearwater, Florida 33765
    United States

    Active - Recruiting

  • Jacksonville Center for Clinical Research

    Jacksonville, Florida 32216
    United States

    Active - Recruiting

  • Altoona Center for Clinical Research

    Duncansville, Pennsylvania 16635
    United States

    Site Not Available

  • Accurate Clinical Research, Inc.

    Houston, Texas 77089
    United States

    Active - Recruiting

  • 1600 Republic Parkway

    Mesquite, Texas 75150
    United States

    Active - Recruiting

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