RecruitingPhase 1NCT06902519

Study of GS-0151 in Participants With Rheumatoid Arthritis

A Phase 1b, Randomized, Blinded, Placebo-Controlled, Multicenter Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Multiple Ascending Doses of GS-0151 in Adult Participants With Rheumatoid Arthritis

Sponsor

Gilead Sciences

Enrollment

75 participants

Start Date

May 14, 2025

Study Type

INTERVENTIONAL

Conditions

Rheumatoid Arthritis

Summary

The goal of this clinical study is to learn more about the study drug GS-0151. The study is done to find how safe, well-tolerated the drug is. This will also assess how the drug is absorbed, modified, distributed and cleared from the body (the pharmacokinetics (PK) of the drug), when given multiple times to participants with rheumatoid arthritis (RA). The primary objectives of this study is to assess the safety and tolerability of multiple ascending doses of GS-0151 in participants with RA and to characterize the PK of GS-0151 following multiple doses of GS-0151 in participants with RA.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing GS-0151, a new investigational drug, in adults with rheumatoid arthritis whose disease is not well controlled with conventional medications (like methotrexate or leflunomide) alone. The study is looking at the safety, tolerability, and early effectiveness of this drug. **You may be eligible if...** - You have rheumatoid arthritis - You are currently taking 1 to 2 conventional DMARDs (like methotrexate or leflunomide) at a stable dose for at least 6 weeks - You have not been on a biologic or advanced therapy, or have stopped these for at least 4 weeks (or 6 months for B-cell depleting agents like rituximab) - Your disease activity meets specific criteria for moderate-to-severe RA **You may NOT be eligible if...** - You are currently pregnant, breastfeeding, or planning to become pregnant - You have active serious infections - You have significant liver, kidney, or heart problems - You have had prior treatment with certain biologics within the required washout periods Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGGS-0151

Administered for 12 weeks

DRUGPlacebo

Administered for 12 weeks

Locations(32)

Pinnacle Research Group, LLC

Anniston, Alabama, United States

University of California, San Diego

La Jolla, California, United States

Stanford University School of Medicine

Palo Alto, California, United States

Medvin Clinical Research

Tujunga, California, United States

Medvin Clinical Research

Whittier, California, United States

Clinical Research of West Florida, Inc

Clearwater, Florida, United States

Great Lakes Clinical Trials dba Flourish Research Chicago

Chicago, Illinois, United States

DM Clinical Research

Melrose Park, Illinois, United States

Accurate Clinical Research, Inc

Lake Charles, Louisiana, United States

Lynn Health Science Institute

Oklahoma City, Oklahoma, United States

Altoona Center for Clinical Research

Duncansville, Pennsylvania, United States

Accurate Clinical Management, LLC

Baytown, Texas, United States

Accurate Clinical Research, Inc

Houston, Texas, United States

Clinical Trials of Texas LLC, dba Flourish Research

San Antonio, Texas, United States

Tidewater Clinical Research, LLC/ Virginia Rheumatology Clinic

Virginia Beach, Virginia, United States

ARENSIA Exploratory Medicine, LLC

Tbilisi, Georgia

Universitatsklinikum Koln

Cologne, Germany

Krakenhaus Porz am Rhein

Cologne, Germany

Hamburger Rheuma Forschungszentrum II

Hamburg, Germany

Klinikum der Universitat Munchen

München, Germany

Republican Clinical Hospital "Timofei Mosneaga," Arensia EM

Chisinau, Moldova

Clinicmed Daniluk

Bialystok, Poland

FutureMeds Gydinia

Gdynia, Poland

FutureMeds Lodz

Lodz, Poland

MICS Centrum Medyczne Torun

Torun, Poland

FutureMeds Targowek

Warszawa Targówek, Poland

FutureMeds Wroclaw

Wroclaw, Poland

Complejo Hospitalario Universitario A Coruna

A Coruña, Spain

Hospital del Mar

Barcelona, Spain

Hospital Universitario Ramon y Cajal

Madrid, Spain

Hospital Universitari Parc Tauli

Sabadell, Spain

Hospital Quironsalud Infanta Luisa

Seville, Spain

View Full Details on ClinicalTrials.gov

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NCT06902519

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