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Study of GS-0151 in Participants With Rheumatoid Arthritis | Clinical Trials | Clareo Health

RECRUITINGPHASE1

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

NCT06902519•Gilead Sciences

View on ClinicalTrials.gov

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

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Medical History/Physical Characteristics; All Cohorts:
•Individuals must not be on a biologic disease-modifying antirheumatic drug (b/tsDMARD) on Day 1 and must have discontinued all b/tsDMARDs (including biosimilars and generics) at least 4 weeks prior to Day 1 with the exception of B cell-depleting agents (eg, rituximab), which must be discontinued for at least 6 months prior to Day 1.
•Ongoing treatment with at least 1 but no more than 2 protocol-permitted conventional synthetic disease-modifying antirheumatic drug (csDMARDs) for at least 12 weeks, at a stable dose for at least 6 weeks prior to Day 1 and remain stable throughout the treatment period:
•1. Use of oral, intramuscular (IM), or subcutaneous(ly) (SC) methotrexate 7.5 to 25 mg/week. Individuals on methotrexate must be receiving folic or folinic acid supplementation at a stable dose.
•2. Oral hydroxychloroquine ≤ 400 mg/day or chloroquine ≤ 250 mg/day.
•3. Oral sulfasalazine 1 to 3 g/day.
•4. Oral leflunomide 10 to 20 mg/day.
•Use of oral corticosteroids of no more than 10 mg prednisone or equivalent per day is allowed if the dose is stable for at least 14 days prior to Day 1. Inhaled corticosteroids for stable medical conditions are allowed but must have been at a stable dose for at least
•1 week prior to the first dose of study drug. Occasional topical corticosteroids are permitted.
•Where nonsteroidal anti-inflammatory drug (NSAIDs) or acetaminophen are used, the dose must be stable for at least 1 week prior to Day 1
+12 more criteria

Exclusion Criteria

•Medical Conditions; All Cohorts:
•Have a diagnosis of any generalized musculoskeletal disorder that would interfere with study procedures or assessments per the discretion of the investigator.
•History of opportunistic infection or immunodeficiency syndrome that would put the individual at risk, as per investigator's judgment.
•Active infection that is clinically significant, per investigator's judgment, or any infection requiring hospitalization or treatment with intravenous anti-infectives within 60 days of screening; or any infection requiring oral anti-infective therapy within 30 days of screening.
•History of or current moderate to severe congestive heart failure (New York Heart Association class III or IV), or within the last 6 months prior to screening.
•History of lymphoproliferative disease or possible current lymphoproliferative disease.
•History of organ or bone marrow transplant.
•Have a history of major surgery (requiring regional block or general anesthesia) within the last 12 weeks prior to screening or planned major surgery during the study.
•History of an infected joint prosthesis or other implanted device with the prosthesis or device still in situ.
•Clinically significant ECG abnormalities at screening, including electrocardiographic interval between the beginning of the Q wave and termination of the T wave, representing the time for both ventricular depolarization and repolarization to occur (QT) interval corrected for heart rate using the Fridericia formula (QTcF) \> 450 msec, or hypokalemia if recurrent or persistent \< 3.0 mmol/L, or family history of long QT syndrome
+15 more criteria

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

Key Dates

Start Date

May 14, 2025

Primary Completion Date

March 1, 2027

Completion Date

March 1, 2027

Last Updated

January 21, 2026

Enrollment

ESTIMATED participants

Conditions

Rheumatoid Arthritis

Interventions

GS-0151

DRUG

Placebo

DRUG

Contacts

Gilead Clinical Study Information Center

CONTACT

1-833-445-3230 (GILEAD-0)GileadClinicalTrials@gilead.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 21, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Study of GS-0151 in Participants With Rheumatoid Arthritis

Inclusion Criteria

Exclusion Criteria

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