New drug GS-0151 tested for rheumatoid arthritis in early trial

NCT ID NCT06902519

Disease control Sponsor: Gilead Sciences Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Sep 04, 2026 · Updated 3 times

Summary

This early-stage trial is testing a new drug called GS-0151 in 75 adults with rheumatoid arthritis. The main goal is to see if the drug is safe and how the body processes it. Participants will receive either GS-0151 or a placebo for 12 weeks.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: GS-0151
What this could lead to: If successful, this could lead to a new treatment option for rheumatoid arthritis that helps control the disease.
What could go wrong: This is an early Phase 1b trial with only 75 participants, focused on safety and dosing. It is too small to prove effectiveness, and the drug may not work or could have side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

65 people

The number who actually took part.

Started

May 2025

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key 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 * Individuals must have discontinued all high-potency opiates at least 1 week prior to Day 1. Cohort 3 Only: * Individuals must meet all of the following cohort-specific inclusion criteria, in addition to meeting the inclusion criteria for all individuals , to be eligible for participation in Part B: Moderately to severely active RA defined by the following: Screening and Day 1: 1. 6 or more tender joints on the tender joint count based on 68 joints (TJC68), AND. 2. 6 or more swollen joints on the swollen joint count based on 66 joints (SJC66). The distal interphalangeal joints should be evaluated but not included in the total count to determine eligibility. Screening Only 3. Have a hsCRP ≥ ULN * Inadequate response or intolerance to at least 1 but no more than 3 b/tsDMARDs with no more than 2 mechanisms of action. A lack of response is defined as documented continued or recurrent disease activity after at least 12 weeks of treatment of RA. Intolerance is defined as any documented adverse effect associated with a b/tsDMARD used according to its respective label. Laboratory Assessments: Cohort 3 Only: * Anti-cyclic citrullinated peptide antibody (Anti-CCP) positive and/or rheumatoid factor (RF) positive Key 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 Prior/Concurrent Therapy or Clinical Study Experience: * Administration of a live attenuated vaccine 4 weeks prior to Day 1 or planned throughout the study. * Participation in any investigational drug/device clinical study within 4 weeks or 5 half-lives prior to screening, whichever is longer. Exposure to investigational biologics should be discussed with the sponsor. Diagnostic Assessments; All Cohorts: * Any positive tuberculosis (TB) test using interferon-gamma release assay (IGRA) performed by central laboratory at screening. Tests with inconclusive results may be repeated one time. If an inconclusive test is repeated and is returned with inconclusive results a second time, the individual will be excluded from the study. Individuals with a history of latent or active TB who have been treated with a full course of treatment, as per local guidelines, are eligible without the need for an IGRA at screening. Appropriate documentation of prior treatment is required. * Evidence of active hepatitis C virus (HCV) infection. Individuals with positive HCV Ab at screening require reflex testing for HCV ribonucleic acid (RNA). Individuals with positive HCV Ab but negative HCV RNA viral load are eligible per investigator judgment and require HCV viral load monitoring on Day 85 and Day 169. * The results of the following laboratory tests performed at the central laboratory at screening meet any of the criteria below (out-of-range laboratory values may be rechecked 1 time, per investigator's judgment, before individual is considered a screen failure): 1. Hemoglobin \< 10.0 g/dL (SI: \< 100 g/L) 2. White blood cells \< 3.0 x 10\^3 cells/mm\^3 (SI: \< 3.0 x 10\^9 cells/L) 3. Neutrophils \< 1.5 x 10\^3 cells/mm\^3 (SI: \< 1.5 x 10\^9 cells/L) 4. Lymphocytes \< 1.0 x 10\^3 cells/mm\^3 (SI: \< 1.0 x 10\^9 cells/L) 5. Platelets \< 100 x 10\^3 cells/mm\^3 (SI: \< 100 x 10\^9 cells/L) 6. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 1.5 x upper limit of normal (ULN) 7. Total bilirubin level ≥ 2 x ULN unless the individual has been diagnosed with Gilbert's disease and this is clearly documented 8. Creatinine clearance \< 50 mL/min (SI: \< 0.83 mL/s) based on the Cockcroft-Gault formula Note: Other protocol defined Inclusion/Exclusion criteria may apply

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Conditions

The condition(s) this trial relates to.

rheumatoid arthritis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Rheumatoid arthritis

Contacts and locations

Locations

ARENSIA Exploratory Medicine, LLC

Tbilisi, 0112, Georgia
Accurate Clinical Management, LLC

Baytown, Texas, 77521, United States
Accurate Clinical Research, Inc

Lake Charles, Louisiana, 70605, United States
Accurate Clinical Research, Inc

Houston, Texas, 77089, United States
Altoona Center for Clinical Research

Duncansville, Pennsylvania, 16635, United States
Clinical Research of West Florida, Inc

Clearwater, Florida, 33765, United States
Clinical Trials of Texas LLC, dba Flourish Research

San Antonio, Texas, 78229, United States
Clinicmed Daniluk

Bialystok, 15-879, Poland
Complejo Hospitalario Universitario A Coruna

A Coruña, 15006, Spain
DM Clinical Research

Tomball, Texas, 77375, United States
FutureMeds Gydinia

Gdynia, 81-384, Poland
FutureMeds Lodz

Lodz, 91-363, Poland
FutureMeds Targowek

Warszawa Targówek, 03-291, Poland
FutureMeds Wroclaw

Wroclaw, 53-673, Poland
Great Lakes Clinical Trials dba Flourish Research Chicago

Chicago, Illinois, 60640, United States
Hamburger Rheuma Forschungszentrum II

Hamburg, 20095, Germany
Hospital Quironsalud Infanta Luisa

Seville, 41010, Spain
Hospital Universitari Parc Tauli

Sabadell, 08208, Spain
Hospital Universitario Ramon y Cajal

Madrid, 28034, Spain
Hospital del Mar

Barcelona, 8003, Spain
Klinikum der Universitat Munchen

München, 81377, Germany
Krakenhaus Porz am Rhein

Cologne, 51149, Germany
Lynn Health Science Institute

Oklahoma City, Oklahoma, 73112, United States
MICS Centrum Medyczne Torun

Torun, 87-100, Poland
Medvin Clinical Research

Tujunga, California, 91042, United States
Medvin Clinical Research

Whittier, California, 90602, United States
Pinnacle Research Group, LLC

Anniston, Alabama, 36207, United States
Precision Comprehensive Clinical Research Solutions

Colleyville, Texas, 76034, United States
Precision Comprehensive Clinical Research Solutions

Irving, Texas, 75061, United States
Republican Clinical Hospital "Timofei Mosneaga," Arensia EM

Chisinau, MD-2025, Moldova
Southwest Rheumatology Research

Mesquite, Texas, 75150, United States
Stanford University School of Medicine

Palo Alto, California, 94304, United States
Tidewater Clinical Research, LLC/ Virginia Rheumatology Clinic

Virginia Beach, Virginia, 23456, United States
Universitatsklinikum Koln

Cologne, 50937, Germany
University of California, San Diego

La Jolla, California, 92037, United States

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