Study of GS-0151 in Participants With Rheumatoid Arthritis

NCT06902519 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: GS-US-667-68822024-516520-34
• Study Type: interventional
• Target: 75
• Locations: 6 countries
• Sites: 32

Brief 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.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (6)

• Cohort 1, 2 and 3: Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)

  First dose up to 19 Weeks post end of treatment at Week 12

• Cohort 1, 2 and 3: Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities

  First dose up to 19 Weeks post end of treatment at Week 12

• Cohorts 1, 2 and 3: Percentage of Participants Experiencing Serous Adverse Events (SAEs) and Adverse Events (AEs) Leading to Study Discontinuation

  First dose up to 19 Weeks post end of treatment at Week 12

• Cohort 1, 2 and 3: Serum AUCtau Following the Last Dose of GS-0151

  AUCtau is defined as the area under the serum concentration versus time curve over the dosing interval.

  Up to Week 12

• Cohorts 1, 2 and 3: Serum Cmax, Following the Last Dose of GS-0151

  Cmax is defined as the maximum observed plasma drug concentration.

  Up to Week 12

• Cohorts 1, 2 and 3: Serum Tmax Following the Last Dose of GS-0151

  Tmax is defined as the time (observed time point) of Cmax.

  Up to Week 12

Secondary Outcomes (2)

• Cohorts 1, 2, and 3: Percentage of Participants with Antidrug Antibodies (ADAs) During the Study

  Up to Week 12

• Cohort 3: Change From Baseline in Disease Activity Score for 28 Joint Count Using C-Reactive Protein (DAS28-CRP) at Week 12 in Participants With Moderately to Severely Active RA

  Baseline, Week 12

Study Arms (6)

Part A: Cohort 1 (GS-0151 Dose A)

EXPERIMENTAL

Participants with RA will be randomized to receive Dose A of GS-0151 up to 12 weeks.

Drug: GS-0151

Part A: Cohort 1 (Placebo)

PLACEBO COMPARATOR

Participants with RA will be randomized to receive placebo up to 12 weeks.

Drug: Placebo

Part A: Cohort 2 (GS-0151 Dose B)

EXPERIMENTAL

Participants with RA will be randomized to receive Dose B of GS-0151 up to 12 weeks.

Drug: GS-0151

Part A: Cohort 2 (Placebo)

PLACEBO COMPARATOR

Participants with RA will be randomized to receive placebo up to 12 weeks.

Drug: Placebo

Part B: Cohort 3 (GS-0151 Dose C)

EXPERIMENTAL

Participants with moderately to severely active RA will be randomized to receive Dose C of GS-0151.

Drug: GS-0151

Part B: Cohort 3 (Placebo)

PLACEBO COMPARATOR

Participants with moderately to severely active RA will be randomized to receive placebo.

Drug: Placebo

Interventions

GS-0151 DRUG

Administered for 12 weeks

Part A: Cohort 1 (GS-0151 Dose A); Part A: Cohort 2 (GS-0151 Dose B); Part B: Cohort 3 (GS-0151 Dose C)

Placebo DRUG

Administered for 12 weeks

Part A: Cohort 1 (Placebo); Part A: Cohort 2 (Placebo); Part B: Cohort 3 (Placebo)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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.
• Oral hydroxychloroquine ≤ 400 mg/day or chloroquine ≤ 250 mg/day.
• Oral sulfasalazine 1 to 3 g/day.
• 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
• 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:
• Moderately to severely active RA defined by the following:
• Screening and Day 1:
• or more tender joints on the tender joint count based on 68 joints (TJC68), AND.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gilead Sciences: lead

Study Sites (32)

Pinnacle Research Group, LLC

Anniston, Alabama, 36207, United States

RECRUITING

University of California, San Diego

La Jolla, California, 92037, United States

RECRUITING

Stanford University School of Medicine

Palo Alto, California, 94304, United States

RECRUITING

Medvin Clinical Research

Tujunga, California, 91042, United States

RECRUITING

Medvin Clinical Research

Whittier, California, 90602, United States

RECRUITING

Clinical Research of West Florida, Inc

Clearwater, Florida, 33765, United States

RECRUITING

Great Lakes Clinical Trials dba Flourish Research Chicago

Chicago, Illinois, 60640, United States

RECRUITING

Accurate Clinical Research, Inc

Lake Charles, Louisiana, 70605, United States

RECRUITING

Lynn Health Science Institute

Oklahoma City, Oklahoma, 73112, United States

RECRUITING

Altoona Center for Clinical Research

Duncansville, Pennsylvania, 16635, United States

RECRUITING

Accurate Clinical Management, LLC

Baytown, Texas, 77521, United States

RECRUITING

Accurate Clinical Research, Inc

Houston, Texas, 77089, United States

RECRUITING

Clinical Trials of Texas LLC, dba Flourish Research

San Antonio, Texas, 78229, United States

RECRUITING

DM Clinical Research

Tomball, Texas, 77375, United States

RECRUITING

Tidewater Clinical Research, LLC/ Virginia Rheumatology Clinic

Virginia Beach, Virginia, 23456, United States

RECRUITING

ARENSIA Exploratory Medicine, LLC

Tbilisi, 0112, Georgia

RECRUITING

Universitatsklinikum Koln

Cologne, 50937, Germany

RECRUITING

Krakenhaus Porz am Rhein

Cologne, 51149, Germany

RECRUITING

Hamburger Rheuma Forschungszentrum II

Hamburg, 20095, Germany

RECRUITING

Klinikum der Universitat Munchen

München, 81377, Germany

RECRUITING

Republican Clinical Hospital "Timofei Mosneaga," Arensia EM

Chisinau, MD-2025, Moldova

RECRUITING

Clinicmed Daniluk

Bialystok, 15-879, Poland

RECRUITING

FutureMeds Gydinia

Gdynia, 81-384, Poland

RECRUITING

FutureMeds Lodz

Lodz, 91-363, Poland

RECRUITING

MICS Centrum Medyczne Torun

Torun, 87-100, Poland

RECRUITING

FutureMeds Targowek

Warszawa Targówek, 03-291, Poland

RECRUITING

FutureMeds Wroclaw

Wroclaw, 53-673, Poland

RECRUITING

Complejo Hospitalario Universitario A Coruna

A Coruña, 15006, Spain

RECRUITING

Hospital del Mar

Barcelona, 8003, Spain

RECRUITING

Hospital Universitario Ramon y Cajal

Madrid, 28034, Spain

RECRUITING

Hospital Universitari Parc Tauli

Sabadell, 08208, Spain

RECRUITING

Hospital Quironsalud Infanta Luisa

Seville, 41010, Spain

RECRUITING

Related Links

• Gilead Clinical Trials Website

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Gilead Study Director

  Gilead Sciences

  STUDY DIRECTOR

Central Study Contacts

Gilead Clinical Study Information Center

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: In Part A, Cohorts 1 and 2 will be sequential, with participants receiving treatment in parallel and randomized in 6:2 ratio to either GS-0151 or placebo. In Part B, Cohort 3 will also randomized in 2:1 ratio to receive GS-0151 or placebo in parallel.

Study Record Dates

• First Submitted: March 24, 2025
• First Posted: March 30, 2025
• Study Start: May 14, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: May 11, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (15); ES (5); PL (6); DE (4); MO (1); GE (1)