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NCT06902519 | RECRUITING | Rheumatoid Arthritis

Study of GS-0151 in Participants With Rheumatoid Arthritis
Sponsor:

Gilead Sciences

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.

Condition or disease

Rheumatoid Arthritis

Intervention/treatment

GS-0151

Placebo

Phase

PHASE1

Study Type : INTERVENTIONAL
Estimated Enrollment : 75 participants
Masking : DOUBLE
Primary Purpose : TREATMENT
Official Title : 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
Actual Study Start Date : 2025-05-14
Estimated Primary Completion Date : 2027-03
Estimated Study Completion Date : 2027-03

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 75 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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
Study of GS-0151 in Participants With Rheumatoid Arthritis

Location Details

NCT06902519

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, alabama

Pinnacle Research Group, LLC

Anniston, alabama, United States, 36207

RECRUITING

United States, California

University of California, San Diego

La Jolla, California, United States, 92037

RECRUITING

United States, California

Stanford University School of Medicine

Palo Alto, California, United States, 94304

RECRUITING

United States, California

Medvin Clinical Research

Destination, California, United States, 91042

RECRUITING

United States, California

Medvin Clinical Research

Whittier, California, United States, 90602

RECRUITING

United States, Florida

Clinical Research of West Florida, Inc

Clearwater, florida, United States, 33765

RECRUITING

United States, Illinois

Great Lakes Clinical Trials dba Flourish Research Chicago

Chicago, Illinois, United States, 60640

RECRUITING

United States, Illinois

DM Clinical Research

Melrose Park, Illinois, United States, 60160

RECRUITING

United States, Louisiana

Accurate Clinical Research, Inc

Lake Charles, Louisiana, United States, 70605

RECRUITING

United States, Oklahoma

Lynn Health Science Institute

Oklahoma City, Oklahoma, United States, 73112

RECRUITING

United States, Pennsylvania

Altoona Center for Clinical Research

Duncansville, Pennsylvania, United States, 16635

RECRUITING

United States, Texas

Accurate Clinical Management, LLC

Baytown, Texas, United States, 77521

RECRUITING

United States, Texas

Accurate Clinical Research, Inc

Houston, Texas, United States, 77089

RECRUITING

United States, Texas

Clinical Trials of Texas LLC, dba Flourish Research

Saint Anthony, Texas, United States, 78229

RECRUITING

United States, Virginia

Tidewater Clinical Research, LLC/ Virginia Rheumatology Clinic

Virginia Beach, Virginia, United States, 23456

RECRUITING

Georgia,

ARENSIA Exploratory Medicine, LLC

Tbilisi, Georgia, 0112

RECRUITING

Germany,

University Clinic Cologne

Cologne, Germany, 50937

RECRUITING

Germany,

Porz am Rhein Hospital

Cologne, Germany, 51149

RECRUITING

Germany,

Hamburg Rheumatism Research Center II

Hamburg, Germany, 20095

RECRUITING

Germany,

Hospital of the University of Munich

München, Germany, 81377

RECRUITING

Moldova,

Republican Clinical Hospital "Timofei Mosneaga," Arensia EM

Chisinau, Moldova, MD-2025

RECRUITING

Poland,

Clinicmed Daniluk

Bialystok, Poland, 15-879

RECRUITING

Poland,

FutureMeds Gydinia

Gdynia, Poland, 81-384

RECRUITING

Poland,

FutureMeds Lodz

Lodz, Poland, 91-363

RECRUITING

Poland,

MICS Medical Center Torun

Grandchild, Poland, 87-100

RECRUITING

Poland,

FutureMeds Targowek

Warsaw Targówek, Poland, 03-291

RECRUITING

Poland,

FutureMeds Wroclaw

Wroclaw, Poland, 53-673

RECRUITING

Spain,

A Coruna University Hospital Complex

To Coruña, Spain, 15006

RECRUITING

Spain,

Sea Hospital

Barcelona, Spain, 8003

RECRUITING

Spain,

Ramon y Cajal University Hospital

Madrid, Spain, 28034

RECRUITING

Spain,

University Hospital Parc Tauli

Sabadell, Spain, 08208

RECRUITING

Spain,

Quironsalud Infanta Luisa Hospital

Seville, Spain, 41010