Study of GS-0151 in Participants With Rheumatoid Arthritis
NCT ID: NCT06902519
Last Updated: 2025-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
75 participants
INTERVENTIONAL
2025-05-14
2027-03-31
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Part A: Cohort 1 (GS-0151 Dose A)
Participants with RA will be randomized to receive Dose A of GS-0151 up to 12 weeks.
GS-0151
Administered for 12 weeks
Part A: Cohort 1 (Placebo)
Participants with RA will be randomized to receive placebo up to 12 weeks.
Placebo
Administered for 12 weeks
Part A: Cohort 2 (GS-0151 Dose B)
Participants with RA will be randomized to receive Dose B of GS-0151 up to 12 weeks.
GS-0151
Administered for 12 weeks
Part A: Cohort 2 (Placebo)
Participants with RA will be randomized to receive placebo up to 12 weeks.
Placebo
Administered for 12 weeks
Part B: Cohort 3 (GS-0151 Dose C)
Participants with moderately to severely active RA will be randomized to receive Dose C of GS-0151.
GS-0151
Administered for 12 weeks
Part B: Cohort 3 (Placebo)
Participants with moderately to severely active RA will be randomized to receive placebo.
Placebo
Administered for 12 weeks
Interventions
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GS-0151
Administered for 12 weeks
Placebo
Administered for 12 weeks
Eligibility Criteria
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Inclusion Criteria
* 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:
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
Exclusion Criteria
* 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
18 Years
75 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Gilead Study Director
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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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
Hamburger Rheuma Forschungszentrum II
Hamburg, , 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 Infanta Luisa
Seville, , Spain
Countries
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Central Contacts
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Gilead Clinical Study Information Center
Role: CONTACT
Phone: 1-833-445-3230 (GILEAD-0)
Email: [email protected]
Related Links
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Gilead Clinical Trials Website
Other Identifiers
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GS-US-667-6882
Identifier Type: -
Identifier Source: org_study_id
2024-516520-34
Identifier Type: OTHER
Identifier Source: secondary_id