Actively Recruiting
Study of GS-0151 in Participants With Rheumatoid Arthritis
Led by Gilead Sciences · Updated on 2026-05-11
75
Participants Needed
32
Research Sites
93 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Study of GS-0151 in Participants With Rheumatoid Arthritis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years
- Diagnosed with rheumatoid arthritis
- Not taking biologic disease-modifying antirheumatic drugs (b/tsDMARDs) on Day 1 and discontinued these at least 4 weeks before Day 1 (6 months for B cell-depleting agents)
- Currently using 1 or 2 conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) like methotrexate (7.5-25 mg/week with folic/folinic acid), hydroxychloroquine (up to 400 mg/day), chloroquine (up to 250 mg/day), sulfasalazine (1-3 g/day), or leflunomide (10-20 mg/day) for at least 12 weeks and stable for 6 weeks before Day 1
- Oral corticosteroids use of no more than 10 mg prednisone or equivalent per day, stable for at least 14 days before Day 1
- Stable inhaled corticosteroids for at least 1 week before first dose; occasional topical corticosteroids allowed
- Stable dose of NSAIDs or acetaminophen for at least 1 week before Day 1
- Discontinued all high-potency opiates at least 1 week before Day 1
- For Cohort 3 only: moderately to severely active RA with 6 or more tender and swollen joints, hsCRP at or above upper limit of normal, inadequate response or intolerance to 1 to 3 b/tsDMARDs, and positive for anti-CCP and/or rheumatoid factor
You will not qualify if you...
- Diagnosis of generalized musculoskeletal disorder interfering with study procedures
- History of opportunistic infection or immunodeficiency syndrome
- Active clinically significant infection or infection requiring hospitalization or intravenous treatment within 60 days, or oral anti-infective therapy within 30 days before screening
- History or current moderate to severe congestive heart failure (NYHA class III or IV) or within 6 months prior to screening
- History of lymphoproliferative disease
- History of organ or bone marrow transplant
- Major surgery within 12 weeks before screening or planned during the study
- History of infected joint prosthesis or implanted device still in place
- Clinically significant ECG abnormalities including QTcF > 450 msec or recurrent hypokalemia < 3.0 mmol/L or family history of long QT syndrome
- Received live attenuated vaccine within 4 weeks before Day 1 or planned during study
- Participation in investigational drug/device study within 4 weeks or 5 half-lives prior to screening
- Positive tuberculosis test at screening (unless treated fully for latent or active TB)
- Active hepatitis C virus infection
- Abnormal laboratory test results including hemoglobin < 10.0 g/dL, low white blood cells, neutrophils, lymphocytes, platelets, elevated liver enzymes or bilirubin, or reduced creatinine clearance < 50 mL/min
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 32 locations
1
Pinnacle Research Group, LLC
Anniston, Alabama, United States, 36207
Actively Recruiting
2
University of California, San Diego
La Jolla, California, United States, 92037
Actively Recruiting
3
Stanford University School of Medicine
Palo Alto, California, United States, 94304
Actively Recruiting
4
Medvin Clinical Research
Tujunga, California, United States, 91042
Actively Recruiting
5
Medvin Clinical Research
Whittier, California, United States, 90602
Actively Recruiting
6
Clinical Research of West Florida, Inc
Clearwater, Florida, United States, 33765
Actively Recruiting
7
Great Lakes Clinical Trials dba Flourish Research Chicago
Chicago, Illinois, United States, 60640
Actively Recruiting
8
Accurate Clinical Research, Inc
Lake Charles, Louisiana, United States, 70605
Actively Recruiting
9
Lynn Health Science Institute
Oklahoma City, Oklahoma, United States, 73112
Actively Recruiting
10
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States, 16635
Actively Recruiting
11
Accurate Clinical Management, LLC
Baytown, Texas, United States, 77521
Actively Recruiting
12
Accurate Clinical Research, Inc
Houston, Texas, United States, 77089
Actively Recruiting
13
Clinical Trials of Texas LLC, dba Flourish Research
San Antonio, Texas, United States, 78229
Actively Recruiting
14
DM Clinical Research
Tomball, Texas, United States, 77375
Actively Recruiting
15
Tidewater Clinical Research, LLC/ Virginia Rheumatology Clinic
Virginia Beach, Virginia, United States, 23456
Actively Recruiting
16
ARENSIA Exploratory Medicine, LLC
Tbilisi, Georgia, 0112
Actively Recruiting
17
Universitatsklinikum Koln
Cologne, Germany, 50937
Actively Recruiting
18
Krakenhaus Porz am Rhein
Cologne, Germany, 51149
Actively Recruiting
19
Hamburger Rheuma Forschungszentrum II
Hamburg, Germany, 20095
Actively Recruiting
20
Klinikum der Universitat Munchen
München, Germany, 81377
Actively Recruiting
21
Republican Clinical Hospital "Timofei Mosneaga," Arensia EM
Chisinau, Moldova, MD-2025
Actively Recruiting
22
Clinicmed Daniluk
Bialystok, Poland, 15-879
Actively Recruiting
23
FutureMeds Gydinia
Gdynia, Poland, 81-384
Actively Recruiting
24
FutureMeds Lodz
Lodz, Poland, 91-363
Actively Recruiting
25
MICS Centrum Medyczne Torun
Torun, Poland, 87-100
Actively Recruiting
26
FutureMeds Targowek
Warszawa Targówek, Poland, 03-291
Actively Recruiting
27
FutureMeds Wroclaw
Wroclaw, Poland, 53-673
Actively Recruiting
28
Complejo Hospitalario Universitario A Coruna
A Coruña, Spain, 15006
Actively Recruiting
29
Hospital del Mar
Barcelona, Spain, 8003
Actively Recruiting
30
Hospital Universitario Ramon y Cajal
Madrid, Spain, 28034
Actively Recruiting
31
Hospital Universitari Parc Tauli
Sabadell, Spain, 08208
Actively Recruiting
32
Hospital Quironsalud Infanta Luisa
Seville, Spain, 41010
Actively Recruiting
Research Team
G
Gilead Clinical Study Information Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
6
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