Study of GS-0151 for Rheumatoid Arthritis
This study is testing a drug called GS-0151 for people with rheumatoid arthritis (RA). Researchers want to understand how safe GS-0151 is, how well your body tolerates it, and how your body processes the drug (pharmacokinetics or PK). You would receive either GS-0151 or a placebo (an inactive substance) for 12 weeks. The main goal is to track any side effects or changes in lab tests. Around 75 participants aged 18 to 75 can join. To be eligible, you cannot be taking certain other RA medications at the start of the study. The study's current recruitment status is unclear.
- Study design
- This interventional study plans to enroll 75 participants. Participants will receive either GS-0151 or a placebo.
- What's involved
- Participants will receive the study drug or placebo for 12 weeks. Safety will be monitored from the first dose up to 19 weeks after the end of treatment.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for safety up to 19 weeks after the end of the 12-week treatment period.
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NCT06902519
Study of GS-0151 in Participants With Rheumatoid Arthritis
Recruiting
PHASE1Ages 18–75InterventionalTreatmentGilead Sciences
~75 participants
Updated 2026-06-09 on ClinicalTrials.gov
What's tested:GS-0151Placebo
At a glance
Recruiting sites
35 of 35 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Cohort 1, 2 and 3: Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)
Measured over First dose up to 19 Weeks post end of treatment at Week 12
+5 more outcomes measured
Conditions
Where it's being run
35 sites across 14 statesTexas7
Poland6
Spain5
California4
Germany4
Alabama1
Florida1
Illinois1
Study leadership
- Gilead Study Director · STUDY_DIRECTOR · Gilead Sciences
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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 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
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.
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.
Anti-cyclic citrullinated peptide antibody (Anti-CCP) positive and/or rheumatoid factor (RF) positive
Exclusion
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
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.
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):
What this trial measures
- 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 AbnormalitiesFirst 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 DiscontinuationFirst 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-0151Up to Week 12
AUCtau is defined as the area under the serum concentration versus time curve over the dosing interval.
- Cohorts 1, 2 and 3: Serum Cmax, Following the Last Dose of GS-0151Up to Week 12
Cmax is defined as the maximum observed plasma drug concentration.
- Cohorts 1, 2 and 3: Serum Tmax Following the Last Dose of GS-0151Up to Week 12
Tmax is defined as the time (observed time point) of Cmax.