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Rheumatoid ArthritisPhase 1NCT06902519

Study of GS-0151 in Participants With Rheumatoid Arthritis

A Phase 1 study testing GS-0151 in people with Rheumatoid Arthritis, run by Gilead Sciences at 35 sites in 6 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Rheumatoid Arthritis
What is being tested?
GS-0151
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
65 participants
Where
35 sitesin 6 countries
Study dates
14 May 2025to Mar 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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:
  • 6 or more tender joints on the tender joint count based on 68 joints (TJC68), AND.
  • 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
  • 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

Who cannot join

  • 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.
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  • 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):
  • Hemoglobin < 10.0 g/dL (SI: < 100 g/L)
  • White blood cells < 3.0 x 10^3 cells/mm^3 (SI: < 3.0 x 10^9 cells/L)
  • Neutrophils < 1.5 x 10^3 cells/mm^3 (SI: < 1.5 x 10^9 cells/L)
  • Lymphocytes < 1.0 x 10^3 cells/mm^3 (SI: < 1.0 x 10^9 cells/L)
  • Platelets < 100 x 10^3 cells/mm^3 (SI: < 100 x 10^9 cells/L)
  • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 1.5 x upper limit of normal (ULN)
  • Total bilirubin level ≥ 2 x ULN unless the individual has been diagnosed with Gilbert's disease and this is clearly documented
  • 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

Trial locations and contacts

35 sites in 6 countries.

35 sites in 6 countries

United States18 sites

  • Pinnacle Research Group, LLC

    Anniston, Alabama, 36207

  • Accurate Clinical Management, LLC

    Baytown, Texas, 77521

  • Great Lakes Clinical Trials dba Flourish Research Chicago

    Chicago, Illinois, 60640

  • Clinical Research of West Florida, Inc

    Clearwater, Florida, 33765

  • Precision Comprehensive Clinical Research Solutions

    Colleyville, Texas, 76034

  • Altoona Center for Clinical Research

    Duncansville, Pennsylvania, 16635

  • Accurate Clinical Research, Inc

    Houston, Texas, 77089

  • Precision Comprehensive Clinical Research Solutions

    Irving, Texas, 75061

  • University of California, San Diego

    La Jolla, California, 92037

  • Accurate Clinical Research, Inc

    Lake Charles, Louisiana, 70605

  • Southwest Rheumatology Research

    Mesquite, Texas, 75150

  • Lynn Health Science Institute

    Oklahoma City, Oklahoma, 73112

  • Stanford University School of Medicine

    Palo Alto, California, 94304

  • Clinical Trials of Texas LLC, dba Flourish Research

    San Antonio, Texas, 78229

  • DM Clinical Research

    Tomball, Texas, 77375

  • Medvin Clinical Research

    Tujunga, California, 91042

  • Tidewater Clinical Research, LLC/ Virginia Rheumatology Clinic

    Virginia Beach, Virginia, 23456

  • Medvin Clinical Research

    Whittier, California, 90602

Other trials in United States

Poland6 sites

  • Clinicmed Daniluk

    Bialystok, 15-879

  • FutureMeds Gydinia

    Gdynia, 81-384

  • FutureMeds Lodz

    Lodz, 91-363

  • MICS Centrum Medyczne Torun

    Torun, 87-100

  • FutureMeds Targowek

    Warszawa Targówek, 03-291

  • FutureMeds Wroclaw

    Wroclaw, 53-673

Other trials in Poland

Spain5 sites

  • Complejo Hospitalario Universitario A Coruna

    A Coruña, 15006

  • Hospital del Mar

    Barcelona, 8003

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034

  • Hospital Universitari Parc Tauli

    Sabadell, 08208

  • Hospital Quironsalud Infanta Luisa

    Seville, 41010

Other trials in Spain

Germany4 sites

  • Universitatsklinikum Koln

    Cologne, 50937

  • Krakenhaus Porz am Rhein

    Cologne, 51149

  • Hamburger Rheuma Forschungszentrum II

    Hamburg, 20095

  • Klinikum der Universitat Munchen

    München, 81377

Other trials in Germany

Georgia1 site

  • ARENSIA Exploratory Medicine, LLC

    Tbilisi, 0112

Other trials in Georgia

Moldova1 site

  • Republican Clinical Hospital "Timofei Mosneaga," Arensia EM

    Chisinau, MD-2025

Other trials in Moldova

About this study

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

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.

Being tested
GS-0151, Placebo
Medical subject headings
Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GS-0151Drug

    Administered for 12 weeks

  • PlaceboDrug

    Administered for 12 weeks

Study groups in NCT06902519
Study groupRoleWhat they receive
Part A: Cohort 1 (GS-0151 Dose A)ExperimentalParticipants with RA will be randomized to receive Dose A of GS-0151 up to 12 weeks.
Receives: Drug: GS-0151
Part A: Cohort 1 (Placebo)Placebo comparatorParticipants with RA will be randomized to receive placebo up to 12 weeks.
Receives: Drug: Placebo
Part A: Cohort 2 (GS-0151 Dose B)ExperimentalParticipants with RA will be randomized to receive Dose B of GS-0151 up to 12 weeks.
Receives: Drug: GS-0151
Part A: Cohort 2 (Placebo)Placebo comparatorParticipants with RA will be randomized to receive placebo up to 12 weeks.
Receives: Drug: Placebo
Part B: Cohort 3 (GS-0151 Dose C)ExperimentalParticipants with moderately to severely active RA will be randomized to receive Dose C of GS-0151.
Receives: Drug: GS-0151
Part B: Cohort 3 (Placebo)Placebo comparatorParticipants with moderately to severely active RA will be randomized to receive placebo.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

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

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

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

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

  4. 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.

    Measured: Up to Week 12

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

    Cmax is defined as the maximum observed plasma drug concentration.

    Measured: Up to Week 12

  6. 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.

    Measured: Up to Week 12

Secondary outcomes (2)

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

    Measured: Up to Week 12

  2. 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

    The DAS28-CRP Score comprises tender joint count and swollen joint count based on a 28 joint assessment; patient's global assessment of disease activity and CRP. The DAS28-CRP Score is a measure of the participant's disease activity calculated using the tender joint counts (28 joints), swollen joint counts (28 joints), Patient's Global Assessment of Disease Activity (visual analog scale: 0 = no disease activity to 100 = maximum disease activity), and hsCRP (CRP=hsCRP) for a total possible score of 1 to 9.4. Higher values indicate higher disease activity.

    Measured: Baseline, Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Mar 2025
  2. Study start14 May 2025
  3. Primary completionMar 2027 (estimated)
  4. Study completionMar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
65 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06902519
Sponsor's protocol ID
GS-US-667-6882
Other IDs
2024-516520-34
Status last verified
Sep 2026
First submitted
24 Mar 2025
Last updated
3 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing GS-0151 in people with Rheumatoid Arthritis, run by Gilead Sciences at 35 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 23 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 35 sites in United States, Poland, Spain, Germany, Georgia and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cohort 1, 2 and 3: Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) (time frame: First dose up to 19 Weeks post end of treatment at Week 12). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06902519.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.

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