RECRUITING

Study of GS-0151 in Participants With Rheumatoid Arthritis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2025-05-14

Study Completion:2027-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06902519

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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 * 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. * 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: 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. 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. * Anti-cyclic citrullinated peptide antibody (Anti-CCP) positive and/or rheumatoid factor (RF) positive	* 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): 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

Inclusion Criteria

Exclusion 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
* 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.
* 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:
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.
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.
* Anti-cyclic citrullinated peptide antibody (Anti-CCP) positive and/or rheumatoid factor (RF) positive

* 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):
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

Contacts and Locations

Study Contact

Gilead Clinical Study Information Center

CONTACT

1-833-445-3230 (GILEAD-0)

GileadClinicalTrials@gilead.com

Principal Investigator

Gilead Study Director

STUDY_DIRECTOR

Gilead Sciences

Study Locations (Sites)

Pinnacle Research Group, LLC

Anniston, Alabama, 36207

United States

Clinical Research of West Florida, Inc

Clearwater, Florida, 33765

United States

Altoona Center for Clinical Research

Duncansville, Pennsylvania, 16635

United States

Accurate Clinical Research, Inc

Houston, Texas, 77089

United States

Collaborators and Investigators

Sponsor: Gilead Sciences

Gilead Study Director, STUDY_DIRECTOR, Gilead Sciences

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05-14

Study Completion Date2027-01

Study Record Updates

Study Start Date2025-05-14

Study Completion Date2027-01

Terms related to this study

Additional Relevant MeSH Terms

Rheumatoid Arthritis