GS-0151 for Rheumatoid Arthritis

Recruiting at 3 trial locations

Overseen By Gilead Clinical Study Information Center

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Gilead Sciences

Must be taking: Methotrexate, Hydroxychloroquine, Sulfasalazine, Leflunomide

Must not be taking: Biologics, High-potency opiates

Disqualifiers: Infection, Heart failure, Transplant, others

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

75 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Gilead Study Director

Principal Investigator

Gilead Sciences

Eligibility Criteria

This trial is for people with rheumatoid arthritis who are taking certain medications like methotrexate, leflunomide, sulfasalazine, hydroxychloroquine or low-dose corticosteroids. They must not be on strong painkillers or biologic disease-modifying drugs recently and should have at least 6 tender joints.

Inclusion Criteria

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: 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. 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

I haven't taken any biologic arthritis drugs for 4 weeks, or B cell-depleting drugs for 6 months.

I have been on 1 or 2 approved arthritis drugs for over 12 weeks.

Exclusion Criteria

History of opportunistic infection or immunodeficiency syndrome that would put the individual at risk, as per investigator's judgment

I have had an organ or bone marrow transplant.

I have not received a live vaccine within 4 weeks before starting the study.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive multiple ascending doses of GS-0151 or placebo for up to 12 weeks

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• GS-0151

Trial Overview The study tests GS-0151's safety and how the body processes it when given multiple times to participants with RA. It compares GS-0151 against a placebo (a substance with no active drug) to see if there's any improvement in their condition.

Participant Groups

Group I: Part B: Cohort 3 (GS-0151 Dose C) Experimental Treatment 1 Intervention

Participants with moderately to severely active RA will be randomized to receive Dose C of GS-0151.

Group II: Part A: Cohort 2 (GS-0151 Dose B) Experimental Treatment 1 Intervention

Participants with RA will be randomized to receive Dose B of GS-0151 up to 12 weeks.

Group III: Part A: Cohort 1 (GS-0151 Dose A) Experimental Treatment 1 Intervention

Participants with RA will be randomized to receive Dose A of GS-0151 up to 12 weeks.

Group IV: Part A: Cohort 1 (Placebo) Placebo Group 1 Intervention

Participants with RA will be randomized to receive placebo up to 12 weeks.

Group V: Part A: Cohort 2 (Placebo) Placebo Group 1 Intervention

Participants with RA will be randomized to receive placebo up to 12 weeks.

Group VI: Part B: Cohort 3 (Placebo) Placebo Group 1 Intervention

Participants with moderately to severely active RA will be randomized to receive placebo.

Who Is Running the Clinical Trial?

Gilead Sciences

Lead Sponsor

Trials

1,150

Recruited

878,000+

Daniel O'Day

Gilead Sciences

Chief Executive Officer since 2019

MBA from Columbia University

Dietmar Berger

Gilead Sciences

Chief Medical Officer

MD and PhD from Albert-Ludwigs University School of Medicine