Study of GS-0151 in Participants With Rheumatoid Arthritis

Part of paid clinical trials in Anniston, Alabama.

Sponsor
Gilead Sciences
Study ID
NCT06902519
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • GS-0151 — DRUG
    Administered for 12 weeks
  • Placebo — DRUG
    Administered for 12 weeks

Study Details

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.

Key Dates

Start date
May 14, 2025
Status verified
Jun 2026
Primary completion
Mar 31, 2027
Completion
Mar 31, 2027

Study Design

Enrollment
75 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Part A: Cohort 1 (GS-0151 Dose A)
    Participants with RA will be randomized to receive Dose A of GS-0151 up to 12 weeks.
  • Placebo Comparator: Part A: Cohort 1 (Placebo)
    Participants with RA will be randomized to receive placebo up to 12 weeks.
  • Experimental: Part A: Cohort 2 (GS-0151 Dose B)
    Participants with RA will be randomized to receive Dose B of GS-0151 up to 12 weeks.
  • Placebo Comparator: Part A: Cohort 2 (Placebo)
    Participants with RA will be randomized to receive placebo up to 12 weeks.
  • Experimental: Part B: Cohort 3 (GS-0151 Dose C)
    Participants with moderately to severely active RA will be randomized to receive Dose C of GS-0151.
  • Placebo Comparator: Part B: Cohort 3 (Placebo)
    Participants with moderately to severely active RA will be randomized to receive placebo.

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 ]

Central Contacts

Locations (18)

FacilityCityStateZIPSite coordinators
Pinnacle Research Group, LLCAnnistonAlabama36207-
University of California, San DiegoLa JollaCalifornia92037-
Stanford University School of MedicinePalo AltoCalifornia94304-
Medvin Clinical ResearchTujungaCalifornia91042-
Medvin Clinical ResearchWhittierCalifornia90602-
Clinical Research of West Florida, IncClearwaterFlorida33765-
Great Lakes Clinical Trials dba Flourish Research ChicagoChicagoIllinois60640-
Accurate Clinical Research, IncLake CharlesLouisiana70605-
Lynn Health Science InstituteOklahoma CityOklahoma73112-
Altoona Center for Clinical ResearchDuncansvillePennsylvania16635-
Accurate Clinical Management, LLCBaytownTexas77521-
Precision Comprehensive Clinical Research SolutionsColleyvilleTexas76034-
Accurate Clinical Research, IncHoustonTexas77089-
Precision Comprehensive Clinical Research SolutionsIrvingTexas75061-
Southwest Rheumatology ResearchMesquiteTexas75150-
Clinical Trials of Texas LLC, dba Flourish ResearchSan AntonioTexas78229-
DM Clinical ResearchTomballTexas77375-
Tidewater Clinical Research, LLC/ Virginia Rheumatology ClinicVirginia BeachVirginia23456-

Find similar trials in Anniston, AL

By condition
Rheumatoid arthritis
By specialty
RheumatologyAutoimmune diseaseMusculoskeletal disorders
By research site
Pinnacle Research Group, LLC· Anniston, ALUniversity of California, San Diego· La Jolla, CAStanford University School of Medicine· Palo Alto, CAMedvin Clinical Research· Tujunga, CAMedvin Clinical Research· Whittier, CAClinical Research of West Florida, Inc· Clearwater, FL

Related Studies