Study to Evaluate Safety, Tolerability, and Efficacy of GS-5718 in Participants With Active Rheumatoid Arthritis Who Have an Inadequate Response to Disease-modifying Antirheumatic Drug(s) (bDMARDs) Treatment

Sponsor
Gilead Sciences
Study ID
NCT05165771
Phase
PHASE2
Status
Withdrawn

Conditions

Eligibility Criteria

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

Interventions

  • GS-5718 — DRUG
    Tablets administered orally
  • GS-5718 — DRUG
    Tablets administered orally
  • Placebo to match GS-5718 — DRUG
    Tablets administered orally
  • Tofacitinib 5 mg — DRUG
    Tablets administered orally
  • Placebo to match Tofacitinib — DRUG
    Tablets administered orally

Study Details

The primary objective of the study is to evaluate the effect of GS-5718 versus placebo for the treatment of rheumatoid arthritis (RA) as measured by change from baseline in Disease Activity Score (DAS) based on 28 joints using C-reactive protein (CRP) (DAS28\[CRP\]) at Week 12.

Key Dates

Start date
Jul 31, 2022
Status verified
May 2022
Primary completion
Feb 28, 2023
Completion
Mar 31, 2023

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: GS-5718 Dose A
    Participants will receive GS-5718 Dose A once daily + placebo to match (PTM) GS-5718 Dose B once daily + PTM tofacitinib twice daily for up to 12 weeks.
  • Experimental: GS-5718 Dose B
    Participants will receive GS-5718 Dose B once daily + PTM GS-5718 Dose A once daily + PTM tofacitinib twice daily for up to 12 weeks.
  • Active Comparator: Tofacitinib
    Participants will receive tofacitinib 5 mg twice daily + PTM GS-5718 (Dose A + Dose B) once daily for up to 12 weeks.
  • Placebo Comparator: Placebo
    Participants will receive PTM GS-5718 (Dose A + Dose B) once daily + PTM tofacitinib twice daily for up to 12 weeks.

Primary Outcome Measure

Change From Baseline in Disease Activity Score (DAS) Based on 28 Joints Using C-reactive Protein (CRP) DAS28 (CRP) at Week 12 [ Time Frame: Baseline, Week 12 ]

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