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

Not Recruiting

Trial ID: NCT05165771

Purpose

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.

Official Title

A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 2 Proof-of-Concept Study to Evaluate Safety, Tolerability, and Efficacy of GS-5718 on Background Therapy With Conventional Synthetic Disease-modifying Antirheumatic Drug(s) (csDMARDs) in Participants With Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD(s) Treatment

Stanford Investigator(s)

Matthew C. Baker, MD MS
Matthew C. Baker, MD MS

Assistant Professor of Medicine (Immunology and Rheumatology)

Eligibility


Key Inclusion Criteria:

   - Diagnosis of rheumatoid arthritis (RA) ≥ 3 months prior to screening fulfilling the
   2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR)
   classification criteria for RA

   - Rheumatoid factor (RF) and/or anti-citrullinated protein antibodies (ACPA) positivity

   - Individual fulfills all of the following minimum disease activity criteria:

      - ≥ 6 swollen joints (from a swollen joint count based on 66 joints [SJC66])
      provided this would also fulfill ≥ 4 swollen joints (from a swollen joint count
      based on 28 joints [SJC28]) at screening and Day 1, and

      - ≥ 6 tender joints (from a tender joint count based on 68 joints [TJC68]),
      provided this would also fulfill ≥ 4 tender joints (from a tender joint count
      based on 28 joints [TJC28]) at screening and Day 1, and

      - hsCRP > upper limit of normal at screening

   - Received at least one bDMARD for the treatment of RA to which there is a lack of
   efficacy and/or intolerance.

Key Exclusion Criteria:

   - Individuals who do not qualify per the tofacitinib label and/or local guidelines
   should not be enrolled.

   - Prior exposure to any Janus kinase inhibitor

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Intervention(s):

drug: GS-5718

drug: GS-5718

drug: Placebo to match GS-5718

drug: Tofacitinib 5 mg

drug: Placebo to match Tofacitinib

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305