NCT05165771

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

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

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	GS-5718	Tablets administered orally
DRUG	GS-5718	Tablets administered orally
DRUG	Placebo to match GS-5718	Tablets administered orally
DRUG	Tofacitinib 5 mg	Tablets administered orally
DRUG	Placebo to match Tofacitinib	Tablets administered orally

Timeline

• Start date: 2022-07-01
• Primary completion: 2023-02-01
• Completion: 2023-03-01
• First posted: 2021-12-21
• Last updated: 2022-05-18

Regulatory

• FDA-regulated drug study