NCT06902519

Study of GS-0151 in Participants With Rheumatoid Arthritis

A Phase 1b, Randomized, Blinded, Placebo-Controlled, Multicenter Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Multiple Ascending Doses of GS-0151 in Adult Participants With Rheumatoid Arthritis

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 75 (estimated)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	GS-0151	Administered for 12 weeks
DRUG	Placebo	Administered for 12 weeks

Timeline

• Start date: 2025-05-14
• Primary completion: 2027-03-01
• Completion: 2027-03-01
• First posted: 2025-03-30
• Last updated: 2026-01-21

Locations

32 sites across 6 countries: United States, Georgia, Germany, Moldova, Poland, Spain

Regulatory

• FDA-regulated drug study