NCT06754462

A Study to Evaluate the Efficacy, Safety, and Tolerability of IMVT-1402 in Adult Participants With Active, Difficult to Treat Rheumatoid Arthritis

A Phase 2b, Multicenter, Double-blind, Placebo-controlled Randomized Withdrawal Study to Assess the Efficacy, Safety, and Tolerability of IMVT-1402 in Adult Participants With Active, Difficult to Treat, ACPA-Positive Rheumatoid Arthritis

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Immunovant Sciences GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This Phase 2b, multicenter, double-blind, placebo-controlled, randomized withdrawal study is designed to assess the efficacy and safety of IMVT-1402 in adult participants with active, difficult-to-treat, anti-citrullinated protein autoantibody (ACPA) positive rheumatoid arthritis (RA).

Detailed description

The primary objective is to evaluate the effects of IMVT-1402 compared to placebo, as measured by the American College of Rheumatology 20% (ACR20) response at Week 28. The total duration of study participation is expected to be up to 86 weeks for an individual participant with 16 weeks of open-label treatment, 12 weeks of blinded randomized treatment, and 48 weeks of optional long-term extension treatment.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	IMVT-1402	Administered once weekly by subcutaneous injection.
DRUG	Placebo	Administered once weekly by subcutaneous injection.

Timeline

• Start date: 2025-01-10
• Primary completion: 2027-09-01
• Completion: 2027-09-01
• First posted: 2024-12-31
• Last updated: 2025-12-12

Locations

83 sites across 11 countries: United States, Argentina, Bulgaria, Czechia, Georgia, Germany, Hungary, Poland, Romania, Spain, United Kingdom

Regulatory

• FDA-regulated drug study