A Study to Evaluate the Efficacy, Safety, and Tolerability of IMVT-1402 in Adult Participants With Active, Difficult to Treat Rheumatoid Arthritis
NCT06754462 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120
Last updated 2026-04-22
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).
Conditions
Interventions
- DRUG
-
IMVT-1402
Administered once weekly by subcutaneous injection.
- DRUG
-
Administered once weekly by subcutaneous injection.
Sponsors & Collaborators
-
Immunovant Sciences GmbH
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-01-10
- Primary Completion
- 2027-09-30
- Completion
- 2027-09-30
- FDA Drug
- Yes
Countries
- United States
- Argentina
- Bulgaria
- Czechia
- Georgia
- Germany
- Hungary
- Poland
- Romania
- Spain
- United Kingdom
Study Locations
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