NCT07032662

IMVT-1402 in Adult Participants With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

A Phase 2b, Multi-center, Randomized, Double-blind, Placebo-controlled Study of IMVT-1402 Treatment in Adult Participants With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 162 (estimated)
• Sponsor: Immunovant Sciences GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 2b study to evaluate the efficacy and safety of IMVT-1402 in adults with CIDP.

Detailed description

This is a multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of IMVT-1402 in adult participants with active CIDP.

Conditions

• Chronic Inflammatory Demyelinating Polyneuropathy

Interventions

Type	Name	Description
DRUG	IMVT-1402	Dose 1 subcutaneous (SC) once weekly (QW) for 24 weeks (Period 1) and 52 weeks (Period 2)
DRUG	Placebo	Matching placebo SC QW for 24 weeks (Period 1)

Timeline

• Start date: 2025-03-18
• Primary completion: 2028-08-01
• Completion: 2030-05-01
• First posted: 2025-06-24
• Last updated: 2026-04-02

Locations

135 sites across 30 countries: United States, Argentina, Australia, Austria, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Colombia, Denmark, Estonia, Finland, Germany, Greece, Hungary, Ireland, Italy, Mexico, Netherlands, Norway, Peru, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study