NCT07188844

An Open-Label Extension Study of Batoclimab in Adult Participants With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

An Open-Label Extension Study to Assess Long-term Safety and Tolerability of Batoclimab in Adult Participants With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

• Status: Enrolling By Invitation
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 108 (estimated)
• Sponsor: Immunovant Sciences GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label extension (OLE) study designed to evaluate the long-term safety and tolerability of batoclimab in participants with CIDP who have completed Study IMVT-1401-2401 (NCT05581199). In this study, participants will receive 340 mg of batoclimab subcutaneously (SC) once weekly (QW) for up to 52 weeks. Upon completion of the Week 52 or early termination (ET) Visit, participants will transition into the 4-week Follow-up Period, which concludes with a Follow-up Visit approximately 28 (± 7) days after the Week 52 or ET Visit.

Conditions

• Chronic Inflammatory Demyelinating Polyneuropathy

Interventions

Type	Name	Description
DRUG	Batoclimab	Batoclimab 340 mg SC QW

Timeline

• Start date: 2025-08-28
• Primary completion: 2028-11-01
• Completion: 2028-11-01
• First posted: 2025-09-23
• Last updated: 2025-12-26

Locations

30 sites across 11 countries: United States, Argentina, Belgium, Brazil, Germany, Greece, Italy, Poland, Romania, Serbia, Slovakia

Regulatory

• FDA-regulated drug study