Clinical Trial

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

Terminated Phase 2
View on ClinicalTrials.gov →
Why the trial stopped
Sponsor Decision
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.
Protocol Amendment History 5 changes
critical Trial status changed: Enrolling by Invitation → Terminated 2026-08-12
critical Trial terminated: Sponsor Decision 2026-08-12
notable Enrollment reduced: 108 -> 26 participants 2026-08-12
notable Primary completion moved earlier: 2028-11 -> 2026-07-16 2026-08-12
minor Completion moved earlier: 2028-11 -> 2026-07-16 2026-08-12
Trial Details
NCT Number NCT07188844
Lead Sponsor Immunovant Sciences GmbH
Conditions Chronic Inflammatory Demyelinating Polyneuropathy
Enrollment 26 participants
Start Date 2025-08-28
Primary Completion 2026-07-16 (estimated)
Study Completion 2026-07-16 (estimated)
Updated on ClinicalTrials.gov 2026-08-11