drugset / Trial / NCT07188844

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

NCT07188844 ↗

Phase 2 Enrolling by invitation 108 enrolled Immunovant Sciences GmbH
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2025-08-28
Primary completion
2028-11
Completion
2028-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Batoclimab Monoclonal antibody 340 mg Subcutaneous