To Assess Efficacy and Safety of Batoclimab in Adult Participants With Active CIDP

This is a multi-center, randomized, quadruple-blind, placebo-controlled study to evaluate the efficacy and safety of batoclimab in adult participants with active CIDP. The study includes an up to 4-week Screening Period, an up to 12-week Washout Period, a 12-week Randomized Treatment Period (Period 1), an up to 24-week Randomized Withdrawal Period (Period 2), an up to 52-week Long-term Extension (LTE) Period (optional), and Safety Follow-up 4 weeks after the last dose of study treatment. The total study duration will be up to approximately 109 weeks. Eligible participants will be assigned to one of four cohorts based upon their baseline CIDP treatment (Cohorts A and D - immunoglobulin \[Ig\] or plasma exchange \[PLEX\]; Cohort B - corticosteroids; Cohort C - naive or untreated in previous 3-24 months) and whether they meet diagnosis according to the European Academy of Neurology/Peripheral Nerve Society (EAN/PNS) criteria (Cohorts A, B, and C) or clinical criteria only (Cohort D) at the time of screening.

NCT Number	NCT05581199
Lead Sponsor	Immunovant Sciences GmbH
Conditions	Chronic Inflammatory Demyelinating Polyneuropathy
Enrollment	94 participants
Start Date	2022-12-15
Primary Completion	2026-07-20 (estimated)
Study Completion	2026-07-20 (estimated)
Updated on ClinicalTrials.gov	2026-08-11