To Assess Efficacy and Safety of Batoclimab in Adult Participants With Active CIDP
Status:
Not yet recruiting
Trial end date:
2027-01-01
Target enrollment:
Participant gender:
Summary
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
a 4-week Screening Phase, an up to 12-week Washout Phase, a 12-week Randomized Treatment
Phase (Period 1), an up to 24-week Randomized Withdrawal Phase (Period 2), a 4-week Safety
follow-up for participants not entering Long-Term Extension (LTE), and a 52-week LTE Phase.
The total study duration will be up to 104 weeks. Eligible participants will be assigned to
one of three cohorts (A, B, C) based upon their CIDP treatment at the time of screening.