NCT05581199

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

A Phase 2b, Multi-center, Randomized, Quadruple-blind, Placebo-controlled Study of Batoclimab Treatment in Adult Participants With Active Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 277 (estimated)
• Sponsor: Immunovant Sciences GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Chronic Inflammatory Demyelinating Polyneuropathy

Interventions

Type	Name	Description
DRUG	Batoclimab 680 milligrams (mg) subcutaneous (SC) weekly	Batoclimab is a fully human anti-neonatal fragment crystallizable receptor (FcRn) monoclonal antibody
DRUG	Batoclimab 340 mg SC weekly	Batoclimab is a fully human anti-neonatal fragment crystallizable receptor (FcRn) monoclonal antibody
DRUG	Placebo	Matching placebo SC

Timeline

• Start date: 2022-12-15
• Primary completion: 2026-01-01
• Completion: 2027-01-01
• First posted: 2022-10-14
• Last updated: 2024-11-25

Locations

116 sites across 21 countries: United States, Argentina, Belgium, Brazil, Bulgaria, Canada, Denmark, Finland, Germany, Greece, Italy, Norway, Poland, Portugal, Romania, Serbia, Slovakia, South Korea, Spain, Sweden, United Kingdom

Regulatory

• FDA-regulated drug study