Phase 2/3, Multistage, Multicenter, Randomized, Double-Blind, Placebo-Controlled Parallel Group Withdrawal Study to Evaluate the Efficacy and Safety of Nipocalimab Administered to Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Janssen Research & Development, LLC

Summary

The main purpose of this study is to evaluate the safety and efficacy of nipocalimab compared to placebo in delaying relapse in adults with chronic inflammatory demyelinating polyneuropathy (CIDP) who initially respond to nipocalimab in Stage A.

Eligibility

Age range: 18+ years
Sex: All
Healthy volunteers: No

Detailed criteria

Inclusion Criteria: * Adults greater than or equal to (\>=) 18 years of age at the time of consent and as applicable, must also meet the legal age of consent in the jurisdiction in which the study is taking place * Diagnosed with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) according to criteria of the European Academy of Neurology/Peripheral Nerve Society (EAN/PNS) 2021, progressing or relapsing forms. CIDP diagnosis to be adjudicated by independent committee during screening period * Inflammatory Neuropathy Cause and Treatment (INCAT) disability score between 2 and 9 at the Run-…

Locations (120)

IMMUNOe Health and Research Centers
Centennial, Colorado
Healthcare Innovations Institute Inc
Coral Springs, Florida
Neurology Associates PA
Maitland, Florida
ALS Center at the University of Miami
Miami, Florida
Augusta University
Augusta, Georgia
University of Kansas Medical Center
Kansas City, Kansas

Summary

Eligibility

Interventions

Locations (120)