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
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-…
Interventions
- DrugNipocalimab
Nipocalimab will be administered intravenously.
- DrugPlacebo
Placebo will be administered intravenously.
Locations (113)
- IMMUNOe Health and Research CentersCentennial, Colorado
- Healthcare Innovations Institute IncCoral Springs, Florida
- Neurology Associates PAMaitland, Florida
- University of Kansas Medical CenterKansas City, Kansas
- Johns Hopkins HospitalBaltimore, Maryland
- Boston Clinical TrialsBoston, Massachusetts