IRB Study Number 23-1318
Status Recruiting
Phase Phase 2
Institute Neurological Institute
Description
To evaluate the efficacy of nipocalimab compared to placebo in delaying relapse in participants with CIDP who initially respond to nipocalimab.
Inclusion Criteria
Adults, over 18 years.
Diagnosed with CIDP according to criteria of the EAN/PNS 2021, progressing or relapsing forms. CIDP diagnosis to be adjudicated by independent committee during screening period.
Exclusion Criteria
Has a history of severe and/or uncontrolled hepatic (e.g., viral/alcoholic/autoimmune hepatitis/cirrhosis and/or metabolic liver disease), gastrointestinal, renal, pulmonary, cardiovascular, psychiatric, neurological or musculoskeletal disorder, hypertension and/or any other medical or uncontrolled autoimmune disorder(s) (e.g., diabetes mellitus) or clinically significant abnormalities in screening laboratory that might interfere with the patient’s full participation in the study.
Pure sensory CIDP or CISP (EAN/PNS definition)
Polyneuropathy of other causes
Currently has a malignancy or has a history of malignancy within 3 years before
screening.
