Nipocalimab: Nipocalimab will be administered intravenously.
Placebo: Placebo will be administered intravenously.
Study 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
Sex
ALL
Min age
18 Years
Max age
—
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-In Baseline visit for participants entering Run-In, or Stage A Baseline visit for participants directly entering Stage A. Participants with an INCAT score of 2 at trial entry must have this score exclusively from the leg disability score
* Fulfilling any of the following treatment conditions: a) Currently treated with oral corticosteroids (CS) less than or equal to (\<=) 20 milligrams (mg)/day; or b) Currently treated with pulsed CS, and/or intravenous immunoglobulin (IVIg) or subcutaneous immunoglobulin (SCIg) and the participant is willing to discontinue no later than the run-in baseline visit; or c) Currently treated with oral CS greater than (\>) 20 mg/day and the participant is willing to taper to \<=20 mg/day during the run-in period; or d) Without previous treatment (treatment naive); or treatment with CS and/or IVIg or SCIg discontinued at least 3 months prior to screening (untreated)
* Active disease as determined by CIDP Disease Activity Status (CDAS) score \>= 3
* Other protocol-defined inclusion criteria will apply
Exclusion Criteria:
* Has a history of severe and/or uncontrolled hepatic (example, 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) (example, diabetes mellitus) or clinically significant abnormalities in screening laboratory that, might interfere with the participants full participation in the study, or might jeopardize the safety of the participant or the validity of the study results
* Pure sensory CIDP or chronic immune sensory polyradiculopathy (CISP) (EAN/PNS definition)
* Any other disease that could better explain the participant's signs and symptoms, such as significant persisting neurological deficits from stroke or central nervous system (CNS) trauma or peripheral neuropathy from another cause such as connective tissue disease or systemic lupus erythematosus
* Polyneuropathy of other causes, including the following: Multifocal motor neuropathy (MMN); Monoclonal gammopathy of uncertain significance with antimyelin associated glycoprotein (anti-MAG) immunoglobulin M (IgM) antibodies; Hereditary motor neuropathy; Hereditary neuropathy with liability to pressure palsies (HNPP); Polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin change syndromes; Lumbosacral radiculoplexus neuropathy; Polyneuropathy most likely due to diabetes mellitus; Polyneuropathy most likely due to systemic illnesses; Drug- or toxin-induced polyneuropathy Note: A concomitant polyneuropathy of other causes (example, a mild, stable diabetic polyneuropathy) is not necessarily exclusionary if chronic inflammatory demyelinating polyneuropathy (CIDP) is confirmed as the main diagnosis, as determined by the investigator and confirmed by the adjudication committee
* Has known allergies, hypersensitivity, or intolerance to nipocalimab or its excipients
* Other protocol-defined exclusion criteria will apply
Primary outcome measure(s)
Stage B: Time to First Occurrence of a Relapse Event — Up to 52 weeks Stage B time to first occurrence of a relapse event will be reported.
Trial sites (120)
Facility
City
Region
Status
IMMUNOe Health and Research Centers
Centennial
Colorado
Recruiting
Healthcare Innovations Institute Inc
Coral Springs
Florida
Recruiting
Neurology Associates PA
Maitland
Florida
Completed
ALS Center at the University of Miami
Miami
Florida
Recruiting
Augusta University
Augusta
Georgia
Recruiting
University of Kansas Medical Center
Kansas City
Kansas
Recruiting
Johns Hopkins Hospital
Baltimore
Maryland
Recruiting
Boston Clinical Trials
Boston
Massachusetts
Completed
Beaumont Hospital Royal Oak
Royal Oak
Michigan
Completed
Kansas City Veterans Affairs Medical Center
Kansas City
Missouri
Recruiting
The Neurological Institute of New York
New York
New York
Completed
South Shore Neurologic Associates - Patchogue
Patchogue
New York
Recruiting
The Neurological Institute, PA
Charlotte
North Carolina
Recruiting
Cleveland Clinic Main Campus
Cleveland
Ohio
Recruiting
Austin Neuromuscular Center
Austin
Texas
Recruiting
Advocate Health - Aurora St. Luke's Medical Center
Milwaukee
Wisconsin
Recruiting
Hospital Italiano de Buenos Aires
Buenos Aires
Argentina
Recruiting
Instituto Fleni
Buenos Aires
Argentina
Recruiting
Hospital Gral Agudos Ignacio Pirovano
Buenos Aires
Argentina
Recruiting
INECO Neurociencias Orono
Rosario
Argentina
Recruiting
The Alfred Hospital
Melbourne
Australia
Completed
Gold Coast University Hospital
Parkwood
Australia
Completed
The Ottawa Hospital Ottawa NeuroMuscular Centre
Ottawa
Canada
Recruiting
Peking University First Hospital
Beijing
China
Recruiting
Xuanwu Hospital ,Capital Medical University
Beijing
China
Recruiting
Beijing Tiantan Hospital, Capital Medical University
Beijing
China
Recruiting
Peking University Third Hospital
Beijing
China
Recruiting
The First Hospital of Jilin University
Changchun
China
Recruiting
The Third Xiangya Hospital of Central Sourth University
Changsha
China
Recruiting
Xiangya Hospital Central South University
Changsha
China
Recruiting
Sichuan Provincial Peoples Hospital
Chengdu
China
Recruiting
Chifeng Municipal Hospital
Chifeng
China
Recruiting
Fujian Medical University Union Hospital
Fuzhou
China
Recruiting
The First Affiliated Hospital Sun Yat sen University
Guangzhou
China
Recruiting
Qilu Hospital of Shandong University
Jinan
China
Recruiting
Qianfoshan hospital of Shandong Province
Jinan
China
Completed
The First Affiliated Hospital of NanChang University
Nanchang
China
Recruiting
Huashan Hospital Fudan University
Shanghai
China
Recruiting
Tong Ren Hospital Shanghai Jiao Tong University school of medicine
Shanghai
China
Completed
Renmin Hospital of Wuhan University
Wuhan
China
Recruiting
+ 80 more sites — see the full list on the official registry below.
More Janssen Research & Development, LLC trials in the UK
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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