Efficacy and Safety Study of Nipocalimab for Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
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)
- Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
At a glance
- Phase
- Phase 2
- Study type
- Interventional
- Sponsor
- Janssen Research & Development, LLC
- Enrolment target
- 201
- Started
- 23 September 2022
- Main results due
- 14 May 2027
- Study sites
- 120
- Registry updated
- 25 September 2026
Can you take part?
- Aged 18 years and over.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility 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-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
What this study is about
In the sponsor’s own words, from the registry.
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.
Study sites(120)
IMMUNOe Health and Research Centers
Centennial, Colorado, United States
Recruiting
Healthcare Innovations Institute Inc
Coral Springs, Florida, United States
Recruiting
Neurology Associates PA
Maitland, Florida, United States
Completed
ALS Center at the University of Miami
Miami, Florida, United States
Recruiting
Augusta University
Augusta, Georgia, United States
Recruiting
University of Kansas Medical Center
Kansas City, Kansas, United States
Recruiting
Johns Hopkins Hospital
Baltimore, Maryland, United States
Recruiting
Boston Clinical Trials
Boston, Massachusetts, United States
Completed
Beaumont Hospital Royal Oak
Royal Oak, Michigan, United States
Completed
Kansas City Veterans Affairs Medical Center
Kansas City, Missouri, United States
Recruiting
The Neurological Institute of New York
New York, New York, United States
Completed
South Shore Neurologic Associates - Patchogue
Patchogue, New York, United States
Recruiting
The Neurological Institute, PA
Charlotte, North Carolina, United States
Recruiting
Cleveland Clinic Main Campus
Cleveland, Ohio, United States
Recruiting
Austin Neuromuscular Center
Austin, Texas, United States
Recruiting
Advocate Health - Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, United States
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
Tangdu hospital the Fourth Military Medical
Xi'an, China
Recruiting
Xi 'an GaoXin Hospital
Xi'an, China
Recruiting
Fundación Cardiovascular de Colombia - Instituto del Corazón Floridablanca
Floridablanca, Colombia
Recruiting
Instituto Neurológico de Colombia
Medellín, Colombia
Recruiting
Fakultni nemocnice Hradec Kralove
Hradec Králové, Czechia
Recruiting
Fakultni Nemocnice Ostrava
Ostrava, Czechia
Completed
Pardubicka krajska nemocnice a s
Pardubice, Czechia
Completed
CHU Bordeaux
Bordeaux, France
Recruiting
Hospices Civils de Lyon HCL
Bron, France
Recruiting
Hopital de Bicetre
Le Kremlin-Bicêtre, France
Recruiting
Hopital de la Timone
Marseille, France
Recruiting
Hopital PASTEUR
Nice, France
Recruiting
CHU Nimes Hopital Caremeau
Nîmes, France
Recruiting
Hopital de la Pitie Salpetriere
Paris, France
Recruiting
Fondation Adolphe de Rothschild Hospital
Paris, France
Recruiting
CHRU Strasbourg
Strasbourg, France
Recruiting
Judisches Krankenhaus Berlin
Berlin, Germany
Recruiting
St. Josef-Hospital, Ruhr-Universität Bochum
Bochum, Germany
Recruiting
Städtisches Krankenhaus Martha-Maria Halle-Dölau gGmbH
Halle, Germany
Recruiting
Medizinische Hochschule Hannover
Hanover, Germany
Recruiting
Showing 60 of 120 sites — filter to narrow it down. 100 of the 120 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT05327114. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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