Efficacy and Safety Study of Nipocalimab for Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
NCT ID: NCT05327114
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2/PHASE3
201 participants
INTERVENTIONAL
2022-09-23
2028-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Nipocalimab
Participants in Stage A (Open-label) will receive a loading dose of nipocalimab (Dose 1) intravenous (IV) infusion on Day 1, followed by nipocalimab (Dose 2) IV infusion once every 2 weeks (q2w) from Week 2 to Week 12. Participants who demonstrate evidence of clinical improvement in Stage A (responders) will enter Stage B (Double-blind) and receive nipocalimab (Dose 2) IV infusion q2w starting on Day 1 up to Week 52. After completion of Stage B or discontinuation from Stage B due to relapse, participants will have the option to enter the open label extension (OLE) phase and receive nipocalimab (Dose 2) IV infusion q2w starting on OLE Day 1 until 2 years after marketing authorization in a participant's local country or until nipocalimab becomes available commercially or via other continued access program, whichever comes first.
Nipocalimab
Nipocalimab will be administered intravenously.
Placebo
Participants receiving nipocalimab in Stage A and who demonstrate evidence of clinical improvement in Stage A (responders) will enter Stage B (Double-blind) and receive placebo IV infusion q2w starting on Day 1 up to Week 52. After completion of Stage B or discontinuation from Stage B due to relapse, participants will have the option to enter the open label extension (OLE) phase and receive nipocalimab (Dose 2) IV infusion q2w starting on OLE Day 1 until 2 years after marketing authorization in a participant's local country or until nipocalimab becomes available commercially or via other continued access program, whichever comes first.
Placebo
Placebo will be administered intravenously.
Interventions
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Nipocalimab
Nipocalimab will be administered intravenously.
Placebo
Placebo will be administered intravenously.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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IMMUNOe Health and Research Centers
Centennial, Colorado, United States
Neurology Associates PA
Maitland, Florida, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Johns Hopkins Hospital
Baltimore, Maryland, United States
Boston Clinical Trials
Boston, Massachusetts, United States
Beaumont Hospital Royal Oak
Royal Oak, Michigan, United States
The Neurological Institute of New York
New York, New York, United States
South Shore Neurologic Associates - Patchogue
Patchogue, New York, United States
The Neurological Institute, PA
Charlotte, North Carolina, United States
Cleveland Clinic Main Campus
Cleveland, Ohio, United States
Austin Neuromuscular Center
Austin, Texas, United States
Advocate Health - Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, United States
The Alfred Hospital
Melbourne, , Australia
Gold Coast University Hospital
Parkwood, , Australia
Peking University First Hospital
Beijing, , China
Xuanwu Hospital ,Capital Medical University
Beijing, , China
Beijing Tiantan Hospital, Capital Medical University
Beijing, , China
Peking University Third Hospital
Beijing, , China
The First Hospital of Jilin University
Changchun, , China
The Third Xiangya Hospital of Central Sourth University
Changsha, , China
Xiangya Hospital Central South University
Changsha, , China
Chifeng Municipal Hospital
Chifeng, , China
Fujian Medical University Union Hospital
Fuzhou, , China
The First Affiliated Hospital Sun Yat sen University
Guangzhou, , China
Qianfoshan hospital of Shandong Province
Jinan, , China
The First Affiliated Hospital of NanChang University
Nanchang, , China
Huashan Hospital Fudan University
Shanghai, , China
Tong Ren Hospital Shanghai Jiao Tong University school of medicine
Shanghai, , China
Xi 'an GaoXin Hospital
Xi'an, , China
Fundación Cardiovascular de Colombia - Instituto del Corazón Floridablanca
Floridablanca, , Colombia
Instituto Neurológico de Colombia
Medellín, , Colombia
Fakultni nemocnice Hradec Kralove
Hradec Králové, , Czechia
Fakultni Nemocnice Ostrava
Ostrava, , Czechia
Pardubicka krajska nemocnice a s
Pardubice, , Czechia
CHU Bordeaux
Bordeaux, , France
Hospices Civils de Lyon HCL
Bron, , France
Hopital de Bicetre
Le Kremlin-Bicêtre, , France
Hopital PASTEUR
Nice, , France
Hopital de la Pitie Salpetriere
Paris, , France
CHRU Strasbourg
Strasbourg, , France
Judisches Krankenhaus Berlin
Berlin, , Germany
St. Josef-Hospital, Ruhr-Universität Bochum
Bochum, , Germany
Medizinische Hochschule Hannover
Hanover, , Germany
Universitaetsklinikum Leipzig
Leipzig, , Germany
St Josefs Krankenhaus Potsdam Sanssouci
Potsdam, , Germany
Attikon General Hospital of Athens
Athens, , Greece
Patras University Hospital
Pátrai, , Greece
Papageorgiou General Hospital Of Thessaloniki
Thessaloniki, , Greece
Azienda Ospedaliera di Rilievo Nazionale A Cardarelli
Naples, , Italy
IRCCS Istituto Clinico Humanitas
Rozzano, , Italy
National Hospital Organization Asahikawa Medical Center
Asahikawa, , Japan
Institute of Science Tokyo Hospital
Bunkyō City, , Japan
Chiba University Hospital
Chiba, , Japan
Seirei Hamamatsu General Hospital
Hamamatsu, , Japan
Tokai University Hospital
Isehara, , Japan
Kobe City Medical Center General Hospital
Kobe, , Japan
National Center of Neurology and Psychiatry
Kodaira-shi, , Japan
Saitama Medical Center
Koshigaya, , Japan
Kumamoto University Hospital
Kumamoto, , Japan
Chubu Rosai Hospital
Nagoya, , Japan
Nagoya University Hospital
Nagoya, , Japan
Kindai University Hospital
Osaka Sayama Shi, , Japan
National Hospital Organization Sendai Medical Center
Sendai, , Japan
Dokkyo Medical University Hospital
Shimotsuga Gun, , Japan
Tokyo Women's Medical University Hospital
Shinjuku-ku, , Japan
Tenri Hospital
Tenri, , Japan
Ehime University Hospital
Toon-shi, , Japan
Toyama University Hospital
Toyama, , Japan
Yamaguchi University Hospital
Ube, , Japan
i Can Oncology Center
Monterrey, , Mexico
Clinical Research Institute S.C.
Tlalnepantla, , Mexico
Centrum Medyczne
Chorzów, , Poland
Specjalistyczne Gabinety Lekarskie
Krakow, , Poland
Prywatny Gabinet Lekarski
Lublin, , Poland
Clinical Research Center sp z o o MEDIC R s k
Poznan, , Poland
Hospital Garcia de Orta
Almada, , Portugal
Hospital de Braga
Braga, , Portugal
Centro Hospitalar de Sao Joao Epe
Porto, , Portugal
Kyunghee University Medical Center
Seoul, , South Korea
Konkuk University Medical Center
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Hosp. Gral. Univ. de Alicante
Alicante, , Spain
Hosp Univ Vall D Hebron
Barcelona, , Spain
Hosp. Univ. de Basurto
Bilbao, , Spain
Hosp. Univ. Donostia
Donostia / San Sebastian, , Spain
Hosp. Clinico San Carlos
Madrid, , Spain
Hosp. Virgen Macarena
Seville, , Spain
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Shin Kong Wu Ho Su Memorial Hospital
Taipei, , Taiwan
University Hospitals Birmingham NHS Foundation Trust
Birmingham, , United Kingdom
Royal Devon & Exeter Hospital
Devon, , United Kingdom
NHS Greater Glasgow and Clyde
Glasgow, , United Kingdom
Royal Free Hospital
London, , United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, , United Kingdom
Countries
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Central Contacts
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Other Identifiers
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80202135CDP3001
Identifier Type: OTHER
Identifier Source: secondary_id
2021-003234-37
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2023-508425-28-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
CR109195
Identifier Type: -
Identifier Source: org_study_id