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Efficacy and Safety Study of Nipocalimab for Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Sponsor: 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.
Official title: 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)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
201
Start Date
2022-09-23
Completion Date
2028-07-11
Last Updated
2026-03-13
Healthy Volunteers
No
Interventions
Nipocalimab
Nipocalimab will be administered intravenously.
Placebo
Placebo will be administered intravenously.
Locations (103)
IMMUNOe Health and Research Centers
Centennial, Colorado, United States
Healthcare Innovations Institute Inc
Coral Springs, Florida, 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
Hospital Italiano de Buenos Aires
Buenos Aires, Argentina
Hospital Gral Agudos Ignacio Pirovano
Buenos Aires, Argentina
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
Sichuan Provincial Peoples Hospital
Chengdu, China
Chifeng Municipal Hospital
Chifeng, China
Fujian Medical University Union Hospital
Fuzhou, China
The First Affiliated Hospital Sun Yat sen University
Guangzhou, China
Qilu Hospital of Shandong University
Jinan, 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
Tangdu hospital the Fourth Military Medical
Xi'an, 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 Universitaria San Martino di Genova
Genova, Italy
Azienda Ospedaliera di Rilievo Nazionale A Cardarelli
Naples, Italy
Fondazione Policlinico Universitario A Gemelli IRCCS
Roma, 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