Phase
Condition
N/ATreatment
Placebo
Nipocalimab
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Adults greater than or equal to (>=) 18 years of age at the time of consent and asapplicable, must also meet the legal age of consent in the jurisdiction in which thestudy is taking place
Diagnosed with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) according tocriteria of the European Academy of Neurology/Peripheral Nerve Society (EAN/PNS) 2021, progressing or relapsing forms. CIDP diagnosis to be adjudicated byindependent committee during screening period
Inflammatory Neuropathy Cause and Treatment (INCAT) disability score between 2 and 9at the Run-In Baseline visit for participants entering Run-In, or Stage A Baselinevisit for participants directly entering Stage A. Participants with an INCAT scoreof 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 oralcorticosteroids (CS) less than or equal to (<=) 20 milligrams (mg)/day; or b)Currently treated with pulsed CS, and/or intravenous immunoglobulin (IVIg) orsubcutaneous immunoglobulin (SCIg) and the participant is willing to discontinue nolater than the run-in baseline visit; or c) Currently treated with oral CS greaterthan (>) 20 mg/day and the participant is willing to taper to <=20 mg/day during therun-in period; or d) Without previous treatment (treatment naive); or treatment withCS 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
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 ormusculoskeletal disorder, hypertension and/or any other medical or uncontrolledautoimmune disorder(s) (example, diabetes mellitus) or clinically significantabnormalities in screening laboratory that, might interfere with the participantsfull participation in the study, or might jeopardize the safety of the participantor the validity of the study results
Pure sensory CIDP or chronic immune sensory polyradiculopathy (CISP) (EAN/PNSdefinition)
Any other disease that could better explain the participant's signs and symptoms,such as significant persisting neurological deficits from stroke or central nervoussystem (CNS) trauma or peripheral neuropathy from another cause such as connectivetissue disease or systemic lupus erythematosus
Polyneuropathy of other causes, including the following: Multifocal motor neuropathy (MMN); Monoclonal gammopathy of uncertain significance with antimyelin associatedglycoprotein (anti-MAG) immunoglobulin M (IgM) antibodies; Hereditary motorneuropathy; Hereditary neuropathy with liability to pressure palsies (HNPP);Polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin changesyndromes; Lumbosacral radiculoplexus neuropathy; Polyneuropathy most likely due todiabetes mellitus; Polyneuropathy most likely due to systemic illnesses; Drug- ortoxin-induced polyneuropathy Note: A concomitant polyneuropathy of other causes (example, a mild, stable diabetic polyneuropathy) is not necessarily exclusionary ifchronic inflammatory demyelinating polyneuropathy (CIDP) is confirmed as the maindiagnosis, as determined by the investigator and confirmed by the adjudicationcommittee
Has known allergies, hypersensitivity, or intolerance to nipocalimab or itsexcipients
Other protocol-defined exclusion criteria will apply
Study Design
Connect with a study center
Hospital Gral Agudos Ignacio Pirovano
Buenos Aires, C1428
ArgentinaCompleted
Hospital Italiano de Buenos Aires
Buenos Aires, C1199ABB
ArgentinaSite Not Available
Instituto Fleni
Buenos Aires, C1428AQK
ArgentinaActive - Recruiting
INECO Neurociencias Orono
Rosario, 2900
ArgentinaActive - Recruiting
The Alfred Hospital
Melbourne, 3004
AustraliaCompleted
Gold Coast University Hospital
Parkwood, 4215
AustraliaCompleted
The Ottawa Hospital Ottawa NeuroMuscular Centre
Ottawa, K1N 6N5
CanadaActive - Recruiting
Beijing Tiantan Hospital, Capital Medical University
Beijing, 100070
ChinaSite Not Available
Peking University First Hospital
Beijing, 100034
ChinaCompleted
Peking University Third Hospital
Beijing, 100191
ChinaCompleted
Xuanwu Hospital ,Capital Medical University
Beijing, 100053
ChinaSite Not Available
The First Hospital of Jilin University
Changchun, 130021
ChinaSite Not Available
The Third Xiangya Hospital of Central Sourth University
Changsha, 410008
ChinaSite Not Available
Xiangya Hospital Central South University
Changsha, 410008
ChinaCompleted
Sichuan Provincial Peoples Hospital
Chengdu, 610072
ChinaCompleted
Chifeng Municipal Hospital
Chifeng, 024000
ChinaCompleted
Fujian Medical University Union Hospital
Fuzhou, 350001
ChinaSite Not Available
The First Affiliated Hospital Sun Yat sen University
Guangzhou, 510080
ChinaSite Not Available
Qianfoshan hospital of Shandong Province
Jinan, 250014
ChinaCompleted
Qilu Hospital of Shandong University
Jinan, 250012
ChinaSite Not Available
The First Affiliated Hospital of NanChang University
Nanchang, 330006
ChinaSite Not Available
Huashan Hospital Fudan University
Shanghai, 200040
ChinaSite Not Available
Tong Ren Hospital Shanghai Jiao Tong University school of medicine
Shanghai, 200336
ChinaCompleted
Renmin Hospital of Wuhan University
Wuhan, 430023
ChinaCompleted
Tangdu hospital the Fourth Military Medical
Xi'an, 710032
ChinaCompleted
Xi 'an GaoXin Hospital
Xi'an, 710075
ChinaSite Not Available
Fundación Cardiovascular de Colombia - Instituto del Corazón Floridablanca
Floridablanca, 681004
ColombiaCompleted
Instituto Neurológico de Colombia
Medellín, 50021
ColombiaSite Not Available
Fakultni nemocnice Hradec Kralove
Hradec Králové, 500 05
CzechiaSite Not Available
Fakultni Nemocnice Ostrava
Ostrava, 708 52
CzechiaCompleted
Pardubicka krajska nemocnice a s
Pardubice, 53203
CzechiaCompleted
CHU Bordeaux
Bordeaux, 33000
FranceCompleted
Hospices Civils de Lyon HCL
Bron, 69699
FranceCompleted
Hopital de Bicetre
Le Kremlin-Bicêtre, 94270
FranceSite Not Available
Hopital de la Timone
Marseille, 13385
FranceSite Not Available
Hopital PASTEUR
Nice, 06000
FranceSite Not Available
CHU Nimes Hopital Caremeau
Nîmes, 30029
FranceSite Not Available
Fondation Adolphe de Rothschild Hospital
Paris, 75019
FranceCompleted
Hopital de la Pitie Salpetriere
Paris, 75013
FranceCompleted
CHRU Strasbourg
Strasbourg, 67200
FranceSite Not Available
Judisches Krankenhaus Berlin
Berlin, 13347
GermanySite Not Available
St. Josef-Hospital, Ruhr-Universität Bochum
Bochum, 44791
GermanyCompleted
Städtisches Krankenhaus Martha-Maria Halle-Dölau gGmbH
Halle, 6120
GermanySite Not Available
Medizinische Hochschule Hannover
Hanover, 30625
GermanySite Not Available
Universitaetsklinikum Leipzig
Leipzig, 4103
GermanyCompleted
St Josefs Krankenhaus Potsdam Sanssouci
Potsdam, 14471
GermanyCompleted
Attikon General Hospital of Athens
Athens, 12462
GreeceActive - Recruiting
Papageorgiou General Hospital Of Thessaloniki
Athens, 11527
GreeceCompleted
Patras University Hospital
Pátrai, 26504
GreeceCompleted
Ahepa Hospital Aristotle University of Thessaloniki
Thessaloniki, 54636
GreeceActive - Recruiting
Azienda Ospedaliero-Universitaria Policlinico di Catania
Catania, 95123
ItalyCompleted
Azienda Ospedaliera Universitaria San Martino di Genova
Genova, 16132
ItalyCompleted
Casa di Cura del Policlinico
Milan, 20144
ItalyCompleted
Istituto Neurologico Carlo Besta
Milan, 20133
ItalyCompleted
Azienda Ospedaliera di Rilievo Nazionale A Cardarelli
Naples, 80131
ItalySite Not Available
Aou San Luigi Gonzaga
Orbassano, 10043
ItalyCompleted
Fondazione Istituto Neurologico Casimiro Mondino
Pavia, 27100
ItalyCompleted
Fondazione Policlinico Universitario A Gemelli IRCCS
Roma, 00168
ItalyCompleted
IRCCS Istituto Clinico Humanitas
Rozzano, 20086
ItalyCompleted
National Hospital Organization Asahikawa Medical Center
Asahikawa, 070-0901
JapanSite Not Available
Institute of Science Tokyo Hospital
Bunkyō City, 113 8519
JapanSite Not Available
Chiba University Hospital
Chiba, 260-8677
JapanCompleted
Seirei Hamamatsu General Hospital
Hamamatsu, 430-8558
JapanSite Not Available
Tokai University Hospital
Isehara, 259-1193
JapanSite Not Available
Kobe City Medical Center General Hospital
Kobe, 650 0047
JapanCompleted
National Center of Neurology and Psychiatry
Kodaira-shi, 187-8551
JapanSite Not Available
Saitama Medical Center
Koshigaya, 343-8555
JapanSite Not Available
Kumamoto University Hospital
Kumamoto, 860-8556
JapanCompleted
Chubu Rosai Hospital
Nagoya, 455-8530
JapanSite Not Available
Nagoya University Hospital
Nagoya, 466-8560
JapanSite Not Available
Kindai University Hospital
Osaka Sayama Shi, 589 8511
JapanCompleted
National Hospital Organization Sendai Medical Center
Sendai, 983-8520
JapanSite Not Available
Dokkyo Medical University Hospital
Shimotsuga Gun, 321 0293
JapanCompleted
Tokyo Women's Medical University Hospital
Shinjuku-ku, 162-8666
JapanCompleted
Tenri Hospital
Tenri, 632-0015
JapanCompleted
Ehime University Hospital
Toon-shi, 791-0295
JapanCompleted
Toyama University Hospital
Toyama, 930-0194
JapanCompleted
Yamaguchi University Hospital
Ube, 755-8505
JapanCompleted
i Can Oncology Center
Monterrey, 64710
MexicoCompleted
Clinical Research Institute S.C.
Tlalnepantla, 54055
MexicoActive - Recruiting
Centrum Medyczne
Chorzów, 41 500
PolandCompleted
Specjalistyczne Gabinety Lekarskie
Krakow, 30 539
PolandCompleted
Prywatny Gabinet Lekarski
Lublin, 20 093
PolandCompleted
Clinical Research Center sp z o o MEDIC R s k
Poznan, 61 731
PolandSite Not Available
Hospital Garcia de Orta
Almada, 2805-267
PortugalSite Not Available
Hospital de Braga
Braga, 4710-243
PortugalCompleted
Centro Hospitalar de Sao Joao Epe
Porto, 4200 319
PortugalSite Not Available
Konkuk University Medical Center
Seoul, 05030
South KoreaCompleted
Kyunghee University Medical Center
Seoul, 02447
South KoreaCompleted
Samsung Medical Center
Seoul, 135-710
South KoreaCompleted
Hosp. Gral. Univ. de Alicante
Alicante, 03010
SpainSite Not Available
Hosp Univ Vall D Hebron
Barcelona, 8035
SpainCompleted
Hosp. Univ. de Basurto
Bilbao, 48013
SpainSite Not Available
Hosp. Univ. Donostia
Donostia / San Sebastian, 20014
SpainCompleted
Hosp. Clinico San Carlos
Madrid, 28040
SpainCompleted
Hosp. Virgen Macarena
Seville, 41009
SpainSite Not Available
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, 88301
TaiwanCompleted
National Taiwan University Hospital
Taipei, 100
TaiwanSite Not Available
Shin Kong Wu Ho Su Memorial Hospital
Taipei, 111
TaiwanSite Not Available
University Hospitals Birmingham NHS Foundation Trust
Birmingham, B15 2TH
United KingdomCompleted
Royal Devon & Exeter Hospital
Devon, EX2 5DW
United KingdomCompleted
NHS Greater Glasgow and Clyde
Glasgow, G514TF
United KingdomSite Not Available
Royal Free Hospital
London, NW3 2QG
United KingdomCompleted
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, S10 2 JF
United KingdomSite Not Available
IMMUNOe Health and Research Centers
Centennial, Colorado 80112
United StatesSite Not Available
Healthcare Innovations Institute Inc
Coral Springs, Florida 33067
United StatesCompleted
Neurology Associates PA
Maitland, Florida 32751
United StatesCompleted
ALS Center at the University of Miami
Miami, Florida 33136
United StatesSite Not Available
Augusta University
Augusta, Georgia 30912
United StatesCompleted
University of Kansas Medical Center
Kansas City, Kansas 66160
United StatesCompleted
Johns Hopkins Hospital
Baltimore, Maryland 21287
United StatesCompleted
Boston Clinical Trials
Boston, Massachusetts 02111
United StatesCompleted
Beaumont Hospital Royal Oak
Royal Oak, Michigan 48073
United StatesCompleted
Kansas City Veterans Affairs Medical Center
Kansas City, Missouri 64128
United StatesCompleted
The Neurological Institute of New York
New York, New York 10032
United StatesCompleted
South Shore Neurologic Associates - Patchogue
Patchogue, New York 11772
United StatesCompleted
The Neurological Institute, PA
Charlotte, North Carolina 28204
United StatesCompleted
Cleveland Clinic Main Campus
Cleveland, Ohio 44195
United StatesSite Not Available
Austin Neuromuscular Center
Austin, Texas 78756
United StatesCompleted
Advocate Health - Aurora St. Luke's Medical Center
Milwaukee, Wisconsin 53215
United StatesSite Not Available

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