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
ArgentinaSite Not Available
Hospital Italiano de Buenos Aires
Ciudad Autonoma de Buenos Aires, C1199ABB
ArgentinaSite Not Available
The Alfred Hospital
Melbourne, 3004
AustraliaSite Not Available
Gold Coast University Hospital
Parkwood, 4215
AustraliaActive - Recruiting
LKH - Universitätsklinikum Graz
Graz, 8036
AustriaSite Not Available
Medizinische Universität Wien
Vienna, A-1090
AustriaSite Not Available
Hopital Erasme
Brussels,
BelgiumSite Not Available
Universitair Ziekenhuis Leuven
Leuven, 3000
BelgiumSite Not Available
Centre Hospitalier Régional de la Citadelle
Liège, 4000
BelgiumSite Not Available
Instituto de Neurologia de Curitiba
Curitiba, 81210-310
BrazilSite Not Available
Hospital Universitario Antonio Pedro - Universidades Federal Fluminense
Rio de Janeiro, 24033-900
BrazilSite Not Available
Fundação Faculdade Regional de Medicina de São José do Rio Preto - Hospital de Base
Sao Paulo, 04024-002
BrazilSite Not Available
DCC Convex EOOD
Sofia, 1680
BulgariaSite Not Available
University of Alberta Hospital
Edmonton, Alberta T6G 2X8
CanadaSite Not Available
Toronto General Hospital
Toronto, Ontario M5G 2C4
CanadaSite Not Available
Beijing Tiantan Hospital, Capital Medical University
Beijing, 100070
ChinaActive - Recruiting
Peking University First Hospital
Beijing, 100034
ChinaActive - Recruiting
Peking University Third Hospital
Beijing, 100191
ChinaActive - Recruiting
Xuanwu Hospital ,Capital Medical University
Beijing, 100053
ChinaActive - Recruiting
Xuanwu Hospital, Capital Medical University
Beijing, 100053
ChinaActive - Recruiting
The First Hospital of Jilin University
Changchun, 130021
ChinaActive - Recruiting
The Third Xiangya Hospital of Central Sourth University
Changsha, 410008
ChinaActive - Recruiting
Xiangya Hospital Central South University
Changsha, 410008
ChinaActive - Recruiting
Chifeng Municipal Hospital
Chifeng, 024000
ChinaActive - Recruiting
Fujian Medical University Union Hospital
Fuzhou, 350001
ChinaActive - Recruiting
The First Affiliated Hospital Sun Yat sen University
Guang Zhou, 510080
ChinaActive - Recruiting
The First Affiliated Hospital, Sun Yat-sen University
Guang Zhou, 510080
ChinaActive - Recruiting
Qianfoshan hospital of Shandong Province
Jinan, 250014
ChinaActive - Recruiting
The First Affiliated Hospital of NanChang University
Nanchang, 330006
ChinaActive - Recruiting
Huashan Hospital Fudan University
Shanghai, 200040
ChinaActive - Recruiting
Tong Ren Hospital Shanghai Jiao Tong University school of medicine
Shanghai, 200336
ChinaCompleted
Xi 'an GaoXin Hospital
Xi'an, 710075
ChinaSite Not Available
Xi 'an GaoXin Hospital
Xi'an, 710075
ChinaActive - Recruiting
Henan province people's hospital
Zhengzhou, 450003
ChinaSite Not Available
Hospital Universitario San Ignacio
Bogotá, 110231
ColombiaSite Not Available
Fundación Cardiovascular de Colombia - Instituto del Corazón Floridablanca
Floridablanca, 681004
ColombiaActive - Recruiting
Instituto Neurológico de Colombia
Medellin, 50021
ColombiaActive - Recruiting
Fakultni nemocnice Hradec Kralove
Hradec Králové, 500 05
CzechiaActive - Recruiting
Fakultni Nemocnice Ostrava
Ostrava, 708 52
CzechiaCompleted
Fakultni nemocnice Ostrava
Ostrava, 708 52
CzechiaActive - Recruiting
Pardubicka krajska nemocnice a s
Pardubice, 53203
CzechiaActive - Recruiting
Pardubicka krajska nemocnice a.s.
Pardubice, 53203
CzechiaActive - Recruiting
Rigshospitalet
Copenhagen, DK2100
DenmarkSite Not Available
CHU Bordeaux
Bordeaux, 33000
FranceActive - Recruiting
Hospices Civils de Lyon HCL
Bron, 69699
FranceActive - Recruiting
Hopital Raymond Poincare
Garches, 92380
FranceSite Not Available
Hopital de Bicetre
Le Kremlin Bicêtre, 94270
FranceActive - Recruiting
Hopital Roger Salengro - CHU Lille
Lille, 59037
FranceSite Not Available
Hopital PASTEUR
Nice, 06000
FranceActive - Recruiting
CHRU Strasbourg
Strasbourg, 67200
FranceActive - Recruiting
St. Josef-Hospital, Ruhr-Universität Bochum
Bochum, 44791
GermanyActive - Recruiting
Universitätsklinikum Düsseldorf
Dusseldorf, 40225
GermanySite Not Available
Medizinische Hochschule Hannover
Hannover, 30625
GermanyActive - Recruiting
Universitaetsklinikum Leipzig
Leipzig, 4103
GermanyActive - Recruiting
Universitatsklinikum Leipzig
Leipzig, 4103
GermanySite Not Available
Klinikum rechts der Isar - der Technischen Universität München
Munchen, 81675
GermanySite Not Available
St Josefs Krankenhaus Potsdam Sanssouci
Potsdam, 14471
GermanyActive - Recruiting
Universitätsklinikum Tübingen
Tubingen, 72076
GermanySite Not Available
Patras University Hospital
Patras, 26504
GreeceCompleted
'Papageorgiou' General Hospital of Thessaloniki
Thessaloniki, 56429
GreeceActive - Recruiting
Papageorgiou General Hospital Of Thessaloniki
Thessaloniki, 56429
GreeceActive - Recruiting
ASST Spedali Civili di Brescia
Brescia, 25123
ItalySite Not Available
Casa di Cura del Policlinico
Milan, 20144
ItalySite Not Available
Seconda Università degli Studi di Napoli, Neurologica
Napoli, 80138
ItalySite Not Available
Pisa University Hospital
Pisa, 56126
ItalySite Not Available
Azienda Ospedaliera Sant Andrea
Rome, 00189
ItalySite Not Available
IRCCS Istituto Clinico Humanitas
Rozzano, 20086
ItalySite Not Available
Asahikawa Medical Center
Asahikawa, 070-0901
JapanActive - Recruiting
National Hospital Organization Asahikawa Medical Center
Asahikawa, 070-0901
JapanActive - Recruiting
Tokyo Medical and Dental University Hospital
Bunkyo Ku, 113 8519
JapanActive - Recruiting
Tokyo Medical and Dental University Hospital
Bunkyo-Ku, 113-8510
JapanSite Not Available
Chiba University Hospital
Chiba-shi, 260-8677
JapanActive - Recruiting
Seirei Hamamatsu General Hospital
Hamamatsu, 430-8558
JapanActive - Recruiting
Kobe City Medical Center General Hospital
Hyogo, 650-0047
JapanSite Not Available
Tokai University Hospital
Isehara, 259-1193
JapanActive - Recruiting
Kobe City Medical Center General Hospital
Kobe City, 650 0047
JapanActive - Recruiting
National Center of Neurology and Psychiatry
Kodaira-shi, 187-8551
JapanActive - Recruiting
Saitama Medical Center
Koshigaya, 343-8555
JapanActive - Recruiting
Kumamoto University Hospital
Kumamoto, 860-8556
JapanActive - Recruiting
Chubu Rosai Hospital
Nagoya, 455-8530
JapanActive - Recruiting
Nagoya University Hospital
Nagoya-shi, 466-8560
JapanActive - Recruiting
JA Hokkaido Koseiren Obihiro Kosei Hospital
Obihiro-shi, 080-0024
JapanSite Not Available
Kindai University Hospital
Osaka Sayama shi, 589 8511
JapanActive - Recruiting
Kindai University Hospital
Osaka-Sayama-shi, 589-8511
JapanSite Not Available
National Hospital Organization Sendai Medical Center
Sendai-City, 983-8520
JapanActive - Recruiting
Dokkyo Medical University Hospital
Shimotsuga Gun, 321 0293
JapanActive - Recruiting
Dokkyo Medical University Hospital
Shimotsuga-gun, 321-0293
JapanSite Not Available
Tokyo Women's Medical University Hospital
Shinjuku-ku, 162-8666
JapanCompleted
Tenri Hospital
Tenri, 632-0015
JapanActive - Recruiting
Tokushima University Hospital
Tokushima, 770-8503
JapanSite Not Available
Ehime University Hospital
Toon-shi, 791-0295
JapanActive - Recruiting
Toyama University Hospital
Toyama-shi, 930-0194
JapanActive - Recruiting
Yamaguchi University Hospital
Ube, 755-8505
JapanActive - Recruiting
Kyungpook National University Chilgok Hospital
Daegu, 41404
Korea, Republic ofSite Not Available
CHA Bundang Medical Center, CHA University
Gyeonggi-do, 13496
Korea, Republic ofSite Not Available
Severance Hospital
Seodaemun, 120-752
Korea, Republic ofSite Not Available
Konkuk University Medical Center
Seoul, 05030
Korea, Republic ofCompleted
Samsung Medical Center
Seoul, 135-710
Korea, Republic ofActive - Recruiting
Instituto Nacional de Ciencias Medicas y Nutrición Salvador Zubirán
Ciudad de México, 14080
MexicoSite Not Available
i Can Oncology Center
Monterrey, 64710
MexicoActive - Recruiting
Clinical Research Institute S.C.
Tlalnepantla, 54055
MexicoSuspended
Centrum Medyczne
Chorzow, 41 500
PolandCompleted
Centrum Medyczne
Chorzów, 41-500
PolandSite Not Available
Specjalistyczne Gabinety Lekarskie
Krakow, 30 539
PolandCompleted
Gabinety Krakowskie Tradycja
Kraków, 31-426
PolandSite Not Available
Specjalistyczne Gabinety Lekarskie
Kraków, 30-539
PolandActive - Recruiting
Prywatny Gabinet Lekarski
Lublin, 20 093
PolandActive - Recruiting
Centrum Medyczne Oporow
Wrocław, 52-416
PolandSite Not Available
Hospital Garcia de Orta
Almada, 2805-267
PortugalActive - Recruiting
Hospital de Braga
Braga, 4710-243
PortugalActive - Recruiting
Centro Hospitalar de Sao Joao Epe
Porto, 4200 319
PortugalActive - Recruiting
Centro Hospitalar de São João, EPE
Porto, 4200-319
PortugalSite Not Available
Institutul de Boli Cardiovasculare Iasi
Iasi, 700503
RomaniaSite Not Available
Spitalul Clinic Judetean de Urgenta Targu Mures
Tg. Mures, 540136
RomaniaSite Not Available
Institutul de Boli Cardiovasculare Timisoara
Timisoara, 300310
RomaniaSite Not Available
Neurologicka ambulancia MUDr.Dupejova s.r.o.
Banská Bystrica, 97404
SlovakiaSite Not Available
Nemocnica Agel Levoca
Levoca, 5401
SlovakiaSite Not Available
Iatros International
Bloemfontein, 9324
South AfricaSite Not Available
Hosp. Univ. Vall D Hebron
Barcelona, 8035
SpainSite Not Available
Hosp. Univ. de Basurto
Bilbao, 48013
SpainActive - Recruiting
Hosp. Virgen Macarena
Sevilla, 41009
SpainActive - Recruiting
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung, 88301
TaiwanActive - Recruiting
National Taiwan University Hospital
Taipei, 100
TaiwanActive - Recruiting
Shin Kong Wu Ho Su Memorial Hospital
Taipei, 111
TaiwanActive - Recruiting
Taipei Veterans General Hospital
Taipei, 112
TaiwanSite Not Available
University Hospitals Birmingham NHS Foundation Trust
Birmingham, B15 2TH
United KingdomSite Not Available
NHS Greater Glasgow and Clyde
Glasgow, G514TF
United KingdomActive - Recruiting
Royal Free Hospital
London, NW3 2QG
United KingdomActive - Recruiting
Salford Royal Hospital
Salford, M6 8HD
United KingdomSite Not Available
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, S10 2 JF
United KingdomActive - Recruiting
Keck School of Medicine of USC
Los Angeles, California 90033
United StatesSite Not Available
Forbes Norris MDA/ALS Research and Treatment Center
San Francisco, California 94115
United StatesSite Not Available
University of Colorado
Aurora, Colorado 80045
United StatesSite Not Available
IMMUNOe Health and Research Centers
Centennial, Colorado 80112
United StatesActive - Recruiting
Neurology Associates PA
Maitland, Florida 32751
United StatesCompleted
Augusta University
Augusta, Georgia 30912
United StatesSite Not Available
University of Kansas Medical Center
Kansas City, Kansas 66160
United StatesActive - Recruiting
Johns Hopkins Hospital
Baltimore, Maryland 21287
United StatesActive - Recruiting
Beaumont Hospital - Royal Oak
Royal Oak, Michigan 48073
United StatesSite Not Available
Beaumont Hospital Royal Oak
Royal Oak, Michigan 48073
United StatesCompleted
Virtua Medical Group, PA
Marlton, New Jersey 08053
United StatesSite Not Available
The Neurological Institute of New York
New York, New York 10032
United StatesCompleted
South Shore Neurologic Associates - Patchogue
Patchogue, New York 11772
United StatesActive - Recruiting
Atrium Health
Charlotte, North Carolina 28207
United StatesSite Not Available
The Neurological Institute, PA
Charlotte, North Carolina 28204
United StatesActive - Recruiting
Duke University School of Medicine
Durham, North Carolina 27710
United StatesSite Not Available
Cleveland Clinic Main Campus
Cleveland, Ohio 44195
United StatesActive - Recruiting
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania 19104
United StatesSite Not Available
Austin Neuromuscular Center
Austin, Texas 78756
United StatesActive - Recruiting
Advocate Health - Aurora St. Luke's Medical Center
Milwaukee, Wisconsin 53215
United StatesSite Not Available
Advocate Health - Aurora St. Luke's Medical Center
Milwaukee, Wisconsin 53215
United StatesActive - Recruiting
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