Phase
Condition
N/ATreatment
Nipocalimab
Placebo
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
ArgentinaActive - Recruiting
Hospital Italiano de Buenos Aires
Buenos Aires, C1199ABB
ArgentinaActive - Recruiting
Hospital Italiano de Buenos Aires
Buenos Aires 3435910, C1199ABB
ArgentinaActive - Recruiting
INECO Neurociencias Orono
Rosario, 2900
ArgentinaActive - Recruiting
The Alfred Hospital
Melbourne, 3004
AustraliaActive - Recruiting
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
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
Beijing Tiantan Hospital, Capital Medical University
Beijing 1816670, 100070
ChinaActive - Recruiting
Peking University First Hospital
Beijing 1816670, 100034
ChinaActive - Recruiting
Xuanwu Hospital ,Capital Medical University
Beijing 1816670, 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
Xiangya Hospital Central South University
Changsha 1815577, 410008
ChinaActive - Recruiting
Sichuan Provincial Peoples Hospital
Chengdu, 610072
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
Guangzhou, 510080
ChinaActive - Recruiting
Qianfoshan hospital of Shandong Province
Jinan, 250014
ChinaActive - Recruiting
Qilu Hospital of Shandong University
Jinan, 250012
ChinaActive - Recruiting
Qianfoshan hospital of Shandong Province
Jinan 1805753, 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
Huashan Hospital Fudan University
Shanghai 1796236, 200040
ChinaActive - Recruiting
Renmin Hospital of Wuhan University
Wuhan, 430023
ChinaActive - Recruiting
Tangdu hospital the Fourth Military Medical
Xi'an, 710032
ChinaActive - Recruiting
Xi 'an GaoXin Hospital
Xi'an, 710075
ChinaActive - Recruiting
Xi 'an GaoXin Hospital
Xi'an 1790630, 710075
ChinaActive - Recruiting
Fundación Cardiovascular de Colombia - Instituto del Corazón Floridablanca
Floridablanca, 681004
ColombiaActive - Recruiting
Instituto Neurológico de Colombia
Medellín, 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
CzechiaCompleted
Pardubicka krajska nemocnice a.s.
Pardubice, 53203
CzechiaActive - Recruiting
CHU Bordeaux
Bordeaux, 33000
FranceActive - Recruiting
Hospices Civils de Lyon HCL
Bron, 69699
FranceActive - Recruiting
Hopital de Bicetre
Le Kremlin-Bicêtre, 94270
FranceActive - Recruiting
Hopital de la Timone
Marseille, 13385
FranceActive - Recruiting
Hopital PASTEUR
Nice, 06000
FranceActive - Recruiting
CHU Nimes Hopital Caremeau
Nîmes, 30029
FranceActive - Recruiting
Fondation Adolphe de Rothschild Hospital
Paris, 75019
FranceActive - Recruiting
Hopital de la Pitie Salpetriere
Paris, 75013
FranceActive - Recruiting
CHRU Strasbourg
Strasbourg, 67200
FranceActive - Recruiting
Judisches Krankenhaus Berlin
Berlin, 13347
GermanyActive - Recruiting
St. Josef-Hospital, Ruhr-Universität Bochum
Bochum, 44791
GermanyActive - Recruiting
Medizinische Hochschule Hannover
Hanover, 30625
GermanyActive - Recruiting
Universitaetsklinikum Leipzig
Leipzig, 4103
GermanyActive - Recruiting
St Josefs Krankenhaus Potsdam Sanssouci
Potsdam, 14471
GermanyActive - Recruiting
Attikon General Hospital of Athens
Athens, 12462
GreeceActive - Recruiting
Patras University Hospital
Pátrai, 26504
GreeceCompleted
'Papageorgiou' General Hospital of Thessaloniki
Thessaloniki, 56429
GreeceActive - Recruiting
Ahepa Hospital Aristotle University of Thessaloniki
Thessaloniki, 54636
GreeceActive - Recruiting
Papageorgiou General Hospital Of Thessaloniki
Thessaloniki, 56429
GreeceActive - Recruiting
Azienda Ospedaliera Universitaria San Martino di Genova
Genova, 16132
ItalyActive - Recruiting
Casa di Cura del Policlinico
Milan, 20144
ItalyActive - Recruiting
Istituto Neurologico Carlo Besta
Milan, 20133
ItalyActive - Recruiting
Azienda Ospedaliera di Rilievo Nazionale A Cardarelli
Naples, 80131
ItalyActive - Recruiting
Aou San Luigi Gonzaga
Orbassano, 10043
ItalyActive - Recruiting
Fondazione Istituto Neurologico Casimiro Mondino
Pavia, 27100
ItalyActive - Recruiting
Fondazione Policlinico Universitario A Gemelli IRCCS
Roma, 00168
ItalyActive - Recruiting
IRCCS Istituto Clinico Humanitas
Rozzano, 20086
ItalyActive - Recruiting
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, 113-8519
JapanActive - Recruiting
Institute of Science Tokyo Hospital
Bunkyō City, 113 8519
JapanActive - Recruiting
Chiba University Hospital
Chiba, 260-8677
JapanActive - Recruiting
Seirei Hamamatsu General Hospital
Hamamatsu, 430-8558
JapanActive - Recruiting
Tokai University Hospital
Isehara, 259-1193
JapanActive - Recruiting
Kobe City Medical Center General Hospital
Kobe, 650 0047
JapanCompleted
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, 466-8560
JapanActive - Recruiting
Chubu Rosai Hospital
Nagoya 1856057, 455-8530
JapanActive - Recruiting
Kindai University Hospital
Osaka Sayama Shi, 589 8511
JapanActive - Recruiting
National Hospital Organization Sendai Medical Center
Sendai, 983-8520
JapanActive - Recruiting
Dokkyo Medical University Hospital
Shimotsuga Gun, 321 0293
JapanActive - Recruiting
Tokyo Women's Medical University Hospital
Shinjuku-ku, 162-8666
JapanCompleted
Tenri Hospital
Tenri, 632-0015
JapanActive - Recruiting
Ehime University Hospital
Toon-shi, 791-0295
JapanActive - Recruiting
Toyama University Hospital
Toyama, 930-0194
JapanActive - Recruiting
Yamaguchi University Hospital
Ube, 755-8505
JapanActive - Recruiting
Konkuk University Medical Center
Seoul, 05030
Korea, Republic ofCompleted
Samsung Medical Center
Seoul, 135-710
Korea, Republic ofActive - Recruiting
i Can Oncology Center
Monterrey, 64710
MexicoActive - Recruiting
Clinical Research Institute S.C.
Tlalnepantla, 54055
MexicoActive - Recruiting
Centrum Medyczne
Chorzów, 41 500
PolandCompleted
Specjalistyczne Gabinety Lekarskie
Krakow, 30 539
PolandCompleted
Specjalistyczne Gabinety Lekarskie
Kraków, 30-539
PolandActive - Recruiting
Prywatny Gabinet Lekarski
Lublin, 20 093
PolandActive - Recruiting
Clinical Research Center sp z o o MEDIC R s k
Poznan, 61 731
PolandActive - Recruiting
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
Konkuk University Medical Center
Seoul, 05030
South KoreaCompleted
Kyunghee University Medical Center
Seoul, 02447
South KoreaActive - Recruiting
Samsung Medical Center
Seoul, 135-710
South KoreaActive - Recruiting
Kyunghee University Medical Center
Seoul 1835848, 02447
South KoreaActive - Recruiting
Samsung Medical Center
Seoul 1835848, 135-710
South KoreaActive - Recruiting
Hosp. Gral. Univ. de Alicante
Alicante, 03010
SpainActive - Recruiting
Hosp Univ Vall D Hebron
Barcelona, 8035
SpainActive - Recruiting
Hosp. Univ. de Basurto
Bilbao, 48013
SpainActive - Recruiting
Hosp. Univ. Donostia
Donostia / San Sebastian, 20014
SpainActive - Recruiting
Hosp. Clinico San Carlos
Madrid, 28040
SpainActive - Recruiting
Hosp. Virgen Macarena
Seville, 41009
SpainActive - Recruiting
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, 88301
TaiwanActive - Recruiting
National Taiwan University Hospital
Taipei, 100
TaiwanActive - Recruiting
Shin Kong Wu Ho Su Memorial Hospital
Taipei, 111
TaiwanActive - Recruiting
Shin Kong Wu Ho Su Memorial Hospital
Taipei 1668341, 111
TaiwanActive - Recruiting
University Hospitals Birmingham NHS Foundation Trust
Birmingham, B15 2TH
United KingdomActive - Recruiting
Royal Devon & Exeter Hospital
Devon, EX2 5DW
United KingdomActive - Recruiting
NHS Greater Glasgow and Clyde
Glasgow, G514TF
United KingdomActive - Recruiting
Royal Free Hospital
London, NW3 2QG
United KingdomSuspended
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, S10 2 JF
United KingdomActive - Recruiting
IMMUNOe Health and Research Centers
Centennial, Colorado 80112
United StatesActive - Recruiting
Healthcare Innovations Institute Inc
Coral Springs, Florida 33067
United StatesActive - Recruiting
Neurology Associates PA
Maitland, Florida 32751
United StatesCompleted
University of Kansas Medical Center
Kansas City, Kansas 66160
United StatesActive - Recruiting
Johns Hopkins Hospital
Baltimore, Maryland 21287
United StatesActive - Recruiting
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 StatesActive - Recruiting
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
The Neurological Institute, PA
Charlotte, North Carolina 28204
United StatesActive - Recruiting
Cleveland Clinic Main Campus
Cleveland, Ohio 44195
United StatesActive - Recruiting
Austin Neuromuscular Center
Austin, Texas 78756
United StatesActive - Recruiting
Advocate Health - Aurora St. Luke's Medical Center
Milwaukee, Wisconsin 53215
United StatesActive - Recruiting

Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.