Efficacy and Safety Study of Nipocalimab for Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Last updated: June 4, 2026
Sponsor: Janssen Research & Development, LLC
Overall Status: Active - Recruiting

Phase

2/3

Condition

N/A

Treatment

Nipocalimab

Placebo

Clinical Study ID

NCT05327114
CR109195
80202135CDP3001
2021-003234-37
2023-508425-28-00
  • Ages > 18
  • All Genders

Study 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.

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

Total Participants: 201
Treatment Group(s): 2
Primary Treatment: Nipocalimab
Phase: 2/3
Study Start date:
September 23, 2022
Estimated Completion Date:
June 18, 2029

Connect with a study center

  • Hospital Gral Agudos Ignacio Pirovano

    Buenos Aires, C1428
    Argentina

    Active - Recruiting

  • Hospital Italiano de Buenos Aires

    Buenos Aires, C1199ABB
    Argentina

    Active - Recruiting

  • Hospital Italiano de Buenos Aires

    Buenos Aires 3435910, C1199ABB
    Argentina

    Active - Recruiting

  • INECO Neurociencias Orono

    Rosario, 2900
    Argentina

    Active - Recruiting

  • The Alfred Hospital

    Melbourne, 3004
    Australia

    Active - Recruiting

  • Gold Coast University Hospital

    Parkwood, 4215
    Australia

    Completed

  • The Ottawa Hospital Ottawa NeuroMuscular Centre

    Ottawa, K1N 6N5
    Canada

    Active - Recruiting

  • Beijing Tiantan Hospital, Capital Medical University

    Beijing, 100070
    China

    Active - Recruiting

  • Peking University First Hospital

    Beijing, 100034
    China

    Active - Recruiting

  • Peking University Third Hospital

    Beijing, 100191
    China

    Active - Recruiting

  • Xuanwu Hospital ,Capital Medical University

    Beijing, 100053
    China

    Active - Recruiting

  • Xuanwu Hospital, Capital Medical University

    Beijing, 100053
    China

    Active - Recruiting

  • Beijing Tiantan Hospital, Capital Medical University

    Beijing 1816670, 100070
    China

    Active - Recruiting

  • Peking University First Hospital

    Beijing 1816670, 100034
    China

    Active - Recruiting

  • Xuanwu Hospital ,Capital Medical University

    Beijing 1816670, 100053
    China

    Active - Recruiting

  • The First Hospital of Jilin University

    Changchun, 130021
    China

    Active - Recruiting

  • The Third Xiangya Hospital of Central Sourth University

    Changsha, 410008
    China

    Active - Recruiting

  • Xiangya Hospital Central South University

    Changsha, 410008
    China

    Active - Recruiting

  • Xiangya Hospital Central South University

    Changsha 1815577, 410008
    China

    Active - Recruiting

  • Sichuan Provincial Peoples Hospital

    Chengdu, 610072
    China

    Active - Recruiting

  • Chifeng Municipal Hospital

    Chifeng, 024000
    China

    Active - Recruiting

  • Fujian Medical University Union Hospital

    Fuzhou, 350001
    China

    Active - Recruiting

  • The First Affiliated Hospital, Sun Yat-sen University

    Guang Zhou, 510080
    China

    Active - Recruiting

  • The First Affiliated Hospital Sun Yat sen University

    Guangzhou, 510080
    China

    Active - Recruiting

  • Qianfoshan hospital of Shandong Province

    Jinan, 250014
    China

    Active - Recruiting

  • Qilu Hospital of Shandong University

    Jinan, 250012
    China

    Active - Recruiting

  • Qianfoshan hospital of Shandong Province

    Jinan 1805753, 250014
    China

    Active - Recruiting

  • The First Affiliated Hospital of NanChang University

    Nanchang, 330006
    China

    Active - Recruiting

  • Huashan Hospital Fudan University

    Shanghai, 200040
    China

    Active - Recruiting

  • Tong Ren Hospital Shanghai Jiao Tong University school of medicine

    Shanghai, 200336
    China

    Completed

  • Huashan Hospital Fudan University

    Shanghai 1796236, 200040
    China

    Active - Recruiting

  • Renmin Hospital of Wuhan University

    Wuhan, 430023
    China

    Active - Recruiting

  • Tangdu hospital the Fourth Military Medical

    Xi'an, 710032
    China

    Active - Recruiting

  • Xi 'an GaoXin Hospital

    Xi'an, 710075
    China

    Active - Recruiting

  • Xi 'an GaoXin Hospital

    Xi'an 1790630, 710075
    China

    Active - Recruiting

  • Fundación Cardiovascular de Colombia - Instituto del Corazón Floridablanca

    Floridablanca, 681004
    Colombia

    Active - Recruiting

  • Instituto Neurológico de Colombia

    Medellín, 50021
    Colombia

    Active - Recruiting

  • Fakultni nemocnice Hradec Kralove

    Hradec Králové, 500 05
    Czechia

    Active - Recruiting

  • Fakultni Nemocnice Ostrava

    Ostrava, 708 52
    Czechia

    Completed

  • Fakultni nemocnice Ostrava

    Ostrava, 708 52
    Czechia

    Active - Recruiting

  • Pardubicka krajska nemocnice a s

    Pardubice, 53203
    Czechia

    Completed

  • Pardubicka krajska nemocnice a.s.

    Pardubice, 53203
    Czechia

    Active - Recruiting

  • CHU Bordeaux

    Bordeaux, 33000
    France

    Active - Recruiting

  • Hospices Civils de Lyon HCL

    Bron, 69699
    France

    Active - Recruiting

  • Hopital de Bicetre

    Le Kremlin-Bicêtre, 94270
    France

    Active - Recruiting

  • Hopital de la Timone

    Marseille, 13385
    France

    Active - Recruiting

  • Hopital PASTEUR

    Nice, 06000
    France

    Active - Recruiting

  • CHU Nimes Hopital Caremeau

    Nîmes, 30029
    France

    Active - Recruiting

  • Fondation Adolphe de Rothschild Hospital

    Paris, 75019
    France

    Active - Recruiting

  • Hopital de la Pitie Salpetriere

    Paris, 75013
    France

    Active - Recruiting

  • CHRU Strasbourg

    Strasbourg, 67200
    France

    Active - Recruiting

  • Judisches Krankenhaus Berlin

    Berlin, 13347
    Germany

    Active - Recruiting

  • St. Josef-Hospital, Ruhr-Universität Bochum

    Bochum, 44791
    Germany

    Active - Recruiting

  • Medizinische Hochschule Hannover

    Hanover, 30625
    Germany

    Active - Recruiting

  • Universitaetsklinikum Leipzig

    Leipzig, 4103
    Germany

    Active - Recruiting

  • St Josefs Krankenhaus Potsdam Sanssouci

    Potsdam, 14471
    Germany

    Active - Recruiting

  • Attikon General Hospital of Athens

    Athens, 12462
    Greece

    Active - Recruiting

  • Patras University Hospital

    Pátrai, 26504
    Greece

    Completed

  • 'Papageorgiou' General Hospital of Thessaloniki

    Thessaloniki, 56429
    Greece

    Active - Recruiting

  • Ahepa Hospital Aristotle University of Thessaloniki

    Thessaloniki, 54636
    Greece

    Active - Recruiting

  • Papageorgiou General Hospital Of Thessaloniki

    Thessaloniki, 56429
    Greece

    Active - Recruiting

  • Azienda Ospedaliera Universitaria San Martino di Genova

    Genova, 16132
    Italy

    Active - Recruiting

  • Casa di Cura del Policlinico

    Milan, 20144
    Italy

    Active - Recruiting

  • Istituto Neurologico Carlo Besta

    Milan, 20133
    Italy

    Active - Recruiting

  • Azienda Ospedaliera di Rilievo Nazionale A Cardarelli

    Naples, 80131
    Italy

    Active - Recruiting

  • Aou San Luigi Gonzaga

    Orbassano, 10043
    Italy

    Active - Recruiting

  • Fondazione Istituto Neurologico Casimiro Mondino

    Pavia, 27100
    Italy

    Active - Recruiting

  • Fondazione Policlinico Universitario A Gemelli IRCCS

    Roma, 00168
    Italy

    Active - Recruiting

  • IRCCS Istituto Clinico Humanitas

    Rozzano, 20086
    Italy

    Active - Recruiting

  • Asahikawa Medical Center

    Asahikawa, 070-0901
    Japan

    Active - Recruiting

  • National Hospital Organization Asahikawa Medical Center

    Asahikawa, 070-0901
    Japan

    Active - Recruiting

  • Tokyo Medical and Dental University Hospital

    Bunkyo Ku, 113 8519
    Japan

    Active - Recruiting

  • Tokyo Medical and Dental University Hospital

    Bunkyo-Ku, 113-8519
    Japan

    Active - Recruiting

  • Institute of Science Tokyo Hospital

    Bunkyō City, 113 8519
    Japan

    Active - Recruiting

  • Chiba University Hospital

    Chiba, 260-8677
    Japan

    Active - Recruiting

  • Seirei Hamamatsu General Hospital

    Hamamatsu, 430-8558
    Japan

    Active - Recruiting

  • Tokai University Hospital

    Isehara, 259-1193
    Japan

    Active - Recruiting

  • Kobe City Medical Center General Hospital

    Kobe, 650 0047
    Japan

    Completed

  • National Center of Neurology and Psychiatry

    Kodaira-shi, 187-8551
    Japan

    Active - Recruiting

  • Saitama Medical Center

    Koshigaya, 343-8555
    Japan

    Active - Recruiting

  • Kumamoto University Hospital

    Kumamoto, 860-8556
    Japan

    Active - Recruiting

  • Chubu Rosai Hospital

    Nagoya, 455-8530
    Japan

    Active - Recruiting

  • Nagoya University Hospital

    Nagoya, 466-8560
    Japan

    Active - Recruiting

  • Chubu Rosai Hospital

    Nagoya 1856057, 455-8530
    Japan

    Active - Recruiting

  • Kindai University Hospital

    Osaka Sayama Shi, 589 8511
    Japan

    Active - Recruiting

  • National Hospital Organization Sendai Medical Center

    Sendai, 983-8520
    Japan

    Active - Recruiting

  • Dokkyo Medical University Hospital

    Shimotsuga Gun, 321 0293
    Japan

    Active - Recruiting

  • Tokyo Women's Medical University Hospital

    Shinjuku-ku, 162-8666
    Japan

    Completed

  • Tenri Hospital

    Tenri, 632-0015
    Japan

    Active - Recruiting

  • Ehime University Hospital

    Toon-shi, 791-0295
    Japan

    Active - Recruiting

  • Toyama University Hospital

    Toyama, 930-0194
    Japan

    Active - Recruiting

  • Yamaguchi University Hospital

    Ube, 755-8505
    Japan

    Active - Recruiting

  • Konkuk University Medical Center

    Seoul, 05030
    Korea, Republic of

    Completed

  • Samsung Medical Center

    Seoul, 135-710
    Korea, Republic of

    Active - Recruiting

  • i Can Oncology Center

    Monterrey, 64710
    Mexico

    Active - Recruiting

  • Clinical Research Institute S.C.

    Tlalnepantla, 54055
    Mexico

    Active - Recruiting

  • Centrum Medyczne

    Chorzów, 41 500
    Poland

    Completed

  • Specjalistyczne Gabinety Lekarskie

    Krakow, 30 539
    Poland

    Completed

  • Specjalistyczne Gabinety Lekarskie

    Kraków, 30-539
    Poland

    Active - Recruiting

  • Prywatny Gabinet Lekarski

    Lublin, 20 093
    Poland

    Active - Recruiting

  • Clinical Research Center sp z o o MEDIC R s k

    Poznan, 61 731
    Poland

    Active - Recruiting

  • Hospital Garcia de Orta

    Almada, 2805-267
    Portugal

    Active - Recruiting

  • Hospital de Braga

    Braga, 4710-243
    Portugal

    Active - Recruiting

  • Centro Hospitalar de Sao Joao Epe

    Porto, 4200 319
    Portugal

    Active - Recruiting

  • Konkuk University Medical Center

    Seoul, 05030
    South Korea

    Completed

  • Kyunghee University Medical Center

    Seoul, 02447
    South Korea

    Active - Recruiting

  • Samsung Medical Center

    Seoul, 135-710
    South Korea

    Active - Recruiting

  • Kyunghee University Medical Center

    Seoul 1835848, 02447
    South Korea

    Active - Recruiting

  • Samsung Medical Center

    Seoul 1835848, 135-710
    South Korea

    Active - Recruiting

  • Hosp. Gral. Univ. de Alicante

    Alicante, 03010
    Spain

    Active - Recruiting

  • Hosp Univ Vall D Hebron

    Barcelona, 8035
    Spain

    Active - Recruiting

  • Hosp. Univ. de Basurto

    Bilbao, 48013
    Spain

    Active - Recruiting

  • Hosp. Univ. Donostia

    Donostia / San Sebastian, 20014
    Spain

    Active - Recruiting

  • Hosp. Clinico San Carlos

    Madrid, 28040
    Spain

    Active - Recruiting

  • Hosp. Virgen Macarena

    Seville, 41009
    Spain

    Active - Recruiting

  • Kaohsiung Chang Gung Memorial Hospital

    Kaohsiung City, 88301
    Taiwan

    Active - Recruiting

  • National Taiwan University Hospital

    Taipei, 100
    Taiwan

    Active - Recruiting

  • Shin Kong Wu Ho Su Memorial Hospital

    Taipei, 111
    Taiwan

    Active - Recruiting

  • Shin Kong Wu Ho Su Memorial Hospital

    Taipei 1668341, 111
    Taiwan

    Active - Recruiting

  • University Hospitals Birmingham NHS Foundation Trust

    Birmingham, B15 2TH
    United Kingdom

    Active - Recruiting

  • Royal Devon & Exeter Hospital

    Devon, EX2 5DW
    United Kingdom

    Active - Recruiting

  • NHS Greater Glasgow and Clyde

    Glasgow, G514TF
    United Kingdom

    Active - Recruiting

  • Royal Free Hospital

    London, NW3 2QG
    United Kingdom

    Suspended

  • Sheffield Teaching Hospitals NHS Foundation Trust

    Sheffield, S10 2 JF
    United Kingdom

    Active - Recruiting

  • IMMUNOe Health and Research Centers

    Centennial, Colorado 80112
    United States

    Active - Recruiting

  • Healthcare Innovations Institute Inc

    Coral Springs, Florida 33067
    United States

    Active - Recruiting

  • Neurology Associates PA

    Maitland, Florida 32751
    United States

    Completed

  • University of Kansas Medical Center

    Kansas City, Kansas 66160
    United States

    Active - Recruiting

  • Johns Hopkins Hospital

    Baltimore, Maryland 21287
    United States

    Active - Recruiting

  • Boston Clinical Trials

    Boston, Massachusetts 02111
    United States

    Completed

  • Beaumont Hospital Royal Oak

    Royal Oak, Michigan 48073
    United States

    Completed

  • Kansas City Veterans Affairs Medical Center

    Kansas City, Missouri 64128
    United States

    Active - Recruiting

  • The Neurological Institute of New York

    New York, New York 10032
    United States

    Completed

  • South Shore Neurologic Associates - Patchogue

    Patchogue, New York 11772
    United States

    Active - Recruiting

  • The Neurological Institute, PA

    Charlotte, North Carolina 28204
    United States

    Active - Recruiting

  • Cleveland Clinic Main Campus

    Cleveland, Ohio 44195
    United States

    Active - Recruiting

  • Austin Neuromuscular Center

    Austin, Texas 78756
    United States

    Active - Recruiting

  • Advocate Health - Aurora St. Luke's Medical Center

    Milwaukee, Wisconsin 53215
    United States

    Active - Recruiting

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