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

Last updated: March 21, 2025
Sponsor: Janssen Research & Development, LLC
Overall Status: Active - Recruiting

Phase

2/3

Condition

N/A

Treatment

Placebo

Nipocalimab

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: Placebo
Phase: 2/3
Study Start date:
September 23, 2022
Estimated Completion Date:
September 30, 2028

Connect with a study center

  • Hospital Gral Agudos Ignacio Pirovano

    Buenos Aires, C1428
    Argentina

    Site Not Available

  • Hospital Italiano de Buenos Aires

    Ciudad Autonoma de Buenos Aires, C1199ABB
    Argentina

    Site Not Available

  • The Alfred Hospital

    Melbourne, 3004
    Australia

    Site Not Available

  • Gold Coast University Hospital

    Parkwood, 4215
    Australia

    Active - Recruiting

  • LKH - Universitätsklinikum Graz

    Graz, 8036
    Austria

    Site Not Available

  • Medizinische Universität Wien

    Vienna, A-1090
    Austria

    Site Not Available

  • Hopital Erasme

    Brussels,
    Belgium

    Site Not Available

  • Universitair Ziekenhuis Leuven

    Leuven, 3000
    Belgium

    Site Not Available

  • Centre Hospitalier Régional de la Citadelle

    Liège, 4000
    Belgium

    Site Not Available

  • Instituto de Neurologia de Curitiba

    Curitiba, 81210-310
    Brazil

    Site Not Available

  • Hospital Universitario Antonio Pedro - Universidades Federal Fluminense

    Rio de Janeiro, 24033-900
    Brazil

    Site Not Available

  • Fundação Faculdade Regional de Medicina de São José do Rio Preto - Hospital de Base

    Sao Paulo, 04024-002
    Brazil

    Site Not Available

  • DCC Convex EOOD

    Sofia, 1680
    Bulgaria

    Site Not Available

  • University of Alberta Hospital

    Edmonton, Alberta T6G 2X8
    Canada

    Site Not Available

  • Toronto General Hospital

    Toronto, Ontario M5G 2C4
    Canada

    Site Not Available

  • 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

  • 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

  • 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

    Guang Zhou, 510080
    China

    Active - Recruiting

  • Qianfoshan hospital of Shandong Province

    Jinan, 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

  • Xi &#39;an GaoXin Hospital

    Xi'an, 710075
    China

    Site Not Available

  • Xi 'an GaoXin Hospital

    Xi'an, 710075
    China

    Active - Recruiting

  • Henan province people's hospital

    Zhengzhou, 450003
    China

    Site Not Available

  • Hospital Universitario San Ignacio

    Bogotá, 110231
    Colombia

    Site Not Available

  • Fundación Cardiovascular de Colombia - Instituto del Corazón Floridablanca

    Floridablanca, 681004
    Colombia

    Active - Recruiting

  • Instituto Neurológico de Colombia

    Medellin, 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

    Active - Recruiting

  • Pardubicka krajska nemocnice a.s.

    Pardubice, 53203
    Czechia

    Active - Recruiting

  • Rigshospitalet

    Copenhagen, DK2100
    Denmark

    Site Not Available

  • CHU Bordeaux

    Bordeaux, 33000
    France

    Active - Recruiting

  • Hospices Civils de Lyon HCL

    Bron, 69699
    France

    Active - Recruiting

  • Hopital Raymond Poincare

    Garches, 92380
    France

    Site Not Available

  • Hopital de Bicetre

    Le Kremlin Bicêtre, 94270
    France

    Active - Recruiting

  • Hopital Roger Salengro - CHU Lille

    Lille, 59037
    France

    Site Not Available

  • Hopital PASTEUR

    Nice, 06000
    France

    Active - Recruiting

  • CHRU Strasbourg

    Strasbourg, 67200
    France

    Active - Recruiting

  • St. Josef-Hospital, Ruhr-Universität Bochum

    Bochum, 44791
    Germany

    Active - Recruiting

  • Universitätsklinikum Düsseldorf

    Dusseldorf, 40225
    Germany

    Site Not Available

  • Medizinische Hochschule Hannover

    Hannover, 30625
    Germany

    Active - Recruiting

  • Universitaetsklinikum Leipzig

    Leipzig, 4103
    Germany

    Active - Recruiting

  • Universitatsklinikum Leipzig

    Leipzig, 4103
    Germany

    Site Not Available

  • Klinikum rechts der Isar - der Technischen Universität München

    Munchen, 81675
    Germany

    Site Not Available

  • St Josefs Krankenhaus Potsdam Sanssouci

    Potsdam, 14471
    Germany

    Active - Recruiting

  • Universitätsklinikum Tübingen

    Tubingen, 72076
    Germany

    Site Not Available

  • Patras University Hospital

    Patras, 26504
    Greece

    Completed

  • 'Papageorgiou' General Hospital of Thessaloniki

    Thessaloniki, 56429
    Greece

    Active - Recruiting

  • Papageorgiou General Hospital Of Thessaloniki

    Thessaloniki, 56429
    Greece

    Active - Recruiting

  • ASST Spedali Civili di Brescia

    Brescia, 25123
    Italy

    Site Not Available

  • Casa di Cura del Policlinico

    Milan, 20144
    Italy

    Site Not Available

  • Seconda Università degli Studi di Napoli, Neurologica

    Napoli, 80138
    Italy

    Site Not Available

  • Pisa University Hospital

    Pisa, 56126
    Italy

    Site Not Available

  • Azienda Ospedaliera Sant Andrea

    Rome, 00189
    Italy

    Site Not Available

  • IRCCS Istituto Clinico Humanitas

    Rozzano, 20086
    Italy

    Site Not Available

  • 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, 113-8510
    Japan

    Site Not Available

  • Chiba University Hospital

    Chiba-shi, 260-8677
    Japan

    Active - Recruiting

  • Seirei Hamamatsu General Hospital

    Hamamatsu, 430-8558
    Japan

    Active - Recruiting

  • Kobe City Medical Center General Hospital

    Hyogo, 650-0047
    Japan

    Site Not Available

  • Tokai University Hospital

    Isehara, 259-1193
    Japan

    Active - Recruiting

  • Kobe City Medical Center General Hospital

    Kobe City, 650 0047
    Japan

    Active - Recruiting

  • 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-shi, 466-8560
    Japan

    Active - Recruiting

  • JA Hokkaido Koseiren Obihiro Kosei Hospital

    Obihiro-shi, 080-0024
    Japan

    Site Not Available

  • Kindai University Hospital

    Osaka Sayama shi, 589 8511
    Japan

    Active - Recruiting

  • Kindai University Hospital

    Osaka-Sayama-shi, 589-8511
    Japan

    Site Not Available

  • National Hospital Organization Sendai Medical Center

    Sendai-City, 983-8520
    Japan

    Active - Recruiting

  • Dokkyo Medical University Hospital

    Shimotsuga Gun, 321 0293
    Japan

    Active - Recruiting

  • Dokkyo Medical University Hospital

    Shimotsuga-gun, 321-0293
    Japan

    Site Not Available

  • Tokyo Women's Medical University Hospital

    Shinjuku-ku, 162-8666
    Japan

    Completed

  • Tenri Hospital

    Tenri, 632-0015
    Japan

    Active - Recruiting

  • Tokushima University Hospital

    Tokushima, 770-8503
    Japan

    Site Not Available

  • Ehime University Hospital

    Toon-shi, 791-0295
    Japan

    Active - Recruiting

  • Toyama University Hospital

    Toyama-shi, 930-0194
    Japan

    Active - Recruiting

  • Yamaguchi University Hospital

    Ube, 755-8505
    Japan

    Active - Recruiting

  • Kyungpook National University Chilgok Hospital

    Daegu, 41404
    Korea, Republic of

    Site Not Available

  • CHA Bundang Medical Center, CHA University

    Gyeonggi-do, 13496
    Korea, Republic of

    Site Not Available

  • Severance Hospital

    Seodaemun, 120-752
    Korea, Republic of

    Site Not Available

  • Konkuk University Medical Center

    Seoul, 05030
    Korea, Republic of

    Completed

  • Samsung Medical Center

    Seoul, 135-710
    Korea, Republic of

    Active - Recruiting

  • Instituto Nacional de Ciencias Medicas y Nutrición Salvador Zubirán

    Ciudad de México, 14080
    Mexico

    Site Not Available

  • i Can Oncology Center

    Monterrey, 64710
    Mexico

    Active - Recruiting

  • Clinical Research Institute S.C.

    Tlalnepantla, 54055
    Mexico

    Suspended

  • Centrum Medyczne

    Chorzow, 41 500
    Poland

    Completed

  • Centrum Medyczne

    Chorzów, 41-500
    Poland

    Site Not Available

  • Specjalistyczne Gabinety Lekarskie

    Krakow, 30 539
    Poland

    Completed

  • Gabinety Krakowskie Tradycja

    Kraków, 31-426
    Poland

    Site Not Available

  • Specjalistyczne Gabinety Lekarskie

    Kraków, 30-539
    Poland

    Active - Recruiting

  • Prywatny Gabinet Lekarski

    Lublin, 20 093
    Poland

    Active - Recruiting

  • Centrum Medyczne Oporow

    Wrocław, 52-416
    Poland

    Site Not Available

  • 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

  • Centro Hospitalar de São João, EPE

    Porto, 4200-319
    Portugal

    Site Not Available

  • Institutul de Boli Cardiovasculare Iasi

    Iasi, 700503
    Romania

    Site Not Available

  • Spitalul Clinic Judetean de Urgenta Targu Mures

    Tg. Mures, 540136
    Romania

    Site Not Available

  • Institutul de Boli Cardiovasculare Timisoara

    Timisoara, 300310
    Romania

    Site Not Available

  • Neurologicka ambulancia MUDr.Dupejova s.r.o.

    Banská Bystrica, 97404
    Slovakia

    Site Not Available

  • Nemocnica Agel Levoca

    Levoca, 5401
    Slovakia

    Site Not Available

  • Iatros International

    Bloemfontein, 9324
    South Africa

    Site Not Available

  • Hosp. Univ. Vall D Hebron

    Barcelona, 8035
    Spain

    Site Not Available

  • Hosp. Univ. de Basurto

    Bilbao, 48013
    Spain

    Active - Recruiting

  • Hosp. Virgen Macarena

    Sevilla, 41009
    Spain

    Active - Recruiting

  • Kaohsiung Chang Gung Memorial Hospital

    Kaohsiung, 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

  • Taipei Veterans General Hospital

    Taipei, 112
    Taiwan

    Site Not Available

  • University Hospitals Birmingham NHS Foundation Trust

    Birmingham, B15 2TH
    United Kingdom

    Site Not Available

  • NHS Greater Glasgow and Clyde

    Glasgow, G514TF
    United Kingdom

    Active - Recruiting

  • Royal Free Hospital

    London, NW3 2QG
    United Kingdom

    Active - Recruiting

  • Salford Royal Hospital

    Salford, M6 8HD
    United Kingdom

    Site Not Available

  • Sheffield Teaching Hospitals NHS Foundation Trust

    Sheffield, S10 2 JF
    United Kingdom

    Active - Recruiting

  • Keck School of Medicine of USC

    Los Angeles, California 90033
    United States

    Site Not Available

  • Forbes Norris MDA/ALS Research and Treatment Center

    San Francisco, California 94115
    United States

    Site Not Available

  • University of Colorado

    Aurora, Colorado 80045
    United States

    Site Not Available

  • IMMUNOe Health and Research Centers

    Centennial, Colorado 80112
    United States

    Active - Recruiting

  • Neurology Associates PA

    Maitland, Florida 32751
    United States

    Completed

  • Augusta University

    Augusta, Georgia 30912
    United States

    Site Not Available

  • University of Kansas Medical Center

    Kansas City, Kansas 66160
    United States

    Active - Recruiting

  • Johns Hopkins Hospital

    Baltimore, Maryland 21287
    United States

    Active - Recruiting

  • Beaumont Hospital - Royal Oak

    Royal Oak, Michigan 48073
    United States

    Site Not Available

  • Beaumont Hospital Royal Oak

    Royal Oak, Michigan 48073
    United States

    Completed

  • Virtua Medical Group, PA

    Marlton, New Jersey 08053
    United States

    Site Not Available

  • 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

  • Atrium Health

    Charlotte, North Carolina 28207
    United States

    Site Not Available

  • The Neurological Institute, PA

    Charlotte, North Carolina 28204
    United States

    Active - Recruiting

  • Duke University School of Medicine

    Durham, North Carolina 27710
    United States

    Site Not Available

  • Cleveland Clinic Main Campus

    Cleveland, Ohio 44195
    United States

    Active - Recruiting

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Austin Neuromuscular Center

    Austin, Texas 78756
    United States

    Active - Recruiting

  • Advocate Health - Aurora St. Luke&#39;s Medical Center

    Milwaukee, Wisconsin 53215
    United States

    Site Not Available

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

    Milwaukee, Wisconsin 53215
    United States

    Active - Recruiting

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