Back to Trials
NCT05327114PHASE2, PHASE3Recruiting

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

Janssen Research & Development, LLC

Start Date

9/23/2022

Completion Date

7/11/2028

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

Age Range: 18 years to No maximum

Inclusion Criteria: * Adults greater than or equal to (\>=) 18 years of age at the time of consent and as applicable, must also meet the legal age of consent in the jurisdiction in which the study is taking place * Diagnosed with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) according to criteria of the European Academy of Neurology/Peripheral Nerve Society (EAN/PNS) 2021, progressing or relapsing forms. CIDP diagnosis to be adjudicated by independent committee during screening period * Inflammatory Neuropathy Cause and Treatment (INCAT) disability score between 2 and 9 at the Run-In Baseline visit for participants entering Run-In, or Stage A Baseline visit for participants directly entering Stage A. Participants with an INCAT score of 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 oral corticosteroids (CS) less than or equal to (\<=) 20 milligrams (mg)/day; or b) Currently treated with pulsed CS, and/or intravenous immunoglobulin (IVIg) or subcutaneous immunoglobulin (SCIg) and the participant is willing to discontinue no later than the run-in baseline visit; or c) Currently treated with oral CS greater than (\>) 20 mg/day and the participant is willing to taper to \<=20 mg/day during the run-in period; or d) Without previous treatment (treatment naive); or treatment with CS 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 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 or musculoskeletal disorder, hypertension and/or any other medical or uncontrolled autoimmune disorder(s) (example, diabetes mellitus) or clinically significant abnormalities in screening laboratory that, might interfere with the participants full participation in the study, or might jeopardize the safety of the participant or the validity of the study results * Pure sensory CIDP or chronic immune sensory polyradiculopathy (CISP) (EAN/PNS definition) * Any other disease that could better explain the participant's signs and symptoms, such as significant persisting neurological deficits from stroke or central nervous system (CNS) trauma or peripheral neuropathy from another cause such as connective tissue disease or systemic lupus erythematosus * Polyneuropathy of other causes, including the following: Multifocal motor neuropathy (MMN); Monoclonal gammopathy of uncertain significance with antimyelin associated glycoprotein (anti-MAG) immunoglobulin M (IgM) antibodies; Hereditary motor neuropathy; Hereditary neuropathy with liability to pressure palsies (HNPP); Polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin change syndromes; Lumbosacral radiculoplexus neuropathy; Polyneuropathy most likely due to diabetes mellitus; Polyneuropathy most likely due to systemic illnesses; Drug- or toxin-induced polyneuropathy Note: A concomitant polyneuropathy of other causes (example, a mild, stable diabetic polyneuropathy) is not necessarily exclusionary if chronic inflammatory demyelinating polyneuropathy (CIDP) is confirmed as the main diagnosis, as determined by the investigator and confirmed by the adjudication committee * Has known allergies, hypersensitivity, or intolerance to nipocalimab or its excipients * Other protocol-defined exclusion criteria will apply

Interventions

DRUG

Nipocalimab

DRUG

Placebo

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

Locations

IMMUNOe Health and Research Centers

Centennial, Colorado 80112

United States

Healthcare Innovations Institute Inc

Coral Springs, Florida 33067

United States

Neurology Associates PA

Maitland, Florida 32751

United States

ALS Center at the University of Miami

Miami, Florida 33136

United States

University of Kansas Medical Center

Kansas City, Kansas 66160

United States

Johns Hopkins Hospital

Baltimore, Maryland 21287

United States

Boston Clinical Trials

Boston, Massachusetts 02111

United States

Beaumont Hospital Royal Oak

Royal Oak, Michigan 48073

United States

Kansas City Veterans Affairs Medical Center

Kansas City, Missouri 64128

United States

The Neurological Institute of New York

New York, New York 10032

United States

South Shore Neurologic Associates - Patchogue

Patchogue, New York 11772

United States

The Neurological Institute, PA

Charlotte, North Carolina 28204

United States

Cleveland Clinic Main Campus

Cleveland, Ohio 44195

United States

Austin Neuromuscular Center

Austin, Texas 78756

United States

Advocate Health - Aurora St. Luke's Medical Center

Milwaukee, Wisconsin 53215

United States

Hospital Italiano de Buenos Aires

Buenos Aires, C1199ABB

Argentina

Instituto Fleni

Buenos Aires, C1428AQK

Argentina

Hospital Gral Agudos Ignacio Pirovano

Buenos Aires, C1428

Argentina

INECO Neurociencias Orono

Rosario, 2900

Argentina

The Alfred Hospital

Melbourne, 3004

Australia

Gold Coast University Hospital

Parkwood, 4215

Australia

The Ottawa Hospital Ottawa NeuroMuscular Centre

Ottawa, K1N 6N5

Canada

Peking University First Hospital

Beijing, 100034

China

Xuanwu Hospital ,Capital Medical University

Beijing, 100053

China

Beijing Tiantan Hospital, Capital Medical University

Beijing, 100070

China

Peking University Third Hospital

Beijing, 100191

China

The First Hospital of Jilin University

Changchun, 130021

China

The Third Xiangya Hospital of Central Sourth University

Changsha, 410008

China

Xiangya Hospital Central South University

Changsha, 410008

China

Sichuan Provincial Peoples Hospital

Chengdu, 610072

China

Chifeng Municipal Hospital

Chifeng, 024000

China

Fujian Medical University Union Hospital

Fuzhou, 350001

China

The First Affiliated Hospital Sun Yat sen University

Guangzhou, 510080

China

Qilu Hospital of Shandong University

Jinan, 250012

China

Qianfoshan hospital of Shandong Province

Jinan, 250014

China

The First Affiliated Hospital of NanChang University

Nanchang, 330006

China

Huashan Hospital Fudan University

Shanghai, 200040

China

Tong Ren Hospital Shanghai Jiao Tong University school of medicine

Shanghai, 200336

China

Renmin Hospital of Wuhan University

Wuhan, 430023

China

Tangdu hospital the Fourth Military Medical

Xi'an, 710032

China

Xi 'an GaoXin Hospital

Xi'an, 710075

China

Fundación Cardiovascular de Colombia - Instituto del Corazón Floridablanca

Floridablanca, 681004

Colombia

Instituto Neurológico de Colombia

Medellín, 50021

Colombia

Fakultni nemocnice Hradec Kralove

Hradec Králové, 500 05

Czechia

Fakultni Nemocnice Ostrava

Ostrava, 708 52

Czechia

Pardubicka krajska nemocnice a s

Pardubice, 53203

Czechia

CHU Bordeaux

Bordeaux, 33000

France

Hospices Civils de Lyon HCL

Bron, 69699

France

Hopital de Bicetre

Le Kremlin-Bicêtre, 94270

France

Hopital de la Timone

Marseille, 13385

France

Hopital PASTEUR

Nice, 06000

France

CHU Nimes Hopital Caremeau

Nîmes, 30029

France

Hopital de la Pitie Salpetriere

Paris, 75013

France

Fondation Adolphe de Rothschild Hospital

Paris, 75019

France

CHRU Strasbourg

Strasbourg, 67200

France

Judisches Krankenhaus Berlin

Berlin, 13347

Germany

St. Josef-Hospital, Ruhr-Universität Bochum

Bochum, 44791

Germany

Städtisches Krankenhaus Martha-Maria Halle-Dölau gGmbH

Halle, 6120

Germany

Medizinische Hochschule Hannover

Hanover, 30625

Germany

Universitaetsklinikum Leipzig

Leipzig, 4103

Germany

St Josefs Krankenhaus Potsdam Sanssouci

Potsdam, 14471

Germany

Attikon General Hospital of Athens

Athens, 12462

Greece

Patras University Hospital

Pátrai, 26504

Greece

Ahepa Hospital Aristotle University of Thessaloniki

Thessaloniki, 54636

Greece

Papageorgiou General Hospital Of Thessaloniki

Thessaloniki, 56429

Greece

Azienda Ospedaliero-Universitaria Policlinico di Catania

Catania, 95123

Italy

Azienda Ospedaliera Universitaria San Martino di Genova

Genova, 16132

Italy

Casa di Cura del Policlinico

Milan, 20144

Italy

Istituto Neurologico Carlo Besta

Milan, 20133

Italy

Azienda Ospedaliera di Rilievo Nazionale A Cardarelli

Naples, 80131

Italy

Aou San Luigi Gonzaga

Orbassano, 10043

Italy

Fondazione Istituto Neurologico Casimiro Mondino

Pavia, 27100

Italy

Fondazione Policlinico Universitario A Gemelli IRCCS

Roma, 00168

Italy

IRCCS Istituto Clinico Humanitas

Rozzano, 20086

Italy

National Hospital Organization Asahikawa Medical Center

Asahikawa, 070-0901

Japan

Institute of Science Tokyo Hospital

Bunkyō City, 113 8519

Japan

Chiba University Hospital

Chiba, 260-8677

Japan

Seirei Hamamatsu General Hospital

Hamamatsu, 430-8558

Japan

Tokai University Hospital

Isehara, 259-1193

Japan

Kobe City Medical Center General Hospital

Kobe, 650 0047

Japan

National Center of Neurology and Psychiatry

Kodaira-shi, 187-8551

Japan

Saitama Medical Center

Koshigaya, 343-8555

Japan

Kumamoto University Hospital

Kumamoto, 860-8556

Japan

Chubu Rosai Hospital

Nagoya, 455-8530

Japan

Nagoya University Hospital

Nagoya, 466-8560

Japan

Kindai University Hospital

Osaka Sayama Shi, 589 8511

Japan

National Hospital Organization Sendai Medical Center

Sendai, 983-8520

Japan

Dokkyo Medical University Hospital

Shimotsuga Gun, 321 0293

Japan

Tokyo Women's Medical University Hospital

Shinjuku-ku, 162-8666

Japan

Tenri Hospital

Tenri, 632-0015

Japan

Ehime University Hospital

Toon-shi, 791-0295

Japan

Toyama University Hospital

Toyama, 930-0194

Japan

Yamaguchi University Hospital

Ube, 755-8505

Japan

i Can Oncology Center

Monterrey, 64710

Mexico

Clinical Research Institute S.C.

Tlalnepantla, 54055

Mexico

Centrum Medyczne

Chorzów, 41 500

Poland

Specjalistyczne Gabinety Lekarskie

Krakow, 30 539

Poland

Prywatny Gabinet Lekarski

Lublin, 20 093

Poland

Clinical Research Center sp z o o MEDIC R s k

Poznan, 61 731

Poland

Hospital Garcia de Orta

Almada, 2805-267

Portugal

Hospital de Braga

Braga, 4710-243

Portugal

Centro Hospitalar de Sao Joao Epe

Porto, 4200 319

Portugal

Kyunghee University Medical Center

Seoul, 02447

South Korea

Konkuk University Medical Center

Seoul, 05030

South Korea

Samsung Medical Center

Seoul, 135-710

South Korea

Hosp. Gral. Univ. de Alicante

Alicante, 03010

Spain

Hosp Univ Vall D Hebron

Barcelona, 8035

Spain

Hosp. Univ. de Basurto

Bilbao, 48013

Spain

Hosp. Univ. Donostia

Donostia / San Sebastian, 20014

Spain

Hosp. Clinico San Carlos

Madrid, 28040

Spain

Hosp. Virgen Macarena

Seville, 41009

Spain

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, 88301

Taiwan

National Taiwan University Hospital

Taipei, 100

Taiwan

Shin Kong Wu Ho Su Memorial Hospital

Taipei, 111

Taiwan

University Hospitals Birmingham NHS Foundation Trust

Birmingham, B15 2TH

United Kingdom

Royal Devon & Exeter Hospital

Devon, EX2 5DW

United Kingdom

NHS Greater Glasgow and Clyde

Glasgow, G514TF

United Kingdom

Royal Free Hospital

London, NW3 2QG

United Kingdom

Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, S10 2 JF

United Kingdom