Efficacy and Safety Study of Nipocalimab for Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Phase 2/3, Multistage, Multicenter, Randomized, Double-Blind, Placebo-Controlled Parallel Group Withdrawal Study to Evaluate the Efficacy and Safety of Nipocalimab Administered to Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
4 other identifiers
interventional
201
19 countries
108
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2022
Longer than P75 for phase_2
108 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 7, 2022
CompletedFirst Posted
Study publicly available on registry
April 14, 2022
CompletedStudy Start
First participant enrolled
September 23, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 14, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 18, 2029
April 13, 2026
April 1, 2026
4.6 years
April 7, 2022
April 9, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Stage B: Time to First Occurrence of a Relapse Event
Stage B time to first occurrence of a relapse event will be reported.
Up to 52 weeks
Secondary Outcomes (29)
Stage A: Time to Initial Confirmed Evidence of Clinical Improvement (ECI)
12 weeks
Stage A: Percentage of Responders as Determined by ECI
12 weeks
Stage A: Change from Baseline Over Time in Adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) Disability Scale Score
Baseline to 12 weeks
Stage A: Change from Stage A Baseline Over Time in Medical Research Council (MRC) Muscle Grading Scale Sum Score
Baseline to 12 weeks
Stage A: Change from Baseline Over Time in Inflammatory Rasch-Built Overall Disability Scale (I-RODS) Centile Score
Baseline to 12 weeks
- +24 more secondary outcomes
Study Arms (2)
Nipocalimab
EXPERIMENTALParticipants in Stage A (Open-label) will receive a loading dose of nipocalimab (Dose 1) intravenous (IV) infusion on Day 1, followed by nipocalimab (Dose 2) IV infusion once every 2 weeks (q2w) from Week 2 to Week 12. Participants who demonstrate evidence of clinical improvement in Stage A (responders) will enter Stage B (Double-blind) and receive nipocalimab (Dose 2) IV infusion q2w starting on Day 1 up to Week 52. After completion of Stage B or discontinuation from Stage B due to relapse, participants will have the option to enter the open label extension (OLE) phase and receive nipocalimab (Dose 2) IV infusion q2w starting on OLE Day 1 until 2 years after marketing authorization in a participant's local country or until nipocalimab becomes available commercially or via other continued access program, whichever comes first.
Placebo
PLACEBO COMPARATORParticipants receiving nipocalimab in Stage A and who demonstrate evidence of clinical improvement in Stage A (responders) will enter Stage B (Double-blind) and receive placebo IV infusion q2w starting on Day 1 up to Week 52. After completion of Stage B or discontinuation from Stage B due to relapse, participants will have the option to enter the open label extension (OLE) phase and receive nipocalimab (Dose 2) IV infusion q2w starting on OLE Day 1 until 2 years after marketing authorization in a participant's local country or until nipocalimab becomes available commercially or via other continued access program, whichever comes first.
Interventions
Nipocalimab will be administered intravenously.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- Has known allergies, hypersensitivity, or intolerance to nipocalimab or its excipients
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (108)
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
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
Hospital Gral Agudos Ignacio Pirovano
Buenos Aires, C1428, 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 PASTEUR
Nice, 06000, 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
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 Ospedaliera Universitaria San Martino di Genova
Genova, 16132, Italy
Azienda Ospedaliera di Rilievo Nazionale A Cardarelli
Naples, 80131, 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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
April 7, 2022
First Posted
April 14, 2022
Study Start
September 23, 2022
Primary Completion (Estimated)
May 14, 2027
Study Completion (Estimated)
June 18, 2029
Last Updated
April 13, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
The data sharing policy of Johnson \& Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu