Actively Recruiting
Phase 2/3 Study of Nipocalimab to Evaluate Safety and Efficacy in Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Led by Janssen Research & Development, LLC · Updated on 2026-06-05
201
Participants Needed
115
Research Sites
109 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This trial is studying adults with chronic inflammatory demyelinating polyneuropathy (CIDP), a condition that affects the nerves. Researchers are evaluating the safety and effectiveness of nipocalimab compared to a placebo in delaying the return of symptoms in patients who initially respond to nipocalimab treatment. The study is designed as a Phase 2/3, randomized, double-blind, placebo-controlled trial. Participants first enter Stage A, where everyone receives nipocalimab intravenously, with a loading dose on Day 1 followed by doses every two weeks for 12 weeks. Those who show improvement then move to Stage B, where they are randomly assigned to receive either nipocalimab or a placebo intravenously every two weeks for up to 52 weeks. After Stage B, participants may join an open-label extension phase to receive nipocalimab every two weeks for up to two years or until the drug becomes commercially available. Throughout the study, participants will have regular assessments including disability and muscle strength scales, grip strength measurements, and monitoring for any adverse events or changes in laboratory tests, vital signs, and electrocardiograms. The main outcome measured is the time until the first relapse during Stage B over 52 weeks. Safety and antibody responses to the drug are also closely monitored. The total participation time can extend up to two years depending on the study phase and extension.
CONDITIONS
Brief Title
Efficacy and Safety Study of Nipocalimab for Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years of age or older
- Diagnosed with CIDP according to European Academy of Neurology/Peripheral Nerve Society 2021 criteria
- INCAT disability score between 2 and 9 at baseline; score of 2 must come from leg disability only
- Currently treated with oral corticosteroids ≤20 mg/day, or treated with pulsed corticosteroids and/or intravenous/subcutaneous immunoglobulin willing to stop by baseline, or treated with oral corticosteroids >20 mg/day willing to taper to ≤20 mg/day during run-in, or treatment naive, or stopped corticosteroids/immunoglobulins at least 3 months prior
- Active disease with CIDP Disease Activity Status score ≥3
- Other protocol-defined inclusion criteria
You will not qualify if you...
- History of severe or uncontrolled liver, gastrointestinal, kidney, lung, heart, psychiatric, neurological, musculoskeletal, hypertension, or other medical or uncontrolled autoimmune disorders
- Pure sensory CIDP or chronic immune sensory polyradiculopathy
- Other diseases explaining symptoms such as stroke deficits, CNS trauma, connective tissue disease, or systemic lupus erythematosus
- Polyneuropathy due to other causes including multifocal motor neuropathy, anti-MAG IgM antibodies, hereditary neuropathies, organomegaly syndromes, diabetic or systemic illness polyneuropathy, drug- or toxin-induced polyneuropathy
- Known allergies or intolerance to nipocalimab or its ingredients
- Other protocol-defined exclusion criteria
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants receive a loading dose of nipocalimab intravenously on Day 1, followed by nipocalimab IV infusion once every 2 weeks from Week 2 to Week 12.
6 infusions every 2 weeks
Duration - Up to 52 weeks
Participants who respond to Stage A receive either nipocalimab or placebo IV infusion once every 2 weeks up to Week 52 under double-blind conditions.
Approximately 26 infusions every 2 weeks
Duration - Up to 2 years after marketing authorization
Participants who complete or discontinue Stage B may receive nipocalimab IV infusion every 2 weeks until 2 years after marketing authorization or until commercial availability or other continued access is available.
Infusions every 2 weeks during extension
Trial Site Locations
Total: 115 locations
1
IMMUNOe Health and Research Centers
Centennial, Colorado, United States, 80112
Actively Recruiting
2
Healthcare Innovations Institute Inc
Coral Springs, Florida, United States, 33067
Actively Recruiting
3
Neurology Associates PA
Maitland, Florida, United States, 32751
Completed
4
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Actively Recruiting
5
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
Actively Recruiting
6
Boston Clinical Trials
Boston, Massachusetts, United States, 02111
Completed
7
Beaumont Hospital Royal Oak
Royal Oak, Michigan, United States, 48073
Completed
8
Kansas City Veterans Affairs Medical Center
Kansas City, Missouri, United States, 64128
Actively Recruiting
9
The Neurological Institute of New York
New York, New York, United States, 10032
Completed
10
South Shore Neurologic Associates - Patchogue
Patchogue, New York, United States, 11772
Actively Recruiting
11
The Neurological Institute, PA
Charlotte, North Carolina, United States, 28204
Actively Recruiting
12
Cleveland Clinic Main Campus
Cleveland, Ohio, United States, 44195
Actively Recruiting
13
Austin Neuromuscular Center
Austin, Texas, United States, 78756
Actively Recruiting
14
Advocate Health - Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, United States, 53215
Actively Recruiting
15
Hospital Italiano de Buenos Aires
Buenos Aires, Argentina, C1199ABB
Actively Recruiting
16
Hospital Gral Agudos Ignacio Pirovano
Buenos Aires, Argentina, C1428
Actively Recruiting
17
INECO Neurociencias Orono
Rosario, Argentina, 2900
Actively Recruiting
18
The Alfred Hospital
Melbourne, Australia, 3004
Actively Recruiting
19
Gold Coast University Hospital
Parkwood, Australia, 4215
Completed
20
The Ottawa Hospital Ottawa NeuroMuscular Centre
Ottawa, Canada, K1N 6N5
Actively Recruiting
21
Peking University First Hospital
Beijing, China, 100034
Actively Recruiting
22
Xuanwu Hospital ,Capital Medical University
Beijing, China, 100053
Actively Recruiting
23
Beijing Tiantan Hospital, Capital Medical University
Beijing, China, 100070
Actively Recruiting
24
Peking University Third Hospital
Beijing, China, 100191
Actively Recruiting
25
The First Hospital of Jilin University
Changchun, China, 130021
Actively Recruiting
26
The Third Xiangya Hospital of Central Sourth University
Changsha, China, 410008
Actively Recruiting
27
Xiangya Hospital Central South University
Changsha, China, 410008
Actively Recruiting
28
Sichuan Provincial Peoples Hospital
Chengdu, China, 610072
Actively Recruiting
29
Chifeng Municipal Hospital
Chifeng, China, 024000
Actively Recruiting
30
Fujian Medical University Union Hospital
Fuzhou, China, 350001
Actively Recruiting
31
The First Affiliated Hospital Sun Yat sen University
Guangzhou, China, 510080
Actively Recruiting
32
Qilu Hospital of Shandong University
Jinan, China, 250012
Actively Recruiting
33
Qianfoshan hospital of Shandong Province
Jinan, China, 250014
Actively Recruiting
34
The First Affiliated Hospital of NanChang University
Nanchang, China, 330006
Actively Recruiting
35
Huashan Hospital Fudan University
Shanghai, China, 200040
Actively Recruiting
36
Tong Ren Hospital Shanghai Jiao Tong University school of medicine
Shanghai, China, 200336
Completed
37
Renmin Hospital of Wuhan University
Wuhan, China, 430023
Actively Recruiting
38
Tangdu hospital the Fourth Military Medical
Xi'an, China, 710032
Actively Recruiting
39
Xi 'an GaoXin Hospital
Xi'an, China, 710075
Actively Recruiting
40
Fundación Cardiovascular de Colombia - Instituto del Corazón Floridablanca
Floridablanca, Colombia, 681004
Actively Recruiting
41
Instituto Neurológico de Colombia
Medellín, Colombia, 50021
Actively Recruiting
42
Fakultni nemocnice Hradec Kralove
Hradec Králové, Czechia, 500 05
Actively Recruiting
43
Fakultni Nemocnice Ostrava
Ostrava, Czechia, 708 52
Completed
44
Pardubicka krajska nemocnice a s
Pardubice, Czechia, 53203
Completed
45
CHU Bordeaux
Bordeaux, France, 33000
Actively Recruiting
46
Hospices Civils de Lyon HCL
Bron, France, 69699
Actively Recruiting
47
Hopital de Bicetre
Le Kremlin-Bicêtre, France, 94270
Actively Recruiting
48
Hopital de la Timone
Marseille, France, 13385
Actively Recruiting
49
Hopital PASTEUR
Nice, France, 06000
Actively Recruiting
50
CHU Nimes Hopital Caremeau
Nîmes, France, 30029
Actively Recruiting
51
Hopital de la Pitie Salpetriere
Paris, France, 75013
Actively Recruiting
52
Fondation Adolphe de Rothschild Hospital
Paris, France, 75019
Actively Recruiting
53
CHRU Strasbourg
Strasbourg, France, 67200
Actively Recruiting
54
Judisches Krankenhaus Berlin
Berlin, Germany, 13347
Actively Recruiting
55
St. Josef-Hospital, Ruhr-Universität Bochum
Bochum, Germany, 44791
Actively Recruiting
56
Medizinische Hochschule Hannover
Hanover, Germany, 30625
Actively Recruiting
57
Universitaetsklinikum Leipzig
Leipzig, Germany, 4103
Actively Recruiting
58
St Josefs Krankenhaus Potsdam Sanssouci
Potsdam, Germany, 14471
Actively Recruiting
59
Attikon General Hospital of Athens
Athens, Greece, 12462
Actively Recruiting
60
Patras University Hospital
Pátrai, Greece, 26504
Completed
61
Ahepa Hospital Aristotle University of Thessaloniki
Thessaloniki, Greece, 54636
Actively Recruiting
62
Papageorgiou General Hospital Of Thessaloniki
Thessaloniki, Greece, 56429
Actively Recruiting
63
Azienda Ospedaliera Universitaria San Martino di Genova
Genova, Italy, 16132
Actively Recruiting
64
Casa di Cura del Policlinico
Milan, Italy, 20144
Actively Recruiting
65
Istituto Neurologico Carlo Besta
Milan, Italy, 20133
Actively Recruiting
66
Azienda Ospedaliera di Rilievo Nazionale A Cardarelli
Naples, Italy, 80131
Actively Recruiting
67
Aou San Luigi Gonzaga
Orbassano, Italy, 10043
Actively Recruiting
68
Fondazione Istituto Neurologico Casimiro Mondino
Pavia, Italy, 27100
Actively Recruiting
69
Fondazione Policlinico Universitario A Gemelli IRCCS
Roma, Italy, 00168
Actively Recruiting
70
IRCCS Istituto Clinico Humanitas
Rozzano, Italy, 20086
Actively Recruiting
71
National Hospital Organization Asahikawa Medical Center
Asahikawa, Japan, 070-0901
Actively Recruiting
72
Institute of Science Tokyo Hospital
Bunkyō City, Japan, 113 8519
Actively Recruiting
73
Chiba University Hospital
Chiba, Japan, 260-8677
Actively Recruiting
74
Seirei Hamamatsu General Hospital
Hamamatsu, Japan, 430-8558
Actively Recruiting
75
Tokai University Hospital
Isehara, Japan, 259-1193
Actively Recruiting
76
Kobe City Medical Center General Hospital
Kobe, Japan, 650 0047
Completed
77
National Center of Neurology and Psychiatry
Kodaira-shi, Japan, 187-8551
Actively Recruiting
78
Saitama Medical Center
Koshigaya, Japan, 343-8555
Actively Recruiting
79
Kumamoto University Hospital
Kumamoto, Japan, 860-8556
Actively Recruiting
80
Chubu Rosai Hospital
Nagoya, Japan, 455-8530
Actively Recruiting
81
Nagoya University Hospital
Nagoya, Japan, 466-8560
Actively Recruiting
82
Kindai University Hospital
Osaka Sayama Shi, Japan, 589 8511
Actively Recruiting
83
National Hospital Organization Sendai Medical Center
Sendai, Japan, 983-8520
Actively Recruiting
84
Dokkyo Medical University Hospital
Shimotsuga Gun, Japan, 321 0293
Actively Recruiting
85
Tokyo Women's Medical University Hospital
Shinjuku-ku, Japan, 162-8666
Completed
86
Tenri Hospital
Tenri, Japan, 632-0015
Actively Recruiting
87
Ehime University Hospital
Toon-shi, Japan, 791-0295
Actively Recruiting
88
Toyama University Hospital
Toyama, Japan, 930-0194
Actively Recruiting
89
Yamaguchi University Hospital
Ube, Japan, 755-8505
Actively Recruiting
90
i Can Oncology Center
Monterrey, Mexico, 64710
Actively Recruiting
91
Clinical Research Institute S.C.
Tlalnepantla, Mexico, 54055
Actively Recruiting
92
Centrum Medyczne
Chorzów, Poland, 41 500
Completed
93
Specjalistyczne Gabinety Lekarskie
Krakow, Poland, 30 539
Completed
94
Prywatny Gabinet Lekarski
Lublin, Poland, 20 093
Actively Recruiting
95
Clinical Research Center sp z o o MEDIC R s k
Poznan, Poland, 61 731
Actively Recruiting
96
Hospital Garcia de Orta
Almada, Portugal, 2805-267
Actively Recruiting
97
Hospital de Braga
Braga, Portugal, 4710-243
Actively Recruiting
98
Centro Hospitalar de Sao Joao Epe
Porto, Portugal, 4200 319
Actively Recruiting
99
Kyunghee University Medical Center
Seoul, South Korea, 02447
Actively Recruiting
100
Konkuk University Medical Center
Seoul, South Korea, 05030
Completed
101
Samsung Medical Center
Seoul, South Korea, 135-710
Actively Recruiting
102
Hosp. Gral. Univ. de Alicante
Alicante, Spain, 03010
Actively Recruiting
103
Hosp Univ Vall D Hebron
Barcelona, Spain, 8035
Actively Recruiting
104
Hosp. Univ. de Basurto
Bilbao, Spain, 48013
Actively Recruiting
105
Hosp. Univ. Donostia
Donostia / San Sebastian, Spain, 20014
Actively Recruiting
106
Hosp. Clinico San Carlos
Madrid, Spain, 28040
Actively Recruiting
107
Hosp. Virgen Macarena
Seville, Spain, 41009
Actively Recruiting
108
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, Taiwan, 88301
Actively Recruiting
109
National Taiwan University Hospital
Taipei, Taiwan, 100
Actively Recruiting
110
Shin Kong Wu Ho Su Memorial Hospital
Taipei, Taiwan, 111
Actively Recruiting
111
University Hospitals Birmingham NHS Foundation Trust
Birmingham, United Kingdom, B15 2TH
Actively Recruiting
112
Royal Devon & Exeter Hospital
Devon, United Kingdom, EX2 5DW
Actively Recruiting
113
NHS Greater Glasgow and Clyde
Glasgow, United Kingdom, G514TF
Actively Recruiting
114
Royal Free Hospital
London, United Kingdom, NW3 2QG
Suspended
115
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, United Kingdom, S10 2 JF
Actively Recruiting
Research Team
S
Study Contact
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Frequently Asked Questions
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