Actively Recruiting
Efficacy and Safety Study of Nipocalimab for Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Led by Janssen Research & Development, LLC · Updated on 2026-05-08
201
Participants Needed
113
Research Sites
351 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 or older at the time of consent
- Diagnosed with progressing or relapsing Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) as per EAN/PNS 2021 criteria
- CIDP diagnosis confirmed by an independent committee during screening
- Inflammatory Neuropathy Cause and Treatment (INCAT) disability score between 2 and 9 at baseline
- If INCAT score is 2, this must come only from leg disability
- Currently treated with oral corticosteroids at 20 mg/day or less, or treated with pulsed corticosteroids and/or immunoglobulin with willingness to discontinue before baseline, or treatment naive, or treatment discontinued at least 3 months before screening
- Active disease with a CIDP Disease Activity Status (CDAS) score of 3 or higher
- Other protocol-defined inclusion criteria may apply
You will not qualify if you...
- History of severe or uncontrolled liver, gastrointestinal, kidney, lung, heart, psychiatric, neurological, musculoskeletal, or autoimmune disorders that may affect participation or safety
- Pure sensory CIDP or chronic immune sensory polyradiculopathy (CISP)
- Other diseases better explaining symptoms, such as stroke, CNS trauma, or other causes of peripheral neuropathy like connective tissue disease or lupus
- Polyneuropathy from other causes including multifocal motor neuropathy, monoclonal gammopathy with anti-MAG antibodies, hereditary motor neuropathy, HNPP, POEMS syndrome, lumbosacral radiculoplexus neuropathy, diabetic or systemic illness-related polyneuropathy, or drug/toxin-induced polyneuropathy
- Known allergies or intolerance to nipocalimab or its ingredients
- Other protocol-defined exclusion criteria may apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 113 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
Actively Recruiting
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
The Alfred Hospital
Melbourne, Australia, 3004
Actively Recruiting
18
Gold Coast University Hospital
Parkwood, Australia, 4215
Actively Recruiting
19
The Ottawa Hospital Ottawa NeuroMuscular Centre
Ottawa, Canada, K1N 6N5
Actively Recruiting
20
Peking University First Hospital
Beijing, China, 100034
Actively Recruiting
21
Xuanwu Hospital ,Capital Medical University
Beijing, China, 100053
Actively Recruiting
22
Beijing Tiantan Hospital, Capital Medical University
Beijing, China, 100070
Actively Recruiting
23
Peking University Third Hospital
Beijing, China, 100191
Actively Recruiting
24
The First Hospital of Jilin University
Changchun, China, 130021
Actively Recruiting
25
The Third Xiangya Hospital of Central Sourth University
Changsha, China, 410008
Actively Recruiting
26
Xiangya Hospital Central South University
Changsha, China, 410008
Actively Recruiting
27
Sichuan Provincial Peoples Hospital
Chengdu, China, 610072
Actively Recruiting
28
Chifeng Municipal Hospital
Chifeng, China, 024000
Actively Recruiting
29
Fujian Medical University Union Hospital
Fuzhou, China, 350001
Actively Recruiting
30
The First Affiliated Hospital Sun Yat sen University
Guangzhou, China, 510080
Actively Recruiting
31
Qilu Hospital of Shandong University
Jinan, China, 250012
Actively Recruiting
32
Qianfoshan hospital of Shandong Province
Jinan, China, 250014
Actively Recruiting
33
The First Affiliated Hospital of NanChang University
Nanchang, China, 330006
Actively Recruiting
34
Huashan Hospital Fudan University
Shanghai, China, 200040
Actively Recruiting
35
Tong Ren Hospital Shanghai Jiao Tong University school of medicine
Shanghai, China, 200336
Completed
36
Renmin Hospital of Wuhan University
Wuhan, China, 430023
Actively Recruiting
37
Tangdu hospital the Fourth Military Medical
Xi'an, China, 710032
Actively Recruiting
38
Xi 'an GaoXin Hospital
Xi'an, China, 710075
Actively Recruiting
39
Fundación Cardiovascular de Colombia - Instituto del Corazón Floridablanca
Floridablanca, Colombia, 681004
Actively Recruiting
40
Instituto Neurológico de Colombia
Medellín, Colombia, 50021
Actively Recruiting
41
Fakultni nemocnice Hradec Kralove
Hradec Králové, Czechia, 500 05
Actively Recruiting
42
Fakultni Nemocnice Ostrava
Ostrava, Czechia, 708 52
Completed
43
Pardubicka krajska nemocnice a s
Pardubice, Czechia, 53203
Completed
44
CHU Bordeaux
Bordeaux, France, 33000
Actively Recruiting
45
Hospices Civils de Lyon HCL
Bron, France, 69699
Actively Recruiting
46
Hopital de Bicetre
Le Kremlin-Bicêtre, France, 94270
Actively Recruiting
47
Hopital de la Timone
Marseille, France, 13385
Actively Recruiting
48
Hopital PASTEUR
Nice, France, 06000
Actively Recruiting
49
CHU Nimes Hopital Caremeau
Nîmes, France, 30029
Actively Recruiting
50
Hopital de la Pitie Salpetriere
Paris, France, 75013
Actively Recruiting
51
Fondation Adolphe de Rothschild Hospital
Paris, France, 75019
Actively Recruiting
52
CHRU Strasbourg
Strasbourg, France, 67200
Actively Recruiting
53
Judisches Krankenhaus Berlin
Berlin, Germany, 13347
Actively Recruiting
54
St. Josef-Hospital, Ruhr-Universität Bochum
Bochum, Germany, 44791
Actively Recruiting
55
Medizinische Hochschule Hannover
Hanover, Germany, 30625
Actively Recruiting
56
Universitaetsklinikum Leipzig
Leipzig, Germany, 4103
Actively Recruiting
57
St Josefs Krankenhaus Potsdam Sanssouci
Potsdam, Germany, 14471
Actively Recruiting
58
Attikon General Hospital of Athens
Athens, Greece, 12462
Actively Recruiting
59
Patras University Hospital
Pátrai, Greece, 26504
Completed
60
Ahepa Hospital Aristotle University of Thessaloniki
Thessaloniki, Greece, 54636
Actively Recruiting
61
Papageorgiou General Hospital Of Thessaloniki
Thessaloniki, Greece, 56429
Actively Recruiting
62
Azienda Ospedaliera Universitaria San Martino di Genova
Genova, Italy, 16132
Actively Recruiting
63
Casa di Cura del Policlinico
Milan, Italy, 20144
Actively Recruiting
64
Istituto Neurologico Carlo Besta
Milan, Italy, 20133
Actively Recruiting
65
Azienda Ospedaliera di Rilievo Nazionale A Cardarelli
Naples, Italy, 80131
Actively Recruiting
66
Fondazione Istituto Neurologico Casimiro Mondino
Pavia, Italy, 27100
Actively Recruiting
67
Fondazione Policlinico Universitario A Gemelli IRCCS
Roma, Italy, 00168
Actively Recruiting
68
IRCCS Istituto Clinico Humanitas
Rozzano, Italy, 20086
Actively Recruiting
69
National Hospital Organization Asahikawa Medical Center
Asahikawa, Japan, 070-0901
Actively Recruiting
70
Institute of Science Tokyo Hospital
Bunkyō City, Japan, 113 8519
Actively Recruiting
71
Chiba University Hospital
Chiba, Japan, 260-8677
Actively Recruiting
72
Seirei Hamamatsu General Hospital
Hamamatsu, Japan, 430-8558
Actively Recruiting
73
Tokai University Hospital
Isehara, Japan, 259-1193
Actively Recruiting
74
Kobe City Medical Center General Hospital
Kobe, Japan, 650 0047
Completed
75
National Center of Neurology and Psychiatry
Kodaira-shi, Japan, 187-8551
Actively Recruiting
76
Saitama Medical Center
Koshigaya, Japan, 343-8555
Actively Recruiting
77
Kumamoto University Hospital
Kumamoto, Japan, 860-8556
Actively Recruiting
78
Chubu Rosai Hospital
Nagoya, Japan, 455-8530
Actively Recruiting
79
Nagoya University Hospital
Nagoya, Japan, 466-8560
Actively Recruiting
80
Kindai University Hospital
Osaka Sayama Shi, Japan, 589 8511
Actively Recruiting
81
National Hospital Organization Sendai Medical Center
Sendai, Japan, 983-8520
Actively Recruiting
82
Dokkyo Medical University Hospital
Shimotsuga Gun, Japan, 321 0293
Actively Recruiting
83
Tokyo Women's Medical University Hospital
Shinjuku-ku, Japan, 162-8666
Completed
84
Tenri Hospital
Tenri, Japan, 632-0015
Actively Recruiting
85
Ehime University Hospital
Toon-shi, Japan, 791-0295
Actively Recruiting
86
Toyama University Hospital
Toyama, Japan, 930-0194
Actively Recruiting
87
Yamaguchi University Hospital
Ube, Japan, 755-8505
Actively Recruiting
88
i Can Oncology Center
Monterrey, Mexico, 64710
Actively Recruiting
89
Clinical Research Institute S.C.
Tlalnepantla, Mexico, 54055
Actively Recruiting
90
Centrum Medyczne
Chorzów, Poland, 41 500
Completed
91
Specjalistyczne Gabinety Lekarskie
Krakow, Poland, 30 539
Completed
92
Prywatny Gabinet Lekarski
Lublin, Poland, 20 093
Actively Recruiting
93
Clinical Research Center sp z o o MEDIC R s k
Poznan, Poland, 61 731
Actively Recruiting
94
Hospital Garcia de Orta
Almada, Portugal, 2805-267
Actively Recruiting
95
Hospital de Braga
Braga, Portugal, 4710-243
Actively Recruiting
96
Centro Hospitalar de Sao Joao Epe
Porto, Portugal, 4200 319
Actively Recruiting
97
Kyunghee University Medical Center
Seoul, South Korea, 02447
Actively Recruiting
98
Konkuk University Medical Center
Seoul, South Korea, 05030
Completed
99
Samsung Medical Center
Seoul, South Korea, 135-710
Actively Recruiting
100
Hosp. Gral. Univ. de Alicante
Alicante, Spain, 03010
Actively Recruiting
101
Hosp Univ Vall D Hebron
Barcelona, Spain, 8035
Actively Recruiting
102
Hosp. Univ. de Basurto
Bilbao, Spain, 48013
Actively Recruiting
103
Hosp. Univ. Donostia
Donostia / San Sebastian, Spain, 20014
Actively Recruiting
104
Hosp. Clinico San Carlos
Madrid, Spain, 28040
Actively Recruiting
105
Hosp. Virgen Macarena
Seville, Spain, 41009
Actively Recruiting
106
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, Taiwan, 88301
Actively Recruiting
107
National Taiwan University Hospital
Taipei, Taiwan, 100
Actively Recruiting
108
Shin Kong Wu Ho Su Memorial Hospital
Taipei, Taiwan, 111
Actively Recruiting
109
University Hospitals Birmingham NHS Foundation Trust
Birmingham, United Kingdom, B15 2TH
Actively Recruiting
110
Royal Devon & Exeter Hospital
Devon, United Kingdom, EX2 5DW
Actively Recruiting
111
NHS Greater Glasgow and Clyde
Glasgow, United Kingdom, G514TF
Actively Recruiting
112
Royal Free Hospital
London, United Kingdom, NW3 2QG
Suspended
113
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, United Kingdom, S10 2 JF
Actively Recruiting
Research Team
S
Study Contact
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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