Actively Recruiting
A Study to Test the Effects and Safety of Riliprubart in People With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) for Which the Usual Treatments do Not Work
Led by Sanofi · Updated on 2026-05-06
140
Participants Needed
125
Research Sites
227 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of the study is to evaluate efficacy of riliprubart compared to placebo in adult participants with CIDP whose disease is refractory to standard of care. The study duration will be for a maximum of 111 weeks including screening, treatment phases, and follow-up.
CONDITIONS
Official Title
A Study to Test the Effects and Safety of Riliprubart in People With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) for Which the Usual Treatments do Not Work
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults with CIDP or possible CIDP based on European Academy of Neurology/Peripheral Nerve Society guidelines
- Diagnosis of typical CIDP or motor/multifocal CIDP variant confirmed by adjudication committee
- Refractory to immunoglobulin or corticosteroid therapy with documented inadequate response
- INCAT score between 2 and 9
- Use of allowed immunosuppressants (azathioprine, cyclosporine, or mycophenolate mofetil) for 6 months or longer
- Receiving low-dose oral corticosteroids (20 mg/day prednisone or equivalent or less)
- Active disease with CIDP disease activity score (CDAS) of 2 or higher at screening
- Documented vaccinations against encapsulated bacterial pathogens within 5 years prior to Day 1 or at least 14 days before first dose
- Use of contraception if sexually active; not pregnant or breastfeeding; males not donating sperm
- Body weight between 35 kg and 154 kg (77 to 340 lbs) inclusive
You will not qualify if you...
- Polyneuropathy due to other causes such as Guillain-Barré syndrome, hereditary neuropathies, infections, diabetes, toxins, and related disorders
- Sensory, distal, or focal CIDP variants
- Other neurological or systemic diseases affecting treatment or assessments
- Poorly controlled diabetes
- Serious infections requiring hospitalization within 30 days before screening, active infections during screening, or risk factors for infection
- Diagnosis or family history of systemic lupus erythematosus (SLE); SLE must be ruled out if certain antibodies are positive
- Sensitivity or allergy to study drugs or components, including history of severe allergic reactions to monoclonal antibodies
- Significant medical history or conditions affecting safety or data quality
- Recent suicide attempt or high risk of suicide
- CIDP worsening within 6 weeks after prior vaccination considered relapse
- Recent or planned major surgery affecting trial results or safety
- Recent treatment with immunoglobulins or plasma exchange
- Prior treatment with riliprubart or highly immunosuppressive therapies
- Prior treatments including lymphoid irradiation, bone marrow transplantation, B-cell-depleting agents within 6 months
- Use of complement system inhibitors within 12 weeks or longer
- Immunosuppressive treatments within 6 months except allowed immunosuppressants
- Vaccinations within 28 days before dosing except approved exceptions
- Participation in other clinical trials with investigational drugs within 12 weeks or longer
- Abnormal laboratory or ECG results deemed clinically significant
- Positive tests for hepatitis B, C, or HIV as specified
- Pregnancy or lactation
- Institutionalization due to legal or regulatory orders
- Unsuitability for participation as judged by investigator
- Employment or direct involvement with the study site or immediate family
- Country-specific regulations preventing study entry
- Recent treatment with efgartigimod
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 125 locations
1
Alabama Neurology Associates- Site Number : 8400019
Homewood, Alabama, United States, 35209
Actively Recruiting
2
USC Norris Comprehensive Cancer Center- Site Number : 8400002
Los Angeles, California, United States, 90033
Actively Recruiting
3
University of California Irvine - Manchester Pavilion- Site Number : 8400007
Orange, California, United States, 92868
Actively Recruiting
4
Yale University School of Medicine- Site Number : 8400018
New Haven, Connecticut, United States, 06510
Actively Recruiting
5
NorthShore University Health System - Glenbrook Hospital- Site Number : 8400024
Glenview, Illinois, United States, 60026
Actively Recruiting
6
University of Kansas Medical Center (KUMC)- Site Number : 8400010
Westwood, Kansas, United States, 66205-2003
Actively Recruiting
7
NeuroMedical Clinic of Central Louisiana- Site Number : 8400031
Alexandria, Louisiana, United States, 71301
Actively Recruiting
8
Ochsner Medical Center - Jefferson Highway- Site Number : 8400030
New Orleans, Louisiana, United States, 70121
Actively Recruiting
9
Johns Hopkins Hospital- Site Number : 8400015
Baltimore, Maryland, United States, 21287
Actively Recruiting
10
Massachusetts General Hospital- Site Number : 8400009
Boston, Massachusetts, United States, 02114
Actively Recruiting
11
Henry Ford Hospital- Site Number : 8400025
Detroit, Michigan, United States, 48202
Actively Recruiting
12
Michigan State University- Site Number : 8400038
East Lansing, Michigan, United States, 48824
Actively Recruiting
13
Washington University School of Medicine - Siteman Cancer Center- Site Number : 8400037
St Louis, Missouri, United States, 63110
Actively Recruiting
14
Profound Research- Site Number : 8400052
Las Vegas, Nevada, United States, 89106
Actively Recruiting
15
Hospital for Special Surgery- Site Number : 8400041
New York, New York, United States, 10021
Actively Recruiting
16
Columbia University Irving Medical Center- Site Number : 8400003
New York, New York, United States, 10032
Actively Recruiting
17
Raleigh Neurology Associates- Site Number : 8400043
Raleigh, North Carolina, United States, 27607
Actively Recruiting
18
University of Cincinnati Medical Center- Site Number : 8400020
Cincinnati, Ohio, United States, 45219
Actively Recruiting
19
University Hospitals Cleveland Medical Center- Site Number : 8400033
Cleveland, Ohio, United States, 44106
Actively Recruiting
20
Penn State Health Milton South Hershey Medical Center- Site Number : 8400042
Hershey, Pennsylvania, United States, 17033
Actively Recruiting
21
Penn Medicine: University of Pennsylvania Health System- Site Number : 8400022
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
22
Austin Neuromuscular Center- Site Number : 8400040
Austin, Texas, United States, 78756
Actively Recruiting
23
University of Vermont Medical Center- Site Number : 8400012
Burlington, Vermont, United States, 05401
Actively Recruiting
24
University of Virginia- Site Number : 8400023
Charlottesville, Virginia, United States, 22908
Actively Recruiting
25
Investigational Site Number : 0320001
Buenos Aires, Argentina, 1015
Actively Recruiting
26
Investigational Site Number : 0320002
Buenos Aires, Argentina, 1181
Actively Recruiting
27
Investigational Site Number : 0320003
Buenos Aires, Argentina, 1221
Actively Recruiting
28
Investigational Site Number : 0560001
Leuven, Belgium, 3000
Actively Recruiting
29
Centro de Diagnostico e Pesquisa da Osteoporose do Espirito Santo- Site Number : 0760012
Vitória, Espírito Santo, Brazil, 29055-450
Actively Recruiting
30
Hospital Sao Rafael- Site Number : 0760011
Salvador, Estado de Bahia, Brazil, 41253-190
Actively Recruiting
31
Hospital Moinhos de Vento- Site Number : 0760003
Porto Alegre, Rio Grande do Sul, Brazil, 90035-902
Actively Recruiting
32
Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto- Site Number : 0760007
Ribeirão Preto, São Paulo, Brazil, 14049-900
Actively Recruiting
33
PSEG Centro de Pesquisa Clínica- Site Number : 0760009
São Paulo, Brazil, 04038-002
Actively Recruiting
34
Investigational Site Number : 1000002
Blagoevgrad, Bulgaria, 2700
Actively Recruiting
35
Investigational Site Number : 1000001
Pleven, Bulgaria, 5800
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36
Investigational Site Number : 1240001
Québec, Quebec, Canada, G1E 7G9
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37
Investigational Site Number : 1520003
Lo Barnechea, Reg Metropolitana de Santiago, Chile, 7691236
Actively Recruiting
38
Investigational Site Number : 1520002
Santiago, Reg Metropolitana de Santiago, Chile, 8207257
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39
Investigational Site Number : 1520001
Santiago, Reg Metropolitana de Santiago, Chile, 8380456
Actively Recruiting
40
Investigational Site Number : 1560013
Beijing, China, 100034
Actively Recruiting
41
Investigational Site Number : 1560010
Beijing, China, 100050
Actively Recruiting
42
Investigational Site Number : 1560005
Beijing, China, 100053
Actively Recruiting
43
Investigational Site Number : 1560016
Beijing, China, 100730
Actively Recruiting
44
Investigational Site Number : 1560009
Changsha, China, 410008
Actively Recruiting
45
Investigational Site Number : 1560011
Chengdu, China, 610072
Actively Recruiting
46
Investigational Site Number : 1560002
Fuzhou, China, 350001
Actively Recruiting
47
Investigational Site Number : 1560012
Guangzhou, China, 510000
Actively Recruiting
48
Investigational Site Number : 1560007
Guangzhou, China, 510080
Actively Recruiting
49
Investigational Site Number : 1560014
Hangzhou, China, 310003
Actively Recruiting
50
Investigational Site Number : 1560008
Jinan, China, 250014
Actively Recruiting
51
Investigational Site Number : 1560015
Nanchang, China, 330006
Actively Recruiting
52
Investigational Site Number : 1560001
Shanghai, China, 200040
Actively Recruiting
53
Investigational Site Number : 1560003
Wuhan, China, 430030
Actively Recruiting
54
Investigational Site Number : 1560006
Wuhan, China, 430060
Actively Recruiting
55
Investigational Site Number : 1560004
Xi'an, China, 710038
Actively Recruiting
56
Investigational Site Number : 2030004
Brno, Czechia, 625 00
Actively Recruiting
57
Investigational Site Number : 2030003
Hradec Králové, Czechia, 500 05
Actively Recruiting
58
Investigational Site Number : 2030002
Pardubice, Czechia, 532 03
Completed
59
Investigational Site Number : 2080002
Aarhus, Denmark, 8200
Actively Recruiting
60
Investigational Site Number : 2080001
Copenhagen, Denmark, 2100
Actively Recruiting
61
Investigational Site Number : 2500001
Le Kremlin-Bicêtre, France, 94270
Actively Recruiting
62
Investigational Site Number : 2500003
Lille, France, 59037
Actively Recruiting
63
Investigational Site Number : 2500002
Marseille, France, 13885
Actively Recruiting
64
Investigational Site Number : 2500005
Montpellier, France, 34295
Actively Recruiting
65
Investigational Site Number : 2500004
Paris, France, 75013
Actively Recruiting
66
Investigational Site Number : 2760001
Bad Homburg, Germany, 61348
Actively Recruiting
67
Investigational Site Number : 2760004
Berlin, Germany, 12163
Actively Recruiting
68
Investigational Site Number : 2760007
Bochum, Germany, 44791
Actively Recruiting
69
Investigational Site Number : 2760003
Giessen, Germany, 35392
Actively Recruiting
70
Investigational Site Number : 2760006
Tübingen, Germany, 72076
Actively Recruiting
71
Investigational Site Number : 3000002
Athens, Greece, 124 62
Actively Recruiting
72
Investigational Site Number : 3000003
Larissa, Greece, 411 10
Actively Recruiting
73
Investigational Site Number : 3000001
Thessaloniki, Greece, 546 36
Actively Recruiting
74
Investigational Site Number : 3800001
Milan, Milano, Italy, 20132
Actively Recruiting
75
Investigational Site Number : 3800009
Rozzano, Milano, Italy, 20089
Actively Recruiting
76
Investigational Site Number : 3800006
Rome, Roma, Italy, 00133
Actively Recruiting
77
Investigational Site Number : 3800002
Rome, Roma, Italy, 00168
Actively Recruiting
78
Investigational Site Number : 3800008
Rome, Roma, Italy, 00189
Actively Recruiting
79
Investigational Site Number : 3800007
Messina, Italy, 98125
Actively Recruiting
80
Investigational Site Number : 3800003
Palermo, Italy, 90127
Actively Recruiting
81
Investigational Site Number : 3800005
Pavia, Italy, 27100
Actively Recruiting
82
Investigational Site Number : 3800004
Pisa, Italy, 56126
Actively Recruiting
83
Investigational Site Number : 3920006
Sayama, Osaka, Japan, 589-8511
Actively Recruiting
84
Investigational Site Number : 3920005
Kawagoe, Saitama, Japan, 350-8550
Actively Recruiting
85
Investigational Site Number : 3920014
Yaizu, Shizuoka, Japan, 425-8505
Actively Recruiting
86
Investigational Site Number : 3920011
Bunkyo, Tokyo, Japan, 113-8510
Actively Recruiting
87
Investigational Site Number : 3920008
Kodaira, Tokyo, Japan, 187-8551
Actively Recruiting
88
Investigational Site Number : 3920001
Chiba, Japan, 260-8677
Actively Recruiting
89
Investigational Site Number : 3920003
Fukuoka, Japan, 812-8582
Actively Recruiting
90
Investigational Site Number : 3920009
Saga, Japan, 849-0937
Actively Recruiting
91
Investigational Site Number : 3920013
Tokyo, Japan, 173-8605
Actively Recruiting
92
Investigational Site Number : 4840003
Guadalajara, Jalisco, Mexico, 44670
Actively Recruiting
93
Investigational Site Number : 4840005
Culiacán, Sinaloa, Mexico, 80020
Actively Recruiting
94
Investigational Site Number : 4840002
Veracruz, Mexico, 91900
Actively Recruiting
95
Investigational Site Number : 5280001
Amsterdam, Netherlands, 1105 AZ
Actively Recruiting
96
Investigational Site Number : 5280002
Rotterdam, Netherlands, 3015 CE
Actively Recruiting
97
Investigational Site Number : 6160006
Krakow, Lesser Poland Voivodeship, Poland, 31-501
Actively Recruiting
98
Investigational Site Number : 6160002
Lublin, Lublin Voivodeship, Poland, 20-016
Actively Recruiting
99
Investigational Site Number : 6160003
Rzeszów, Podkarpackie Voivodeship, Poland, 35-055
Actively Recruiting
100
Investigational Site Number : 6200005
Coimbra, Portugal, 3000-075
Actively Recruiting
101
Investigational Site Number : 6200004
Lisbon, Portugal, 1150-199
Actively Recruiting
102
Investigational Site Number : 6200001
Lisbon, Portugal, 1349-019
Actively Recruiting
103
Investigational Site Number : 6200003
Matosinhos Municipality, Portugal, 4464-513
Actively Recruiting
104
Investigational Site Number : 4100003
Seoul, Seoul-teukbyeolsi, South Korea, 02841
Actively Recruiting
105
Investigational Site Number : 4100002
Seoul, Seoul-teukbyeolsi, South Korea, 05505
Actively Recruiting
106
Investigational Site Number : 4100001
Seoul, Seoul-teukbyeolsi, South Korea, 06351
Actively Recruiting
107
Investigational Site Number : 7240012
Santiago de Compostela, A Coruña [La Coruña], Spain, 15706
Actively Recruiting
108
Investigational Site Number : 7240008
Barcelona, Barcelona [Barcelona], Spain, 08035
Actively Recruiting
109
Investigational Site Number : 7240007
Bilbao, Basque Country, Spain, 48013
Actively Recruiting
110
Investigational Site Number : 7240001
Barcelona, Catalunya [Cataluña], Spain, 08041
Actively Recruiting
111
Investigational Site Number : 7240006
Majadahonda, Madrid, Spain, 28222
Actively Recruiting
112
Investigational Site Number : 7240003
Pamplona, Navarre, Spain, 31008
Actively Recruiting
113
Investigational Site Number : 7240005
Oviedo, Principality of Asturias, Spain, 33011
Actively Recruiting
114
Investigational Site Number : 7240009
Sabadell, Spain, 08208
Actively Recruiting
115
Investigational Site Number : 7240010
Santa Cruz de Tenerife, Spain, 38010
Actively Recruiting
116
Investigational Site Number : 7240002
Valencia, Spain, 46026
Actively Recruiting
117
Investigational Site Number : 7520001
Stockholm, Sweden, 113 65
Actively Recruiting
118
Investigational Site Number : 1580003
Kaohsiung City, Taiwan, 833
Actively Recruiting
119
Investigational Site Number : 1580001
Taipei, Taiwan, 100
Actively Recruiting
120
Investigational Site Number : 1580002
Taipei, Taiwan, 112
Actively Recruiting
121
Investigational Site Number : 7920006
Ankara, Turkey (Türkiye), 06170
Actively Recruiting
122
Investigational Site Number : 7920002
Bursa, Turkey (Türkiye), 16059
Actively Recruiting
123
Investigational Site Number : 7920001
Istanbul, Turkey (Türkiye), 34093
Actively Recruiting
124
Investigational Site Number : 7920004
Istanbul, Turkey (Türkiye), 34785
Actively Recruiting
125
Investigational Site Number : 7920003
Konya, Turkey (Türkiye), 42075
Actively Recruiting
Research Team
T
Trial Transparency email recommended (Toll free for US & Canada)
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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