Actively Recruiting
A Study to Test the Efficacy and Safety of Riliprubart Against the Usual Treatment of Intravenous Immunoglobulin (IVIg) in People With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Led by Sanofi · Updated on 2026-05-06
160
Participants Needed
118
Research Sites
229 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 IVIg in adult participants with CIDP who are receiving maintenance treatment with IVIg. The study duration will be for a maximum of 109 weeks including screening, treatment phases, and follow-up.
CONDITIONS
Official Title
A Study to Test the Efficacy and Safety of Riliprubart Against the Usual Treatment of Intravenous Immunoglobulin (IVIg) in People With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant must have CIDP or possible CIDP criteria based on 2021 EAN/PNS guidelines.
- Diagnosis must be typical CIDP, motor CIDP, or multifocal CIDP confirmed by adjudication committee.
- Participants must have responded to IVIg treatment in the past 5 years.
- Participant must be on a stable maintenance IVIg dosage.
- Participant must have residual disability with an INCAT score of 2 to 9 at Screening and baseline (score of 2 only from leg disability).
- Participant must receive IVIg within standard maintenance dosing per EAN/PNS 2021 guidelines.
- Participants receiving IVIg at home must switch to hospital or infusion center at least one cycle before baseline.
- Participant must have active disease with CIDP disease activity score (CDAS) ≥2 at Screening.
- Participant must have documented vaccinations against encapsulated bacterial pathogens within 5 years before Day 1 or started at least 14 days before first study dose.
- Contraception required for sexually active males or females; not pregnant or breastfeeding; no sperm donation for males.
- Participant must weigh between 35 kg and 154 kg inclusive at Screening.
- Evidence of at least one clinically meaningful CIDP deterioration within 2 years or two within 5 years prior to screening during altered immunoglobulin dosing periods.
You will not qualify if you...
- Polyneuropathy from other causes such as Guillain-Barré syndrome, hereditary neuropathies, diabetic neuropathy, or multifocal motor neuropathy.
- Sensory, distal, or focal CIDP variants.
- Other neurological or systemic diseases affecting treatment or outcomes.
- Poorly controlled diabetes.
- Serious infections requiring hospitalization within 30 days before Screening or active infections needing treatment.
- Diagnosis or family history of Systemic Lupus Erythematosus (SLE).
- Hypersensitivity or severe allergic reactions to riliprubart or related antibodies.
- Contraindications to immunoglobulins like chronic kidney disease, thromboembolic diseases, or IgA deficiency.
- Any other medical condition impacting safety or study data quality.
- Recent suicide attempts or high suicidal risk.
- CIDP worsening within 6 weeks after vaccination deemed a relapse.
- Recent or planned major surgery that may affect study results.
- Recent plasma exchange treatment.
- Immunosuppressive or corticosteroid treatments within 3 months before dosing, except maintenance dose.
- Previous treatment with riliprubart or certain immunosuppressive therapies.
- Recent use of complement inhibitors or B-cell depleting agents within 6 months.
- Vaccination within 28 days before dosing except approved exceptions.
- Participation in another investigational drug study within 12 weeks or five times the drug half-life.
- Abnormal lab results or ECG considered clinically significant.
- Positive tests for hepatitis B, C, or HIV (with some exceptions).
- Pregnancy or breastfeeding.
- Institutionalized due to legal or regulatory orders.
- Employees or immediate family of study site personnel.
- Country-specific regulations preventing participation.
- Recent treatment with efgartigimod.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 118 locations
1
Alabama Neurology Associates- Site Number : 8400019
Homewood, Alabama, United States, 35209
Actively Recruiting
2
Honor Health Scottsdale Osborn Medical Center- Site Number : 8400014
Scottsdale, Arizona, United States, 85251
Actively Recruiting
3
Keck School of Medicine of University of Southern California- Site Number : 8400002
Los Angeles, California, United States, 90033
Actively Recruiting
4
University of California Irvine Medical Center- Site Number : 8400007
Orange, California, United States, 92868
Actively Recruiting
5
Yale University School of Medicine- Site Number : 8400018
New Haven, Connecticut, United States, 06510
Actively Recruiting
6
Nova Clinical Research - Bradenton- Site Number : 8400044
Bradenton, Florida, United States, 34209
Actively Recruiting
7
AdventHealth Orlando- Site Number : 8400006
Orlando, Florida, United States, 32803
Actively Recruiting
8
AdventHealth Site Number : 8400006
Orlando, Florida, United States, 32804-5558
Actively Recruiting
9
NorthShore University Health System - Glenbrook Hospital- Site Number : 8400024
Glenview, Illinois, United States, 60026
Actively Recruiting
10
University of Kansas Medical Center- Site Number : 8400010
Kansas City, Kansas, United States, 66103
Actively Recruiting
11
Ochsner Medical Center - Jefferson Highway- Site Number : 8400030
New Orleans, Louisiana, United States, 70121
Actively Recruiting
12
Johns Hopkins Hospital- Site Number : 8400015
Baltimore, Maryland, United States, 21287
Actively Recruiting
13
Massachusetts General Hospital- Site Number : 8400009
Boston, Massachusetts, United States, 02114
Actively Recruiting
14
Henry Ford Hospital- Site Number : 8400025
Detroit, Michigan, United States, 48202
Actively Recruiting
15
Michigan State University- Site Number : 8400038
East Lansing, Michigan, United States, 48824
Actively Recruiting
16
Washington University School of Medicine - Siteman Cancer Center- Site Number : 8400037
St Louis, Missouri, United States, 63110
Actively Recruiting
17
Profound Research- Site Number : 8400052
Las Vegas, Nevada, United States, 89106
Actively Recruiting
18
Dent Neurologic Institute - Amherst- Site Number : 8400039
Amherst, New York, United States, 14226
Actively Recruiting
19
Hospital for Special Surgery- Site Number : 8400041
New York, New York, United States, 10021
Actively Recruiting
20
Columbia University Irving Medical Center- Site Number : 8400003
New York, New York, United States, 10032
Actively Recruiting
21
Raleigh Neurology Associates- Site Number : 8400043
Raleigh, North Carolina, United States, 27607
Actively Recruiting
22
University of Cincinnati Medical Center- Site Number : 8400020
Cincinnati, Ohio, United States, 45219
Actively Recruiting
23
University Hospitals Cleveland Medical Center- Site Number : 8400033
Cleveland, Ohio, United States, 44106
Actively Recruiting
24
Penn Medicine: University of Pennsylvania Health System- Site Number : 8400022
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
25
Austin Neuromuscular Center- Site Number : 8400040
Austin, Texas, United States, 78756
Actively Recruiting
26
University of Vermont Medical Center- Site Number : 8400012
Burlington, Vermont, United States, 05401
Actively Recruiting
27
University of Virginia- Site Number : 8400023
Charlottesville, Virginia, United States, 22908
Actively Recruiting
28
Investigational Site Number : 0320001
Buenos Aires, Argentina, 1015
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29
Investigational Site Number : 0320002
Buenos Aires, Argentina, 1181
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30
Investigational Site Number : 0320003
Buenos Aires, Argentina, 1221
Actively Recruiting
31
Investigational Site Number : 0560002
Ghent, Belgium, 9000
Completed
32
Investigational Site Number : 0560001
Leuven, Belgium, 3000
Actively Recruiting
33
L2IP - Instituto de Pesquisas Clínicas- Site Number : 0760006
Brasília, Federal District, Brazil, 70200-730
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34
Instituto de Neurologia de Curitiba - Ecoville- Site Number : 0760007
Curitiba, Paraná, Brazil, 81210-310
Actively Recruiting
35
InsCer - Instituto do Cérebro da PUCRS- Site Number : 0760002
Porto Alegre, Rio Grande do Sul, Brazil, 90610-000
Actively Recruiting
36
PSEG Centro de Pesquisa Clínica- Site Number : 0760009
São Paulo, Brazil, 04038-002
Actively Recruiting
37
Investigational Site Number : 1240003
London, Ontario, Canada, N6A 5A5
Actively Recruiting
38
Investigational Site Number : 1240006
Montreal, Quebec, Canada, H3a 2b4
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39
Investigational Site Number : 1240001
Québec, Quebec, Canada, G1E 7G9
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40
Investigational Site Number : 1560013
Beijing, China, 100034
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41
Investigational Site Number : 1560010
Beijing, China, 100050
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42
Investigational Site Number : 1560005
Beijing, China, 100053
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43
Investigational Site Number : 1560017
Beijing, China, 100730
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44
Investigational Site Number : 1560009
Changsha, China, 410008
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45
Investigational Site Number : 1560011
Chengdu, China, 610072
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46
Investigational Site Number : 1560002
Fuzhou, China, 350001
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47
Investigational Site Number : 1560012
Guangzhou, China, 510000
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48
Investigational Site Number : 1560007
Guangzhou, China, 510080
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49
Investigational Site Number : 1560014
Hangzhou, China, 310003
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50
Investigational Site Number : 1560016
Jiazhuang, China, 050000
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51
Investigational Site Number : 1560008
Jinan, China, 250014
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52
Investigational Site Number : 1560015
Nanchang, China, 330006
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53
Investigational Site Number : 1560001
Shanghai, China, 200040
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54
Investigational Site Number : 1560003
Wuhan, China, 430030
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55
Investigational Site Number : 1560006
Wuhan, China, 430060
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56
Investigational Site Number : 1560004
Xi'an, China, 710038
Actively Recruiting
57
Investigational Site Number : 2030004
Brno, Czechia, 625 00
Actively Recruiting
58
Investigational Site Number : 2030003
Hradec Králové, Czechia, 500 05
Actively Recruiting
59
Investigational Site Number : 2030005
Ostrava, Czechia, 708 52
Actively Recruiting
60
Investigational Site Number : 2030002
Pardubice, Czechia, 532 03
Completed
61
Investigational Site Number : 2030001
Prague, Czechia, 128 08
Actively Recruiting
62
Investigational Site Number : 2080002
Aarhus, Denmark, 8200
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63
Investigational Site Number : 2080001
Copenhagen, Denmark, 2100
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64
Investigational Site Number : 2500001
Le Kremlin-Bicêtre, France, 94270
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65
Investigational Site Number : 2500002
Marseille, France, 13885
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66
Investigational Site Number : 2500005
Nice, France, 06001
Actively Recruiting
67
Investigational Site Number : 2500003
Paris, France, 75013
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68
Investigational Site Number : 2760003
Berlin, Germany, 10117
Actively Recruiting
69
Investigational Site Number : 2760008
Bochum, Germany, 44791
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70
Investigational Site Number : 2760006
Göttingen, Germany, 37075
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71
Investigational Site Number : 2760005
Hanover, Germany, 30625
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72
Investigational Site Number : 2760001
Münster, Germany, 48149
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73
Investigational Site Number : 3480003
Budapest, Hungary, 1085
Actively Recruiting
74
Investigational Site Number : 3480004
Győr, Hungary, 9024
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75
Investigational Site Number : 3480001
Szeged, Hungary, 6720
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76
Investigational Site Number : 3760001
Haifa, Israel, 3109601
Actively Recruiting
77
Investigational Site Number : 3800004
Milan, Milano, Italy, 20132
Actively Recruiting
78
Investigational Site Number : 3800001
Padua, Padova, Italy, 35128
Actively Recruiting
79
Investigational Site Number : 3800002
Bologna, Italy, 40139
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80
Investigational Site Number : 3920007
Amagasaki, Hyōgo, Japan, 660-8511
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81
Investigational Site Number : 3920015
Yokohama, Kanagawa, Japan, 222-0036
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82
Investigational Site Number : 3920012
Higashi-Matsuyama, Saitama, Japan, 355-0005
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83
Investigational Site Number : 3920005
Kawagoe, Saitama, Japan, 350-8550
Actively Recruiting
84
Investigational Site Number : 3920014
Yaizu, Shizuoka, Japan, 425-8505
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85
Investigational Site Number : 3920008
Kodaira, Tokyo, Japan, 187-8551
Actively Recruiting
86
Investigational Site Number : 3920010
Ōta-ku, Tokyo, Japan, 143-8541
Actively Recruiting
87
Investigational Site Number : 3920001
Chiba, Japan, 260-8677
Actively Recruiting
88
Investigational Site Number : 3920009
Saga, Japan, 849-0937
Actively Recruiting
89
Investigational Site Number : 4840002
Chihuahua City, Mexico, 31000
Actively Recruiting
90
Investigational Site Number : 4840001
Tlalnepantla, Mexico, 54055
Actively Recruiting
91
Investigational Site Number : 5780001
Oslo, Norway, 0450
Actively Recruiting
92
Investigational Site Number : 6200003
Braga, Portugal, 4710-243
Actively Recruiting
93
Investigational Site Number : 6200005
Coimbra, Portugal, 3000-075
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94
Investigational Site Number : 6200002
Lisbon, Portugal, 1150-199
Actively Recruiting
95
Investigational Site Number : 6200001
Lisbon, Portugal, 1349-019
Actively Recruiting
96
Investigational Site Number : 7240012
Santiago de Compostela, A Coruña [La Coruña], Spain, 15706
Actively Recruiting
97
Investigational Site Number : 7240009
Barcelona, Barcelona [Barcelona], Spain, 08035
Actively Recruiting
98
Investigational Site Number : 7240006
Sabadell, Barcelona [Barcelona], Spain, 08208
Actively Recruiting
99
Investigational Site Number : 7240001
Barcelona, Catalunya [Cataluña], Spain, 08041
Actively Recruiting
100
Investigational Site Number : 7240008
Majadahonda, Madrid, Spain, 28222
Actively Recruiting
101
Investigational Site Number : 7240002
Pamplona, Navarre, Spain, 31008
Actively Recruiting
102
Investigational Site Number : 7240003
Oviedo, Principality of Asturias, Spain, 33011
Actively Recruiting
103
Investigational Site Number : 7240007
Málaga, Spain, 29010
Actively Recruiting
104
Investigational Site Number : 7240010
Santa Cruz de Tenerife, Spain, 38010
Actively Recruiting
105
Investigational Site Number : 7240004
Valencia, Spain, 46026
Actively Recruiting
106
Investigational Site Number : 7520001
Stockholm, Sweden, 113 65
Actively Recruiting
107
Investigational Site Number : 7560001
Basel, Switzerland, 4056
Actively Recruiting
108
Investigational Site Number : 7560003
Bern, Switzerland, 3010
Actively Recruiting
109
Investigational Site Number : 1580003
Kaohsiung City, Taiwan, 833
Actively Recruiting
110
Investigational Site Number : 1580001
Taipei, Taiwan, 100
Actively Recruiting
111
Investigational Site Number : 1580002
Taipei, Taiwan, 112
Actively Recruiting
112
Investigational Site Number : 7920004
Bursa, Turkey (Türkiye), 16059
Actively Recruiting
113
Investigational Site Number : 7920001
Istanbul, Turkey (Türkiye), 34093
Actively Recruiting
114
Investigational Site Number : 7920002
Istanbul, Turkey (Türkiye), 34785
Actively Recruiting
115
Investigational Site Number : 7920003
Konya, Turkey (Türkiye), 42075
Actively Recruiting
116
Investigational Site Number : 8260007
London, England, United Kingdom, E1 1BB
Actively Recruiting
117
Investigational Site Number : 8260003
Inverness, Highland, United Kingdom, IV2 3UJ
Actively Recruiting
118
Investigational Site Number : 8260001
Oxford, Oxfordshire, United Kingdom, OX3 9DU
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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