Actively Recruiting
A Phase 3, Randomized, Double-blind Study Evaluating Efficacy and Safety of Riliprubart Versus Intravenous Immunoglobulin (IVIg) in Participants With Chronic Inflammatory Demyelinating Polyneuropathy
Led by Sanofi · Updated on 2026-05-29
160
Participants Needed
123
Research Sites
79 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the efficacy of riliprubart compared to intravenous immunoglobulin (IVIg) in adults with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) who are already receiving maintenance IVIg treatment. The study is a Phase 3, randomized, double-blind trial designed to assess how well riliprubart works and how safe it is over a period lasting up to 109 weeks, including screening, treatment, and follow-up phases. Participants will be randomly assigned to one of two groups. One group will receive riliprubart plus a placebo IVIg treatment for 24 weeks, followed by an open-label extension phase of riliprubart for another 24 weeks. The other group will continue IVIg treatment plus a placebo riliprubart for 24 weeks, then switch to the open-label riliprubart extension phase. Treatments are given by intravenous or subcutaneous solutions as appropriate. Throughout the study, participants will be monitored regularly to assess their response to treatment using measures such as disability scales, grip strength, fatigue severity, and relapse rates. Safety will be closely observed through reports of adverse events and antibody development. The study includes a long-term follow-up period to track ongoing effects, with total participation lasting up to 109 weeks.
CONDITIONS
Brief 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...
- Adults aged 18 years or older
- Diagnosis of CIDP or possible CIDP according to European Academy of Neurology (EAN)/Peripheral Nerve Society (PNS) 2021 guidelines
- Typical CIDP or motor CIDP or multifocal CIDP (Lewis Sumner Syndrome) confirmed by adjudication committee
- Past response to IVIg within the last 5 years
- Stable maintenance dose of IVIg treatment
- Residual disability with INCAT score between 2 and 9 at screening and baseline
- Receiving IVIg within standard maintenance dosing regimen per EAN/PNS guidelines
- If receiving IVIg at home, able to switch to hospital or infusion center at least one cycle before baseline
- Active disease with CIDP disease activity score (CDAS) of 2 or higher at screening
- Documented vaccination against encapsulated bacterial pathogens within 5 years prior to day 1 or started at least 14 days before first study dose
- Use of contraception if sexually active, not pregnant or breastfeeding, and no sperm donation for males
- Body weight between 35 kg and 154 kg (77 to 340 lbs) at screening
- Evidence of clinically meaningful deterioration(s) within 2 or 5 years prior to screening during interrupted or reduced immunoglobulin therapy
You will not qualify if you...
- Polyneuropathy from other causes such as Guillain-Barré syndrome, hereditary neuropathies, diabetic neuropathy, drug-induced neuropathies, multifocal motor neuropathy, and others
- Sensory, distal, or focal CIDP variants
- Other neurological or systemic diseases affecting treatment or assessments
- Poorly controlled diabetes
- Recent serious infections or active infections requiring treatment
- Systemic Lupus Erythematosus (SLE) diagnosis or relevant family history
- Allergic reactions to study drugs or monoclonal antibodies
- Contraindications to immunoglobulin administration including kidney disease or thromboembolic conditions
- Medical history or conditions that affect safety or data quality
- Recent suicide attempts or risk
- Recent worsening of CIDP after vaccination
- Recent/planned major surgery
- Recent treatment with plasma exchange, certain immunosuppressive medications, or B-cell depleting agents
- Prior treatment with riliprubart or specific complement inhibitors
- Recent vaccination within 28 days before dosing
- Participation in other investigational drug trials recently
- Abnormal lab or ECG results deemed clinically significant
- Positive tests for hepatitis B, C, or HIV infections
- Pregnancy or breastfeeding
- Institutionalization or imprisonment
- Unsuitable for study participation or noncompliance risk
- Employment or family relation to 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 24 weeks
Participants receive either riliprubart or intravenous immunoglobulin (IVIg) for 24 weeks. This period involves active treatment with study drugs administered by intravenous or subcutaneous routes.
Regular visits for treatment and assessments during 24 weeks
Duration - 24 weeks
After the initial 24 weeks, participants enter an open-label extension phase where all receive riliprubart for an additional 24 weeks to further assess efficacy and safety.
Regular visits during the open-label extension phase
Trial Site Locations
Total: 123 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, 66160
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11
Ochsner Medical Center - Jefferson Highway- Site Number : 8400030
New Orleans, Louisiana, United States, 70121
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12
Johns Hopkins Hospital- Site Number : 8400015
Baltimore, Maryland, United States, 21287
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13
Massachusetts General Hospital- Site Number : 8400009
Boston, Massachusetts, United States, 02114
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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
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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
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18
Dent Neurologic Institute - Amherst- Site Number : 8400039
Amherst, New York, United States, 14226
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19
Hospital for Special Surgery- Site Number : 8400041
New York, New York, United States, 10021
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20
Columbia University Irving Medical Center- Site Number : 8400003
New York, New York, United States, 10032
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21
Raleigh Neurology Associates- Site Number : 8400043
Raleigh, North Carolina, United States, 27607
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22
University of Cincinnati Medical Center- Site Number : 8400020
Cincinnati, Ohio, United States, 45219
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23
University Hospitals Cleveland Medical Center- Site Number : 8400033
Cleveland, Ohio, United States, 44106
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24
Penn State Health Milton South Hershey Medical Center- Site Number : 8400042
Hershey, Pennsylvania, United States, 17033
Actively Recruiting
25
Penn Medicine: University of Pennsylvania Health System- Site Number : 8400022
Philadelphia, Pennsylvania, United States, 19104
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26
Austin Neuromuscular Center- Site Number : 8400040
Austin, Texas, United States, 78756
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27
UTHealth - The University of Texas Health Sciences Center at Houston- Site Number : 8400050
Houston, Texas, United States, 77054
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28
University of Vermont Medical Center- Site Number : 8400012
Burlington, Vermont, United States, 05401
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29
University of Virginia- Site Number : 8400023
Charlottesville, Virginia, United States, 22908
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30
Investigational Site Number : 0320001
Buenos Aires, Argentina, 1015
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31
Investigational Site Number : 0320002
Buenos Aires, Argentina, 1181
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32
Investigational Site Number : 0320003
Buenos Aires, Argentina, 1221
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33
Investigational Site Number : 0560002
Ghent, Belgium, 9000
Completed
34
Investigational Site Number : 0560001
Leuven, Belgium, 3000
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35
L2IP - Instituto de Pesquisas Clínicas- Site Number : 0760006
Brasília, Federal District, Brazil, 70200-730
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36
Freire Pesquisa Clínica - Belo Horizonte - Rua Piauí- Site Number : 0760016
Belo Horizonte, Minas Gerais, Brazil, 30150-320
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37
Instituto de Neurologia de Curitiba - Ecoville- Site Number : 0760007
Curitiba, Paraná, Brazil, 81210-310
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38
InsCer - Instituto do Cérebro da PUCRS- Site Number : 0760002
Porto Alegre, Rio Grande do Sul, Brazil, 90610-000
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39
PSEG Centro de Pesquisa Clínica- Site Number : 0760009
São Paulo, Brazil, 04038-002
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40
Investigational Site Number : 1240003
London, Ontario, Canada, N6A 5A5
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41
Investigational Site Number : 1240006
Montreal, Quebec, Canada, H3a 2b4
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42
Investigational Site Number : 1240001
Québec, Quebec, Canada, G1E 7G9
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43
Investigational Site Number : 1560013
Beijing, China, 100034
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44
Investigational Site Number : 1560010
Beijing, China, 100050
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45
Investigational Site Number : 1560005
Beijing, China, 100053
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46
Investigational Site Number : 1560017
Beijing, China, 100730
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47
Investigational Site Number : 1560009
Changsha, China, 410008
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48
Investigational Site Number : 1560011
Chengdu, China, 610072
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49
Investigational Site Number : 1560002
Fuzhou, China, 350001
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50
Investigational Site Number : 1560012
Guangzhou, China, 510000
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51
Investigational Site Number : 1560007
Guangzhou, China, 510080
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52
Investigational Site Number : 1560014
Hangzhou, China, 310003
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53
Investigational Site Number : 1560016
Jiazhuang, China, 050000
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54
Investigational Site Number : 1560008
Jinan, China, 250014
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55
Investigational Site Number : 1560015
Nanchang, China, 330006
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56
Investigational Site Number : 1560001
Shanghai, China, 200040
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57
Investigational Site Number : 1560003
Wuhan, China, 430030
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58
Investigational Site Number : 1560006
Wuhan, China, 430060
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59
Investigational Site Number : 1560004
Xi'an, China, 710038
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60
Investigational Site Number : 2030004
Brno, Czechia, 625 00
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61
Investigational Site Number : 2030003
Hradec Králové, Czechia, 500 05
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62
Investigational Site Number : 2030005
Ostrava, Czechia, 708 52
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63
Investigational Site Number : 2030002
Pardubice, Czechia, 532 03
Completed
64
Investigational Site Number : 2030001
Prague, Czechia, 128 08
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65
Investigational Site Number : 2080002
Aarhus, Denmark, 8200
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66
Investigational Site Number : 2080001
Copenhagen, Denmark, 2100
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67
Investigational Site Number : 2500001
Le Kremlin-Bicêtre, France, 94270
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68
Investigational Site Number : 2500002
Marseille, France, 13885
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69
Investigational Site Number : 2500005
Nice, France, 06001
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70
Investigational Site Number : 2500003
Paris, France, 75013
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71
Investigational Site Number : 2760003
Berlin, Germany, 10117
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72
Investigational Site Number : 2760008
Bochum, Germany, 44791
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73
Investigational Site Number : 2760007
Essen, Germany, 45147
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74
Investigational Site Number : 2760006
Göttingen, Germany, 37075
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75
Investigational Site Number : 2760005
Hanover, Germany, 30625
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76
Investigational Site Number : 2760001
Münster, Germany, 48149
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77
Investigational Site Number : 3480003
Budapest, Hungary, 1085
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78
Investigational Site Number : 3480005
Budapest, Hungary, 1125
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79
Investigational Site Number : 3480004
Győr, Hungary, 9024
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80
Investigational Site Number : 3480001
Szeged, Hungary, 6720
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81
Investigational Site Number : 3760001
Haifa, Israel, 3109601
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82
Investigational Site Number : 3800004
Milan, Milano, Italy, 20132
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83
Investigational Site Number : 3800001
Padua, Padova, Italy, 35128
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84
Investigational Site Number : 3800002
Bologna, Italy, 40139
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85
Investigational Site Number : 3920007
Amagasaki, Hyōgo, Japan, 660-8511
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86
Investigational Site Number : 3920015
Yokohama, Kanagawa, Japan, 222-0036
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87
Investigational Site Number : 3920012
Higashi-Matsuyama, Saitama, Japan, 355-0005
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88
Investigational Site Number : 3920005
Kawagoe, Saitama, Japan, 350-8550
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89
Investigational Site Number : 3920014
Yaizu, Shizuoka, Japan, 425-8505
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90
Investigational Site Number : 3920008
Kodaira, Tokyo, Japan, 187-8551
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91
Investigational Site Number : 3920010
Ōta-ku, Tokyo, Japan, 143-8541
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92
Investigational Site Number : 3920001
Chiba, Japan, 260-8677
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93
Investigational Site Number : 3920009
Saga, Japan, 849-0937
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94
Investigational Site Number : 4840002
Chihuahua City, Mexico, 31000
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95
Investigational Site Number : 4840001
Tlalnepantla, Mexico, 54055
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96
Investigational Site Number : 5780001
Oslo, Norway, 0450
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97
Investigational Site Number : 6200003
Braga, Portugal, 4710-243
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98
Investigational Site Number : 6200005
Coimbra, Portugal, 3000-075
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99
Investigational Site Number : 6200002
Lisbon, Portugal, 1150-199
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100
Investigational Site Number : 6200001
Lisbon, Portugal, 1349-019
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101
Investigational Site Number : 7240012
Santiago de Compostela, A Coruña [La Coruña], Spain, 15706
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102
Investigational Site Number : 7240009
Barcelona, Barcelona [Barcelona], Spain, 08035
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103
Investigational Site Number : 7240006
Sabadell, Barcelona [Barcelona], Spain, 08208
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104
Investigational Site Number : 7240001
Barcelona, Catalunya [Cataluña], Spain, 08041
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105
Investigational Site Number : 7240008
Majadahonda, Madrid, Spain, 28222
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106
Investigational Site Number : 7240002
Pamplona, Navarre, Spain, 31008
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107
Investigational Site Number : 7240003
Oviedo, Principality of Asturias, Spain, 33011
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108
Investigational Site Number : 7240007
Málaga, Spain, 29010
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109
Investigational Site Number : 7240010
Santa Cruz de Tenerife, Spain, 38010
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110
Investigational Site Number : 7240004
Valencia, Spain, 46026
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111
Investigational Site Number : 7520001
Stockholm, Sweden, 113 65
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112
Investigational Site Number : 7560001
Basel, Switzerland, 4056
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113
Investigational Site Number : 7560003
Bern, Switzerland, 3010
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114
Investigational Site Number : 1580003
Kaohsiung City, Taiwan, 833
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115
Investigational Site Number : 1580001
Taipei, Taiwan, 100
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116
Investigational Site Number : 1580002
Taipei, Taiwan, 112
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117
Investigational Site Number : 7920004
Bursa, Turkey (Türkiye), 16059
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118
Investigational Site Number : 7920001
Istanbul, Turkey (Türkiye), 34093
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119
Investigational Site Number : 7920002
Istanbul, Turkey (Türkiye), 34785
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120
Investigational Site Number : 7920003
Konya, Turkey (Türkiye), 42075
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121
Investigational Site Number : 8260007
London, England, United Kingdom, E1 1BB
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122
Investigational Site Number : 8260003
Inverness, Highland, United Kingdom, IV2 3UJ
Actively Recruiting
123
Investigational Site Number : 8260001
Oxford, Oxfordshire, United Kingdom, OX3 9DU
Actively Recruiting
Research Team
T
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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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