Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT06290128

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

Actively Recruiting

36

Investigational Site Number : 1240001

Québec, Quebec, Canada, G1E 7G9

Actively Recruiting

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

Actively Recruiting

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

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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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