A Phase 3, Double-blind, Placebo-controlled Study Evaluating Efficacy and Safety of Riliprubart in Participants With Refractory Chronic Inflammatory Demyelinating Polyneuropathy

Status: Recruiting
Location: See all (104) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

‣ Participants are eligible to be included in the study only if all of the following criteria apply:

• Participant must have CIDP or possible CIDP criteria, based on European Academy of Neurology (EAN)/ Peripheral Nerve Society (PNS) Task Force CIDP guidelines, second revision (2021).

⁃ Participant must have either typical CIDP, or one of the following two CIDP variants: motor CIDP (including motor predominant), multifocal CIDP (also known as Lewis Sumner Syndrome). Diagnosis must be confirmed by the adjudication committee.

⁃ Participant must be refractory to either immunoglobulin therapy or corticosteroid therapy, as defined below.

∙ Immunoglobulinrefractory subgroup: Historic evidence of failure or inadequate response to immunoglobulin therapy prior to screening, defined as no clinically meaningful improvement or persistent INCAT score ≥2 after a minimum of:

⁃ One dose of IVIg of 2 g/kg, followed by a second dose of 2 g/kg or two doses of 1 g/kg, with a separation of approximately 3 weeks between doses (each dose can be divided over 2 to 5 days), as indicated in the EAN/PNS 2021 guidelines OR

• SCIg maintenance therapy with at least 0.2 g/kg weekly for 5 weeks

‣ Corticosteroidrefractory subgroup:

‣ Historic evidence of failure or inadequate response to corticosteroid therapy prior to screening, defined as no clinically meaningful improvement or persistent INCAT score ≥2 after a minimum of 12 weeks of corticosteroid therapy. Corticosteroid regimen can be daily oral prednisone/prednisolone, at least 60 mg, equivalent to methylprednisolone 48 mg, tapered over 6 to 8 months, or alternative regimens, e.g. pulsed high-dose corticosteroid treatment (40 mg/day oral dexamethasone or 500 mg/day IV methylprednisolone, each daily for 4 days per month for 6 months), as indicated in the EAN/PNS 2021 guidelines A clinically meaningful improvement is defined as one or more of the following:

⁃ A ≥1 point decrease in adjusted INCAT disability score

⁃ An increase in IRODS centile score ≥4 points

⁃ An increase in MRC Sum score ≥3 points

⁃ An improvement in hand grip strength of ≥8 kilopascals or

⁃ Equivalent improvement based on information from medical records and per the Investigator's judgment

∙ Participant has an adjusted INCAT score of 2 to 9

• -(a score of 2 should be exclusively from the leg disability component of INCAT).

‣ Any allowed immunosuppressant drugs (azathioprine, cyclosporine, or mycophenolate mofetil) have been taken for ≥6 months at a stable dose for ≥3 months prior to Screening

‣ Participant may be receiving low-dose oral corticosteroids (≤20 mg/day of prednisone \[or equivalent dose for other oral corticosteroids\]), but only if taken at a stable dose for ≥3 months prior to Screening

‣ Participant must have active disease, defined by a CIDP disease activity score (CDAS) of ≥ 2 points at Screening

‣ Participant must have documented vaccinations against encapsulated bacterial pathogens given within 5 years prior to Day 1 or initiated a minimum of 14 days prior to first dose of study intervention

‣ All participants must agree to use contraception methods during and after the study as required.

‣ Contraceptive use by men and women participating in the study should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

⁃ Male participants are eligible to participate if they agree to the following during the study intervention period and for at least 55 weeks after the last dose of study medication:

⁃ Refrain from donating or cryopreserving sperm PLUS

⁃ Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent OR

⁃ Must agree to use contraception/barrier as detailed below:

⁃ \---- A male condom and an additional highly effective contraceptive method as described in the protocol.

⁃ \-- A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies:

⁃ Is a woman of nonchildbearing potential (WONCBP) as defined by the protocol OR

⁃ Is a woman of childbearing potential (WOCBP) and agrees to use a contraceptive method that is highly effective (with a failure rate of \<1% per year), as described in Appendix 10.4 Contraception and barrier guidance during the study intervention period (to be effective before starting the intervention) and for at least 55 weeks after the last administration of study intervention and agrees not to donate or cryopreserve eggs (ova, oocytes) for the purpose of reproduction during this period.

∙ Body weight at Screening of 35 kg to 154 kg (77 to 340 lbs), inclusive

Locations
United States
Alabama
Alabama Neurology Associates- Site Number : 8400019
RECRUITING
Homewood
California
University Of Southern California- Site Number : 8400002
RECRUITING
Los Angeles
University of California Irvine- Site Number : 8400007
RECRUITING
Orange
Connecticut
Yale University School of Medicine- Site Number : 8400018
RECRUITING
New Haven
Illinois
Northshore Medical Group- Site Number : 8400024
RECRUITING
Glenview
Kansas
University of Kansas Medical Center (KUMC)- Site Number : 8400010
RECRUITING
Westwood
Louisiana
Neuromedical Clinic of CENLA, LLC- Site Number : 8400031
RECRUITING
Alexandria
Ochsner Clinic Foundation- Site Number : 8400030
RECRUITING
New Orleans
Massachusetts
~Mass General Hospital- Site Number : 8400009
RECRUITING
Boston
Maryland
Johns Hopkins School of Medicine- Site Number : 8400015
RECRUITING
Baltimore
Michigan
~Henry Ford Hospital- Site Number : 8400025
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Detroit
Michigan State University- Site Number : 8400038
RECRUITING
East Lansing
Missouri
Washington University School of Medicine - Siteman Cancer Center- Site Number : 8400037
RECRUITING
St Louis
New York
Columbia University- Site Number : 8400003
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New York
Ohio
University of Cincinnati - Internal Medicine- Site Number : 8400020
RECRUITING
Cincinnati
Pennsylvania
University of Pennsylvania Medical Center- Site Number : 8400022
RECRUITING
Philadelphia
Texas
Austin Neuromuscular Center, National Neuromuscular Research Institute - Site Number : 8400040
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Austin
Virginia
University of Virginia- Site Number : 8400023
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Charlottesville
Vermont
University of Vermont Medical Center- Site Number : 8400012
RECRUITING
South Burlington
Other Locations
Argentina
Investigational Site Number : 0320003
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Buenos Aires
Investigational Site Number : 0320001
RECRUITING
Caba
Investigational Site Number : 0320002
RECRUITING
Ciudad Autonoma Buenos Aires
Belgium
Investigational Site Number : 0560001
RECRUITING
Leuven
Brazil
Hospital Moinhos de Vento - HMV - Site Number : 0760003
RECRUITING
Porto Alegre
Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto da Universidade de Sao Paulo (HCFMRP-USP)- Site Number : 0760007
RECRUITING
Ribeirão Preto
Hospital Sao Rafael - Rede D'OR Sao Luiz- Site Number : 0760011
RECRUITING
Salvador
PSEG Centro de Pesquisa Clinica- Site Number : 0760009
RECRUITING
São Paulo
Centro de Diagnostico e Pesquisa da Osteoporose do Espirito Santo- Site Number : 0760012
RECRUITING
Vitória
Bulgaria
Investigational Site Number : 1000002
RECRUITING
Blagoevgrad
Investigational Site Number : 1000001
RECRUITING
Pleven
Canada
Investigational Site Number : 1240001
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Québec
Chile
Investigational Site Number : 1520001
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Santiago
Investigational Site Number : 1520002
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Santiago
Investigational Site Number : 1520003
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Santiago
China
Investigational Site Number : 1560005
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Beijing
Investigational Site Number : 1560010
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Beijing
Investigational Site Number : 1560013
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Beijing
Investigational Site Number : 1560009
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Changsha
Investigational Site Number : 1560011
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Chengdu
Investigational Site Number : 1560002
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Fuzhou
Investigational Site Number : 1560007
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Guangzhou
Investigational Site Number : 1560012
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Guangzhou
Investigational Site Number : 1560014
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Hangzhou
Investigational Site Number : 1560008
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Jinan
Investigational Site Number : 1560015
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Nanchang
Investigational Site Number : 1560001
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Shanghai
Investigational Site Number : 1560003
RECRUITING
Wuhan
Investigational Site Number : 1560006
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Wuhan
Investigational Site Number : 1560004
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Xi'an
Denmark
Investigational Site Number : 2080002
RECRUITING
Aarhus N
Investigational Site Number : 2080001
RECRUITING
Copenhagen
France
Investigational Site Number : 2500001
RECRUITING
Le Kremlin-bicêtre
Investigational Site Number : 2500002
RECRUITING
Marseille
Investigational Site Number : 2500005
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Montpellier
Investigational Site Number : 2500004
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Paris
Germany
Investigational Site Number : 2760001
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Bad Homburg
Greece
Investigational Site Number : 3000002
RECRUITING
Athens
Investigational Site Number : 3000001
RECRUITING
Thessaloniki
Italy
Investigational Site Number : 3800007
RECRUITING
Messina
Investigational Site Number : 3800001
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Milan
Investigational Site Number : 3800003
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Palermo
Investigational Site Number : 3800005
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Pavia
Investigational Site Number : 3800004
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Pisa
Investigational Site Number : 3800008
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Roma
Investigational Site Number : 3800002
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Rome
Investigational Site Number : 3800006
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Rome
Investigational Site Number : 3800009
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Rozzano
Japan
Investigational Site Number : 3920011
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Bunkyo-ku
Investigational Site Number : 3920001
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Chiba
Investigational Site Number : 3920003
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Fukuoka
Investigational Site Number : 3920013
RECRUITING
Itabashi-ku
Investigational Site Number : 3920005
RECRUITING
Kawagoe
Investigational Site Number : 3920008
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Kodaira-shi
Investigational Site Number : 3920006
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Osaka Sayama-shi
Investigational Site Number : 3920009
RECRUITING
Saga
Mexico
Investigational Site Number : 4840005
RECRUITING
Culiacán
Investigational Site Number : 4840003
RECRUITING
Guadalajara
Investigational Site Number : 4840002
RECRUITING
Veracruz
Netherlands
Investigational Site Number : 5280002
RECRUITING
Rotterdam
Poland
Investigational Site Number : 6160006
RECRUITING
Krakow
Investigational Site Number : 6160002
RECRUITING
Lublin
Investigational Site Number : 6160003
RECRUITING
Rzeszów
Portugal
Investigational Site Number : 6200005
RECRUITING
Coimbra
Investigational Site Number : 6200001
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Lisbon
Investigational Site Number : 6200004
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Lisbon
Investigational Site Number : 6200003
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Matosinhos Municipality
Republic of Korea
Investigational Site Number : 4100001
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Seoul
Investigational Site Number : 4100002
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Seoul
Investigational Site Number : 4100003
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Seoul
Spain
Investigational Site Number : 7240001
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Barcelona
Investigational Site Number : 7240008
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Barcelona
Investigational Site Number : 7240007
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Bilbao
Investigational Site Number : 7240006
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Majadahonda
Investigational Site Number : 7240005
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Oviedo
Investigational Site Number : 7240003
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Pamplona
Investigational Site Number : 7240002
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Valencia
Sweden
Investigational Site Number : 7520001
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Stockholm
Taiwan
Investigational Site Number : 1580003
RECRUITING
Kaohsiung City
Investigational Site Number : 1580001
RECRUITING
Taipei
Investigational Site Number : 1580002
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Taipei
Turkey
Investigational Site Number : 7920002
RECRUITING
Bursa
Investigational Site Number : 7920001
RECRUITING
Istanbul
Investigational Site Number : 7920004
RECRUITING
Istanbul
Investigational Site Number : 7920003
RECRUITING
Konya
Contact Information
Primary
Trial Transparency email recommended (Toll free for US & Canada)
contact-us@sanofi.com
800-633-1610
Time Frame
Start Date: 2024-07-12
Estimated Completion Date: 2027-10-12
Participants
Target number of participants: 140
Treatments
Experimental: Riliprubart Arm
Riliprubart for 24 weeks followed by open-label extension phase with riliprubart for 24 weeks
Placebo_comparator: Placebo Arm
Placebo for 24 weeks followed by open-label extension phase with riliprubart for 24 weeks
Sponsors
Leads: Sanofi

This content was sourced from clinicaltrials.gov