A Phase 3, Randomized, Double-blind, Study Evaluating Efficacy and Safety of Riliprubart Versus Intravenous Immunoglobulin (IVIg) in Participants With Chronic Inflammatory Demyelinating Polyneuropathy

Status: Recruiting
Location: See all (87) 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 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.

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)/ Peripherial Nerve Society (PNS) Task Force CIDP guidelines, second revision (2021).

• Participant must have either typical CIDP, or one of the following 2 CIDP variants: motor CIDP (including motor-predominant CIDP), multifocal CIDP (also known as Lewis Sumner Syndrome). Diagnosis must be confirmed by the study adjudication committee.

• Participants must have responded to IVIg in the past 5 years. Response must be an objective clinically meaningful improvement defined by at least one of the following: ≥1 point decrease in adjusted INCAT score, ≥4 points increase in I-RODS centile score, ≥3 points increase in the MRC-SS, ≥8 kilopascal improvement in mean grip strength (1 hand), or an equivalent improvement based on information documented in medical records as per the Investigator's judgment.

• Participant must be on a stable maintenance dosage of IVIg, defined as no change greater than 10% in frequency or dose of IVIg within 8 weeks prior to Screening, and remaining stable until baseline.

• Participant must have residual disability, defined as an INCAT score of 2 to 9 at Screening that is confirmed at baseline (a score of 2 should be exclusively from leg disability component of INCAT).

• Participant must be receiving treatment with IVIg within a standard maintenance dosing regimen, defined as per EAN/PNS 2021 CIDP guidelines: 0.4 to 1 g/kg every 2 to 6 weeks. The IVIg maintenance dosing regimen should be equivalent or higher than a weekly dose of 0.1 g/kg body weight (for example, 0.3 g/kg every 3 weeks).

• Participants receiving IVIg infusions at home are eligible, as long as IVIg infusions are switched to a hospital or infusion center setting at least 1 cycle prior to baseline.

• 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.

⁃ A male participant is 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, either:

‣ -Be abstinent from heterosexual intercourse (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 (Contraceptive and barrier guidance per protocol) when having sexual intercourse with a woman of childbearing potential (WOCBP) who is not currently pregnant.

⁃ 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 WOCBP and agrees to use a contraceptive method that is highly effective (with a failure rate of \<1% per year), as described in the protocol 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.

⁃ Participant must have a body weight at Screening of 35 kg to 154 kg (77 to 340 lbs) inclusive.

⁃ Evidence of at least one clinically meaningful deterioration within 2 years, or at least 2 clinically meaningful deteriorations within 5 years prior to screening which occurred during period of interrupted dosing, reduced dosage, or extended intervals between doses of immunoglobin therapy, as verified by clinical examination or medical records.

Locations
United States
Alabama
Alabama Neurology Associates- Site Number : 8400019
RECRUITING
Homewood
Arizona
Phoenix Neurological Associates - Phoenix- Site Number : 8400014
RECRUITING
Phoenix
California
USC- Site Number : 8400002
RECRUITING
Los Angeles
University of California Irvine Medical Center- Site Number : 8400007
RECRUITING
Orange
Connecticut
Yale University School of Medicine- Site Number : 8400018
RECRUITING
New Haven
Florida
AdventHealth Site Number : 8400006
RECRUITING
Orlando
AdventHealth- Site Number : 8400006
RECRUITING
Orlando
Kansas
University of Kansas Medical Center- Site Number : 8400010
RECRUITING
Kansas City
Louisiana
Ochsner Clinic Foundation- Site Number : 8400030
RECRUITING
New Orleans
Massachusetts
~Mass General Hospital- Site Number : 8400009
RECRUITING
Boston
Michigan
~Henry Ford Hospital- Site Number : 8400025
RECRUITING
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
Dent Neurologic Institute- Site Number : 8400039
RECRUITING
Amherst
Columbia University- Site Number : 8400003
RECRUITING
New York
Ohio
University of Cincinnati - Internal Medicine- Site Number : 8400020
RECRUITING
Cincinnati
Texas
Austin Neuromuscular Center, National Neuromuscular Research Institute - Site Number : 8400040
RECRUITING
Austin
Virginia
University of Virginia- Site Number : 8400023
RECRUITING
Charlottesville
Other Locations
Argentina
Investigational Site Number : 0320003
RECRUITING
Buenos Aires
Investigational Site Number : 0320001
RECRUITING
Caba
Investigational Site Number : 0320002
RECRUITING
Ciudad Autonoma Buenos Aires
Belgium
Investigational Site Number : 0560002
RECRUITING
Ghent
Investigational Site Number : 0560001
RECRUITING
Leuven
Brazil
L2IP Instituto de Pesquisas Clinicas- Site Number : 0760006
RECRUITING
Brasília
Instituto de Neurologia de Curitiba - Ecoville- Site Number : 0760007
RECRUITING
Curitiba
Instituto do Cerebro - InsCer- Site Number : 0760002
RECRUITING
Porto Alegre
PSEG Centro de Pesquisa Clinica- Site Number : 0760009
RECRUITING
São Paulo
Canada
Investigational Site Number : 1240003
RECRUITING
London
Investigational Site Number : 1240006
RECRUITING
Montreal
Investigational Site Number : 1240001
RECRUITING
Québec
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
RECRUITING
Shanghai
Investigational Site Number : 1560003
RECRUITING
Wuhan
Investigational Site Number : 1560006
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Wuhan
Investigational Site Number : 1560004
RECRUITING
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 : 2500005
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Nice
Germany
Investigational Site Number : 2760005
RECRUITING
Hanover
Investigational Site Number : 2760001
RECRUITING
Münster
Hungary
Investigational Site Number : 3480003
RECRUITING
Budapest
Investigational Site Number : 3480004
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Győr
Investigational Site Number : 3480001
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Szeged
Israel
Investigational Site Number : 3760001
RECRUITING
Haifa
Japan
Investigational Site Number : 3920007
RECRUITING
Amagasaki
Investigational Site Number : 3920001
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Chiba
Investigational Site Number : 3920012
RECRUITING
Higashimatsuyama-shi
Investigational Site Number : 3920005
RECRUITING
Kawagoe
Investigational Site Number : 3920008
RECRUITING
Kodaira-shi
Investigational Site Number : 3920010
RECRUITING
Ōta-ku
Investigational Site Number : 3920009
RECRUITING
Saga
Investigational Site Number : 3920014
RECRUITING
Yaizu
Investigational Site Number : 3920015
RECRUITING
Yokohama
Mexico
Investigational Site Number : 4840002
RECRUITING
Chihuahua City
Investigational Site Number : 4840001
RECRUITING
Tlalnepantla
Portugal
Investigational Site Number : 6200003
RECRUITING
Braga
Investigational Site Number : 6200005
RECRUITING
Coimbra
Investigational Site Number : 6200001
RECRUITING
Lisbon
Investigational Site Number : 6200002
RECRUITING
Lisbon
Spain
Investigational Site Number : 7240008
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Majadahonda
Investigational Site Number : 7240007
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Málaga
Investigational Site Number : 7240003
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Oviedo
Investigational Site Number : 7240002
RECRUITING
Pamplona
Investigational Site Number : 7240006
RECRUITING
Sabadell
Investigational Site Number : 7240004
RECRUITING
Valencia
Sweden
Investigational Site Number : 7520001
RECRUITING
Stockholm
Switzerland
Investigational Site Number : 7560003
RECRUITING
Bern
Taiwan
Investigational Site Number : 1580003
RECRUITING
Kaohsiung City
Investigational Site Number : 1580001
RECRUITING
Taipei
Investigational Site Number : 1580002
RECRUITING
Taipei
Turkey
Investigational Site Number : 7920004
RECRUITING
Bursa
Investigational Site Number : 7920001
RECRUITING
Istanbul
Investigational Site Number : 7920002
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Istanbul
Investigational Site Number : 7920003
RECRUITING
Konya
United Kingdom
Investigational Site Number : 8260003
RECRUITING
Inverness
Investigational Site Number : 8260001
RECRUITING
Oxford
Contact Information
Primary
Trial Transparency email recommended (Toll free for US & Canada)
contact-us@sanofi.com
800-633-1610
Time Frame
Start Date: 2024-08-21
Estimated Completion Date: 2027-11-19
Participants
Target number of participants: 160
Treatments
Experimental: Riliprubart Arm
Riliprubart + Placebo IVIg for 24 weeks followed by open-label extension phase with riliprubart for 24 weeks
Active_comparator: IVIg Arm
IVIg (IVIg continuation) + Placebo riliprubart for 24 weeks followed by open-label extension phase with riliprubart for 24 weeks
Sponsors
Leads: Sanofi

This content was sourced from clinicaltrials.gov