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

Part of paid clinical trials in Homewood, Alabama.

Sponsor
Sanofi
Study ID
NCT06290128
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Chronic Inflammatory Demyelinating Polyradiculoneuropathy
  • Polyneuropathy, Inflammatory Demyelinating, Chronic

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Riliprubart — DRUG
    Pharmaceutical form: Solution Route of administration: IV Infusion
  • Placebo — DRUG
    Pharmaceutical form: Solution Route of administration: IV Infusion
  • Riliprubart — DRUG
    Pharmaceutical form: Solution Route of administration: SC Injection
  • Placebo — DRUG
    Pharmaceutical form: Solution Route of administration: SC Injection

Study Details

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.

Key Dates

First listed
Mar 4, 2024
Start date
Jul 12, 2024
Status verified
Aug 2026
Primary completion
Jun 10, 2026
Completion
Oct 31, 2027

Study Design

Enrollment
109 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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

Primary Outcome Measure

Percentage of participants experiencing a response [ Time Frame: Baseline to week 24 ]

Locations (28)

FacilityCityStateZIPSite coordinators
Alabama Neurology Associates- Site Number : 8400019HomewoodAlabama35209-
USC Norris Comprehensive Cancer Center- Site Number : 8400002Los AngelesCalifornia90033-
University of California Irvine - Manchester Pavilion- Site Number : 8400007OrangeCalifornia92868-
IMMUNOe International Research Centers - Centennial- Site Number : 8400049CentennialColorado80112-
Yale University School of Medicine- Site Number : 8400018New HavenConnecticut06510-
Nova Clinical Research - Bradenton- Site Number : 8400044BradentonFlorida34209-
Design Neuroscience Center- Site Number : 8400053Miami LakesFlorida33016-
NorthShore University Health System - Glenbrook Hospital- Site Number : 8400024GlenviewIllinois60026-
University of Kansas Medical Center- Site Number : 8400010Kansas CityKansas66160-
NeuroMedical Clinic of Central Louisiana- Site Number : 8400031AlexandriaLouisiana71301-
Ochsner Medical Center - Jefferson Highway- Site Number : 8400030New OrleansLouisiana70121-
Johns Hopkins Hospital- Site Number : 8400015BaltimoreMaryland21287-
Massachusetts General Hospital- Site Number : 8400009BostonMassachusetts02114-
Henry Ford Hospital- Site Number : 8400025DetroitMichigan48202-
Michigan State University- Site Number : 8400038East LansingMichigan48824-
Washington University School of Medicine - Siteman Cancer Center- Site Number : 8400037St LouisMissouri63110-
Profound Research- Site Number : 8400052Las VegasNevada89106-
Columbia University Irving Medical Center- Site Number : 8400003New YorkNew York10032-
Hospital for Special Surgery - Site Number : 8400041New YorkNew York10021-
Raleigh Neurology Associates- Site Number : 8400043RaleighNorth Carolina27607-
University of Cincinnati Medical Center- Site Number : 8400020CincinnatiOhio45219-
University Hospitals Cleveland Medical Center- Site Number : 8400033ClevelandOhio44106-
Penn State Health Milton South Hershey Medical Center- Site Number : 8400042HersheyPennsylvania17033-
Penn Medicine: University of Pennsylvania Health System- Site Number : 8400022PhiladelphiaPennsylvania19104-
Austin Neuromuscular Center- Site Number : 8400040AustinTexas78756-
UTHealth - The University of Texas Health Sciences Center at Houston- Site Number : 8400050HoustonTexas77054-
University of Vermont Medical Center- Site Number : 8400012BurlingtonVermont05401-
University of Virginia- Site Number : 8400023CharlottesvilleVirginia22908-

Find similar trials in Homewood, AL

By research site
Alabama Neurology Associates· Homewood, ALUSC Norris Comprehensive Cancer Center· Los Angeles, CAUniversity of California Irvine - Manchester Pavilion· Orange, CAIMMUNOe International Research Centers - Centennial· Centennial, COYale University School of Medicine· New Haven, CTNova Clinical Research - Bradenton· Bradenton, FL

Related Studies