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)

Part of paid clinical trials in Homewood, Alabama.

Sponsor
Sanofi
Study ID
NCT06290141
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Chronic Inflammatory Demyelinating Polyneuropathy

Eligibility Criteria

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

Interventions

  • riliprubart — DRUG
    Pharmaceutical form: Solution Route of administration: IV solution
  • Placebo — DRUG
    Pharmaceutical form: Solution Route of administration: IV solution
  • riliprubart — DRUG
    Pharmaceutical form: Solution Route of administration: SC solution
  • Placebo — DRUG
    Pharmaceutical form: Solution Route of administration: SC solution
  • IVIg — DRUG
    Pharmaceutical form: Concentrate for solution for infusion (or any other formulation approved locally) Route of administration: IV solution
  • Placebo — DRUG
    Pharmaceutical form: Placebo to match intravenous immunoglobulin IVIg for IV infusio Route of administration: IV solution

Study Details

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.

Key Dates

Start date
Aug 21, 2024
Status verified
May 2026
Primary completion
Jul 9, 2027
Completion
Jan 12, 2029

Study Design

Enrollment
160 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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

Primary Outcome Measure

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

Central Contacts

  • Trial Transparency email recommended (Toll free for US & Canada)
    800-633-1610
    [email protected]

Locations (29)

FacilityCityStateZIPSite coordinators
Alabama Neurology Associates- Site Number : 8400019HomewoodAlabama35209-
Honor Health Scottsdale Osborn Medical Center- Site Number : 8400014ScottsdaleArizona85251-
Keck School of Medicine of University of Southern California- Site Number : 8400002Los AngelesCalifornia90033-
University of California Irvine Medical Center- Site Number : 8400007OrangeCalifornia92868-
Yale University School of Medicine- Site Number : 8400018New HavenConnecticut06510-
Nova Clinical Research - Bradenton- Site Number : 8400044BradentonFlorida34209-
AdventHealth Orlando- Site Number : 8400006OrlandoFlorida32803-
AdventHealth Site Number : 8400006OrlandoFlorida32804-5558-
NorthShore University Health System - Glenbrook Hospital- Site Number : 8400024GlenviewIllinois60026-
University of Kansas Medical Center- Site Number : 8400010Kansas CityKansas66160-
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-
Dent Neurologic Institute - Amherst- Site Number : 8400039AmherstNew York14226-
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, ALHonor Health Scottsdale Osborn Medical Center· Scottsdale, AZKeck School of Medicine of University of Southern California· Los Angeles, CAUniversity of California Irvine Medical Center· Orange, CAYale University School of Medicine· New Haven, CTNova Clinical Research - Bradenton· Bradenton, FL

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