Long-term Safety and Efficacy Study of Riliprubart in Participants With CIDP

Part of paid clinical trials in Homewood, Alabama.

Sponsor
Sanofi
Study ID
NCT06859099
Phase
PHASE3
Status
Enrolling By Invitation

Conditions

  • Polyneuropathy, Inflammatory Demyelinating, Chronic

Eligibility Criteria

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

Interventions

Study Details

This study is a Phase 3 extension, global, multicenter open-label study. The purpose of this study is to evaluate long-term safety and efficacy of riliprubart in adult participants with chronic inflammatory demyelinating polyneuropathy (CIDP) who have completed Part B in 1 of 3 parent studies (PDY16744, EFC17236, or EFC18156) and wish to continue treatment with riliprubart. Up to approximately 300 participants will be enrolled to continue receiving treatment with riliprubart. The duration of participation for each participant will be up to approximately 4 years, including posttreatment follow-up. The treatment duration will be up to approximately 3 years. A participant who discontinues riliprubart treatment at any time during the study will be followed for safety for a minimum of 55 weeks after the last dose of riliprubart received.

Key Dates

Start date
Apr 1, 2025
Status verified
May 2026
Primary completion
Oct 3, 2029
Completion
Oct 3, 2029

Study Design

Enrollment
300 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: riliprubart
    Participants receive subcutaneous injection with a riliprubart prefilled pen (PFP)

Primary Outcome Measure

Number of participants having any AEs, SAEs, adverse events leading to treatment discontinuation, AESIs, and potentially clinically significant abnormalities (PCSAs) in safety laboratory tests, ECGs, and vital signs during the study period [ Time Frame: Up to End of Study (approx. 4 years) ]

Locations (3)

FacilityCityStateZIPSite coordinators
Alabama Neurology Associates- Site Number : 8400019HomewoodAlabama35209-
University of Kansas Medical Center- Site Number : 8400010Kansas CityKansas66160-
Penn Medicine: University of Pennsylvania Health System- Site Number : 8400022PhiladelphiaPennsylvania19104-

Find similar trials in Homewood, AL

By research site
Alabama Neurology Associates· Homewood, ALUniversity of Kansas Medical Center· Kansas City, KSPenn Medicine: University of Pennsylvania Health System· Philadelphia, PA

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