Riliprubart for CIDP

(LTS Trial)

Recruiting at 2 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Sanofi

Must be taking: Riliprubart

Disqualifiers: Pregnancy, Lupus, Hypersensitivity, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 12

Duration: 3 years

300 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the study team or your doctor.

Eligibility Criteria

This trial is for adults with Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) who have already been treated with riliprubart in earlier studies. They must be willing to use contraception and comply with study requirements.

Inclusion Criteria

I agree to use birth control as required during and after the study.

I have CIDP and completed treatment with riliprubart in specified studies.

I can sign and follow the study's consent form and its rules.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive riliprubart weekly for up to 3 years

3 years

12 visits (in-person)

Follow-up

Participants are monitored for safety for a minimum of 55 weeks after the last dose of riliprubart

55 weeks

Treatment Details

Interventions

• Riliprubart

Trial Overview The trial is testing the long-term safety and effectiveness of a medication called Riliprubart, administered through a prefilled pen, in individuals with CIDP over approximately 4 years.

Participant Groups

Group I: riliprubart Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Sanofi

Lead Sponsor

Trials

2,246

Recruited

4,085,000+

Paul Hudson

Sanofi

Chief Executive Officer since 2019

Degree in Economics from Manchester Metropolitan University

Christopher Corsico

Sanofi

Chief Medical Officer

MD from Cornell University, MPH in Chronic Disease Epidemiology from Yale University