Riliprubart vs IVIg for CIDP (VITALIZE Trial)

Phase 3

Recruiting

Research Sponsored by Sanofi

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Participant must have active disease, defined by a CIDP disease activity score (CDAS) XE " CDAS " \f Abbreviation \t "CIDP disease activity score" of ≥2 points at Screening.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 24 to week 48

Awards & highlights

Pivotal Trial

Summary

This trial aims to determine if riliprubart is effective for treating CIDP in adults compared to the current standard treatment, IVIg. The study will last for up to 109 weeks

Who is the study for?

This trial is for adults with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) who have responded to IVIg treatment in the past. They must meet specific diagnostic criteria, have a stable dose of IVIg, and some ongoing disability from CIDP. Vaccinations against certain bacteria are required, and participants must agree to use contraception.

What is being tested?

The study tests Riliprubart's effectiveness compared to standard IVIg treatment in managing CIDP symptoms over up to 109 weeks. Participants will be randomly assigned either the new drug or usual treatment and monitored for changes in their condition.

What are the potential side effects?

While not specified here, side effects may include reactions similar to those experienced with IVIg such as headache, nausea, muscle pain, fever or chills; plus any additional risks associated with Riliprubart which would be detailed by the study.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with CIDP or a specific type of it.

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My CIDP is active with a score of 2 or more.

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I am on a standard IVIg treatment plan for CIDP as per 2021 guidelines.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 24 to week 48

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 24 to week 48

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 24 to week 48 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percentage of participants experiencing a response

Percentage of participants randomized to riliprubart who responded during the double-blind period and had a lasting response during the open-label period

Secondary study objectives

Percentage of participants experiencing a relapse

Percentage of participants randomized to IVIg continuation experiencing a relapse

Percentage of participants randomized to IVIg continuation who experience a response

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