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Monoclonal Antibodies
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
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 belowSelect...
I have been diagnosed with CIDP or a specific type of it.
Select...
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
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
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Riliprubart ArmExperimental Treatment3 Interventions
Riliprubart + Placebo IVIg for 24 weeks followed by open-label extension phase with riliprubart for 24 weeks
Group II: IVIg ArmActive Control4 Interventions
IVIg (IVIg continuation) + Placebo riliprubart for 24 weeks followed by open-label extension phase with riliprubart for 24 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670
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Who is running the clinical trial?
SanofiLead Sponsor
2,187 Previous Clinical Trials
3,979,618 Total Patients Enrolled
1 Trials studying Chronic Inflammatory Demyelinating Polyradiculoneuropathy
140 Patients Enrolled for Chronic Inflammatory Demyelinating Polyradiculoneuropathy
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