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Riliprubart for Chronic Inflammatory Demyelinating Polyneuropathy (MOBILIZE 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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 24 to week 48
Awards & highlights
Pivotal Trial
Summary
"This trial is testing a new drug called riliprubart to see if it works better than a placebo in adults with CIDP who haven't improved with standard treatments. The study will last up
Who is the study for?
This trial is for adults with a condition called CIDP, which affects the nerves and doesn't respond to usual treatments like immunoglobulin or corticosteroids. Participants must meet specific diagnostic criteria and have certain levels of disability as measured by medical scales.
What is being tested?
The study tests Riliprubart against a placebo in people with refractory CIDP over approximately 109 weeks. It aims to see if Riliprubart is more effective than a non-active treatment in improving symptoms.
What are the potential side effects?
While the side effects of Riliprubart are not detailed here, typical drug trials may observe issues such as headache, nausea, allergic reactions, or other immune-related effects depending on how it interacts with the body's nervous system.
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 randomized to placebo who experience a response
Percentage of participants randomized to riliprubart who experience a response
Percentage of participants randomized to riliprubart with lasting response
+1 moreSecondary study objectives
Percentage of participants refractory to immunoglobulins experiencing a response
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Riliprubart ArmExperimental Treatment2 Interventions
Riliprubart for 24 weeks followed by open-label extension phase with riliprubart for 24 weeks
Group II: Placebo ArmPlacebo Group2 Interventions
Placebo 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
Find a Location
Who is running the clinical trial?
SanofiLead Sponsor
2,215 Previous Clinical Trials
4,046,992 Total Patients Enrolled