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Riliprubart Arm for Chronic Inflammatory Demyelinating Polyradiculoneuropathy (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 109

Awards & highlights

MOBILIZE 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.Check my eligibility

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.See study design

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.

MOBILIZE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 24 to week 109

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 24 to week 109

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 24 to week 109 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 more

Secondary outcome measures

Change from baseline in EQ-5D-5L score

Change from baseline in I RODS score

Change from baseline in Inflammatory Raschbuilt Overall Disability Scale (IRODS) score

+13 more

MOBILIZE 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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

SanofiLead Sponsor

2,164 Previous Clinical Trials

3,514,840 Total Patients Enrolled

1 Trials studying Chronic Inflammatory Demyelinating Polyradiculoneuropathy

160 Patients Enrolled for Chronic Inflammatory Demyelinating Polyradiculoneuropathy

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are researchers currently seeking participants for this study?

"Affirmative. Clinical trial details on clinicaltrials.gov affirm that patient recruitment is ongoing for this particular study, initially uploaded on April 9th, 2024, with the latest update made on March 27th in the same year. The aim is to enroll a total of 140 participants at one specified site."

Answered by AI

What is the uppermost limit for participant enrollment in this research endeavor?

"Indeed, as outlined on clinicaltrials.gov, the ongoing recruitment of participants for this trial is apparent. The trial was first listed on 4/9/2024 and underwent its latest update on 3/27/2024. Enrollment aims to include 140 individuals from a single site."

Answered by AI

Has the FDA officially endorsed the use of Riliprubart Arm?

"Based on our evaluation at Power, the safety rating of Riliprubart Arm is deemed as 3 due to its Phase 3 trial status. This indicates a level of efficacy support and consistent data affirming its safety profile."

Answered by AI