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NCT06290128 · ClinicalTrials.gov registry record · Phase 3

A Study to Test the Effects and Safety of Riliprubart in People With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) for Which the Usual Treatments do Not Work

A Phase 3 study of Chronic Inflammatory Demyelinating Polyradiculoneuropathy and Polyneuropathy, Inflammatory Demyelinating, Chronic, sponsored by Sanofi.

Recruiting
Registry status
Phase 3
Development phase
140
Enrollment target
20
Study locations

NCT06290128: Recruiting Phase 3 study of Chronic Inflammatory Demyelinating Polyradiculoneuropathy and Polyneuropathy, Inflammatory Demyelinating, Chronic, sponsored by Sanofi.

NCT06290128 is a Phase 3 study of Chronic Inflammatory Demyelinating Polyradiculoneuropathy and Polyneuropathy, Inflammatory Demyelinating, Chronic that is actively recruiting participants, run by Sanofi. The registered enrollment target is 140 participants, above the 116-participant average among 4 other Chronic Inflammatory Demyelinating Polyradiculoneuropathy trials with a reported enrollment target (21% higher). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06290128, a Phase 3 study of Chronic Inflammatory Demyelinating Polyradiculoneuropathy and Polyneuropathy, Inflammatory Demyelinating, Chronic, is actively recruiting participants, sponsored by Sanofi.

RECRUITING
Registry status
Phase 3
Development phase
140 participants
Enrollment target
20
Study locations

Study Summary

The purpose of the study is to evaluate efficacy of riliprubart compared to placebo in adult participants with CIDP whose disease is refractory to standard of care. The study duration will be for a maximum of 111 weeks including screening, treatment phases, and follow-up.

Primary Outcome

A response is defined as a decrease of ≥1 point from baseline in adjusted INCAT disability score at Week 24.

Interventions

  • DRUG Placebo
  • DRUG Riliprubart

Study Locations (20)

California

  • USC Norris Comprehensive Cancer Center- Site Number : 8400002 - Los Angeles
  • University of California Irvine - Manchester Pavilion- Site Number : 8400007 - Orange

Louisiana

  • NeuroMedical Clinic of Central Louisiana- Site Number : 8400031 - Alexandria
  • Ochsner Medical Center - Jefferson Highway- Site Number : 8400030 - New Orleans

Michigan

  • Henry Ford Hospital- Site Number : 8400025 - Detroit
  • Michigan State University- Site Number : 8400038 - East Lansing

New York

  • Hospital for Special Surgery- Site Number : 8400041 - New York
  • Columbia University Irving Medical Center- Site Number : 8400003 - New York

Ohio

  • University of Cincinnati Medical Center- Site Number : 8400020 - Cincinnati
  • University Hospitals Cleveland Medical Center- Site Number : 8400033 - Cleveland

Pennsylvania

  • Penn State Health Milton South Hershey Medical Center- Site Number : 8400042 - Hershey
  • Penn Medicine: University of Pennsylvania Health System- Site Number : 8400022 - Philadelphia

Alabama

  • Alabama Neurology Associates- Site Number : 8400019 - Homewood

Connecticut

  • Yale University School of Medicine- Site Number : 8400018 - New Haven

Trial Details

FieldValue
Enrollment Target 140 participants
Start Date 2024-07-12
Est. Completion 2028-11-20
Phase Phase 3
Sanofi

713 total trials

What NCT06290128 shows while recruiting

NCT06290128 is an interventional study that assigns participants to a tested intervention. The registered 140 participants enrollment target is mid-sized for trials with a published cap, above the 116-participant average among 4 other Chronic Inflammatory Demyelinating Polyradiculoneuropathy trials with a reported enrollment target (21% higher).

The record links to 2 conditions, with Chronic Inflammatory Demyelinating Polyradiculoneuropathy appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT06290128 names 20 study sites across 14 states, led by California, Louisiana, Michigan.

Frequently Asked Questions

What is clinical trial NCT06290128 about?

NCT06290128 is a clinical study titled "A Study to Test the Effects and Safety of Riliprubart in People With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) for Which the Usual Treatments do Not Work". The purpose of the study is to evaluate efficacy of riliprubart compared to placebo in adult participants with CIDP whose disease is refractory to standard of care. The study duration will be for a maximum of 111 weeks including screening, treatment phases, and follow-up.

What is the current status of trial NCT06290128?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 140 participants. The study started on 2024-07-12. Estimated completion is 2028-11-20.

What conditions does trial NCT06290128 study?

This clinical trial studies the following conditions: Chronic Inflammatory Demyelinating Polyradiculoneuropathy, Polyneuropathy, Inflammatory Demyelinating, Chronic.

What interventions are being tested in trial NCT06290128?

The interventions under investigation include: Placebo (DRUG), Riliprubart (DRUG).

Who is sponsoring clinical trial NCT06290128?

This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06290128 being conducted?

This trial has 20 study locations across Alabama, California, Connecticut, Illinois, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Source: ClinicalTrials.gov NCT06290128, the US trial registry maintained by the National Library of Medicine. NCT06290128 (mid enrollment · wide site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.