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NCT05123703 · ClinicalTrials.gov registry record · Phase 3

A Study to Evaluate Safety and Efficacy of Ocrelizumab in Comparison With Fingolimod in Children and Adolescents With Relapsing-Remitting Multiple Sclerosis (RRMS)

A Phase 3 study of Relapsing Remitting Multiple Sclerosis, sponsored by Hoffmann-La Roche.

Active
Registry status
Phase 3
Development phase
188
Enrollment target
20
Study locations

NCT05123703 is a Phase 3 study of Relapsing Remitting Multiple Sclerosis that is active but no longer recruiting, run by Hoffmann-La Roche. The registered enrollment target is 188 participants, roughly in line with the 195-participant average among 25 other Relapsing Remitting Multiple Sclerosis trials with a reported enrollment target. The trial reports 20 study locations across 13 states.

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The verdict

NCT05123703, a Phase 3 study of Relapsing Remitting Multiple Sclerosis, is active but no longer recruiting, sponsored by Hoffmann-La Roche.

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
188 participants
Enrollment target
20
Study locations

Study Summary

This double-blind, double-dummy study will evaluate the safety and efficacy of ocrelizumab compared with fingolimod in children and adolescents with RRMS aged between 10 and \< 18 years over a flexible duration. The double-blind period will last until after the last participant randomized has completed 24 weeks.

Conditions Studied

Relapsing Remitting Multiple Sclerosis

Interventions

  • DRUG Fingolimod
  • DRUG Ocrelizumab
  • OTHER Ocrelizumab Placebo
  • OTHER Fingolimod Placebo

Study Locations (20)

Other

  • Hospital de Pediatría S.A.M.I.C.- Prof. Dr. Juan P. Garrahan - Ciudad de Buenos Aires
  • Clinica Universitaria Reina Fabiola - Córdoba
  • Centro de Investigaciones Médicas Tucuman - San Miguel de Tucumán
  • Medizinische Universität Wien - Vienna
  • Hôpital Universitaire des Enfants Reine Fabiola - Brussels
  • Cliniques Universitaires St-Luc - Brussels

California

  • UC San Diego - La Jolla
  • University of California San Francisco - San Francisco

Ohio

  • Cleveland Clinic, Mellen Center for Multiple Sclerosis - Cleveland
  • The Boster Center for Multiple Sclerosis a Singlepoint Healthcare Company - Columbus

Colorado

  • Children's Hospital Colorado - Aurora

District of Columbia

  • Children's National Hospital - Washington D.C.

Maryland

  • Johns Hopkins Medicine - Baltimore

Massachusetts

  • Boston Children's Hospital Central Pharmacy - Boston

Missouri

  • Washington University - St Louis

Trial Details

FieldValue
Enrollment Target 188 participants
Start Date 2022-05-19
Est. Completion 2029-09-17
Phase Phase 3

Sponsor

Hoffmann-La Roche

909 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05123703

The ClinicalTrials.gov registry entry for NCT05123703 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 188 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 195-participant average among 25 other Relapsing Remitting Multiple Sclerosis trials with a reported enrollment target. The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Relapsing Remitting Multiple Sclerosis appearing as the primary indexed condition, and to 4 interventions - of which Fingolimod is the first listed.

NCT05123703 reports 20 study locations spanning 13 distinct geographic areas - top geographies include Other, California, Ohio.

Frequently Asked Questions

What is clinical trial NCT05123703 about?

NCT05123703 is a clinical study titled "A Study to Evaluate Safety and Efficacy of Ocrelizumab in Comparison With Fingolimod in Children and Adolescents With Relapsing-Remitting Multiple Sclerosis (RRMS)". This double-blind, double-dummy study will evaluate the safety and efficacy of ocrelizumab compared with fingolimod in children and adolescents with RRMS aged between 10 and \< 18 years over a flexible duration. The double-blind period will last until after the last participant randomized has comple...

What is the current status of trial NCT05123703?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 188 participants. The study started on 2022-05-19. Estimated completion is 2029-09-17.

What conditions does trial NCT05123703 study?

This clinical trial studies the following conditions: Relapsing Remitting Multiple Sclerosis.

What interventions are being tested in trial NCT05123703?

The interventions under investigation include: Fingolimod (DRUG), Ocrelizumab (DRUG), Ocrelizumab Placebo (OTHER), Fingolimod Placebo (OTHER).

Who is sponsoring clinical trial NCT05123703?

This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05123703 being conducted?

This trial has 20 study locations across California, Colorado, District of Columbia, Maryland, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.