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ACTIVE NOT RECRUITING 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)

NCT05123703 · View on ClinicalTrials.gov ↗

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.

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

758 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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 188 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 758 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05123703 reports 20 study locations spanning 13 distinct geographic areas — top geographies include Other, California, Ohio. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05123703?

The interventions under investigation include: Fingolimod (DRUG), Ocrelizumab (DRUG), Ocrelizumab Placebo (OTHER), Fingolimod Placebo (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05123703?

This trial is sponsored by Hoffmann-La Roche, which has 758 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial