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NCT05123703

NCT05123703
Active, Not Recruiting Phase 3 🇦🇺 Australian site

Who may be able to join

Who might be able to join this trial:

  • You weigh at least 25 kilograms (about 55 pounds)
  • You have been diagnosed with relapsing-remitting multiple sclerosis (RRMS) according to specific recognized medical guidelines for children and young people with MS
  • Your level of disability, as measured by a standard MS scale, falls within a certain range at the time of screening (confirm with trial site)
  • You have had at least one MS relapse in the past year, or two relapses in the past two years, or a brain scan within the last 6 months showed at least one area of active inflammation (this applies to all countries except Germany)

Who may not be able to join:

  • You have, or are suspected to have, another nervous system condition that could look similar to MS
  • You have a serious uncontrolled health condition, an active infection, or another significant health issue that could make it unsafe to participate
  • You have a serious heart condition or your heart screening test showed significant concerns

Notes about an optional extension phase of the trial:

  • If you complete the main part of the trial, you may be able to continue into an optional follow-up phase if your doctor believes you could benefit from switching to a specific treatment (confirm with trial site)
  • You would not be able to join the optional follow-up phase if you stopped participating during the main part of the trial

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.

Trial details

Status
Active, Not Recruiting
Phase
Phase 3
Sponsor
Hoffmann-La Roche
Registry
clinicaltrials_gov
Start date
19 May 2022
Est. completion
9 June 2025

Where this trial is recruiting

🇦🇷 Argentina 🇦🇺 Australia 🇦🇹 Austria 🇧🇪 Belgium 🇧🇷 Brazil 🇨🇦 Canada 🇪🇪 Estonia 🇫🇷 France 🇩🇪 Germany 🇬🇷 Greece 🇭🇺 Hungary 🇮🇳 India 🇮🇹 Italy 🇱🇻 Latvia 🇲🇽 Mexico Morocco 🇵🇱 Poland 🇵🇹 Portugal 🇷🇴 Romania 🇷🇸 Serbia 🇪🇸 Spain 🇨🇭 Switzerland 🇺🇦 Ukraine 🇬🇧 United Kingdom 🇺🇸 United States

1 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Annualized Relapse Rate (ARR)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 30 June 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

View original record on ClinicalTrials.gov