Phase 3 Multiple Sclerosis Trial, Active, Not Recruiting NCT05123703 Sponsor: Hoffmann-La Roche Condition: Multiple Sclerosis
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Trial results

AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

According to the results reported on ClinicalTrials.gov, this trial (NCT05123703) enrolled 93 people in the ocrelizumab group and 94 people in the fingolimod group — 187 participants in total — all of whom had multiple sclerosis (MS). The trial compared these two medicines and measured things like how often participants experienced MS relapses (periods when symptoms flare up or get worse), changes seen on brain scans, and how ocrelizumab moved through the body. Notably, the data shows that zero participants in either group were recorded as having "completed" the study, with all participants listed under "not completed"; no explanation for this was provided in the reported data. The reported data shows that, on average, participants in the ocrelizumab group had a relapse rate of 0.070 relapses per year, compared with 0.135 relapses per year in the fingolimod group. For brain scan findings, the total number of new or enlarging lesions (areas of change visible on a type of brain scan called an MRI) was 495 in the ocrelizumab group and 908 in the fingolimod group. At the 12-week mark, a different type of brain scan lesion — called a T1 Gd lesion (spots that light up when a special dye is used during the scan) — showed 5 in the ocrelizumab group and 33 in the fingolimod group. The trial also measured how ocrelizumab was absorbed and moved through the body, reporting a peak blood level of 142 micrograms per millilitre and a related exposure measure of 3,020 µg/mL·day; these figures were only measured for the ocrelizumab group. Data on adverse events (unwanted medical occurrences during the trial) was not reported in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.

Phase 3 Multiple Sclerosis Trial, Active, Not Recruiting

NCT05123703
Active, Not Recruiting Phase 3 🇦🇺 Australian site

voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice

Who may and may not be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who may be able to join

  • 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

Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.

  • 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.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 27 July 2026

Trial contact details on record

Principal Investigator: Clinical Trials, Hoffmann-La Roche

Australian sites

Royal Children's Hospital Melbourne - PIN, Parkville, Victoria

This trial is not accepting new participants. These are the contact details ClinicalTrials.gov holds for it, kept here for reference. They are not an invitation to enrol, and the sites listed may no longer be running this trial.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Active, Not Recruiting
Phase
Phase 3
Registry
ClinicalTrials.gov
Start date
19 May 2022
Est. completion
9 June 2025

Where this trial was run

🇦🇷 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

These are the locations recorded on the registry, including 1 in Australia. They are a historical record: this trial is not enrolling, so they are not places you can join it.

Primary endpoints

Protocol-defined Annualized Relapse Rate (ARR)

Other options

Expanded access pathways

This trial is not enrolling. Other access pathways exist in general: in Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients. Whether it applies to any treatment studied here is a question for your doctor — nothing on this page says it does.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov