Phase 3 Multiple Sclerosis Trial, Completed NCT04353492 Sponsor: Novartis Pharmaceuticals 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 enrolled 562 people, all of whom received a treatment called ofatumumab. The trial was set up to measure how often participants experienced relapses (periods when multiple sclerosis symptoms flare up or worsen) over the course of the study. Specifically, it tracked the annualised relapse rate — that is, the average number of confirmed relapses per person per year. A total of 523 people completed the study, while 39 did not finish. The reported data shows that the average number of confirmed relapses per person per year was 0.06. To put that in plain terms, on average participants experienced fewer than one tenth of a relapse per year across the study period. The trial had set out to test whether this rate would come in below 0.18 relapses per person per year, and the reported figure of 0.06 sits below that threshold. The reported data also shows that, out of 562 participants, 509 experienced at least one adverse event (an unwanted or unexpected health occurrence during the study), and 33 experienced a serious adverse event (a more significant health occurrence). More specifically, 374 participants had injection-related reactions reported, 5 had abnormal laboratory results or vital signs that qualified as adverse events, and 33 had other adverse events recorded. It is worth noting that recording these events is a standard part of any clinical trial and does not on its own indicate anything about whether a treatment is safe or unsafe. 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, Completed

NCT04353492
Completed 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 have been diagnosed with multiple sclerosis (MS) according to a specific set of recognised diagnostic guidelines (the 2017 McDonald criteria)
  • You have a relapsing form of MS, which includes relapsing MS or a type called secondary progressive MS that still has active flare-ups
  • Your level of physical disability, measured by a standard MS scoring system, falls within a mild to moderate range (confirm with trial site)
  • You have previously been treated with no more than 3 different MS medications in total (with a specific group of similar medicines counting as just one)
  • Your most recent MS medication — taken for at least 6 months — was either a fumarate-based therapy (such as dimethyl fumarate or diroximel fumarate) or a medicine called fingolimod, and you are now switching away from it
  • While taking your fumarate or fingolimod medication, your MS showed signs of still being active — such as having one or more relapses, or new activity showing up on an MRI scan
  • Your MS has been neurologically stable for at least one month before starting the trial

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 primary progressive MS, or a form of secondary progressive MS with no active disease
  • You have a condition called neuromyelitis optica
  • It has been more than 10 years since you were first diagnosed with MS
  • You are currently pregnant or breastfeeding
  • You are a woman who could become pregnant and are not using a highly effective form of contraception during the study and for at least 6 months after finishing the study medication
  • You have another active long-term condition affecting your immune system, or a condition that weakens your immune system
  • You currently have an active bacterial, fungal, or viral infection (such as hepatitis, HIV, or COVID-19), or have been diagnosed with AIDS
  • You have symptoms that suggest, or a confirmed diagnosis of, a serious brain infection called Progressive Multifocal Leukoencephalopathy (PML)
  • You are considered at risk of syphilis or tuberculosis, or have a history of either condition, even if previously treated
  • You have active hepatitis B or hepatitis C
  • You have received a live vaccine within 4 weeks before starting the trial
  • You have previously taken certain specific MS or immune-related medications within particular timeframes (confirm with trial site for the full list)
  • In the opinion of the trial doctor, you may not be able or willing to follow the study requirements

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 22 July 2026

Trial contact details on record

Australian sites

Novartis Investigative Site, New Lambton Heights, New South Wales
Novartis Investigative Site, Woolloongabba, Queensland
Novartis Investigative Site, 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
Completed
Phase
Phase 3
Registry
ClinicalTrials.gov
Start date
14 July 2020
Est. completion
9 October 2024

Where this trial was run

🇦🇷 Argentina 🇦🇺 Australia 🇦🇹 Austria 🇧🇪 Belgium 🇧🇬 Bulgaria 🇨🇦 Canada 🇨🇿 Czechia 🇪🇪 Estonia 🇩🇪 Germany 🇬🇷 Greece 🇭🇺 Hungary 🇮🇹 Italy 🇱🇻 Latvia 🇱🇧 Lebanon 🇲🇽 Mexico 🇳🇴 Norway 🇵🇱 Poland 🇵🇹 Portugal 🇷🇺 Russia 🇸🇦 Saudi Arabia 🇸🇰 Slovakia 🇸🇮 Slovenia 🇪🇸 Spain 🇨🇭 Switzerland Turkey (Türkiye) 🇬🇧 United Kingdom 🇺🇸 United States

These are the locations recorded on the registry, including 3 in Australia. They are a historical record: this trial is not enrolling, so they are not places you can join it.

Primary endpoints

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: 22 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