Phase 3 Multiple Sclerosis Trial, Recruiting NCT07225504 Sponsor: Novartis Pharmaceuticals Condition: Multiple Sclerosis
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Phase 3 Multiple Sclerosis Trial, Recruiting

NCT07225504
Recruiting Phase 3 🇦🇺 Australian site

Who may 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 might be able to join this trial:

  • People who are willing and able to sign a consent form before any assessments take place.
  • People aged 18 to 65 years old (inclusive) at the time of screening.
  • People who have been diagnosed with Secondary Progressive Multiple Sclerosis (SPMS) according to a specific set of medical criteria (the 2017 revised McDonald criteria).
  • People who have had no recorded MS relapses (sudden worsening of symptoms) in the 24 months before screening.
  • People whose level of disability, as measured by a standard MS scale called the EDSS, falls between 3.0 and 6.0 at the time of screening (confirm with trial site what this means for your situation).
  • People who have documented evidence that their disability has been getting worse in the 12 months before screening.

Who may not be able to join:

  • People who are unwilling or unable to have MRI scans, for example due to claustrophobia or having certain metal implants, a pacemaker, or a defibrillator in their body.
  • People who have a significant history of other brain or nervous system conditions, such as stroke, traumatic brain or spinal injury, or other conditions that could look similar to MS.
  • People with ongoing drug or alcohol misuse, or serious mental health conditions that could affect their ability to follow the study procedures.
  • People who have previously been diagnosed with a serious brain infection called Progressive Multifocal Leukoencephalopathy (PML), or who have had neurological symptoms that could suggest PML.
  • Women who are physically capable of becoming pregnant, unless a highly effective form of contraception (less than 1% failure rate per year) is used throughout the study treatment period and for at least one week after stopping treatment.
  • People who have significant problems with bleeding or blood clotting at the time of screening.
  • People who are taking certain medications that are listed as excluded in the trial protocol (confirm with trial site which medications apply).
  • Additional criteria not listed here may also apply, as noted in the full trial protocol.

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 13 July 2026
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.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Phone: 1-888-669-6682

Australian sites

Novartis Investigative Site, Kogarah, New South Wales
Novartis Investigative Site, New Lambton Heights, New South Wales
Novartis Investigative Site, Westmead, New South Wales
Novartis Investigative Site, Clayton, Victoria
Novartis Investigative Site, Heidelberg, Victoria
Novartis Investigative Site, Murdoch, Western Australia
Novartis Investigative Site, Southport,

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

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

Trial details

Status
Recruiting
Phase
Phase 3
Registry
ClinicalTrials.gov
Start date
11 November 2025
Est. completion
3 December 2030

Where this trial is recruiting

🇦🇷 Argentina 🇦🇺 Australia 🇦🇹 Austria 🇧🇪 Belgium 🇧🇷 Brazil 🇧🇬 Bulgaria 🇨🇦 Canada 🇨🇳 China 🇨🇴 Colombia 🇭🇷 Croatia 🇨🇿 Czechia 🇩🇰 Denmark 🇪🇪 Estonia 🇫🇷 France 🇩🇪 Germany 🇬🇷 Greece 🇭🇺 Hungary 🇮🇳 India 🇮🇱 Israel 🇮🇹 Italy 🇱🇹 Lithuania 🇲🇽 Mexico 🇳🇱 Netherlands 🇵🇱 Poland 🇵🇹 Portugal 🇷🇴 Romania 🇸🇰 Slovakia 🇿🇦 South Africa 🇪🇸 Spain 🇨🇭 Switzerland 🇬🇧 United Kingdom 🇺🇸 United States

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

Primary endpoints

Time to 6-month confirmed disability progression (6mCDP) on Expanded Disability Status Scale (EDSS)

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: 13 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