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NCT06372145

NCT06372145
Active, Not Recruiting Phase 3 🇦🇺 Australian site

Who may be able to join

Who might be able to join this trial:

  • You have a form of multiple sclerosis (relapsing MS, primary progressive MS, or non-relapsing secondary progressive MS) and you previously completed a related earlier clinical trial (Phase 2b or one of four Phase 3 studies) while taking the study drug.
  • You were part of one of those earlier trials but had to temporarily stop taking the study drug due to a national emergency, and you completed all required trial visits.

Who may not be able to join:

  • You have an ongoing or recurring serious infection, including a fever above 38°C (100.4°F) that is considered unstable, as assessed by the study doctor.
  • You show signs of active or past hepatitis B or C infection based on blood tests taken at your check-in visit (confirm with trial site).
  • You currently have, or have had in the past year, a problem with alcohol or drug misuse.
  • You currently drink more than 2 alcoholic drinks per day (men) or more than 1 alcoholic drink per day (women).
  • You have an abnormal heart rhythm result on an ECG at your check-in visit that the study doctor considers a concern.
  • You have a bleeding disorder, abnormal platelet levels, or other conditions that may put you at risk of excessive bleeding during the study.
  • Your blood test results at your check-in visit show certain liver enzyme levels that are too high (confirm with trial site).
  • You have an active liver disease, liver scarring (cirrhosis), or a chronic liver condition that has not been stable for at least 6 months.
  • You have developed a significant heart, liver, hormonal, neurological, or other major health condition that the study doctor believes would make participation unsafe or affect the study results.
  • You are currently taking certain medications that are not allowed by this study, including specific drugs that affect how the study drug is processed by your liver (confirm with trial site).

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
Sanofi
Registry
clinicaltrials_gov
Start date
16 April 2024
Est. completion
30 April 2029

Where this trial is recruiting

🇦🇷 Argentina 🇦🇺 Australia 🇦🇹 Austria 🇧🇪 Belgium 🇧🇷 Brazil 🇧🇬 Bulgaria 🇨🇦 Canada 🇨🇱 Chile 🇨🇳 China 🇨🇴 Colombia 🇭🇷 Croatia 🇨🇿 Czechia 🇩🇰 Denmark 🇪🇪 Estonia 🇫🇮 Finland 🇫🇷 France 🇬🇪 Georgia 🇩🇪 Germany 🇬🇷 Greece Hong Kong 🇭🇺 Hungary 🇮🇳 India 🇮🇱 Israel 🇮🇹 Italy 🇯🇵 Japan 🇱🇻 Latvia 🇱🇹 Lithuania 🇲🇽 Mexico 🇳🇱 Netherlands 🇳🇴 Norway 🇵🇱 Poland 🇵🇹 Portugal Puerto Rico 🇷🇴 Romania 🇷🇸 Serbia 🇸🇰 Slovakia 🇿🇦 South Africa 🇰🇷 South Korea 🇪🇸 Spain 🇸🇪 Sweden 🇨🇭 Switzerland 🇹🇼 Taiwan 🇹🇭 Thailand Turkey (Türkiye) 🇺🇦 Ukraine 🇬🇧 United Kingdom 🇺🇸 United States

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

Primary endpoints

Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and AEs leading to permanent study intervention discontinuation; Number of Participants with Potentially clinically significant abnormalities (PCSAs)

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