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NCT06617793

NCT06617793
Recruiting Phase 2 🇦🇺 Australian site

Who may be able to join

Who might be able to join this trial:

  • You must be willing and able to sign a consent form and communicate well with the research team throughout the study
  • Your kidneys, liver, heart, blood, and lungs must be functioning well enough to participate
  • You must be between 18 and 60 years old and have been diagnosed with relapsing multiple sclerosis (MS) based on specific 2017 diagnostic guidelines
  • You must have had signs of your MS getting worse ("breakthrough disease activity") within the last year while taking a strong MS medication (such as rituximab, ocrelizumab, natalizumab, ofatumumab, or ublituximab) for at least 6 months, OR within 2 years after your last dose of alemtuzumab
  • "Breakthrough disease activity" means at least one of the following: a confirmed MS relapse; 2 or more bright spots (called enhancing lesions) on a single MRI scan; the same type of spot on 2 or more separate MRI scans; or 2 or more new lesions compared to a previous scan within one year
  • You must be able to walk, with a disability score between 3 and 6 (measured when not having a relapse)
  • You must have had MS for less than 15 years
  • You must have received all recommended vaccinations for people with a weakened immune system at least 6 weeks before starting treatment

Who may not be able to join:

  • People diagnosed with primary progressive MS (a specific type of MS where symptoms worsen steadily from the start)
  • People who have, or have had, other significant brain or spinal cord conditions — such as a stroke, brain injury, or other neurological disorders that could look similar to MS
  • People with significant heart problems (such as a heart attack, unstable heart disease, severe heart failure, irregular heartbeat, or uncontrolled high blood pressure in the past 6 months), or serious conditions affecting the nervous system (other than MS), mental health, lungs, kidneys, liver, hormones, metabolism, blood, or digestive system that the research team believes could affect safety or the study results
  • People who have donated blood or lost more than 400 mL of blood in the 3 months before screening
  • People who have previously had a stem cell treatment, organ transplant, or gene therapy
  • People who cannot safely have a lumbar puncture (spinal tap) — for example, due to spine abnormalities, bleeding disorders, or currently taking blood-thinning medications (note: low-dose aspirin up to 100 mg/day and low-dose ibuprofen up to 600 mg/day may be allowed — confirm with trial site)
  • People who are unwilling or unable to have MRI scans as required — for example, due to claustrophobia, a pacemaker, defibrillator, or metal implants in the body

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 2: approximately ~30% 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
Recruiting
Phase
Phase 2
Sponsor
Novartis Pharmaceuticals
Registry
clinicaltrials_gov
Start date
24 February 2025
Est. completion
1 October 2030

Where this trial is recruiting

🇦🇺 Australia 🇫🇷 France 🇩🇪 Germany 🇮🇹 Italy 🇪🇸 Spain 🇨🇭 Switzerland

2 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)

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