Phase 3 Multiple Sclerosis Trial, Not Yet Recruiting
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
- The person has been diagnosed with pediatric multiple sclerosis (MS in children or adolescents), as defined by an established medical consensus.
- The person's disability level, measured by a standard MS scale called the EDSS, falls between 0 and 5.0.
- The person has experienced at least one of the following: one or more MS relapses in the past 12 months, two or more relapses in the past 24 months, or brain scan (MRI) results showing active lesions within the past 6 months.
- The person has been neurologically stable with no relapses in the 30 days before the study start date.
- For the later extended phase of the trial: people who completed the main treatment phase through the Week 96 visit in the relevant study groups may be eligible to continue.
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.
- The person has a history of progressive MS (as opposed to relapsing MS).
- The person has a history of other conditions that can look like MS, such as other disorders affecting the nervous system's protective covering, certain autoimmune diseases (such as Sjögren's disease or lupus), certain metabolic conditions, or certain infectious conditions.
- The person has a history of severe allergic reactions, including life-threatening allergic reactions, or any allergic reaction that the study doctor believes could be made worse by the study treatment.
- The person has a history of, or currently has, any form of cancer, including skin cancers or blood cancers.
- The person has had certain bowel or stomach surgeries (except appendix or gallbladder removal more than 6 months before screening), has inflammatory bowel disease such as Crohn's disease or ulcerative colitis, or has another significant and active digestive condition as determined by the study doctor.
- The person is known to be allergic or sensitive to fumaric acid-based compounds or any ingredients in the study medications.
- The person has been diagnosed with a specific eye condition called macular edema before joining the trial.
- For the later extended phase: the person has had significant changes to their health since joining the main trial, including abnormal test results or new conditions that the study doctor believes would have prevented them from joining originally.
- For the later extended phase: the person stopped taking the study treatment during the main phase because they could not tolerate it.
- For the later extended phase: any other reason that the study doctor or study sponsor considers makes participation unsuitable (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.
Contact this trial
Principal Investigator: Medical Director, Biogen
Phone: 866-633-4636
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
Primary endpoints
TP Cohort A and OLE Period: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and AEs Leading to Treatment Discontinuation; TP Cohort B: Annualized Relapse Rate (ARR) Through Week 96
Can't join this trial?
Data last synced from ClinicalTrials.gov: 30 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.