Interventional
No longer recruiting
NSW, QLD, SA, TAS, VIC
Secondary progressive MS
SAR442168 is being developed for the indication of treatment of patients with MS. This study is designed to collect evidence of efficacy and safety of the drug.The goal of this Phase 3 clinical trial is to demonstrate the efficacy and safety of SAR442168 compared to placebo in participants with nonrelapsing secondary progressive multiple sclerosis (nrSPMS). Globally approximately 1700 participants will be screened to achieve 1290 randomly assigned to study intervention (2:1 randomization ratio of SAR442168 to placebo). This study is planned as an event-driven trial based on 6-month confirmed disease progression (CDP) therefore treatment duration ranging from approximately 24 to 48 months in participants with nrSPMS. All participants with 6-month CDP are eligible for open-label active treatment as rescue (SAR442168). In Australia 5 sites will participate to recruit 15 participants.
The above information is not intended to contain all considerations relevant to a patient’s potential participation in a clinical trial.
Currently not recruiting
St Vincent’s Hospital Melbourne, VIC.
Investigator is Dr Neil Shuey; site contact is Judy Chin: JUDY.CHIN@svha.org.au
Centre for Neuroscience and Specialists on College, SA
Investigator is Dr Andrew Lee; site contact is Paul Stockle:Â pstockle@specialistsoncollege.com
Princess Alexandra Hospital, QLD
Investigator is Dr Stefan Blum; site contact is Wendy Smibert:Â wendy.smibert@health.qld.gov.au
Royal Hobart Hospital, TAS
Investigator is Dr Michael Dreyer; site contact is Anna Green:Â anna.green@ths.tas.gov.au
Austin Health, VIC
Investigator is Dr Richard Macdonell, site contact is Elise Heriot: elise.heriot@austin.org.au
Royal North Shore Hospital, NSW
Investigator Is Dr John Parratt, site contact is Katherine Markoulis: katherine.markoulis@health.nsw.gov.au
Further details of the trial can be found here.
SA, VIC, QLD, TAS, NSW
Yes
31/01/2023
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