Clinical Trials

A Phase 3, Randomized, Double-Blind, Efficacy and Safety Study Comparing SAR442168 To Placebo In Participants With Primary Progressive Multiple Sclerosis (PERSEUS)

Type of Study/Intervention

Interventional

Recruitment Status

Recruiting

Form of MS

Primary Progressive MS

Brief summary

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 primary progressive multiple sclerosis (PPMS).

Globally approximately 990 participants will be 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 PPMS.

All participants with 6-month CDP are eligible for open-label active treatment as rescue (SAR442168). In Australia 2 sites will participate to recruit 4 participants.

Inclusion criteria

• 18 to 55 years of age inclusive
• Diagnosis of PPMS according to the 2017 McDonald criteria
• Expanded disability status scale (EDSS) between 2.0 to 6.5 points, inclusive at screening
• Disease duration from the onset of MS symptoms of <15 years if screening EDSS score of >5.0 OR <10 years if screening EDSS score of ≤5.0. • Positive cerebrospinal fluid oligoclonal bands and/or elevated Immunoglobulin G (IgG) index either during screening or documented previous history. • Contraceptive use consistent with local regulations for individuals participating in clinical studies • Participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: - Is not a woman of child bearing potential (WOCBP) OR - Is a WOCBP and agrees to use an acceptable contraceptive method

Exclusion criteria

• The participant has conditions that would adversely affect study participation such as short life expectancy.
• History of organ transplant.
• Evidence of infection with human immuodeficiency virus (HIV), progressive multifocal leukoencephalopathy (PML), active hepatitis B or C, active or latent tuberculosis or other active infections that would adversely affect study participation.
• History of malignancy within 5 years prior to screening.
• History of alcohol or drug abuse within 1 year prior to screening.
• Hospitalized for psychiatric disease within 2 years prior to screening.
• Clinically significant laboratory abnormalities (including evidence of liver injury) or electrocardiogram abnormalities at screening
• Bleeding disorder, known platelet dysfunction or platelet count <150 000/μL at screening. • Lymphocyte count below the lower limit of normal at screening. • Recent live (attenuated) vaccine within 2 months before the first treatment visit. • Recent major surgery (within 4 weeks of screening) or planned major surgery during the study. • The participant has received medications/treatments for MS within a specified time frame. • Receiving strong inducers or inhibitors of cytochrome P450 3A (CYP3A) or CYP2C8 hepatic enzymes. • Receiving anticoagulant or antiplatelet therapy (such as aspirin, clopidogrel, warfarin). • Contraindications to magnetic resonance imaging (MRI). The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Anticipated start date

Currently recruiting.

Recruitment contacts

Concord Repatriation General Hospital, NSW
Investigator is Dr Steve Vucic, Site Contact is Bronwen Orden, bronwen.orden@health.nsw.gov.au

Royal Hobart Hospital, TAS.
Investigator is Dr Michael Dreyer, Site Contact is Michelle Taylor, michelle.taylor@ths.tas.gov.au

Royal North Shore Hospital, NSW
Investigator Is Dr John Parratt, Site contact is Katherine Markoulis Markoulis, katherine.markoulis@health.nsw.gov.au

Further details

Full details of the trial can be found on the ANZCTR clinical trials database or clinicaltrials.gov (please provide link or trial number if applicable) or other (e.g. study website).
NCT04458051 Primary Progressive Multiple Sclerosis (PPMS) Study of Bruton’s Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) – Full Text View – ClinicalTrials.gov

Region

NSW, TAS

Ethics approval

Yes

Last updated

07/03/2022

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