Primary Progressive Multiple Sclerosis (PPMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (PERSEUS)

Investigation of an Investigational Medication for Primary Progressive Multiple Sclerosis

Recruiting
18 years - 55 years
All
Phase 3
700 participants needed
7 Locations

Study Overview

Primary Objective:

To determine the efficacy of SAR442168 compared to placebo in delaying disability progression in primary progressive multiple sclerosis (PPMS)

Secondary Objectives:

To evaluate efficacy of SAR442168 compared to placebo on clinical endpoints, magnetic resonance imaging (MRI) lesions, cognitive performance, physical function, and quality of life To evaluate safety and tolerability of SAR442168 To evaluate population pharmacokinetics (PK) of SAR442168 in PPMS and its relationship to efficacy and safety To evaluate pharmacodynamics of SAR442168

Study Details

Study duration will vary per participant in this event driven trial with a treatment duration of approximately 12 to 60 months.

Eligibility Criteria

You may be eligible for this study if you meet the following criteria:

  • Conditions: Primary Progressive Multiple Sclerosis
  • Age: 18 years - 55 years
  • Gender: All

Inclusion Criteria: - 18 to 55 years of age inclusive

  • Diagnosis of PPMS according to the 2017 McDonald criteria
  • Expanded disability status scale (EDSS) score between 2.0 to 6.5 points, at screening inclusive
  • 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 childbearing potential (WOCBP) or is a WOCBP and agrees to use an acceptable contraceptive method
  • the participant must not have access to ocrelizumab (eg, ocrelizumab not available on the national market or not reimbursed for the approved indication).
  • the participant must have access to and be eligible to be treated with ocrelizumab but: 1) does not tolerate it due to side effects or safety reasons; and/or 2) has failed ocrelizumab treatment due to perceived lack of efficacy Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply:
  • Participant has conditions that would adversely affect study participation such as short life expectancy.
  • Evidence of infection with human immunodeficiency virus (HIV), transplantation, progressive multifocal leukoencephalopathy (PML), active hepatitis B or C, active or latent tuberculosis or other active infection that would adversely affect study participation.
  • Persistent chronic or active or recurring system infection that may adversely affect participation or IMP administration in this study as judged by the investigator
  • 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.
  • A bleeding disorder or known platelet dysfunction at any time prior to the screening visit.
  • A platelet count <150 000/μL at the screening visit.
  • A history of significant bleeding event within 6 months prior to screening, according to the Investigator's judgment such as, but not limited to cerebral or gastrointestinal
  • 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 potent and moderate inducers of cytochrome P450 3A (CYP3A) or potent inhibitors of CYP2C8 hepatic enzymes.
  • Receiving anticoagulant or antiplatelet therapy (such as aspirin >81mg/day, clopidogrel, warfarin).
  • Contraindications to magnetic resonance imaging (MRI). NOTE: Other Inclusion/Exclusion criteria may apply. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial

Updated on 23 Oct 2024. Study ID: NCT04458051

This study investigates the effects of an investigational medication in people with primary progressive multiple sclerosis (PPMS). PPMS is a type of multiple sclerosis (MS) that causes a gradual worsening of symptoms without relapses. The aim is to see if the investigational medication can delay the progression of disability compared to a placebo, which is an inactive substance that looks like the investigational medicine but does not contain any medicine.

Participants will receive either the investigational medication or a placebo. The study will also measure effects on clinical symptoms, MRI scans, cognitive abilities, physical function, and quality of life. Safety and how the body processes the medication will also be studied.

  • Who can participate: Adults aged 18 to 55 with a diagnosis of primary progressive multiple sclerosis can participate. Key eligibility criteria include having a specific range of disability scores and certain test results related to immune system markers. Participants must not have access to or tolerate specific other treatments.
  • Study details: Participants will be randomly assigned to receive either the investigational medication or a placebo. They will undergo various tests and evaluations to monitor their health, including MRIs and assessments of cognitive and physical functions. A placebo is an inactive substance that looks like the investigational medication but does not contain any medicine.
  • Study timelines: The study will last between 12 to 60 months.

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