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

  • STATUS
    Recruiting
  • End date
    Aug 13, 2024
  • participants needed
    990
  • sponsor
    Sanofi
Updated on 23 May 2022
disease or disorder
oligoclonal bands

Summary

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

Description

Study duration will vary per participant in this event driven trial with a treatment duration of approximately 24 to 48 months.

Participants completing the treatment period will be proposed to enroll in a separate long term safety study.

Details
Condition Primary Progressive Multiple Sclerosis
Treatment Placebo, Tolebrutinib
Clinical Study IdentifierNCT04458051
SponsorSanofi
Last Modified on23 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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

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
Bleeding disorder, known platelet dysfunction at any time prior to the screening visit
Lymphocyte count below the lower limit of normal at Screening
A platelet count <150 000/μL at the screening visit
Recent live (attenuated) vaccine within 2 months before the first treatment 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
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
Contraindications to magnetic resonance imaging (MRI)
Receiving potent and moderate inducers or inhibitors of cytochrome P450 3A (CYP3A) or potent inhibitors of CYP2C8 hepatic enzymes
Receiving anticoagulant or antiplatelet therapy (such as aspirin>81mg/day, clopidogrel, warfarin)
The above information is not intended to contain all considerations relevant to a patient's
potential participation in a clinical trial
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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