Primary Progressive Multiple Sclerosis (PPMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor T… (NCT04458051) | Clinical Trial Compass
CompletedPhase 3
Primary Progressive Multiple Sclerosis (PPMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (PERSEUS)
United States767 participantsStarted 2020-08-13
Plain-language 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
Who can participate
Age range18 Years – 55 Years
SexALL
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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 tubercu…