A Phase 3, Randomized, Double-blind, Efficacy and Safety Study Comparing SAR442168 to Placebo in Participants With Primary Progressive Multiple Sclerosis (PERSEUS) (PERSEUS)

STATUS

Recruiting
End date

Aug 25, 2024
participants needed

990
sponsor

Sanofi

Updated on 25 October 2022

See if I qualify

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, SAR442168, Tolebrutinib
Clinical Study Identifier	NCT04458051
Sponsor	Sanofi
Last Modified on	25 October 2022

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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
	History of malignancy within 5 years prior to screening
	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
	History of alcohol or drug abuse within 1 year prior to Screening
	Hospitalized for psychiatric disease within 2 years prior to Screening
	Persistent chronic or active or recurring system infection that may adversely affect participation or IMP administration in this study as judged by the investigator
	Clinically significant laboratory abnormalities (including evidence of liver injury) or electrocardiogram abnormalities 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
	Bleeding disorder, known platelet dysfunction at any time prior to the screening visit
	A platelet count <150 000/μL at the screening visit
	The participant has received medications/treatments for MS within a specified time frame
	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
	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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Step 2 Get screened

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Step 3 Enroll in the clinical study

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Step 4 Get your study results

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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Study Definition

Wikipedia

A Phase 3, Randomized, Double-blind, Efficacy and Safety Study Comparing SAR442168 to Placebo in Participants With Primary Progressive Multiple Sclerosis (PERSEUS) (PERSEUS)