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

STATUS

Recruiting
participants needed

990
sponsor

Sanofi

Updated on 19 February 2024

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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.

Details

Condition	Multiple Sclerosis, Multiple Sclerosis, Chronic progressive multiple sclerosis
Age	18-55 years
Treatment	Placebo, SAR442168
Clinical Study Identifier	NCT04458051
Sponsor	Sanofi
Last Modified on	19 February 2024

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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
Exclusion Criteria
	Participant has conditions that would adversely affect study participation such as short life expectancy
	History of organ transplant
	Evidence of infection with human immunodeficiency virus (HIV), 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 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/L 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

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