2024-514495-41-00RecruitingPhase 3
A Phase 3, randomized, double-blind, efficacy and safety study comparing SAR442168 to placebo in participants with primary progressive multiple sclerosis (PERSEUS)
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Genzyme Corp.
- Enrollment
- 487
- Locations
- 106
- Primary Endpoint
- 6-month composite Confirmed Disability Progression (cCDP)
Study Overview
Brief Summary
To determine the efficacy of SAR442168 compared to placebo in delaying disability progression in Primary Progressive Multiple Sclerosis (PPMS)
Eligibility Criteria
- Ages
- 18 years to 64 years (18-64 Years)
- Accepts Healthy Volunteers
- No
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
- •Participant has conditions that would adversely affect study participation such as short life expectancy.
- •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).
- •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.
Outcomes
Primary Outcomes
6-month composite Confirmed Disability Progression (cCDP)
6-month composite Confirmed Disability Progression (cCDP)
Secondary Outcomes
- 6-month Confirmed Disability Progression (CDP)
- 3-month composite Confirmed Disability Progression (cCDP)
- Change in T2 hyperintense lesions by MRI
- Time to onset of confirmed disability improvement (CDI)
- Percent change in Brain volume (BV)
- Change in cognitive function as assessed by SDMT
- Change in cognitive function as assessed by CVLT-II
- Change in Multiple Sclerosis Quality of Life
- Safety and Tolerability
- Population pharmacokinetics
- Change in plasma neurofilament light chain (NfL)
- Change in lymphocyte phenotype subsets
- Changes in serum Immunoglobulin level
- Change in serum chitinase-3 like protein 1 (Chi3L1)
Investigators
Clinical Sciences and Operations
Scientific
Genzyme Corp.
Study Sites (106)
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