Informations générales (source: ClinicalTrials.gov)
A Phase 3, Randomized, Double-blind, Efficacy and Safety Study Comparing SAR442168 to Placebo in Participants With Primary Progressive Multiple Sclerosis (PERSEUS) (PERSEUS)
Interventional
Phase 3
Sanofi (Voir sur ClinicalTrials)
août 2020
novembre 2025
05 avril 2025
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
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| HOPITAL FONDATION A. DE ROTHSCHILD | Caroline BENSA | 24/06/2024 12:16:02 | Contacter | ||
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CENTRE HOSPITALIER DE GONESSE | Contact (sur clinicalTrials) | ||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Investigational Site Number : 2500001 - 67098 - Strasbourg - France | Contact (sur clinicalTrials) | ||||
| Investigational Site Number : 2500003 - 35033 - Rennes - France | Contact (sur clinicalTrials) | ||||
| Investigational Site Number : 2500004 - 78300 - Poissy - France | Contact (sur clinicalTrials) | ||||
| Investigational Site Number : 2500005 - 63003 - Clermont Ferrand - France | Contact (sur clinicalTrials) | ||||
| Investigational Site Number : 2500006 - 34295 - Montpellier - France | Contact (sur clinicalTrials) | ||||
| Investigational Site Number : 2500007 - 75019 - Paris - France | Contact (sur clinicalTrials) | ||||
| Investigational Site Number : 2500008 - 54035 - Nancy - France | Contact (sur clinicalTrials) | ||||
| Investigational Site Number : 2500009 - 59037 - Lille - France | Contact (sur clinicalTrials) | ||||
| Investigational Site Number : 2500011 - 69500 - Bron - France | Contact (sur clinicalTrials) | ||||
| Investigational Site Number : 2500012 - 31059 - Toulouse - France | Contact (sur clinicalTrials) | ||||
| Investigational Site Number : 2500014 - 75013 - Paris - France | Contact (sur clinicalTrials) | ||||
| Investigational Site Number : 2500017 - 30029 - Nimes - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
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
- 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
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 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.
- 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).
NOTE: Other Inclusion/Exclusion criteria may apply. The above information is not intended
to contain all considerations relevant to a patient's potential participation in a
clinical trial