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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04458051




Registration number
NCT04458051
Ethics application status
Date submitted
1/07/2020
Date registered
7/07/2020

Titles & IDs
Public title
Primary Progressive Multiple Sclerosis (PPMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (PERSEUS)
Scientific title
A Phase 3, Randomized, Double-blind, Efficacy and Safety Study Comparing SAR442168 to Placebo in Participants With Primary Progressive Multiple Sclerosis (PERSEUS)
Secondary ID [1] 0 0
U1111-1238-1318
Secondary ID [2] 0 0
EFC16035
Universal Trial Number (UTN)
Trial acronym
PERSEUS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Primary Progressive Multiple Sclerosis 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Tolebrutinib
Treatment: Drugs - Placebo

Experimental: SAR442168 - Dose 1 of oral SAR442168 once daily

Placebo comparator: Placebo - Placebo to match the SAR442168 once daily


Treatment: Drugs: Tolebrutinib
Pharmaceutical form: Film-coated Tablet Route of administration: Oral

Treatment: Drugs: Placebo
Pharmaceutical form: Film-coated Tablet Route of administration: Oral
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
3-month composite Confirmed Disability Progression (cCDP)
Timepoint [1] 0 0
Up to approximately 60 months
Secondary outcome [1] 0 0
6-month Confirmed Disability Progression (CDP)
Timepoint [1] 0 0
Up to approximately 60 months
Secondary outcome [2] 0 0
6-month composite Confirmed Disability Progression (cCDP)
Timepoint [2] 0 0
Up to approximately 60 months
Secondary outcome [3] 0 0
Change in T2 hyperintense lesions by MRI
Timepoint [3] 0 0
From screening MRI to approximately 60 months
Secondary outcome [4] 0 0
Time to onset of confirmed disability improvement (CDI)
Timepoint [4] 0 0
Up to approximately 60 months
Secondary outcome [5] 0 0
Percent change in Brain volume (BV)
Timepoint [5] 0 0
From 6 months up to approximately 60 months
Secondary outcome [6] 0 0
Change in cognitive function as assessed by SDMT
Timepoint [6] 0 0
From Baseline up to approximately 60 months
Secondary outcome [7] 0 0
Change in cognitive function as assessed by CVLT-II
Timepoint [7] 0 0
From Baseline up to approximately 60 months
Secondary outcome [8] 0 0
Change in Multiple Sclerosis Quality of Life
Timepoint [8] 0 0
From Baseline up to approximately 60 months
Secondary outcome [9] 0 0
Safety and Tolerability
Timepoint [9] 0 0
From screening up to approximately 60 months
Secondary outcome [10] 0 0
Population pharmacokinetics
Timepoint [10] 0 0
Months 6, 9 and 12
Secondary outcome [11] 0 0
Change in plasma neurofilament light chain (NfL)
Timepoint [11] 0 0
From Baseline up to approximately 60 months
Secondary outcome [12] 0 0
Change in lymphocyte phenotype subsets
Timepoint [12] 0 0
From Baseline up to approximately 60 months
Secondary outcome [13] 0 0
Changes in serum Immunoglobulin level
Timepoint [13] 0 0
From Baseline up to approximately 60 months
Secondary outcome [14] 0 0
Change in serum chitinase-3 like protein 1 (Chi3L1)
Timepoint [14] 0 0
From Baseline up to approximately 60 months

Eligibility
Key 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
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
13/08/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
25/07/2025
Actual
Sample size
Target
Accrual to date
Final
766
Recruitment in Australia
Recruitment state(s)
NSW,TAS
Recruitment hospital [1] 0 0
Investigational Site Number : 0360005 - Concord
Recruitment hospital [2] 0 0
Investigational Site Number : 0360006 - St Leonards
Recruitment hospital [3] 0 0
Investigational Site Number : 0360003 - Hobart
Recruitment postcode(s) [1] 0 0
2139 - Concord
Recruitment postcode(s) [2] 0 0
2065 - St Leonards
Recruitment postcode(s) [3] 0 0
7001 - Hobart
Recruitment outside Australia
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United States of America
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Braga
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Kent
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Country [209] 0 0
United Kingdom
State/province [209] 0 0
Vale Of Glamorgan, The
Country [210] 0 0
United Kingdom
State/province [210] 0 0
Bristol
Country [211] 0 0
United Kingdom
State/province [211] 0 0
Salford

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Sanofi
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Sciences & Operations
Address 0 0
Sanofi
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Trial Transparency email recommended (Toll free number for US & Canada)
Address 0 0
Country 0 0
Phone 0 0
800-633-1610
Fax 0 0
Email 0 0
Contact-US@sanofi.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04458051