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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04411641




Registration number
NCT04411641
Ethics application status
Date submitted
28/05/2020
Date registered
2/06/2020
Date last updated
10/02/2023

Titles & IDs
Public title
Nonrelapsing Secondary Progressive Multiple Sclerosis (NRSPMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168)
Scientific title
A Phase 3, Randomized, Double-blind, Efficacy and Safety Study Comparing SAR442168 to Placebo in Participants With Nonrelapsing Secondary Progressive Multiple Sclerosis
Secondary ID [1] 0 0
U1111-1246-7768
Secondary ID [2] 0 0
EFC16645
Universal Trial Number (UTN)
Trial acronym
HERCULES
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Secondary 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 to match Tolebrutinib

Experimental: SAR442168 - Dose 1 of oral SAR442168 once daily

Placebo Comparator: Placebo - Placebo tablet to match SAR442168 once daily


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

Treatment: Drugs: Placebo to match Tolebrutinib
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
6-month confirmed disability progression (CDP)
Timepoint [1] 0 0
Up to 48 approximately months
Secondary outcome [1] 0 0
3-months change in T25-FW and 9-HPT
Timepoint [1] 0 0
Up to approximately 48 months
Secondary outcome [2] 0 0
3-month CDP
Timepoint [2] 0 0
Up to approximately48 months
Secondary outcome [3] 0 0
New and enlarging T2 hyperintense lesions by MRI
Timepoint [3] 0 0
From Baseline up to approximately 48 months
Secondary outcome [4] 0 0
Time to onset of confirmed disability improvement (CDI)
Timepoint [4] 0 0
From Baseline up to approximately 48 months
Secondary outcome [5] 0 0
Brain volume loss (BVL)
Timepoint [5] 0 0
From 6 Months up to approximately 48 months
Secondary outcome [6] 0 0
Change in cognitive function
Timepoint [6] 0 0
From Baseline up to approximately 48 months
Secondary outcome [7] 0 0
Change in Multiple Sclerosis Quality of Life-54 (MSQoL-54)
Timepoint [7] 0 0
From Baseline up to approximately 48 months
Secondary outcome [8] 0 0
Safety and Tolerability
Timepoint [8] 0 0
From Screening until end of study up to approximately 48 months
Secondary outcome [9] 0 0
Population pharmacokinetics
Timepoint [9] 0 0
Months 6, 9 and 12
Secondary outcome [10] 0 0
Change in plasma neurofilament light chain (NfL)
Timepoint [10] 0 0
From Baseline up to approximately 48 months
Secondary outcome [11] 0 0
Changes in serum Immunoglobulin level
Timepoint [11] 0 0
From Baseline up to approximately 48 months
Secondary outcome [12] 0 0
Change in lymphocyte phenotype subsets
Timepoint [12] 0 0
From Baseline up to approximately 48 months
Secondary outcome [13] 0 0
Change in serum chitinase-3 like protein 1 (Chi3L1)
Timepoint [13] 0 0
From Baseline up to approximately 48 months

Eligibility
Key inclusion criteria
Inclusion criteria :

- 18 to 60 years of age inclusive

- Diagnosis of nonrelapsing secondary progressive multiple sclerosis according to the
2017 McDonald criteria

- Expanded disability status scale (EDSS) between 3.0 to 6.5 points inclusive, at
screening

- The participant must have documented evidence of disability progression observed
during the 12 months before screening

- Absence of clinical relapses for at least 24 months

- Contraceptive use by men or women should be consistent with local regulations
regarding the methods of contraception for those participating in clinical studies

- A female participant is eligible to participate if she is not pregnant or
breastfeeding, and at least one of the following conditions applies:

- Is not a WOCBP OR

- Is a WOCBP and agrees to use an acceptable contraceptive method
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

- The participant has conditions that would adversely affect study participation such as
short life expectancy.

- History of organ transplant.

- Evidence of infection with human immuodeficiency virus (HIV), transplantation,
progressive multifocal leukoencephalopathy (PML), active hepatitis B or C, active or
latent tuberculosis or other active infections 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

- Bleeding disorder, known platelet dysfunctionat 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 bleeding.

- 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 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).

- 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.

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
24/09/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/08/2024
Actual
Sample size
Target
Accrual to date
Final
1131
Recruitment in Australia
Recruitment state(s)
QLD,SA,TAS,VIC
Recruitment hospital [1] 0 0
Investigational Site Number :0360003 - Woolloongabba
Recruitment hospital [2] 0 0
Investigational Site Number :0360002 - Kent Town
Recruitment hospital [3] 0 0
Investigational Site Number :0360004 - Hobart
Recruitment hospital [4] 0 0
Investigational Site Number :0360001 - Fitzroy
Recruitment hospital [5] 0 0
Investigational Site Number :0360006 - Heidelberg West
Recruitment postcode(s) [1] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [2] 0 0
- Kent Town
Recruitment postcode(s) [3] 0 0
7001 - Hobart
Recruitment postcode(s) [4] 0 0
3065 - Fitzroy
Recruitment postcode(s) [5] 0 0
3081 - Heidelberg West
Recruitment outside Australia
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United States of America
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State/province [209] 0 0
Oxfordshire
Country [210] 0 0
United Kingdom
State/province [210] 0 0
Bristol
Country [211] 0 0
United Kingdom
State/province [211] 0 0
Cardiff
Country [212] 0 0
United Kingdom
State/province [212] 0 0
London
Country [213] 0 0
United Kingdom
State/province [213] 0 0
Newcastle Upon Tyne
Country [214] 0 0
United Kingdom
State/province [214] 0 0
Salford

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

Ethics approval
Ethics application status

Summary
Brief summary
Primary Objective:

To determine the efficacy of SAR442168 compared to placebo in delaying disability progression
in NRSPMS

Secondary Objective:

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 and relevant metabolites in NRSPMS and its relationship to efficacy and
safety To evaluate pharmacodynamics (PD) of SAR442168
Trial website
https://clinicaltrials.gov/ct2/show/NCT04411641
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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04411641