Nonrelapsing Secondary Progressive Multiple Sclerosis (NRSPMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168)

  • STATUS
    Recruiting
  • End date
    Aug 23, 2024
  • participants needed
    1290
  • sponsor
    Sanofi
Updated on 23 July 2021
Investigator
For site information, send an email with site number to
Primary Contact
Investigational Site Number 3920018 (9.3 mi away) Contact
+223 other location
contraceptive use
disease or disorder
chronic progressive multiple sclerosis
secondary progressive multiple sclerosis

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

Description

Study duration will vary per participant in this event driven trial with a treatment duration of approximately 24 to 48 months.

Participants completing the treatment period will be proposed to enroll in a separate long term safety study.

Details
Condition Multiple Sclerosis, Chronic progressive multiple sclerosis, Radiologically Isolated Syndrome, Dermatite Atopique modérée ou grave, secondary progressive multiple sclerosis
Treatment SAR442168, Placebo to match SAR442168, Tolebrutinib, Placebo to match Tolebrutinib
Clinical Study IdentifierNCT04411641
SponsorSanofi
Last Modified on23 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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

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), progressive multifocal leukoencephalopathy (PML), active hepatitis B or C, active or latent tuberculosis or other active infections 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
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 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
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

0/250
Preferred Language
Other Language
Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note