Clinical trial NCT03996291: Long Term Safety and Efficacy Study of Tolebrutinib (SAR442168) in Participants With Relapsing Multiple Sclerosis
Official title: Long-term Extension Safety and Efficacy Study of SAR442168 in Participants With Relapsing Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Relapsing Multiple Sclerosis
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2019-06-24
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Primary Objective:

To determine the long-term safety and tolerability of SAR442168 in RMS participants

Secondary Objective:

To evaluate efficacy of SAR442168 on disease activity, assessed by clinical and imaging methods

Detailed description: Approximately 62 months including the 8 weeks post-treatment visit

Eligibility criteria: Inclusion criteria:

* Participants must have completed treatment in the DRI15928 study
* Female participants must continue to use an acceptable effective contraception method of birth control from inclusion and until the last dose of study drug, except if she has undergone sterilization at least 3 months earlier or is postmenopausal. Menopause is defined as being amenorrheic for ≥12 months with plasma follicle stimulating hormone (FSH) level \>30 UI/L.
* The participant must have given written informed consent prior to undertaking any study related procedure.

Exclusion criteria:

* The participant has a confirmed concomitant laboratory or ECG abnormality or medical condition deemed by the investigator incompatible with continuation of SAR442168 treatment.
* The participant has received any live (attenuated) vaccine (including but not limited to varicella zoster, oral polio, and nasal influenza) between the last DRI15928 visit and the first treatment visit in the LTS16004 study.
* The participant has received a non-study MS disease modifying treatment between the last IMP treatment in Study DRI15928 and inclusion in Study LTS16004, which by judgement of the Investigator may add unjustified risk to switching back and continuing treatment with SAR442168. Washout periods after treatment with non-study DMTs should be respected except for interferons or glatiramer acetate treatment.
* The participant is receiving strong inducers or inhibitors of CYP3A or CYP2C8 hepatic enzymes.
* The participant is receiving anticoagulant/antiplatelet therapies, including:

  * Acetylsalicylic acid (aspirin)
  * Antiplatelet drugs (eg, clopidogrel)
  * Warfarin (vitamin K antagonist)
  * Heparin, including low molecular weight heparin (antithrombin agents)
  * Dabigatran (direct thrombin inhibitor)
  * Apixaban, edoxaban, rivaroxaban (direct factor Xa inhibitors)

Note: All above drugs need to be stopped at least 5 half-lives before study drug administration except for aspirin, which needs to be stopped at least 8 days beforehand.

* Prior/concurrent clinical study experience. The participant is taking part in another interventional clinical trial of another drug substance.
* Uncooperative behavior or any condition that could make the participant potentially non-adherent with the study procedures
* The participant is pregnant or is a breastfeeding woman.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Baseline to final follow-up visit ( Month 60 plus 8 weeks)
measure: Number of Participants with Potentially Clinically Significant Abnormalities
timeFrame: Baseline to final follow-up visit ( Month 60 plus 8 weeks)
Secondary outcomes:
measure: Number of new gadolinium (Gd)-enhancing T1 hyperintense lesions
timeFrame: Baseline to final follow-up visit ( Month 60 plus 8 weeks)
measure: Number of new or enlarging T2 lesions
timeFrame: Baseline to final follow-up visit ( Month 60 plus 8 weeks)
measure: Total number of Gd-enhancing T1-hyperintense lesions
timeFrame: Baseline to final follow-up visit ( Month 60 plus 8 weeks)
measure: Number of participants wih relapse (Annualized Relapse rate)
timeFrame: Baseline to Month 60
measure: Change in Expanded Disability Status Scale (EDSS) from baseline over time
timeFrame: Baseline to final follow-up visit ( Month 60 plus 8 weeks)
Other outcomes:
Locations:
city: Cullman
country: United States
facility: North Central Neurology Associates, PC Site Number : 8400005
state: Alabama
city: Maitland
country: United States
facility: Neurology Associates, PA Site Number : 8400002
state: Florida
city: Tampa
country: United States
facility: University of South Florida Site Number : 8400009
state: Florida
city: Savannah
country: United States
facility: Velocity Clinical Research Site Number : 8400007
state: Georgia
city: Northbrook
country: United States
facility: Consultants In Neurology Site Number : 8400001
state: Illinois
city: Dayton
country: United States
facility: UC Health, LLC Site Number : 8400008
state: Ohio
city: Westerville
country: United States
facility: MDH Research LLC Site Number : 8400006
state: Ohio
city: Knoxville
country: United States
facility: Neurology PC Site Number : 8400003
state: Tennessee
city: Vancouver
country: Canada
facility: Investigational Site Number : 1240003
state: British Columbia
city: Greenfield Park
country: Canada
facility: Investigational Site Number : 1240001
state: Quebec
city: Brno
country: Czechia
facility: Investigational Site Number : 2030007
city: Hradec Kralove
country: Czechia
facility: Investigational Site Number : 2030004
city: Jihlava
country: Czechia
facility: Investigational Site Number : 2030003
city: Ostrava - Poruba
country: Czechia
facility: Investigational Site Number : 2030005
city: Pardubice
country: Czechia
facility: Investigational Site Number : 2030006
city: Praha 2
country: Czechia
facility: Investigational Site Number : 2030001
city: Praha 5 - Motol
country: Czechia
facility: Investigational Site Number : 2030002
city: Tallinn
country: Estonia
facility: Investigational Site Number : 2330001
city: Nancy
country: France
facility: Investigational Site Number : 2500004
city: Amsterdam
country: Netherlands
facility: Investigational Site Number : 5280001
city: Kazan
country: Russian Federation
facility: Investigational Site Number : 6430006
city: Moscow
country: Russian Federation
facility: Investigational Site Number : 6430003
city: Saint-Petersburg
country: Russian Federation
facility: Investigational Site Number : 6430001
city: St-Petersburg
country: Russian Federation
facility: Investigational Site Number : 6430005
city: Tyumen
country: Russian Federation
facility: Investigational Site Number : 6430007
city: Sevilla
country: Spain
facility: Investigational Site Number : 7240003
state: Andalucia
city: Barcelona
country: Spain
facility: Investigational Site Number : 7240002
state: Barcelona [Barcelona]
city: Salt
country: Spain
facility: Investigational Site Number : 7240005
state: Girona [Gerona]
city: Madrid
country: Spain
facility: Investigational Site Number : 7240001
city: Murcia
country: Spain
facility: Investigational Site Number : 7240004
city: Chernivtsi
country: Ukraine
facility: Investigational Site Number : 8040002
city: Dnipro
country: Ukraine
facility: Investigational Site Number : 8040005
city: Lviv
country: Ukraine
facility: Investigational Site Number : 8040001
city: Lviv
country: Ukraine
facility: Investigational Site Number : 8040006
city: Odesa
country: Ukraine
facility: Investigational Site Number : 8040009
city: Vinnytsya
country: Ukraine
facility: Investigational Site Number : 8040003
city: Zhytomyr
country: Ukraine
facility: Investigational Site Number : 8040007
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: