Relapsing Multiple SclerosisPhase 2NCT03996291

Long Term Safety and Efficacy Study of Tolebrutinib (SAR442168) in Participants With Relapsing Multiple Sclerosis

A Phase 2 study testing Tolebrutinib in people with Relapsing Multiple Sclerosis, run by Sanofi at 37 sites in 9 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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 Read more about this study

Who is it for?: Ages 18 to 55 years
Conditions the study is for: Relapsing Multiple Sclerosis
What is being tested?: Tolebrutinib
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 125 participants
Where: 37 sitesin 9 countries
Study dates: 23 Sep 2019to 26 Nov 2024
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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

Who cannot join

The participant had a confirmed concomitant laboratory or ECG abnormality or medical condition deemed by the investigator incompatible with continuation of SAR442168 treatment.
The participant had 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 had 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 had to be respected except for interferons or glatiramer acetate treatment.
The participant was receiving strong inducers or inhibitors of CYP3A or CYP2C8 hepatic enzymes.
The participant was receiving anticoagulant/antiplatelet therapies, including:
Acetylsalicylic acid (aspirin)

Show all 16Show fewer

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 needed to be stopped at least 5 half-lives before study drug administration except for aspirin, which needed to be stopped at least 8 days beforehand.
Prior/concurrent clinical study experience. The participant was 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 was pregnant or was a breastfeeding woman.
The above information was not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Trial locations and contacts

37 sites in 9 countries.

Country

City, postcode or hospital

37 sites in 9 countries

United States8 sites

North Central Neurology Associates, PC Site Number : 8400005
Cullman, Alabama, 35058
UC Health, LLC Site Number : 8400008
Dayton, Ohio, 45417
Neurology PC Site Number : 8400003
Knoxville, Tennessee, 37922
Neurology Associates, PA Site Number : 8400002
Maitland, Florida, 32761
Consultants In Neurology Site Number : 8400001
Northbrook, Illinois, 60062
Velocity Clinical Research Site Number : 8400007
Savannah, Georgia, 31406
University of South Florida Site Number : 8400009
Tampa, Florida, 33612
MDH Research LLC Site Number : 8400006
Westerville, Ohio, 43081

Other trials in United States

Czechia7 sites

Investigational Site Number : 2030007
Brno, 62500
Investigational Site Number : 2030004
Hradec Králové, 50005
Investigational Site Number : 2030003
Jihlava, 58633
Investigational Site Number : 2030005
Ostrava - Poruba, 70852
Investigational Site Number : 2030006
Pardubice, 53203
Investigational Site Number : 2030001
Prague, 12808
Investigational Site Number : 2030002
Praha 5 - Motol, 15006

Other trials in Czechia

Ukraine7 sites

Investigational Site Number : 8040002
Chernivtsi, 58000
Investigational Site Number : 8040005
Dnipro, 49038
Investigational Site Number : 8040001
Lviv, 79010
Investigational Site Number : 8040006
Lviv, 79013
Investigational Site Number : 8040009
Odesa, 65025
Investigational Site Number : 8040003
Vinnytsia, 21005
Investigational Site Number : 8040007
Zhytomyr, 10002

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Russia5 sites

Investigational Site Number : 6430006
Kazan', 420032
Investigational Site Number : 6430003
Moscow, 125367
Investigational Site Number : 6430005
Saint Petersburg, 194044
Investigational Site Number : 6430001
Saint Petersburg, 197110
Investigational Site Number : 6430007
Tyumen, 625000

Other trials in Russia

Spain5 sites

Investigational Site Number : 7240002
Barcelona, Barcelona [Barcelona], 08035
Investigational Site Number : 7240001
Madrid, 28007
Investigational Site Number : 7240004
Murcia, 30120
Investigational Site Number : 7240005
Salt, Girona [Gerona], 17190
Investigational Site Number : 7240003
Seville, Andalusia, 41009

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Canada2 sites

Investigational Site Number : 1240001
Greenfield Park, Quebec, J4V 2J2
Investigational Site Number : 1240003
Vancouver, British Columbia, V6T 2B5

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Estonia1 site

Investigational Site Number : 2330001
Tallinn, 11315

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France1 site

Investigational Site Number : 2500004
Nancy, 54035

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Netherlands1 site

Investigational Site Number : 5280001
Amsterdam, 1081 HV

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About this study

Official title: Long-term Extension Safety and Efficacy Study of SAR442168 in Participants With Relapsing Multiple Sclerosis

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

Read the detailed description

Approximately 62 months including the 8 weeks post-treatment visit

Conditions: Relapsing Multiple Sclerosis
Being tested: Tolebrutinib

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TolebrutinibDrug
Also called SAR442168
Pharmaceutical form: Film coated tablet Route of administration: Oral

Study groups in NCT03996291
Study group	Role	What they receive
SAR442168	Experimental	SAR442168 : Experimental - Part A: Double-blind period of continued treatment with the respective SAR442168 dose was administered in the DRI15928 study until selection of Phase 3 dose. Part B: Open-label period of a single-group treatment with SAR442168 selected Phase 3 dose of 60 mg. All participants were switched to this 60 mg dose. Receives: Drug: Tolebrutinib

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. An SAE was any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent disability/incapacity, was a congenital anomaly/birth defect or was an important medical event. TEAEs were defined as AEs that developed, worsened or became serious during the respective on-treatment periods.
Measured: From first dose of study drug (Day 1) up to maximum exposure, 39 weeks in Part A and 222 weeks in Part B

Secondary outcomes (5)

Mean Number of New Gadolinium (Gd)-Enhancing T1-hyperintense Lesions at Week 240 Relative to Week 192
Magnetic resonance imaging (MRI) of the brain was performed to identify number of new Gd-enhancing T1-hyperintense lesions. Central review was used to identify new Gd-enhancing T1-hyperintense lesions not present at the previous MRI. mITT=modified intent-to-treat; SAP= statistical analysis plan. Only those participants with data collected at specified timepoints are reported.
Measured: Weeks 192 and 240
Mean Number of New or Enlarging T2 Lesions at Week 240 Relative to Week 192
MRI of the brain was performed to identify number of new or enlarging T2 lesions. Central review was used to identify new or enlarging T2 lesions not present at the previous MRI; the values were standardized to per month values by dividing by the number of months (4-week intervals) from the previous MRI to the current MRI.
Measured: Weeks 192 and 240
Total Mean Number of Gd-enhancing T1-hyperintense Lesions at Week 240 Relative to Week 192
MRI of the brain was performed to identify number of Gd-enhancing T1-hyperintense lesions. Central review was used to identify Gd-enhancing T1-hyperintense lesions not present at the previous MRI.
Measured: Weeks 192 and 240
Annualized Relapse Rate (ARR)
Multiple sclerosis (MS) relapse was defined as acute, new neurological symptoms or worsening of previous neurological symptoms with an objective change on neurological examination. Symptoms were attributable to MS, lasted for >=24 hours with or without recovery, present at normal body temperature and preceded by >=30 days of clinical stability. ARR was the total number of relapses for participants by dose group divided by the sum of the standardized study duration for participants in the dose group.
Measured: From Baseline (enrollment in LTS16004, Day 1) to Week 240
Change From Baseline in Expanded Disability Status Scale (EDSS) Score at Week 240
The EDSS is a disability scale that assesses the following 7 functional domains: visual, brainstem, pyramidal (motor), cerebellar (coordination), sensory, cerebral, and bowel/bladder. The total EDSS ranges from 0 (normal) to 10 (death due to MS) (0.5 increments from 1-10; next increase after 0 is 1). Higher scores indicated increased disability. Baseline assessed for long-term tolebrutinib treatment by change from baseline was defined as the last non-missing value prior to the first administration of randomized study drug in DRI15928 study.
Measured: Baseline (Day 1 of DRI15928) and Week 240

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Sep 201926 Nov 2024

First posted24 Jun 2019
Study start23 Sep 2019
Primary completion26 Nov 2024
Study completion26 Nov 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Relapsing Multiple SclerosisStudies of the same condition, open and under way.
More trials run by SanofiThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 125 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03996291
Sponsor's protocol ID: LTS16004
Other IDs: U1111-1223-4256, 2018-004731-76, 2018
Status last verified: Oct 2025
First submitted: 20 Jun 2019
Last updated: 23 Oct 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: 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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Relapsing Multiple Sclerosis trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Long-term Extension Safety and Efficacy Study of SAR442168 in Participants With Relapsing Multiple Sclerosis
ClinicalTrials.gov ID: NCT03996291
Acronym / sponsor ID: LTS16004
Conditions: Relapsing Multiple Sclerosis
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 125 participants (actual)
Lead sponsor: SanofiIndustry (pharma, biotech, devices)
Study start: 23 Sep 2019 (actual)
Primary completion: 26 Nov 2024 (actual)
Study completion: 26 Nov 2024 (actual)
First posted: 24 Jun 2019 (actual)
Results: Posted 23 Oct 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
SAR442168	Experimental	Drug: TolebrutinibSAR442168 : Experimental - Part A: Double-blind period of continued treatment with the respective SAR442168 dose was administered in the DRI15928 study until selection of Phase 3 dose. Part B: Open-label period of a single-group treatment with SAR442168 selected Phase 3 dose of 60 mg. All participants were switched to this 60 mg dose.

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (16 listed)

The participant had a confirmed concomitant laboratory or ECG abnormality or medical condition deemed by the investigator incompatible with continuation of SAR442168 treatment.
The participant had 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 had 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 had to be respected except for interferons or glatiramer acetate treatment.
The participant was receiving strong inducers or inhibitors of CYP3A or CYP2C8 hepatic enzymes.
The participant was receiving anticoagulant/antiplatelet therapies, including:

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TolebrutinibAlso: SAR442168Pharmaceutical form: Film coated tablet Route of administration: Oral	Drug	SAR442168

Primary outcome

Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
Time frame: From first dose of study drug (Day 1) up to maximum exposure, 39 weeks in Part A and 222 weeks in Part B
An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. An SAE was any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent disability/incapacity, was a congenital anomaly/birth defect or was an important medical event. TEAEs were defined as AEs that developed, worsened or became serious during the respective on-treatment periods.

5 secondary outcomes

Mean Number of New Gadolinium (Gd)-Enhancing T1-hyperintense Lesions at Week 240 Relative to Week 192
Time frame: Weeks 192 and 240
Mean Number of New or Enlarging T2 Lesions at Week 240 Relative to Week 192
Time frame: Weeks 192 and 240
Total Mean Number of Gd-enhancing T1-hyperintense Lesions at Week 240 Relative to Week 192
Time frame: Weeks 192 and 240
Annualized Relapse Rate (ARR)
Time frame: From Baseline (enrollment in LTS16004, Day 1) to Week 240
Change From Baseline in Expanded Disability Status Scale (EDSS) Score at Week 240
Time frame: Baseline (Day 1 of DRI15928) and Week 240

Results and safety

Results posted to the registry on 23 Oct 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Part A: Tolebrutinib 5 mg	31	30
Part A: Tolebrutinib 15 mg	31	31
Part A: Tolebrutinib 30 mg	32	32
Part A: Tolebrutinib 60 mg	31	31
Part B: Tolebrutinib 5/60 mg	0	0
Part B: Tolebrutinib 15/60 mg	0	0
Part B: Tolebrutinib 30/60 mg	0	0
Part B: Tolebrutinib 60/60 mg	0	0

Primary outcome: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)

Time frame: From first dose of study drug (Day 1) up to maximum exposure, 39 weeks in Part A and 222 weeks in Part B. Count of participants. Unit: Participants

Measure	Part A: Tolebrutinib 5 mg n = 31	Part A: Tolebrutinib 15 mg n = 31	Part A: Tolebrutinib 30 mg n = 32	Part A: Tolebrutinib 60 mg n = 31	Part B: Tolebrutinib 5/60 mg n = 30	Part B: Tolebrutinib 15/60 mg n = 31	Part B: Tolebrutinib 30/60 mg n = 32	Part B: Tolebrutinib 60/60 mg n = 31
TEAEs	17	17	24	20	26	29	27	27
TESAEs	0	2	1	2	5	3	3	3

Population analysed: The safety population included all participants enrolled in this study and exposed to study drug, regardless of the amount of exposure.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected from first dose of study drug (Day 1) up to maximum exposure, 39 weeks in Part A and 222 weeks in Part B. All-cause mortality (deaths) was collected from signing informed consent form (Week -6) up to end of follow-up, approximately 62 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Part A: Tolebrutinib 5 mg	0 of 31 (0%)	12 of 31 (38.7%)	0 of 31
Part A: Tolebrutinib 15 mg	2 of 31 (6.5%)	6 of 31 (19.4%)	0 of 31
Part A: Tolebrutinib 30 mg	1 of 32 (3.1%)	15 of 32 (46.9%)	0 of 32
Part A: Tolebrutinib 60 mg	2 of 31 (6.5%)	16 of 31 (51.6%)	0 of 31
Part B: Tolebrutinib 5/60 mg	5 of 30 (16.7%)	24 of 30 (80%)	0 of 30
Part B: Tolebrutinib 15/60 mg	3 of 31 (9.7%)	24 of 31 (77.4%)	0 of 31
Part B: Tolebrutinib 30/60 mg	3 of 32 (9.4%)	24 of 32 (75%)	0 of 32
Part B: Tolebrutinib 60/60 mg	3 of 31 (9.7%)	25 of 31 (80.6%)	0 of 31

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
LTS16004 Plain Language Results SummaryLink provided by the sponsor.
Individual participant dataSharing planned: Yes. 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

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A Study of Subcutaneously Administered RO7845860 in Participants With Relapsing Multiple Sclerosis
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Clinical Sciences & Operations study director

Sanofi

37 sites in 9 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tolebrutinib in people with Relapsing Multiple Sclerosis, run by Sanofi at 37 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 37 sites in United States, Czechia, Ukraine, Russia, Spain and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) (time frame: From first dose of study drug (Day 1) up to maximum exposure, 39 weeks in Part A and 222 weeks in Part B). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03996291.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2025.