AzTrials
AzTrials

Relapsing Multiple SclerosisPhase 2NCT03889639

Dose-finding Study for SAR442168 in Relapsing Multiple Sclerosis

A Phase 2 study testing SAR442168 and Locally approved intravenous contrast medium for contrast enhanced magnetic resonance imaging (MRI) in people with Relapsing Multiple Sclerosis, run by Sanofi at 48 sites in 10 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 dose-response relationship for SAR442168 to reduce the number of new active brain lesions. Secondary Objectives: To evaluate efficacy of SAR442168 on disease activity as assessed by imaging measures. To evaluate the safety and tolerability of SAR442168. 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?
SAR442168 and Locally approved intravenous contrast medium for contrast enhanced magnetic resonance imaging (MRI)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
130 participants
Where
48 sitesin 10 countries
Study dates
29 Mar 2019to 2 Jan 2020
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

  • Participant must be 18 to 55 years of age, inclusive, at the time of signing the informed consent.
  • Participant was diagnosed with relapsing multiple sclerosis (RMS) according to the 2017 revision of the McDonald diagnostic criteria.
  • Participant must had at least 1 documented relapse within the previous year, OR greater than or equal to (>=) 2 documented relapses within the previous 2 years, OR >=1 active Gadolinium (Gd) enhancing brain lesion on an MRI scan in the past 6 months and prior to screening.
  • A female participant must had used a double contraception method including a highly effective method of birth control from inclusion and up to 2 months after the last study dose, except if she had undergone sterilization at least 3 months earlier or was postmenopausal. Menopause was defined as being amenorrheic for >=12 months with serum follicle-stimulating hormone (FSH) level greater than (>) 30 International Units per liters.
  • Male participants, whose partners were of childbearing potential (including breastfeeding women), must had accepted to use, during sexual intercourse, a double contraceptive method according to the following algorithm: (condom) plus (intrauterine device or hormonal contraceptive) from inclusion up to 3 months after the last dose.
  • Male participants whose partners were pregnant must had used, during sexual intercourse, a condom from inclusion up to 3 months after the last dose.
  • Male participants had agreed not to donate sperm from the inclusion up to 3 months after the last dose.
  • Participant had given written informed consent prior to undertaking any study-related procedure.

Who cannot join

  • The participant had been diagnosed with primary progressive multiple sclerosis according to the 2017 revision of the McDonald diagnostic criteria or with non relapsing secondary progressive multiple sclerosis.
  • Requirement for concomitant treatment that could bias the primary evaluation.
  • Contraindication for MRI.
  • Contraindications to use MRI Gd contrast-enhancing preparations.
  • History of infection with the human immunodeficiency virus (HIV).
  • History of active or latent tuberculosis.
Show all 21Show fewer
  • Any other active infections that would adversely affect participation or investigational medicinal product administration in this study, as judged by the Investigator.
  • Presence of any screening laboratory or electrocardiogram values outside normal limits that were considered in the Investigator's judgment to be clinically significant.
  • Presence of liver injury.
  • At screening, the participant was positive for hepatitis B surface antigen and/or hepatitis B core antibody and/or was positive for hepatitis C antibody.
  • Bleeding disorder or known platelet dysfunction at any time prior to screening visit.
  • Participant had received any live (attenuated) vaccine (including but not limited to varicella zoster, oral polio, and nasal influenza) within 2 months before first treatment visit.
  • Participant was receiving strong inducers or inhibitors of cytochrome P450 3A (CYP3A) or CYP2C8 hepatic enzymes.
  • Participant was receiving anticoagulant/antiplatelet therapies.
  • Participant had taken other investigational drugs within 3 months or 5 half lives, whichever was longer, before screening visit.
  • Participant had an Expanded Disability Status Scale score >5.5 at first screening visit.
  • Participant had a relapse in the 30 days prior to randomization.
  • Participant was pregnant or a breastfeeding woman.
  • History or presence of significant other concomitant illness.
  • The participant had received medications/treatments for multiple sclerosis within a specified time frame.
  • The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Trial locations and contacts

48 sites in 10 countries.

48 sites in 10 countries

United States9 sites

  • Investigational Site Number 8400005

    Cullman, Alabama, 35058

  • Investigational Site Number 8400008

    Dayton, Ohio, 45417

  • Investigational Site Number 8400003

    Knoxville, Tennessee, 37922

  • Investigational Site Number 8400002

    Maitland, Florida, 32761

  • Investigational Site Number 8400001

    Northbrook, Illinois, 60062

  • Investigational Site Number 8400007

    Savannah, Georgia, 31406

  • Investigational Site Number 8400004

    Sunrise, Florida, 33351

  • Investigational Site Number 8400009

    Tampa, Florida, 33612

  • Investigational 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

Russia7 sites

  • Investigational Site Number 6430006

    Kazan', 420021

  • Investigational Site Number 6430003

    Moscow, 125367

  • Investigational Site Number 6430002

    Moscow, 127015

  • Investigational Site Number 6430005

    Saint Petersburg, 194044

  • Investigational Site Number 6430004

    Saint Petersburg, 197022

  • Investigational Site Number 6430001

    Saint Petersburg, 197110

  • Investigational Site Number 6430007

    Tyumen, 625000

Other trials in Russia

Ukraine7 sites

  • Investigational Site Number 8040002

    Chernivtsi, 58018

  • Investigational Site Number 8040005

    Dnipro, 49005

  • 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

Other trials in Ukraine

Spain6 sites

  • Investigational Site Number 7240006

    Barakaldo, 48903

  • Investigational Site Number 7240002

    Barcelona, 08035

  • Investigational Site Number 7240001

    Madrid, 28007

  • Investigational Site Number 7240004

    Murcia, 30120

  • Investigational Site Number 7240005

    Salt, 17190

  • Investigational Site Number 7240003

    Seville, 41071

Other trials in Spain

France4 sites

  • Investigational Site Number 2500004

    Nancy, 54035

  • Investigational Site Number 2500001

    Nantes, 44093

  • Investigational Site Number 2500002

    Strasbourg, 67098

  • Investigational Site Number 2500003

    Toulouse, 31059

Other trials in France

Canada3 sites

  • Investigational Site Number 1240002

    Gatineau, J8Y 1W2

  • Investigational Site Number 1240001

    Greenfield Park, J4V 2J2

  • Investigational Site Number 1240003

    Vancouver, V6T 2B5

Other trials in Canada

Netherlands2 sites

  • Investigational Site Number 5280001

    Amsterdam, 1081 HV

  • Investigational Site Number 5280002

    Sittard-Geleen, 6162 BG

Other trials in Netherlands

Slovakia2 sites

  • Investigational Site Number 7030001

    Bratislava, 82606

  • Investigational Site Number 7030002

    Martin, 03659

Other trials in Slovakia

Estonia1 site

  • Investigational Site Number 2330001

    Tallinn, 11315

Other trials in Estonia

About this study

Official title: A Phase 2b Dose-finding Study for SAR442168, a Bruton's Tyrosine Kinase Inhibitor, in Participants With Relapsing Multiple Sclerosis

Primary Objective:

To determine the dose-response relationship for SAR442168 to reduce the number of new active brain lesions.

Secondary Objectives:

  • To evaluate efficacy of SAR442168 on disease activity as assessed by imaging measures.
  • To evaluate the safety and tolerability of SAR442168.
Read the detailed description

The total study duration was 24 weeks which included a screening period of 4 weeks, a treatment period of 16 weeks, and a follow-up period of up to 4 weeks. Participants who completed the Week 16 visit were proposed to be enrolled in a long-term extension safety and efficacy study to assess safety, tolerability and efficacy of SAR442168.

Being tested
SAR442168, Placebo, Locally approved intravenous contrast medium for contrast enhanced magnetic resonance imaging (MRI)

What participants receive

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

  • SAR442168Drug

    Pharmaceutical form: Film coated tablet; Route of administration: Oral

  • PlaceboDrug

    Pharmaceutical form: Film coated tablet; Route of administration: Oral

  • Locally approved intravenous contrast medium for contrast enhanced magnetic resonance imaging (MRI)Drug

    Pharmaceutical form: Solution for injection; Route of administration: Intravenous

Study groups in NCT03889639
Study groupRoleWhat they receive
Cohort 1: SAR442168 5 mg Then PlaceboExperimentalParticipants received SAR442168 5 milligrams (mg), orally once daily for first 12 weeks then crossed over to matching placebo orally once daily for 4 weeks during the 16 weeks treatment period. To maintain the blinding, each participant was given a total of 4 tablets daily, either of SAR442168 or SAR442168 and placebo, to achieve the specified daily dose of SAR442168.
Receives: Drug: SAR442168; Drug: Placebo; Drug: Locally approved intravenous contrast medium for contrast enhanced magnetic resonance imaging (MRI)
Cohort 1: SAR442168 15 mg Then PlaceboExperimentalParticipants received SAR442168 15 mg, orally once daily for first 12 weeks then crossed over to matching placebo orally once daily for 4 weeks during the 16 weeks treatment period. To maintain the blinding, each participant was given a total of 4 tablets daily, either of SAR442168 or SAR442168 and placebo, to achieve the specified daily dose of SAR442168.
Receives: Drug: SAR442168; Drug: Placebo; Drug: Locally approved intravenous contrast medium for contrast enhanced magnetic resonance imaging (MRI)
Cohort 1: SAR442168 30 mg Then PlaceboExperimentalParticipants received SAR442168 30 mg, orally once daily for first 12 weeks then crossed over to matching placebo orally once daily for 4 weeks during the 16 weeks treatment period. To maintain the blinding, each participant was given a total of 4 tablets daily, either of SAR442168 or SAR442168 and placebo, to achieve the specified daily dose of SAR442168.
Receives: Drug: SAR442168; Drug: Placebo; Drug: Locally approved intravenous contrast medium for contrast enhanced magnetic resonance imaging (MRI)
Cohort 1: SAR442168 60 mg Then PlaceboExperimentalParticipants received SAR442168 60 mg, orally once daily for first 12 weeks then crossed over to matching placebo orally once daily for 4 weeks during the 16 weeks treatment period. To maintain the blinding, each participant was given a total of 4 tablets daily, either of SAR442168 or SAR442168 and placebo, to achieve the specified daily dose of SAR442168.
Receives: Drug: SAR442168; Drug: Placebo; Drug: Locally approved intravenous contrast medium for contrast enhanced magnetic resonance imaging (MRI)
Cohort 2: Placebo Then SAR442168 5 mgExperimentalParticipants received placebo matching to SAR442168 tablets, orally once daily for first 4 weeks then crossed over to SAR442168 5 mg orally once daily for 12 weeks during the 16 weeks treatment period. To maintain the blinding, each participant was given a total of 4 tablets daily, either of SAR442168 or SAR442168 and placebo, to achieve the specified daily dose of SAR442168.
Receives: Drug: SAR442168; Drug: Placebo; Drug: Locally approved intravenous contrast medium for contrast enhanced magnetic resonance imaging (MRI)
Cohort 2: Placebo Then SAR442168 15 mgExperimentalParticipants received placebo matching to SAR442168 tablets, orally once daily for first 4 weeks then crossed over to SAR442168 15 mg orally once daily for 12 weeks during the 16 weeks treatment period. To maintain the blinding, each participant was given a total of 4 tablets daily, either of SAR442168 or SAR442168 and placebo, to achieve the specified daily dose of SAR442168.
Receives: Drug: SAR442168; Drug: Placebo; Drug: Locally approved intravenous contrast medium for contrast enhanced magnetic resonance imaging (MRI)
Cohort 2: Placebo Then SAR442168 30 mgExperimentalParticipants received placebo matching to SAR442168 tablets, orally once daily for first 4 weeks then crossed over to SAR442168 30 mg orally once daily for 12 weeks during the 16 weeks treatment period. To maintain the blinding, each participant was given a total of 4 tablets daily, either of SAR442168 or SAR442168 and placebo, to achieve the specified daily dose of SAR442168.
Receives: Drug: SAR442168; Drug: Placebo; Drug: Locally approved intravenous contrast medium for contrast enhanced magnetic resonance imaging (MRI)
Cohort 2: Placebo Then SAR442168 60 mgExperimentalParticipants received placebo matching to SAR442168 tablets, orally once daily for first 4 weeks then crossed over to SAR442168 60 mg orally once daily for 12 weeks during the 16 weeks treatment period. To maintain the blinding, each participant was given a total of 4 tablets daily, either of SAR442168 or SAR442168 and placebo, to achieve the specified daily dose of SAR442168.
Receives: Drug: SAR442168; Drug: Placebo; Drug: Locally approved intravenous contrast medium for contrast enhanced magnetic resonance imaging (MRI)

What is being measured

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

  1. Brain Magnetic Resonance Imaging (MRI) Assessment: Number of New Gadolinium (Gd) Enhancing T1-hyperintense Lesions

    Number of new Gd-enhancing T1-hyperintense lesions was detected by brain MRI at the end of 12 weeks of SAR442168 treatment (i.e., at Week 12 for Cohort 1 participants and Week 16 for Cohort 2 participants). Data was planned to be collected and analyzed on pooled population of participants at each dose level of SAR442168 (either in Cohort 1 and 2) and pooled population of participants receiving placebo in Cohort 2 and was not planned to collected during placebo administration in Cohort 1 (Weeks 12 to 16).

    Measured: After 12 weeks of SAR442168 treatment for SAR442168 reporting arms (i.e., at Week 12 for Cohort 1 participants, at Week 16 for Cohort 2 participants) and at Week 4 for Cohort 2 placebo

Secondary outcomes (5)

  1. Number of New or Enlarging T2 Lesions

    Number of new and enlarging T2 lesions was detected by brain MRI at the end of 12 weeks of SAR442168 treatment (i.e., at Week 12 for Cohort 1 participants and Week 16 for Cohort 2 participants).

    Measured: After 12 weeks of SAR442168 treatment for SAR442168 reporting arms (i.e., at Week 12 for Cohort 1 participants, at Week 16 for Cohort 2 participants), and at Week 4 for Cohort 2 placebo

  2. Total Number of Gd-enhancing T1-hyperintense Lesions

    Total number of Gd-enhancing T1-hyperintense lesions was detected by brain MRI at the end of 12 weeks of SAR442168 treatment (i.e., at Week 12 for Cohort 1 participants and Week 16 for Cohort 2 participants).

    Measured: After 12 weeks of SAR442168 treatment for SAR442168 reporting arms (i.e., at Week 12 for Cohort 1 participants, at Week 16 for Cohort 2 participants), and at Week 4 for Cohort 2 placebo

  3. Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs): Weeks 1-4 Period

    Adverse event (AE) was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug. Serious AE (SAE) was defined as any untoward medical occurrence that, at any dose resulted in death, life-threatening, inpatient hospitalization or prolongation of existing hospitalization, disability/incapacity, congenital anomaly/birth defect, or medical event. TEAEs were defined as AEs (serious/non-serious) that developed, worsened, or became serious during on-treatment period (for this outcome measure- "Weeks 1 to 4 period": time from 1st administration of study drug to Week 4). Cohorts 1 and 2 received SAR442168 and placebo for first 4 weeks, respectively.

    Measured: From Baseline up to Week 4

  4. Number of Participants With Treatment-emergent Adverse Events and Treatment-emergent Serious Adverse Events: SAR442168 Treatment Period

    AE was defined as any unfavorable and unintended sign (including abnormal laboratory finding), symptom, or disease temporally associated with use of study drug. SAE was defined as any untoward medical occurrence that, at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, persistent disability/incapacity, congenital anomaly/birth defect, or medical event. TEAEs: AEs that developed, worsened, or became serious during on-treatment period (for this outcome measure defined as "SAR442168 treatment period" which was considered as Weeks 1 to 12 for Cohort 1 and Weeks 4 to 16 for Cohort 2).

    Measured: Weeks 1 to 12 for Cohort 1 participants and Weeks 4 to 16 for Cohort 2 participants

  5. Number of Participants With Individual Clinically Relevant Abnormalities in Laboratory Tests (Hematology, Chemistry, Urinalysis), Vital Signs, and Electrocardiograms (ECG)

    Individual clinically relevant abnormalities was defined as potentially clinically significant abnormalities (PCSA) considered as SAEs or TEAEs leading to study treatment discontinuation or study discontinuation during the on-treatment period (time from first study drug administration until Week 16), considering all evaluations performed during the on-treatment period that included unscheduled or repeated evaluations.

    Measured: Baseline up to Week 12 for Cohort 1 participants; Baseline up to Week 4 for Cohort 2 Placebo and from Weeks 4 to 16 for Cohort 2 SAR442168 receiving participants

Timeline

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

  1. First posted26 Mar 2019
  2. Study start29 Mar 2019
  3. Primary completion2 Jan 2020
  4. Study completion2 Jan 2020

Resources

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
Randomised
Intervention model
Crossover
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
130 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03889639
Sponsor's protocol ID
DRI15928
Other IDs
2018-003927-12, U1111-1220-0572, 2018
Status last verified
Sep 2025
First submitted
1 Mar 2019
Last updated
17 Sep 2025
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

Publications

  • Reich DS, Arnold DL, Vermersch P, Bar-Or A, Fox RJ, Matta A, Turner T, Wallstrom E, Zhang X, Mares M, Khabirov FA, Traboulsee A; Tolebrutinib Phase 2b Study Group. Safety and efficacy of tolebrutinib, an oral brain-penetrant BTK inhibitor, in relapsing multiple sclerosis: a phase 2b, randomised, double-blind, placebo-controlled trial. Lancet Neurol. 2021 Sep;20(9):729-738. doi: 10.1016/S1474-4422(21)00237-4.

    PubMed 34418400

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SAR442168 and Locally approved intravenous contrast medium for contrast enhanced magnetic resonance imaging (MRI) in people with Relapsing Multiple Sclerosis, run by Sanofi at 48 sites in 10 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 8 inclusion and 21 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 17 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 48 sites in United States, Czechia, Russia, Ukraine, Spain and 5 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 8 Mar 2023). 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?

Brain Magnetic Resonance Imaging (MRI) Assessment: Number of New Gadolinium (Gd) Enhancing T1-hyperintense Lesions (time frame: After 12 weeks of SAR442168 treatment for SAR442168 reporting arms (i.e., at Week 12 for Cohort 1 participants, at Week 16 for Cohort 2 participants) and at Week 4 for Cohort 2 placebo). 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 NCT03889639, which also lists 1 linked publication.

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 17 Sep 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in