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CompletedNCT03889639Updated Sep 17, 2025Results posted

Dose-finding Study for SAR442168 in Relapsing Multiple Sclerosis

A Phase 2 interventional study of SAR442168 and Placebo in Relapsing Multiple Sclerosis, sponsored by Sanofi. Completed at 48 sites in 10 countries. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2025-09-17.

Sponsored by Sanofi · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
130
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Relapsing Multiple Sclerosis
03

In context

Lead sponsor

Sanofi is the lead sponsor of 1,508 studies on the registry; 90 are open to participants now.

Of its 198 completed or terminated interventional studies of FDA-regulated products, 118 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion criteria:

  • 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.
  • 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.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
130 participants (actual)

Study arms

  • Experimental
    Cohort 1: SAR442168 5 mg Then Placebo

    Participants 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.

    Drug: SAR442168 · Drug: Placebo · Drug: Locally approved intravenous contrast medium for contrast enhanced magnetic resonance imaging (MRI)

  • Experimental
    Cohort 1: SAR442168 15 mg Then Placebo

    Participants 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.

    Drug: SAR442168 · Drug: Placebo · Drug: Locally approved intravenous contrast medium for contrast enhanced magnetic resonance imaging (MRI)

  • Experimental
    Cohort 1: SAR442168 30 mg Then Placebo

    Participants 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.

    Drug: SAR442168 · Drug: Placebo · Drug: Locally approved intravenous contrast medium for contrast enhanced magnetic resonance imaging (MRI)

  • Experimental
    Cohort 1: SAR442168 60 mg Then Placebo

    Participants 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.

    Drug: SAR442168 · Drug: Placebo · Drug: Locally approved intravenous contrast medium for contrast enhanced magnetic resonance imaging (MRI)

  • Experimental
    Cohort 2: Placebo Then SAR442168 5 mg

    Participants 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.

    Drug: SAR442168 · Drug: Placebo · Drug: Locally approved intravenous contrast medium for contrast enhanced magnetic resonance imaging (MRI)

  • Experimental
    Cohort 2: Placebo Then SAR442168 15 mg

    Participants 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.

    Drug: SAR442168 · Drug: Placebo · Drug: Locally approved intravenous contrast medium for contrast enhanced magnetic resonance imaging (MRI)

  • Experimental
    Cohort 2: Placebo Then SAR442168 30 mg

    Participants 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.

    Drug: SAR442168 · Drug: Placebo · Drug: Locally approved intravenous contrast medium for contrast enhanced magnetic resonance imaging (MRI)

  • Experimental
    Cohort 2: Placebo Then SAR442168 60 mg

    Participants 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.

    Drug: SAR442168 · Drug: Placebo · Drug: Locally approved intravenous contrast medium for contrast enhanced magnetic resonance imaging (MRI)

Interventions

  • DrugSAR442168

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

  • DrugPlacebo

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

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

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

06

What researchers measure

Primary outcomes

  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).

    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

Secondary outcomes

  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).

    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

  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).

    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

  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.

    Time frame: 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).

    Time frame: 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.

    Time frame: 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

07

Results

Posted Mar 8, 2023

Participant flow

The study was conducted at 44 active centers in 10 countries. A total of 168 participants were screened from 29-March-2019 to 29-August-2019, of which 38 participants were screen failures. Screen failures were mainly due to selection criteria not met.

Participant flow — Overall Study
MilestoneCohort 1: SAR442168 5 mg Then PlaceboCohort 1: SAR442168 15 mg Then PlaceboCohort 1: SAR442168 30 mg Then PlaceboCohort 1: SAR442168 60 mg Then PlaceboCohort 2: Placebo Then SAR442168 5 mgCohort 2: Placebo Then SAR442168 15 mgCohort 2: Placebo Then SAR442168 30 mgCohort 2: Placebo Then SAR442168 60 mg
Started1616161617161716
Completed1616161617161715
Not completed00000001
Withdrew: Withdrawal by subject00000001

Outcome measures

PrimaryBrain 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).

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
Reported as:
Mean · lesions
Brain Magnetic Resonance Imaging (MRI) Assessment: Number of New Gadolinium (Gd) Enhancing T1-hyperintense Lesions
lesionsCohort 2: Pooled PlaceboCohorts 1 and 2: SAR442168 5 mgCohorts 1 and 2: SAR442168 15 mgCohorts 1 and 2: SAR442168 30 mgCohorts 1 and 2: SAR442168 60 mg
Brain Magnetic Resonance Imaging (MRI) Assessment: Number of New Gadolinium (Gd) Enhancing T1-hyperintense Lesions1.03 ± 2.501.39 ± 3.200.77 ± 1.480.76 ± 3.310.13 ± 0.43
Statistical analysis
  • Cohort 2: Pooled Placebo vs Cohorts 1 and 2: SAR442168 5 mg · Negative binomial regression model · p = 0.1673 · Relative reduction in lesions: -56.16 · 95% CI -193.99 to 17.05Threshold for significance for p-value was 0.05.
  • Cohort 2: Pooled Placebo vs Cohorts 1 and 2: SAR442168 15 mg · Negative binomial regression model · p = 0.3540 · Relative reduction in lesions: -62.80 · 95% CI -356.24 to 41.91Threshold for significance for p-value was 0.05.
  • Cohort 2: Pooled Placebo vs Cohorts 1 and 2: SAR442168 30 mg · Negative binomial regression model · p = 0.7674 · Relative reduction in lesions: 13.49 · 95% CI -126.05 to 66.89Threshold for significance for p-value was 0.05.
  • Cohort 2: Pooled Placebo vs Cohorts 1 and 2: SAR442168 60 mg · Negative binomial regression model · p = 0.0178 · Relative reduction in lesions: 85.02 · 95% CI 28.02 to 96.88Threshold for significance for p-value was 0.05.
SecondaryNumber 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).

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
Reported as:
Mean · lesions
Number of New or Enlarging T2 Lesions
lesionsCohort 2: Pooled PlaceboCohorts 1 and 2: SAR442168 5 mgCohorts 1 and 2: SAR442168 15 mgCohorts 1 and 2: SAR442168 30 mgCohorts 1 and 2: SAR442168 60 mg
Number of New or Enlarging T2 Lesions2.12 ± 5.161.90 ± 3.971.32 ± 1.831.30 ± 4.900.23 ± 0.62
Statistical analysis
  • Cohort 2: Pooled Placebo vs Cohorts 1 and 2: SAR442168 5 mg · Negative binomial regression model · p = 0.7736 · Relative reduction in lesions: 10.17 · 95% CI -86.49 to 56.73Threshold for significance for p-value was 0.05.
  • Cohort 2: Pooled Placebo vs Cohorts 1 and 2: SAR442168 15 mg · Negative binomial regression model · p = 0.2480 · Relative reduction in lesions: 37.07 · 95% CI -38.08 to 71.32Threshold for significance for p-value was 0.05.
  • Cohort 2: Pooled Placebo vs Cohorts 1 and 2: SAR442168 30 mg · Negative binomial regression model · p = 0.3081 · Relative reduction in lesions: 38.5 · 95% CI -56.61 to 75.85Threshold for significance for p-value was 0.05.
  • Cohort 2: Pooled Placebo vs Cohorts 1 and 2: SAR442168 60 mg · Negative binomial regression model · p = 0.0001 · Relative reduction in lesions: 89.34 · 95% CI 68.39 to 96.41Threshold for significance for p-value was 0.05.
SecondaryTotal 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).

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
Reported as:
Mean · lesions
Total Number of Gd-enhancing T1-hyperintense Lesions
lesionsCohort 2: Pooled PlaceboCohorts 1 and 2: SAR442168 5 mgCohorts 1 and 2: SAR442168 15 mgCohorts 1 and 2: SAR442168 30 mgCohorts 1 and 2: SAR442168 60 mg
Total Number of Gd-enhancing T1-hyperintense Lesions1.36 ± 3.521.77 ± 4.100.87 ± 1.591.18 ± 4.870.29 ± 0.86
Statistical analysis
  • Cohort 2: Pooled Placebo vs Cohorts 1 and 2: SAR442168 5 mg · Negative binomial regression model · p = 0.1525 · Relative reduction in lesions: -62.16 · 95% CI -214.44 to 16.38Threshold for significance for p-value was 0.05.
  • Cohort 2: Pooled Placebo vs Cohorts 1 and 2: SAR442168 15 mg · Negative binomial regression model · p = 0.4606 · Relative reduction in lesions: -47.38 · 95% CI -312.91 to 47.40Threshold for significance for p-value was 0.05.
  • Cohort 2: Pooled Placebo vs Cohorts 1 and 2: SAR442168 30 mg · Negative binomial regression model · p = 0.9490 · Relative reduction in lesions: 2.90 · 95% CI -138.96 to 60.54Threshold for significance for p-value was 0.05.
  • Cohort 2: Pooled Placebo vs Cohorts 1 and 2: SAR442168 60 mg · Negative binomial regression model · p = 0.2324 · Relative reduction in lesions: 65.05 · 95% CI -96.21 to 93.77Threshold for significance for p-value was 0.05.
SecondaryNumber 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.

Time frame:
From Baseline up to Week 4
Reported as:
Count of participants · Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs): Weeks 1-4 Period
ParticipantsCohort 2: Pooled PlaceboCohort 1: SAR442168 5 mgCohort 1: SAR442168 15 mgCohort 1: SAR442168 30 mgCohort 1: SAR442168 60 mg
TEAE235325
TESAE00000
SecondaryNumber 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).

Time frame:
Weeks 1 to 12 for Cohort 1 participants and Weeks 4 to 16 for Cohort 2 participants
Reported as:
Count of participants · Participants
Number of Participants With Treatment-emergent Adverse Events and Treatment-emergent Serious Adverse Events: SAR442168 Treatment Period
ParticipantsCohorts 1 and 2: SAR442168 5 mgCohorts 1 and 2: SAR442168 15 mgCohorts 1 and 2: SAR442168 30 mgCohorts 1 and 2: SAR442168 60 mg
TEAE19171816
TESAE0001
SecondaryNumber 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.

Time frame:
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
Reported as:
Count of participants · Participants
Number of Participants With Individual Clinically Relevant Abnormalities in Laboratory Tests (Hematology, Chemistry, Urinalysis), Vital Signs, and Electrocardiograms (ECG)
ParticipantsCohort 2: Pooled PlaceboCohorts 1 and 2: SAR442168 5 mgCohorts 1 and 2: SAR442168 15 mgCohorts 1 and 2: SAR442168 30 mgCohorts 1 and 2: SAR442168 60 mg
Hematology00000
Chemistry00000
Urinalysis00000
Vitals00000
ECGs00000

Adverse events

Collected over All AEs were collected from the first dose of study drug until the end of the study (Week 16) regardless of seriousness or relationship to study drug. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Cohort 1 and 2: SAR442168 5 mg0/33 (0%)0/33 (0%)19/33 (57.6%)
Cohort 1 and 2: SAR442168 15 mg0/32 (0%)0/32 (0%)17/32 (53.1%)
Cohort 1 and 2: SAR442168 30 mg0/33 (0%)0/33 (0%)18/33 (54.5%)
Cohort 1 and 2: SAR442168 60 mg0/32 (0%)1/32 (3.1%)16/32 (50%)
Cohort 1: Pooled Placebo0/64 (0%)0/64 (0%)10/64 (15.6%)
Cohort 2: Pooled Placebo0/66 (0%)0/66 (0%)23/66 (34.8%)
Most frequent serious events
Most frequent serious events
EventCohort 1 and 2: SAR442168 5 mgCohort 1 and 2: SAR442168 15 mgCohort 1 and 2: SAR442168 30 mgCohort 1 and 2: SAR442168 60 mgCohort 1: Pooled PlaceboCohort 2: Pooled Placebo
Multiple Sclerosis RelapseNervous system disorders0/330/320/331/320/640/66
Most frequent other events
Showing 10 of 91
Most frequent other events
EventCohort 1 and 2: SAR442168 5 mgCohort 1 and 2: SAR442168 15 mgCohort 1 and 2: SAR442168 30 mgCohort 1 and 2: SAR442168 60 mgCohort 1: Pooled PlaceboCohort 2: Pooled Placebo
HeadacheNervous system disorders1/333/321/334/322/644/66
NasopharyngitisInfections and infestations1/330/321/333/321/642/66
Accidental OverdoseInjury, poisoning and procedural complications0/330/320/333/320/641/66
GastroenteritisInfections and infestations1/330/320/332/321/641/66
RhinitisInfections and infestations0/332/320/330/320/640/66
Upper Respiratory Tract InfectionInfections and infestations2/332/321/331/320/641/66
Muscle SpasticityNervous system disorders0/330/321/332/320/640/66
VomitingGastrointestinal disorders0/332/320/330/320/641/66
Oedema PeripheralGeneral disorders2/330/320/332/322/640/66
Back PainMusculoskeletal and connective tissue disorders1/331/322/330/320/640/66

Baseline characteristics

Baseline analysis was performed on randomized population that included any participant who had been allocated to a randomly assigned treatment, regardless of whether the treatment kit was used.

Age, Continuous
Age, Continuous(years)Cohort 1: SAR442168 5 mg Then PlaceboCohort 1: SAR442168 15 mg Then PlaceboCohort 1: SAR442168 30 mg Then PlaceboCohort 1: SAR442168 60 mg Then PlaceboCohort 2: Placebo Then SAR442168 5 mgCohort 2: Placebo Then SAR442168 15 mgCohort 2: Placebo Then SAR442168 30 mgCohort 2: Placebo Then SAR442168 60 mgTotal
Mean37.4 ± 11.135.1 ± 7.940.8 ± 8.738.1 ± 9.134.8 ± 8.636.7 ± 10.737.5 ± 11.636.1 ± 8.737.1 ± 9.5
Sex: Female, Male
Sex: Female, Male(Participants)Cohort 1: SAR442168 5 mg Then PlaceboCohort 1: SAR442168 15 mg Then PlaceboCohort 1: SAR442168 30 mg Then PlaceboCohort 1: SAR442168 60 mg Then PlaceboCohort 2: Placebo Then SAR442168 5 mgCohort 2: Placebo Then SAR442168 15 mgCohort 2: Placebo Then SAR442168 30 mgCohort 2: Placebo Then SAR442168 60 mgTotal
Female9101115161110991
Male7651157739
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Cohort 1: SAR442168 5 mg Then PlaceboCohort 1: SAR442168 15 mg Then PlaceboCohort 1: SAR442168 30 mg Then PlaceboCohort 1: SAR442168 60 mg Then PlaceboCohort 2: Placebo Then SAR442168 5 mgCohort 2: Placebo Then SAR442168 15 mgCohort 2: Placebo Then SAR442168 30 mgCohort 2: Placebo Then SAR442168 60 mgTotal
American Indian or Alaska Native000000000
Asian000000011
Native Hawaiian or Other Pacific Islander000000000
Black or African American102101016
White1515131517141614119
More than one race000001001
Unknown or Not Reported011000103
08

Study locations

48 sites
  • Investigational Site Number 8400005
    Cullman, Alabama 35058, United States
  • Investigational Site Number 8400002
    Maitland, Florida 32761, United States
  • Investigational Site Number 8400004
    Sunrise, Florida 33351, United States
  • Investigational Site Number 8400009
    Tampa, Florida 33612, United States
  • Investigational Site Number 8400007
    Savannah, Georgia 31406, United States
  • Investigational Site Number 8400001
    Northbrook, Illinois 60062, United States
  • Investigational Site Number 8400008
    Dayton, Ohio 45417, United States
  • Investigational Site Number 8400006
    Westerville, Ohio 43081, United States
  • Investigational Site Number 8400003
    Knoxville, Tennessee 37922, United States
  • Investigational Site Number 1240002
    Gatineau, J8Y 1W2, Canada
  • Investigational Site Number 1240001
    Greenfield Park, J4V 2J2, Canada
  • Investigational Site Number 1240003
    Vancouver, V6T 2B5, Canada
  • Investigational Site Number 2030007
    Brno, 62500, Czechia
  • Investigational Site Number 2030004
    Hradec Králové, 50005, Czechia
  • Investigational Site Number 2030003
    Jihlava, 58633, Czechia
  • Investigational Site Number 2030005
    Ostrava - Poruba, 70852, Czechia
  • Investigational Site Number 2030006
    Pardubice, 53203, Czechia
  • Investigational Site Number 2030001
    Prague, 12808, Czechia
  • Investigational Site Number 2030002
    Praha 5 - Motol, 15006, Czechia
  • Investigational Site Number 2330001
    Tallinn, 11315, Estonia
  • Investigational Site Number 2500004
    Nancy, 54035, France
  • Investigational Site Number 2500001
    Nantes, 44093, France
  • Investigational Site Number 2500002
    Strasbourg, 67098, France
  • Investigational Site Number 2500003
    Toulouse, 31059, France
  • Investigational Site Number 5280001
    Amsterdam, 1081 HV, Netherlands
  • Investigational Site Number 5280002
    Sittard-Geleen, 6162 BG, Netherlands
  • Investigational Site Number 6430006
    Kazan', 420021, Russia
  • Investigational Site Number 6430003
    Moscow, 125367, Russia
  • Investigational Site Number 6430002
    Moscow, 127015, Russia
  • Investigational Site Number 6430005
    Saint Petersburg, 194044, Russia
  • Investigational Site Number 6430004
    Saint Petersburg, 197022, Russia
  • Investigational Site Number 6430001
    Saint Petersburg, 197110, Russia
  • Investigational Site Number 6430007
    Tyumen, 625000, Russia
  • Investigational Site Number 7030001
    Bratislava, 82606, Slovakia
  • Investigational Site Number 7030002
    Martin, 03659, Slovakia
  • Investigational Site Number 7240006
    Barakaldo, 48903, Spain
  • Investigational Site Number 7240002
    Barcelona, 08035, Spain
  • Investigational Site Number 7240001
    Madrid, 28007, Spain
  • Investigational Site Number 7240004
    Murcia, 30120, Spain
  • Investigational Site Number 7240005
    Salt, 17190, Spain
  • Investigational Site Number 7240003
    Seville, 41071, Spain
  • Investigational Site Number 8040002
    Chernivtsi, 58018, Ukraine
  • Investigational Site Number 8040005
    Dnipro, 49005, Ukraine
  • Investigational Site Number 8040001
    Lviv, 79010, Ukraine
  • Investigational Site Number 8040006
    Lviv, 79013, Ukraine
  • Investigational Site Number 8040009
    Odesa, 65025, Ukraine
  • Investigational Site Number 8040003
    Vinnytsia, 21005, Ukraine
  • Investigational Site Number 8040007
    Zhytomyr, 10002, Ukraine
09

References and documents

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 ↗

Study documents

  • Study protocol · Apr 9, 2019
  • Statistical analysis plan · Oct 25, 2019

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: 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

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 17, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03889639
Lead sponsor
Sanofi
Responsible party
Sponsor
First posted
Mar 26, 2019
Start date
Mar 29, 2019
Primary completion
Jan 2, 2020
Completion
Jan 2, 2020
Results posted
Mar 8, 2023
Last update
Sep 17, 2025

Study contacts

Clinical Sciences & Operations
study director · Sanofi

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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