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Trial record 1 of 1 for:    SAR442168
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Dose-finding Study for SAR442168 in Relapsing Multiple Sclerosis

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ClinicalTrials.gov Identifier: NCT03889639
Recruitment Status : Recruiting
First Posted : March 26, 2019
Last Update Posted : June 6, 2019
Sponsor:
Information provided by (Responsible Party):
Sanofi

Brief Summary:

Primary Objective:

To determine the efficacy of SAR442168 in reducing the number of new brain lesions reported in Magnetic Resonance Imaging (MRI)

Secondary Objectives:

  • To evaluate the efficacy of SAR442168 on clinical symptoms and imaging measures
  • To evaluate the safety and tolerability of SAR442168

Condition or disease Intervention/treatment Phase
Relapsing Multiple Sclerosis Drug: SAR442168 Drug: Placebo Drug: Locally approved intravenous contrast medium for contrast enhanced MRI Phase 2

Detailed Description:
The total study duration is 24 weeks which includes a screening period of 4 weeks, a treatment period of 16 weeks and a follow-up period of up to 4 weeks. Participants completing the Week 16 visit will be proposed to enroll in a long-term safety (LTS) follow-up study to assess safety and tolerability of SAR442168.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2b Dose-finding Study for SAR442168, a Bruton's Tyrosine Kinase Inhibitor, in Participants With Relapsing Multiple Sclerosis
Actual Study Start Date : March 29, 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Arm 1
12 weeks of SAR442186 dose 1 followed by 4 weeks of Placebo
Drug: SAR442168

Pharmaceutical form: Film coated tablet

Route of administration: Oral


Drug: Placebo

Pharmaceutical form: Film coated tablet

Route of administration: Oral


Drug: Locally approved intravenous contrast medium for contrast enhanced MRI

Pharmaceutical form: Solution for injection

Route of administration: Intravenous


Experimental: Arm 2
12 weeks of SAR442186 dose 2 followed by 4 weeks of Placebo
Drug: SAR442168

Pharmaceutical form: Film coated tablet

Route of administration: Oral


Drug: Placebo

Pharmaceutical form: Film coated tablet

Route of administration: Oral


Drug: Locally approved intravenous contrast medium for contrast enhanced MRI

Pharmaceutical form: Solution for injection

Route of administration: Intravenous


Experimental: Arm 3
12 weeks of SAR442186 dose 3 followed by 4 weeks of Placebo
Drug: SAR442168

Pharmaceutical form: Film coated tablet

Route of administration: Oral


Drug: Placebo

Pharmaceutical form: Film coated tablet

Route of administration: Oral


Drug: Locally approved intravenous contrast medium for contrast enhanced MRI

Pharmaceutical form: Solution for injection

Route of administration: Intravenous


Experimental: Arm 4
12 weeks of SAR442186 dose 4 followed by 4 weeks of Placebo
Drug: SAR442168

Pharmaceutical form: Film coated tablet

Route of administration: Oral


Drug: Placebo

Pharmaceutical form: Film coated tablet

Route of administration: Oral


Drug: Locally approved intravenous contrast medium for contrast enhanced MRI

Pharmaceutical form: Solution for injection

Route of administration: Intravenous


Experimental: Arm 5
4 weeks of Placebo followed by 12 weeks of SAR442186 dose 1
Drug: SAR442168

Pharmaceutical form: Film coated tablet

Route of administration: Oral


Drug: Placebo

Pharmaceutical form: Film coated tablet

Route of administration: Oral


Drug: Locally approved intravenous contrast medium for contrast enhanced MRI

Pharmaceutical form: Solution for injection

Route of administration: Intravenous


Experimental: Arm 6
4 weeks of Placebo followed by 12 weeks of SAR442186 dose 2
Drug: SAR442168

Pharmaceutical form: Film coated tablet

Route of administration: Oral


Drug: Placebo

Pharmaceutical form: Film coated tablet

Route of administration: Oral


Drug: Locally approved intravenous contrast medium for contrast enhanced MRI

Pharmaceutical form: Solution for injection

Route of administration: Intravenous


Experimental: Arm 7
4 weeks of Placebo followed by 12 weeks of SAR442186 dose 3
Drug: SAR442168

Pharmaceutical form: Film coated tablet

Route of administration: Oral


Drug: Placebo

Pharmaceutical form: Film coated tablet

Route of administration: Oral


Drug: Locally approved intravenous contrast medium for contrast enhanced MRI

Pharmaceutical form: Solution for injection

Route of administration: Intravenous


Experimental: Arm 8
4 weeks of Placebo followed by 12 weeks of SAR442186 dose 4
Drug: SAR442168

Pharmaceutical form: Film coated tablet

Route of administration: Oral


Drug: Placebo

Pharmaceutical form: Film coated tablet

Route of administration: Oral


Drug: Locally approved intravenous contrast medium for contrast enhanced MRI

Pharmaceutical form: Solution for injection

Route of administration: Intravenous





Primary Outcome Measures :
  1. Number of new Gd-enhancing T1 hyperintense lesions [ Time Frame: Week 12 for Arms 1 - 4, Week 4 and Week 16 for Arms 5 - 8 ]
    Number of new Gd-enhancing T1 hyperintense lesions at the end of 12 weeks of SAR442168 treatment as detected by brain MRI


Secondary Outcome Measures :
  1. Number of new or enlarging T2 lesions [ Time Frame: Week 12 for Arms 1 - 4, Week 4 and Week 16 for Arms 5 - 8 ]
    Number of new or enlarging T2 lesions at the end of 12 weeks of SAR442168 treatment

  2. Total number of Gd-enhancing T1 hyperintense lesions [ Time Frame: Week 12 for Arms 1 - 4, Week 4 and Week 16 for Arms 5 - 8 ]
    Total number of Gd-enhancing T1-hyperintense lesions at the end of 12 weeks of SAR442168 treatment

  3. Number of participants experiencing adverse events [ Time Frame: From baseline to the end of study (approximately 20 weeks) ]
    Number (n) of participants experiencing an adverse event (AE)/Serious Adverse Event (SAE) or potentially clinically significant abnormalities in laboratory tests, electrocardiogram (ECG), or vital signs

  4. Percentage of participants experiencing adverse events [ Time Frame: From baseline to the end of study (approximately 20 weeks) ]
    Percentage (%) of participants experiencing an adverse event (AE)/Serious Adverse Event (SAE) or potentially clinically significant abnormalities in laboratory tests, electrocardiogram (ECG), or vital signs



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Participant must be 18 to 55 years of age, inclusive, at the time of signing the informed consent.
  • Participant must have been diagnosed with relapsing multiple sclerosis (RMS) according to the 2017 revision of the McDonald diagnostic criteria.
  • Participant must have at least 1 documented relapse within the previous year, ≥2 documented relapses within the previous 2 years, or ≥1 active Gadolinium (Gd)-enhancing brain lesion on a magnetic resonance imaging (MRI) scan in the past 6 months and prior to screening.
  • A female participant must use a double contraception method including a highly effective method of birth control, except if she has undergone sterilization at least 3 months earlier or is postmenopausal.
  • Male participants, whose partners are of childbearing potential (including breastfeeding women), must accept 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 are pregnant must use, during sexual intercourse, a condom from inclusion up to 3 months after the last dose.
  • Male participants must have agreed not to donate sperm from the inclusion up to 3 months after the last dose.
  • Participant must have given written informed consent prior to undertaking any study-related procedure.

Exclusion criteria:

  • The participant has been diagnosed with primary progressive multiple sclerosis (PPMS) according to the 2017 revision of the McDonald diagnostic criteria or with non relapsing secondary progressive multiple sclerosis (SPMS).
  • 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 (IMP) administration in this study, as judged by the Investigator.
  • Presence of any screening laboratory or ECG values outside normal limits that are considered in the Investigator's judgment to be clinically significant.
  • Presence of liver injury.
  • At screening, the participant is positive for hepatitis B surface antigen and/or hepatitis B core antibody and/or is positive for hepatitis C antibody.
  • Bleeding disorder or known platelet dysfunction at any time prior to screening visit.
  • Participant has 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 is receiving strong inducers or inhibitors of cytochrome P450 3A (CYP3A) or CYP2C8 hepatic enzymes.
  • Participant is receiving anticoagulant/antiplatelet therapies.
  • Participant has taken other investigational drugs within 3 months or 5 half lives, whichever is longer, before screening visit.
  • Participant has an Expanded Disability Status Scale (EDSS) score >5.5 at screening visit.
  • Participant has had a relapse in the 30 days prior to randomization.
  • Participant is pregnant or a breastfeeding woman.
  • History or presence of significant other concomitant illness.
  • The participant has received medications/treatments for MS within a specified time frame.

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03889639


Contacts
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Contact: Trial Transparency email recommended (Toll free number for US & Canada) 800-633-1610 ext 1 then # Contact-US@sanofi.com

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Sponsors and Collaborators
Sanofi
Investigators
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Study Director: Clinical Sciences & Operations Sanofi

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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT03889639     History of Changes
Other Study ID Numbers: DRI15928
2018-003927-12 ( EudraCT Number )
U1111-1220-0572 ( Other Identifier: UTN )
First Posted: March 26, 2019    Key Record Dates
Last Update Posted: June 6, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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://www.clinicalstudydatarequest.com/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases