Dose-finding Study for SAR442168 in Relapsing Multiple Sclerosis
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| ClinicalTrials.gov Identifier: NCT03889639 |
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Recruitment Status :
Completed
First Posted : March 26, 2019
Last Update Posted : January 13, 2020
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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 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 128 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 |
| Actual Primary Completion Date : | January 2, 2020 |
| Actual Study Completion Date : | January 2, 2020 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Arm 1
12 weeks of SAR442186 dose 1 followed by 4 weeks of Placebo
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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 |
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Experimental: Arm 2
12 weeks of SAR442186 dose 2 followed by 4 weeks of Placebo
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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 |
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Experimental: Arm 3
12 weeks of SAR442186 dose 3 followed by 4 weeks of Placebo
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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 |
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Experimental: Arm 4
12 weeks of SAR442186 dose 4 followed by 4 weeks of Placebo
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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 |
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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 |
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Experimental: Arm 6
4 weeks of Placebo followed by 12 weeks of SAR442186 dose 2
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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 |
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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 |
- 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
- 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
- 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
- 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
- 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
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| Ages Eligible for Study: | 18 Years to 55 Years (Adult) |
| Sexes Eligible for Study: | 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 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.
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
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| Study Director: | Clinical Sciences & Operations | Sanofi |
| Responsible Party: | Sanofi |
| ClinicalTrials.gov Identifier: | NCT03889639 |
| 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: | January 13, 2020 |
| Last Verified: | January 2020 |
| 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/ |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
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Multiple Sclerosis Sclerosis Pathologic Processes Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System |
Nervous System Diseases Demyelinating Diseases Autoimmune Diseases Immune System Diseases |