Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03889639 | Dose-finding Study for SAR442168 in Relapsing Multiple Sclerosis | PHASE2 | COMPLETED | 130 | — | — | Mar 29, 2019 | Jan 2, 2020 | Sep 17, 2025 | 48 | United States, Canada +8 |
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).
| Arm | Type | Description |
|---|---|---|
| Cohort 1: SAR442168 5 mg Then Placebo | EXPERIMENTAL | 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. |
| Cohort 1: SAR442168 15 mg Then Placebo | EXPERIMENTAL | 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. |
| Cohort 1: SAR442168 30 mg Then Placebo | EXPERIMENTAL | 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. |
| Cohort 1: SAR442168 60 mg Then Placebo | EXPERIMENTAL | 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. |
| Cohort 2: Placebo Then SAR442168 5 mg | EXPERIMENTAL | 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. |
| Cohort 2: Placebo Then SAR442168 15 mg | EXPERIMENTAL | 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. |
| Cohort 2: Placebo Then SAR442168 30 mg | EXPERIMENTAL | 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. |
| Cohort 2: Placebo Then SAR442168 60 mg | EXPERIMENTAL | 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. |
| Name | Type | Description |
|---|---|---|
| SAR442168 | DRUG | Pharmaceutical form: Film coated tablet; Route of administration: Oral |
| Placebo | DRUG | 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 |
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 document...