Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SAR442168 · 2 trials · 2 indications
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).
Fractional and cumulative percentage of radioactive dose excreted in urine and feces of \[14C\]-SAR442168
| 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. |
| SAR442168 | EXPERIMENTAL | Single oral dose of SAR442168 (as a nonsalified compound) containing (NMT) 3.7 MBq of \[14C\]-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...
SAR442168 is an investigational small molecule being developed for the treatment of multiple sclerosis, including relapsing multiple sclerosis. It is currently in clinical development and has not been approved by regulatory authorities. The drug is being studied in patients with relapsing forms of the disease.
SAR442168 is being developed by Sanofi, a global biopharmaceutical company traded on the NASDAQ under the ticker symbol SNY. Sanofi is conducting clinical trials to evaluate the safety, tolerability, and pharmacokinetics of SAR442168 in patients with multiple sclerosis and in healthy volunteers.
SAR442168 is in Phase 1 clinical development. One Phase 1 study has been completed, and a separate dose-finding study listed as Phase 2 has also been completed. The drug remains investigational and has not received FDA approval for any indication.
SAR442168 has been studied in two completed clinical trials. NCT03889639 was a dose-finding study in 130 participants with relapsing multiple sclerosis, conducted across multiple countries including the United States, Canada, and France. NCT04171310 was a Phase 1 excretion balance and pharmacokinetics study in 6 healthy male subjects in the United Kingdom.
SAR442168 is a distinct investigational small molecule developed by Sanofi. It is not identified as being the same as any other approved or investigational drug. Its mechanism of action has not been disclosed in available clinical trial information, and it is being studied specifically for multiple sclerosis indications.