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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04879628 | Proof-of-concept Study for SAR441344 (Frexalimab) in Relapsing Multiple Sclerosis | PHASE2 | ACTIVE NOT_RECRUITING | 129 | — | — | Jun 7, 2021 | Aug 23, 2027 | Sep 30, 2025 | 37 | United States, Bulgaria +8 |
Cranial (brain) MRI was performed to identify number of new GdE T1-hyperintense lesions at Week 12 relative to Week 8 MRI. Central review was used to identify new GdE T1 lesions not present at the previous MRI scans.
| Arm | Type | Description |
|---|---|---|
| Intravenous (IV) SAR441344 | EXPERIMENTAL | SAR441344 IV |
| IV Placebo | PLACEBO_COMPARATOR | Placebo IV |
| Subcutaneous (SC) SAR441344 | EXPERIMENTAL | SAR441344 SC |
| SC Placebo | PLACEBO_COMPARATOR | Placebo SC |
| Name | Type | Description |
|---|---|---|
| SAR441344 IV | DRUG | Pharmaceutical form: Solution Route of administration: IV infusion |
| placebo IV | DRUG | Pharmaceutical form: Solution Route of administration: IV infusion |
| SAR441344 SC | DRUG | Pharmaceutical form: Solution Route of administration: SC injection |
| placebo SC | DRUG | Pharmaceutical form: Solution Route of administration: SC injection |
| MRI contrast-enhancing preparations | DRUG | gadolinium compound, including but not limited to Magnevist, Multihance, Prohance, or Elucirem |
Inclusion criteria: * Participant must be 18 to 55 years of age inclusive, at the time of signing the informed consent. * The participant must have been diagnosed with RMS (relapsing-remitting MS and secondary progressive MS participants with relapses) according to the 2017 revision of the McDonald...