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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07325292 | Non-inferiority Study of Frexalimab Subcutaneous Administration Compared to Intravenous Administration in Adult Participants With Multiple Sclerosis | PHASE3 | RECRUITING | 160 | — | — | Jan 14, 2026 | Nov 30, 2028 | May 29, 2026 | 32 | United States, Belgium +2 |
| NCT06141486 | Efficacy and Safety Study of Frexalimab (SAR441344) in Adults With Nonrelapsing Secondary Progressive Multiple Sclerosis | PHASE3 | ACTIVE NOT_RECRUITING | 943 | — | — | Dec 27, 2023 | Mar 24, 2028 | May 14, 2026 | 311 | United States, Argentina +25 |
| NCT06141473 | Efficacy and Safety Studies of Frexalimab (SAR441344) in Adults With Relapsing Forms of Multiple Sclerosis | PHASE3 | ACTIVE NOT_RECRUITING | 1,655 | — | — | Dec 13, 2023 | May 6, 2027 | May 14, 2026 | 382 | United States, Argentina +39 |
AUCW20-W24
Ctrough,SS
Defined as Increase from the baseline expanded disability status scale (EDSS) score of ≥1.0 point when the baseline is \<5.5, or ≥0.5 point when the baseline is ≥5.5, OR Increase of ≥20% from the baseline time in the 9 hole peg test (9HPT),OR Increase of ≥20% from the baseline time in the timed 25 foot walk (T25FW) test
ARR during the study period assessed by protocol-defined adjudicated relapses. This endpoint will be analyzed in the ITT population of each study using a negative binomial model with the total number of adjudicated relapses per participant occurring during the observation period as the response variable and with terms for treatment group, Gd-enhancing T1 lesions at baseline (presence, absence), EDSS strata (\<4, ≥4), and geographical region (US, non-US).
| Arm | Type | Description |
|---|---|---|
| Frexalimab SC | EXPERIMENTAL | Frexalimab SC (home self-administration via on-body delivery system(OBDS), is allowed from the beginning of Part B after appropriate training and participant and Investigator agreement) |
| Frexalimab IV | EXPERIMENTAL | Frexalimab IV |
| Frexalimab | EXPERIMENTAL | Frexalimab IV administration |
| Placebo | PLACEBO_COMPARATOR | Matching placebo |
| Teriflunomide | ACTIVE_COMPARATOR | Participants will receive teriflunomide tablet and placebo infusion. |
| Name | Type | Description |
|---|---|---|
| Frexalimab | DRUG | Pharmaceutical form:Solution for injection-Route of administration:SC injection |
| MRI contrast-enhancing preparations | DRUG | Route of administration:IV injection |
| Placebo | DRUG | Solution for IV infusion |
| MRI contrast-enhancing agents | DRUG | IV, as per respective label |
| Teriflunomide | DRUG | Aubagio oral tablet |
| Placebo infusion | DRUG | Solution for IV infusion |
| Placebo tablet | DRUG | Oral tablet |
| Cholestyramine | DRUG | oral, 8 g 3 times daily for 11 days for accelerated elimination procedure (4 g 3 times daily for 11 days in case of intolerance). The teriflunomide local label should be followed. |
| Activated charcoal | DRUG | oral, 50 g every 12 hours for 11 days for accelerated elimination procedure. The teriflunomide local label should be followed. |
Inclusion Criteria: The participant must qualify for inclusion per either Group A or B criteria as detailed below, meeting all the inclusion criteria of the applicable group: Group A (RMS) * The participant must be 18 to 55 years of age, inclusive, at the time of signing the informed consent. * T...