Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Frexalimab · 6 trials · 5 indications
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).
BPAR is defined as biopsy confirmed T cell mediated and antibody mediated rejection as categorized by BANFF 2022; graft loss is defined as the first date the patients meet any of the following criteria: chronic dialysis for a least 56 days, day of allograft nephrectomy, or day of re-transplant.
mixed meal tolerance test (MMTT) stimulated C-peptide concentration is to be calculated from AUC
mixed meal tolerance test (MMTT) stimulated C-peptide concentration is to be calculated from AUC
| 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. |
| Tacrolimus | ACTIVE_COMPARATOR | Tacrolimus |
| Brivekimig | EXPERIMENTAL | Brivekimig active dose |
| Rilzabrutinib | EXPERIMENTAL | Rilzabrutinib active dose |
| Frexalimab Dose 1 | EXPERIMENTAL | - |
| Frexalimab Dose 2 | EXPERIMENTAL | - |
| Frexalimab Dose 3 | EXPERIMENTAL | - |
| 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. |
| Tacrolimus | DRUG | Pharmaceutical form:Capsule-Route of administration:Oral |
| rabbit anti-thymocyte globulin | DRUG | Pharmaceutical form:Solution for injection-Route of administration:IV |
| mycophenolate mofetil | DRUG | Pharmaceutical form:Tablet or capsule-Route of administration:Oral |
| mycophenolate sodium | DRUG | Pharmaceutical form:Tablet-Route of administration:Oral |
| methylprednisolone | DRUG | Pharmaceutical form:Solution for injection-Route of administration:IV |
| prednisone | DRUG | Pharmaceutical form:Tablet-Route of administration:Oral |
| brivekimig | DRUG | brivekimig treatment |
| rilzabrutinib | DRUG | rilzabrutinib treatment |
| Insulin | DRUG | SC injection, dose and frequency will be established and/or adjusted by investigator |
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...
Frexalimab is an investigational antibody being studied for multiple sclerosis, type 1 diabetes mellitus, focal segmental glomerulosclerosis, and kidney transplant rejection. In multiple sclerosis, it is being evaluated in relapsing forms, nonrelapsing secondary progressive disease, and as a subcutaneous versus intravenous formulation.
Frexalimab is being developed by Sanofi, a biopharmaceutical company listed on the stock exchange under the ticker SNY. Sanofi is conducting clinical trials of Frexalimab across multiple countries, including the United States, in indications such as multiple sclerosis and kidney transplant rejection.
Frexalimab is in Phase 2 and Phase 3 clinical development. Phase 3 trials are evaluating it in adults with relapsing forms of multiple sclerosis, nonrelapsing secondary progressive multiple sclerosis, and subcutaneous versus intravenous administration. A Phase 2 trial is studying it versus tacrolimus in kidney transplant recipients.
Frexalimab is being studied in several trials. NCT06141473 and NCT06141486 are Phase 3 trials in multiple sclerosis. NCT07325292 is a Phase 3 non-inferiority study comparing subcutaneous to intravenous administration. NCT07412470 is a Phase 2 trial in kidney transplant rejection.
Frexalimab is not FDA approved. It is an investigational drug currently in clinical development, with active Phase 2 and Phase 3 trials. No completed trials have been reported, and its safety and efficacy have not been established for any indication.
Yes, Frexalimab is also known as SAR441344. Clinical trial records refer to the drug as Frexalimab (SAR441344), indicating that both names identify the same investigational antibody being developed by Sanofi.