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 drug being studied for kidney transplant rejection, type 1 diabetes mellitus, multiple sclerosis, and focal segmental glomerulosclerosis. It is currently in Phase 2 and Phase 3 clinical trials for these conditions, with multiple sclerosis being the most advanced area of development.
Frexalimab is a monoclonal antibody, indicated by its -mab suffix. It is being developed by Sanofi for autoimmune and inflammatory conditions. The specific molecular target is not disclosed in available information, but its mechanism involves antibody-mediated modulation of the immune system.
Frexalimab is being developed by Sanofi, a global biopharmaceutical company listed on the stock exchange under the ticker SNY. Sanofi is conducting multiple clinical trials to evaluate the drug's safety and efficacy across several indications.
Frexalimab is in Phase 2 and Phase 3 clinical development. It is not FDA approved and remains investigational. Phase 3 trials are active for relapsing forms of multiple sclerosis and nonrelapsing secondary progressive multiple sclerosis, while a Phase 2 trial is studying type 1 diabetes.
Frexalimab is being studied in four clinical trials. NCT06111586 is a Phase 2 trial in type 1 diabetes. NCT06141473 and NCT06141486 are Phase 3 trials in multiple sclerosis. NCT07325292 is a Phase 3 non-inferiority study comparing subcutaneous and intravenous administration in multiple sclerosis.
Yes, Frexalimab is also known as SAR441344. Clinical trial titles refer to the drug as Frexalimab (SAR441344), confirming that both names identify the same investigational compound being developed by Sanofi.