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...
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