Efficacy and Safety Studies of Frexalimab (SAR441344) in Adults With

Resolution Criteria Trial: NCT06141473 Selected endpoint key: 192d41b7ff6dc924851a39468932340d56abd887375e8fcdb2d64b97572b7b5f Selected endpoint: Annualized relapse rate (ARR) during the study period assessed by protocol defined adjudicated relapses Endpoint type: other Protocol outcome group: primary Endpoint description: 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). Endpoint timeframe: Until Week 156 ClinicalTrials.gov population: Adults aged 18 to 55 years with relapsing forms of multiple sclerosis enrolled in each independent study. Market population: Adults aged 18 to 55 years with relapsing forms of multiple sclerosis enrolled in each independent study. Analysis set: ITT population of each study. Comparison: Frexalimab versus daily oral teriflunomide, assessed independently in each of the two randomized, double-blind Phase 3 studies. Success direction: lower Success rule: Frexalimab must produce a lower annualized relapse rate during the study period, through Week 156, than teriflunomide in the ITT population of each independent study, based on protocol-defined adjudicated relapses. The analysis must use the prespecified negative binomial model with each participant's total number of adjudicated relapses during the observation period as the response and terms for treatment group, baseline Gd-enhancing T1 lesions (presence versus absence), EDSS stratum (<4 versus ≥4), and geographical region (US versus non-US), and must meet the prespecified statistical success criterion; no numerical threshold is stated in the listed outcome. ClinicalTrials.gov source: https://clinicaltrials.gov/study/NCT06141473?tab=researcher#outcome-measures:~:text=Annualized%20relapse%20rate%20(ARR)%20during%20the%20study%20period%20assessed%20by%20protocol%20defined%20adjudicated%20relapses YES 1. The exact selected endpoint (Annualized relapse rate (ARR) during the study period assessed by protocol defined adjudicated relapses) satisfies the approved success rule in the specified population, analysis set, comparison, and timepoint. 2. The result is supported by a qualifying source in the approved evidence hierarchy. NO 1. The exact selected endpoint (Annualized relapse rate (ARR) during the study period assessed by protocol defined adjudicated relapses) misses its approved success rule. 2. No qualifying disclosure of the selected endpoint is available by 2027-12-31 at 23:59:59 UTC. NO DECISION / ADMIN REVIEW 1. Available evidence is contradictory, incomplete, pooled, interim, subgroup-only, or does not match the approved population, analysis set, comparison, and timepoint. Resolution deadline: 2027-12-31T23:59:59Z Deadline evidence: AI bounded approximation (confidence 98/100): official source supports 2027-01-01 through 2027-12-31; market deadline 2027-12-31 is the conservative end of that window. Sanofi's official Q2 2026 press release filed with the SEC lists frexalimab in relapsing multiple sclerosis with Phase 3 data expected in 2027. Because the official evidence supports only the calendar year and not an exact day, the conservative deadline is the final calendar day of 2027. Deadline evidence source: https://www.sec.gov/Archives/edgar/data/1121404/000112140426000008/pressreleaseq22026english.htm Evidence precedence 1. ClinicalTrials.gov posted results 2. Sponsor regulatory filing or official release 3. Peer-reviewed publication or official conference abstract Only the selected endpoint in the specified population, analysis set, comparison, and timeframe can resolve YES. Overall positive messaging, another endpoint, interim results, pooled analyses, or an unmatched subgroup cannot resolve YES.