Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in

Resolution Criteria Trial: NCT06958211 Selected endpoint key: d89c7419a5f86c937024f7d30d8d5ccfc61f7189820a1390fa080d5916010554 Selected endpoint: Proportion of participants who achieve Hidradenitis Suppurativa (HS) Clinical Response 75 (HiSCR75) from baseline Endpoint type: other Protocol outcome group: primary Endpoint description: HiSCR75 is defined as at least a 75% reduction from baseline in the total abscess and/or inflammatory nodule (AN) count with no increase from baseline in abscess or draining tunnel count. Endpoint timeframe: Week 16 ClinicalTrials.gov population: Participants with hidradenitis suppurativa enrolled in TRuE-HS2 Market population: Participants with hidradenitis suppurativa enrolled in TRuE-HS2 Analysis set: Prespecified primary efficacy analysis set; the public ClinicalTrials.gov outcome record does not specify the analysis-set definition. Comparison: Ruxolitinib cream versus vehicle cream at Week 16 Success direction: higher Success rule: At Week 16, the proportion of participants achieving HiSCR75 must be higher with ruxolitinib cream than with vehicle cream, and the prespecified statistical success criterion must be met. HiSCR75 is defined as at least a 75% reduction from baseline in total abscess and/or inflammatory nodule count with no increase from baseline in abscess or draining tunnel count. ClinicalTrials.gov source: https://clinicaltrials.gov/study/NCT06958211?tab=researcher#outcome-measures:~:text=Proportion%20of%20participants%20who%20achieve%20Hidradenitis%20Suppurativa%20(HS)%20Clinical%20Response%2075%20(HiSCR75)%20from%20baseline YES 1. The exact selected endpoint (Proportion of participants who achieve Hidradenitis Suppurativa (HS) Clinical Response 75 (HiSCR75) from baseline) 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 (Proportion of participants who achieve Hidradenitis Suppurativa (HS) Clinical Response 75 (HiSCR75) from baseline) misses its approved success rule. 2. No qualifying disclosure of the selected endpoint is available by 2026-12-31 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: 2026-12-31T23:59:59Z Deadline evidence: AI bounded approximation (confidence 99/100): official source supports 2026-10-01 through 2026-12-31; market deadline 2026-12-31 is the conservative end of that window. Incyte's official second-quarter 2026 business update states that topline results from the Phase 3 TRuE-HS1 and TRuE-HS2 studies of ruxolitinib cream in mild-to-moderate hidradenitis suppurativa are anticipated in the fourth quarter of 2026. Because the source provides a quarter rather than an exact day, the supported window is October 1 through December 31, 2026, and the conservative market deadline is the window's final calendar day. Deadline evidence source: https://investor.incyte.com/news-releases/news-release-details/incyte-reports-second-quarter-2026-financial-results-and 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.