The primary endpoint was the achievement of Hidradenitis Clinical Response (HiSCR) at week 16 (defined as a ≥ 50% reduction in AN count with no increase in abscess count and no increase in draining fistula count relative to baseline [14 (link)]). Ranked secondary endpoints included the achievement of ≥ 30% reduction and ≥ 1 unit reduction from baseline in Numerical Rating Scale (NRS30) in Patient’s Global Assessment of Skin Pain (PGA Skin Pain) at week 8 or at week 16 among patients with baseline NRS scores ≥ 3; an experience of ≥ 25% increase in AN counts with a minimum increase of 2 relative to baseline during the double-blind period; change from baseline to week 16 in the Dermatology Life Quality Index (DLQI); and change from baseline to week 16 in HS-related swelling, HS-related odor, and HS-related worst drainage assessed based on Hidradenitis Suppurativa Symptom Assessment (HSSA). Additional efficacy endpoints included change from baseline to week 16 in lesion count by lesion type (AN count, abscess, draining fistula, and inflammatory nodule) and the achievement of a DLQI score of 0/1 (indicating disease has no or almost no effect on patient’s quality of life) at week 16.
Safety assessments in the two study periods included monitoring of treatment-emergent adverse events (TEAEs) during the double-blind period (in all patients who were randomized and received at least 1 dose of study drug from baseline to week 16) and during the open-label period (in all patients who received at least 1 dose of study drug from week 16 through the time of study termination).
Safety assessments in the two study periods included monitoring of treatment-emergent adverse events (TEAEs) during the double-blind period (in all patients who were randomized and received at least 1 dose of study drug from baseline to week 16) and during the open-label period (in all patients who received at least 1 dose of study drug from week 16 through the time of study termination).
