43019 Spesolimab for hidradenitis suppurativa: A proof-of-concept study

Hidradenitis suppurativa (HS) is a chronic, recurrent inflammatory disorder characterized by painful nodules (N), abscesses (A) and draining tunnels (dT) primarily affecting intertriginous areas. To address the need for effective targeted therapies, this Phase IIa proof-of-clinical-concept study (NCT04762277) explored the effect of spesolimab, an anti-interleukin-36 receptor monoclonal antibody, in patients with moderate-to-severe HS. Patients (N=52) were randomized (2:1) to spesolimab or placebo (intravenous dosing q1w for three weeks, then subcutaneous dosing q2w) for 12 weeks. No formal statistical tests were performed. Mean changes at Week 12 in dT; A; and total A, N, and dT (ANdT) counts were −1.30, −0.53, and −4.87 in the spesolimab arm, and 1.07, 3.07, and −0.86 in the placebo arm, respectively. Mean changes in N count were similar between spesolimab (−3.00) and placebo (−5.00) arms. Of patients with ≥1 dT at baseline, a greater proportion had a decrease in dT count at Week 12 in the spesolimab (16/24, 66.7%) than the placebo (5/13, 38.5%) arm. Least squares mean changes from baseline in total AN count at Week 12 were −38.8% and −34.7% in the spesolimab and placebo arms, respectively, which may have been affected by higher baseline AN and N counts in the placebo vs spesolimab arm. Safety was similar to previous trials in other diseases; 77.8% and 87.5% of patients reported ≥1 adverse event (AE) in the spesolimab and placebo arms, respectively. 1 patient (6.3%) receiving placebo reported a serious AE. No deaths were reported. These results support the development of spesolimab in HS.