Prof. Bryan Kirby (St. Vincent’s University Hospital, Ireland) and his team presented the 12-week results of the double-blind, placebo-controlled, phase 2 MIRA trial (NCT05322473)1. This trial included adult patients with HS, Hurley stage II/III, a total abscess and/or inflammatory nodule count of ≥5, and the presence of HS lesions in ≥2 anatomical regions. They received either 1 of 2 doses of sonelokimab (120 mg or 240 mg), placebo, or adalimumab as an active comparator (to validate clinical findings but not powered for any statistical comparison). The primary study endpoint was the proportion of participants achieving a ≥75% reduction in total nodule counts from baseline with no new abscess or tunnel draining count (i.e. HiSCR 75).
All in all, 234 participants could be included and >95% completed week 12. Significantly more participants treated with sonelokimab achieved the primary endpoint at week 12 compared with placebo (43.3% treated with 120 mg and 34.8% treated with 240 mg versus 14.7% in the placebo group; P<0.001 for the first and P<0.01 for the second comparison).
“Sonelokimab works quickly. We see significant differences versus placebo as early as week 8,” Prof. Kirby said. Moreover, sonelokimab improved quality of life, assessed in the dermatology quality of life questionnaire (improvement ≥4 points, which is considered clinically relevant) and led to less skin pain.
The nanobody was well tolerated in accordance with its known safety profile. Candida infections occurred more frequently in the sonelokimab group but were generally mild-to-moderate and did not lead to treatment withdrawal.