HS: Promising clinical benefits with izokibep

Hidradenitis suppurativa (HS) treatment with izokibep met the primary endpoint of a Hidradenitis Suppurativa Clinical Response (HiSCR)75 in a phase 3 trial at week 12. In addition, 21% of patients achieved HiSCR100 at week 16.

Efficacy and safety of the IL-17A small molecule inhibitor izokibep as treatment for moderate-to-severe HS (Hurley stages 2 and 3) were assessed in a phase 3 study (NCT05905783) [1]. Dr Kim A. Papp (Probity Medical Research, ON, Canada) presented the results for the primary endpoint of HiSCR75 at weeks 12 and 16 of the ongoing study.

Overall, the trial included 258 participants, randomised to receive 160 mg of izokibep or placebo through week 16. The mean age was 37.3; 69% were women. The mean weight was 96.8 kg, and quality-of-life was severely impaired (mean Dermatology Life Quality Index (DLQI) score 11.9).

At week 12, HiSCR75 was significantly higher with izokibep (33%) compared with placebo (20%; P<0.05). A greater difference was observed at week 16: izokibep 37% vs placebo 20% (P<0.01). For more stringent week 16 outcomes, izokibep also outperformed placebo: HiSCR90 in 24% vs 12% (P<0.05) and HiSCR100 in 21% vs 9% (P<0.01).

DLQI improved more in the izokibep arm than placebo (least squares mean change -4.4 vs -2.9). Significantly more patients on izokibep achieved a ≥3-point reduction in skin pain on the numeric rating scale (38% vs 17 %; P<0.01).

Izokibep was overall well-tolerated. Serious treatment-emergent adverse events (AEs) occurred in 1 participant on izokibep and 5 on placebo. The most common AEs were injection-site reactions (67% with izokibep vs 8% with placebo), which were generally mild to moderate. Notably, no cases of candidiasis were reported with izokibep.

In conclusion, Dr Papp highlighted that achieving complete clearance in 1in 5 participants represents a remarkable outcome for both clinicians and patients.

1. Papp KA, et al. Efficacy and safety of izokibep, a novel interleukin-17A inhibitor, in moderate to severe hidradenitis suppurativa: Week 16 results from a randomised, double-blind, placebo-controlled, multicentre, phase 3 study. D1T01.D, EADV Congress 2025, 17–20 September, Paris, France.

Medical writing support was provided by Dr Susanne Kammerer and Karin Drooff

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Posted on 22 September 2025