Izokibep is a small protein that inhibits IL-17A1. The compound currently advanced to the assessment of efficacy and safety in moderate-to-severe HS in an ongoing phase 3 trial (NCT05905783). Dr Kim Papp (Probity Medical Research, ON, Canada) presented the results for the primary endpoint of HiSCR75 at week 12.
The study randomised 258 participants (mean age of 37.3 years; 69% women) to placebo or weekly 160 mg of izokibep over 16 weeks. The mean count of abscesses and nodules was 13.4, draining tunnels 2.2, and the Dermatology Life Quality Index (DLQI) was 11.9.
A first statistically significant separation of the HiSCR75 curves was already seen at week 4. At week 12, 33% of participants in the izokibep arm reached HiSCR75 versus 21% on placebo (P<0.05). “I have some real breaking news,” Dr Papp revealed, explaining that he had only moments ago received the official results of HiSCR75 at week 16. “You will see it in the final publication: week 16 38% izokibep, 20% placebo—spectacular results.”
The results of the secondary endpoints HiSCR90 and 100 also favoured izokibep (25% vs 9%; P<0.001 and 22% vs 8%; P<0.01). Further ameliorations were found in patient-reported outcomes like DLQI and skin pain numeric rating scale (Skin Pain-NRS). Of note, half of the baseline Hurley 2 participants attained a count of 0, 1, or 2 for inflammatory lesions (P<0.01).
The interim rate of serious treatment-emergent adverse events was 0.8% on izokibep and 3.1% on placebo. The most common adverse events were injection-site reaction (65.1% vs 7.8%), headache (10.1% vs 9.3%), and nasopharyngitis (7.0% in both groups). No cases of candidiasis were seen in the izokibep arm.
Medical writing support was provided by Karin Drooff MPH