Lutikizumab clears primary goal in Phase 3 hidradenitis suppurativa trial

AbbVie reported topline Phase 3 INTREPID results for lutikizumab, an investigational IL-1α/1β antagonist, in adults and adolescents with moderate to severe hidradenitis suppurativa. The study met its primary endpoint and all eight ranked secondary endpoints. The HiSCR75 response rate at Week 16 was 31.4% versus 23.4% on placebo, an 8.0-point gap that one analyst (William Blair) judged below Phase 3 benchmarks in the HS field, which raises questions about the commercial size of the opportunity. Pain and flare measures also improved, and no new safety concerns emerged. AbbVie expects 36-week extension data in 2027 and plans regulatory filings in late 2027, and it intends to start an HS platform study later this year that pairs lutikizumab with ABBV-295 and ABBV-701.

1. Phase 3 INTREPID study of lutikizumab in moderate to severe hidradenitis suppurativa met its primary endpoint plus eight ranked secondary endpoints.
2. HiSCR75 at Week 16: 31.4% on lutikizumab vs 23.4% on placebo (8.0-point treatment difference).
3. At Week 8, 26.2% reached NRS3 pain reduction vs 15.0% on placebo; flares over 16 weeks were 18.4% vs 28.1%.
4. Safety profile similar to prior studies with no new safety concerns; zero deaths in the lutikizumab arm vs one on placebo.
5. 36-week extension results expected in 2027, supporting regulatory submissions planned for late 2027.
6. An HS platform study pairing lutikizumab with ABBV-295 and ABBV-701 is planned to start later in 2026.
7. Topline release reported by Benzinga on October 22, 2026.