AbbVie's Lutikizumab Hits Phase 3 Endpoints in Hidradenitis Suppurativa Trial; ABBV Falls 1.85%

AbbVie (ABBV) said Thursday its investigational drug lutikizumab met the primary endpoint and eight ranked secondary endpoints in the Phase 3 INTREPID trial in adults and adolescents with moderate-to-severe hidradenitis suppurativa, a chronic inflammatory skin disease causing painful nodules, abscesses and draining fistulas. At week 16, 31.4% of lutikizumab-treated patients achieved HiSCR75 — at least a 75% reduction in total abscess and inflammatory nodule count without increases in abscess or draining fistula counts — versus 23.4% on placebo. At week eight, 26.2% achieved at least a three-point reduction in skin pain versus 15% on placebo. Disease flares occurred in 18.4% of treated patients versus 28.1% on placebo; all comparisons were statistically significant. The randomized, double-blind, placebo-controlled trial enrolled 1,400 patients. No new safety concerns emerged; adverse events occurred in 53.4% of treated patients and 53.7% of placebo recipients. AbbVie expects 36-week blinded-period data in 2027 to support regulatory submissions in the second half of that year. Shares recently traded down 1.85% at $279.46, after closing Wednesday at $284.80, down 1.48%.