AbbVie’s lutikizumab meets Phase 3 goal, but efficacy falls short of expectations

AbbVie’s investigational drug lutikizumab met the primary endpoint in the Phase 3 INTREPID trial for moderate-to-severe hidradenitis suppurativa (HS), a chronic inflammatory skin disease that can cause painful abscesses and nodules.

At Week 16, 31.4% of patients receiving lutikizumab achieved HiSCR75—a reduction of at least 75% in abscesses and inflammatory nodules without worsening abscesses or draining tunnels—compared with 23.4% on placebo. The difference was statistically significant, but smaller than analysts expected and weaker than the placebo-adjusted effect reported in Phase 2.

The trial also met eight secondary endpoints, including measures of HS-related pain and disease flares. Flares occurred in 18.4% of lutikizumab recipients versus 28.1% of those on placebo during the first 16 weeks.

The results suggest a potential benefit, but the relatively modest placebo-adjusted response raises questions about how competitive the drug could be against existing HS treatments. Further Phase 3 results are expected in 2027, with AbbVie anticipating possible regulatory submissions in the second half of that year.