AbbVie (NYSE: ABBV) clears Phase 3 hurdle for lutikizumab in hidradenitis suppurativa
The INTREPID result establishes placebo-controlled efficacy, while leaving the treatment's competitive position to be demonstrated.
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AbbVie's investigational lutikizumab met the primary endpoint of its Phase 3 INTREPID trial in adults and adolescents with moderate to severe hidradenitis suppurativa. At week 16, 31.4% of treated patients achieved HiSCR75, compared with 23.4% receiving placebo.
That endpoint requires a substantial reduction in abscesses and inflammatory nodules without specified worsening in abscesses or draining fistulas. The difference between groups was eight percentage points. AbbVie also reported success on eight ranked secondary endpoints, including measures of pain and disease flares.
The findings support further development of the medicine, which targets both interleukin-1 alpha and beta. They do not establish superiority over other active treatments: INTREPID's comparator was placebo.
For AbbVie, the commercial opportunity depends on the complete efficacy and tolerability profile, durability and eventual positioning. Statistical success is an essential milestone, but prescribing decisions will also reflect how much additional benefit patients experience and how the medicine fits alongside existing options.