AbbVie Announces Topline Results from the Phase 3 INTREPID Trial Showing Lutikizumab Significantly Improved Signs and Symptoms of Disease in Patients with Hidradenitis Suppurativa
Key Highlights
- ➤Lutikizumab achieved HiSCR75 at Week 16: 31.4% versus 23.4% placebo
- ➤Lutikizumab reduced Week 8 HS-related pain, with NRS3 achieved by 26.2% versus 15.0%
- ➤HS flares occurred in 18.4% with lutikizumab versus 28.1% with placebo
- ➤Lutikizumab met 8 ranked secondary endpoints in the Phase 3 INTREPID study
- ➤Regulatory submissions for hidradenitis suppurativa are planned for the second half of 2027
Expert Statements
Kori Wallace, M.D., Vice President, Global Head of Immunology Clinical Development, AbbVie
“Elevated levels of IL-1α and IL-1β have been identified in HS lesions, supporting the mechanistic rationale for evaluating lutikizumab in HS. These results further validate our science-led approach and demonstrate how AbbVie applies its deep immunology expertise in our efforts to advance potentially differentiated new treatments grounded in disease biology.”
Kori Wallace, M.D., Vice President, Global Head of Immunology Clinical Development, AbbVie
“In addition to achieving the rigorous bar set by HiSCR75, lutikizumab also significantly improved HS-related skin pain and disease flares, reinforcing the importance of an approach to HS that addresses outcomes assessed by both physicians and most importantly, patients.”
Alexa B. Kimball, M.D., M.P.H., President and CEO of Harvard Medical Faculty Physicians at Beth Israel Deaconess Medical Center, Boston, and Professor of Dermatology at Harvard Medical School
“Hidradenitis suppurativa remains an underserved disease and many patients continue to struggle with pain and disease flares despite available therapies.”
Alexa B. Kimball, M.D., M.P.H., President and CEO of Harvard Medical Faculty Physicians at Beth Israel Deaconess Medical Center, Boston, and Professor of Dermatology at Harvard Medical School
“The INTREPID data are notable because the primary endpoint of HiSCR75 sets a rigorous bar for defining clinical response.”
Alexa B. Kimball, M.D., M.P.H., President and CEO of Harvard Medical Faculty Physicians at Beth Israel Deaconess Medical Center, Boston, and Professor of Dermatology at Harvard Medical School
“These are also the first Phase 3 data evaluating the effect of targeting both IL-1α and IL-1β on this disease.”
Alexa B. Kimball, M.D., M.P.H., President and CEO of Harvard Medical Faculty Physicians at Beth Israel Deaconess Medical Center, Boston, and Professor of Dermatology at Harvard Medical School
“Taken together, these results underscore the promising potential of this investigational treatment.”
AbbVie Announces Topline Results from the Phase 3 INTREPID Trial Showing Lutikizumab Significantly Improved Signs and Symptoms of Disease in Patients with Hidradenitis Suppurativa PR Newswire
* In the Phase 3 INTREPID study, lutikizumab achieved the primary endpoint of Hidradenitis Suppurativa Clinical Response 75 (HiSCR75) at Week 16 compared with placebo(1) * Lutikizumab met 8 ranked secondary endpoints, including significant improvements in HS-related skin pain at Week 8 and significant reductions in the occurrence of HS flares over the first 16 weeks,(1) reflecting outcomes assessed by both patients and physicians * Lutikizumab was generally well tolerated, with no new safety concerns identified(1) * INTREPID provides Phase 3 data supporting the continued investigation of simultaneous inhibition of IL-1α and IL-1β as a potential treatment approach in adults and adolescents with moderate to severe HS(1) NORTH CHICAGO, Ill., Oct. 22, 2026 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced positive topline results from the Phase 3 INTREPID study evaluating the safety and efficacy of lutikizumab, an investigational dual-variable-domain interleukin (IL) 1α/1β antagonist, in adults and adolescents with moderate to severe hidradenitis suppurativa (HS). The study met its primary endpoint and 8 ranked secondary endpoints.
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