AbbVie Inc. (NYSE:ABBV) on Thursday shared topline results from its Phase 3 INTREPID study evaluating lutikizumab in adults and adolescents with moderate to severe hidradenitis suppurativa (HS).
The investigational dual-variable-domain IL-1α/1β antagonist met its primary endpoint alongside eight ranked secondary endpoints.
HS is a chronic, non-contagious inflammatory skin condition. It causes painful, boil-like lumps, abscesses, and deep skin tunnels (sinus tracts) in areas where skin rubs together.
Significant Skin Clearance in Phase 3 Trial
In the INTREPID study, patients receiving lutikizumab achieved a 31.4% HiSCR75 response rate at Week 16, compared to 23.4% for placebo.
William Blair noted that the 8.0% treatment difference on HiSCR75 comes in below Phase 3 benchmarks in the HS space, raising questions about the size of the market opportunity for lutikizumab.
Analyst Matt Phipps wrote, “We believe that expectations for lutikizumab in HS were relatively low, particularly after AbbVie did not advance lutikizumab combinations to late-stage development in IBD based on data from the Phase 2a platform study in Crohn’s disease.”
Rapid Pain Reduction and Flare Control
Lutikizumab delivered rapid pain relief and significantly reduced flares. At Week 8, 26.2% of treated patients achieved NRS3 pain reduction—at least a 3-point drop on the Numeric Rating Scale—versus 15.0% on placebo, with improvements beginning as early as Week 1.
Additionally, 36.0% achieved NRS30 (at least a 30% and 2-unit pain drop), versus 22.8% on placebo.
Only 18.4% of lutikizumab patients experienced flares over the first 16 weeks, compared to 28.1% on placebo.
The therapy improved quality-of-life scores on the dermatology life quality index and hidradenitis suppurativa impact assessment and reduced key disease drivers, including IL-17A and IL-17F.
Safety Profile and Upcoming Milestones
Lutikizumab demonstrated a safety profile similar to prior studies, with no new safety concerns.
The study reported zero suicidal ideation and zero deaths in the lutikizumab arm, compared to one death on placebo.
AbbVie anticipates 36-week extension results in 2027 to support regulatory submissions in late 2027. It also plans to initiate an HS platform study later this year, testing lutikizumab with ABBV-295 and ABBV-701.
ABBV Stock Price Activity: AbbVie shares are trading lower by 0.13% at $284.42 at the time of publication on Thursday, according to Benzinga Pro data.
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