Lutikizumab Meets Primary Endpoint in Phase 3 Hidradenitis Suppurativa Trial
KEY TAKEAWAYS
AbbVie's investigational dual IL-1α/IL-1β inhibitor lutikizumab met the primary endpoint in the Phase 3 INTREPID trial, with 31.4% of patients achieving HiSCR75 at Week 16 compared with 23.4% receiving placebo.
Lutikizumab demonstrated statistically significant improvements in HS-related skin pain and reductions in disease flares, with pain improvements reported as early as Week 1.
No new safety concerns were identified during the initial 16-week treatment period. Additional long-term efficacy and safety data are expected in 2027.
AbbVie announced positive topline results from the Phase 3 INTREPID trial evaluating lutikizumab, an investigational dual IL-1α/IL-1β antagonist, in adults and adolescents with moderate-to-severe hidradenitis suppurativa (HS).
The randomized, double-blind, placebo-controlled study enrolled 1,400 patients and met its primary endpoint of Hidradenitis Suppurativa Clinical Response 75 (HiSCR75) at Week 16.1,2 Significantly more patients receiving lutikizumab achieved HiSCR75 compared with placebo (31.4% vs 23.4%; P ≤ .001), representing an 8-percentage-point absolute difference.1
HiSCR75 requires at least a 75% reduction in abscess and inflammatory nodule counts without an increase in abscesses or draining fistulas.
"This phase 3 study showed a significant beneficial clinical effect using the HiSCR75 benchmark," study investigator Alexa B. Kimball, MD, MPH, told Practical Dermatology. "As we continue to see the development of new approaches, the field has been raising the targeted level of improvement, which is why more programs are including the HiSCR75."
Pain Reduction and Fewer HS Flares
Lutikizumab also met eight ranked secondary endpoints. At Week 8, 26.2% of treated patients achieved at least a 3-point reduction in HS-related skin pain compared with 15.0% receiving placebo (P < .0001). Improvements were reported as early as Week 1. Disease flares occurred in 18.4% of lutikizumab-treated patients versus 28.1% receiving placebo over 16 weeks (P < .0001).1
"Pain and flare are some of the most burdensome parts of living with HS and their impact isn't captured by lesion counts alone," Dr. Kimball said.
The investigational agent simultaneously targets IL-1α and IL-1β, inflammatory cytokines elevated in HS lesions. According to Dr. Kimball, blocking both may provide broader inflammatory control by targeting pathways earlier in the inflammatory cascade.
Treatment-emergent adverse events occurred in 53.4% of lutikizumab-treated patients and 53.7% of placebo recipients. Serious adverse events occurred in 3.0% and 2.9%, respectively.1
The findings remain preliminary, with results currently available through a company announcement. Lutikizumab is not FDA approved, and longer-term safety and durability remain under investigation.
"Key questions upcoming data are likely to address include updated and longer-term safety data, improvements in clinical status over time, and durability of response," Dr. Kimball said.
Additional INTREPID data are expected in 2027, ahead of anticipated regulatory submissions.1
REFERENCES
AbbVie. AbbVie announces topline results from the phase 3 INTREPID trial showing lutikizumab significantly improved signs and symptoms of disease in patients with hidradenitis suppurativa. Press release. October 22, 2026. Based on AbbVie data on file ABVRRTI83883.
A study to assess disease activity and safety of lutikizumab in adult and adolescent participants with moderate to severe hidradenitis suppurativa (INTREPID). ClinicalTrials.gov. NCT06468228. Accessed September 29, 2026. https://clinicaltrials.gov/study/NCT06468228