AbbVie says lutikizumab met main goal in Phase 3 hidradenitis suppurativa trial

AbbVie said its experimental drug lutikizumab met the main goal of a late-stage trial in the skin disease hidradenitis suppurativa, setting up planned regulatory filings in 2027.

In the Phase 3 INTREPID study, 31.4% of adults and adolescents with moderate to severe disease who received lutikizumab reached HiSCR75 at Week 16, compared with 23.4% on placebo, the company said in a press release Thursday. HiSCR75 requires at least a 75% reduction in abscess and inflammatory nodule count without a rise in abscesses or draining fistulas.

The study also met all 8 ranked secondary endpoints, including faster reductions in skin pain and fewer flares, AbbVie said. At Week 8, 26.2% of treated patients achieved at least a 3-point drop in pain on a numeric rating scale, versus 15.0% on placebo.

Safety profile

AbbVie said the safety profile matched earlier studies with no new safety concerns. Rates of any adverse event were 53.4% for lutikizumab and 53.7% for placebo, and serious adverse events were 3.0% versus 2.9%. Among the most frequently reported side effects, rates were similar to placebo except for injection-site reactions.

Lutikizumab is an investigational antagonist that blocks both interleukin-1α and interleukin-1β. AbbVie said INTREPID is the first Phase 3 study including adults and adolescents with the disease to show statistically significant HiSCR75 response rates at Week 16 as the primary endpoint.

Next steps

More data from INTREPID, including a 36-week blinded extension period, are expected in 2027 and will be used to support regulatory submissions for the drug in hidradenitis suppurativa in the second half of that year, the company said. The results will be presented at a future medical congress.

By the numbers

• HiSCR75 at Week 16: 31.4% versus 23.4% placebo
• Ranked secondary endpoints met: 8
• Pain response at Week 8: 26.2% versus 15.0%
• Serious adverse events: 3.0% versus 2.9%
• Planned regulatory submissions: second half of 2027

Sources

1. AbbVie Inc., press release dated Oct. 22, 2026, "AbbVie Announces Topline Results from the Phase 3 INTREPID Trial Showing Lutikizumab Significantly Improved Signs and Symptoms of Disease in Patients with Hidradenitis Suppurativa"

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