AbbVie's dual IL-1 antibody lutikizumab meets Phase 3 goal in hidradenitis suppurativa

AbbVie said on 22 October 2026 that lutikizumab, its antibody that blocks both IL-1α and IL-1β, met the primary endpoint and all 8 ranked secondary endpoints of INTREPID, a Phase 3 trial in adults and adolescents with moderate to severe hidradenitis suppurativa (HS) ¹.

What the trial found

INTREPID is a multicentre, randomised, double-blind, placebo-controlled study that enrolled 1400 patients across North America, South America, Europe and Asia, split 1:1 between subcutaneous lutikizumab and placebo ¹. Its primary endpoint was HiSCR75 at Week 16: a fall of at least 75% in the combined count of abscesses and inflammatory nodules, with no rise in abscesses or draining fistulas. 31.4% of patients on lutikizumab reached it, against 23.4% on placebo (p≤0.001) ¹. AbbVie says this is the first Phase 3 study including adolescents with HS to show a statistically significant HiSCR75 response at Week 16 as its primary endpoint ¹.

Pain responded quickly. At Week 8, 26.2% of treated patients had a reduction of at least 3 points in HS-related skin pain on the Numeric Rating Scale, compared with 15.0% on placebo, and 36.0% reached the NRS30 pain measure against 22.8% (p<0.0001 for both) ¹. AbbVie reported improvements in NRS3 from Week 1 ¹. Over the first 16 weeks, 18.4% of the lutikizumab group had a flare, against 28.1% of the placebo group (p<0.0001) ¹. Quality-of-life scores on the DLQI and HSIA also improved, and IL-17A and IL-17F levels fell during the double-blind period ¹.

Adverse event rates were close to placebo: any adverse event 53.4% against 53.7%, serious adverse events 3.0% against 2.9%, and discontinuation for adverse events 1.7% against 1.9% ¹. Oral candidiasis occurred in 0.3% and 0.4% respectively. Injection-site reactions were the one common event more frequent than on placebo, and no suicidal ideation was seen in either arm ¹. There were no deaths in the lutikizumab group and one in the placebo group ¹.

What it means for the market

The result gives AbbVie Phase 3 evidence for a new mechanism in HS, the first Phase 3 data on blocking both forms of IL-1 in the disease, according to Alexa Kimball of Harvard Medical School, who consults for AbbVie ¹. For dermatology developers, the choice of HiSCR75 rather than a looser response measure as the primary endpoint matters: Kimball described it as setting "a rigorous bar for defining clinical response" ¹. HS affects about 1 percent of people worldwide, and diagnosis takes 7 to 10 years on average, AbbVie said ¹.

AbbVie is also building HS into a combination programme. A platform study, due to start later this year, will test lutikizumab with ABBV-295, a long-acting amylin analogue, and possibly with ABBV-701, an anti-TL1A antibody ¹. That points to a strategy of stacking mechanisms rather than relying on a single agent, though the release gives no design or size for the study.

The absolute gap on the primary endpoint was 8 percentage points, and roughly 1 in 4 patients reached HiSCR75 on placebo. The data are topline figures from a company release and have not yet been presented at a congress or peer reviewed ¹. Lutikizumab is investigational and not approved anywhere ¹.

AbbVie expects further INTREPID data, including a 36-week blinded extension, in 2027, and plans to use them for regulatory submissions in HS in the second half of that year ¹.