AbbVie Reports Phase 3 Success for Lutikizumab in Hidradenitis Suppurativa

AbbVie announced positive topline results on October 22, 2026, from INTREPID, a Phase 3 trial evaluating investigational lutikizumab in adults and adolescents with moderate-to-severe hidradenitis suppurativa (HS). The study met its primary endpoint and eight ranked secondary endpoints, supporting further investigation of dual interleukin (IL)-1α and IL-1β inhibition in this chronic inflammatory skin disease.

At Week 16, 31.4% of patients receiving lutikizumab achieved Hidradenitis Suppurativa Clinical Response 75 (HiSCR75), compared with 23.4% receiving placebo ((p \leq 0.001)). HiSCR75 requires at least a 75% reduction from baseline in total abscess and inflammatory nodule counts, without an increase in abscess or draining fistula counts.

The absolute difference was 8.0 percentage points. Although statistically significant, fewer than one-third of lutikizumab-treated patients reached this response threshold. Patients who did not meet HiSCR75 may still have experienced improvement, but the topline data do not establish the extent of benefit across this group.

Pain and Flares Provide Additional Clinical Signals

Lutikizumab also improved HS-related skin pain, a symptom that can substantially affect daily functioning. At Week 8, 26.2% of patients receiving lutikizumab achieved NRS3, defined as a reduction of at least three points from baseline in worst HS-related skin pain, compared with 15.0% receiving placebo ((p<0.0001)). Improvements were reported as early as Week 1.

For NRS30, defined as a reduction of at least 30% and at least two points from baseline in worst skin pain, response rates at Week 8 were 36.0% with lutikizumab and 22.8% with placebo ((p<0.0001)). These pain endpoints were assessed among patients with a baseline pain score of at least 3 on the Numeric Rating Scale.

During the first 16 weeks, 18.4% of patients receiving lutikizumab experienced HS flares, compared with 28.1% receiving placebo ((p<0.0001)). A flare was defined as at least one occurrence of a 25% or greater increase in abscess and inflammatory nodule counts, with a minimum absolute increase of two lesions relative to baseline.

AbbVie also reported improvements from baseline in the Dermatology Life Quality Index (DLQI) and Hidradenitis Suppurativa Impact Assessment (HSIA), with (p<0.0001) for both. IL-17A and IL-17F levels also decreased during the 16-week double-blind period. These biomarker changes are consistent with a biological effect but do not establish that the changes caused the observed clinical improvements.

Safety Findings and Trial Design

Treatment-emergent adverse event rates were similar between groups. Any adverse event occurred in 53.4% of patients receiving lutikizumab versus 53.7% receiving placebo. Serious adverse events occurred in 3.0% versus 2.9%, while adverse events leading to treatment discontinuation occurred in 1.7% versus 1.9%, respectively.

Frequently reported events with lutikizumab included nasopharyngitis, upper respiratory tract infections, headache, fatigue and injection-site reactions. Except for injection-site reactions, their rates were similar to placebo. Oral candidiasis occurred in 0.3% versus 0.4%. No suicidal ideation was reported in either group. No deaths occurred in the lutikizumab group, while one occurred in the placebo group.

INTREPID (NCT06468228) randomized 1,400 patients globally in a 1:1 ratio to subcutaneous lutikizumab or placebo. The study included a placebo-controlled period through Week 16, a blinded lutikizumab treatment period from Week 16 to Week 52, and a 156-week long-term extension during which all patients receive lutikizumab. The primary and ranked secondary endpoints were assessed using a prespecified graphical testing approach to control the overall type I error rate.

AbbVie expects additional results, including data from the 36-week blinded extension, in 2027. The company anticipates regulatory submissions in the second half of 2027. Lutikizumab remains investigational and is not approved for HS.

Clinical Interpretation

INTREPID provides Phase 3 evidence that dual IL-1α/IL-1β inhibition can improve a prespecified HS lesion-response endpoint, with additional benefits reported in pain, flare occurrence and quality-of-life measures. The pain findings broaden the clinical picture beyond inflammatory lesion counts, which do not fully capture the burden of HS.

However, the 8.0-percentage-point difference in HiSCR75 highlights the importance of evaluating the magnitude and distribution of benefit, not just statistical significance. Similar short-term adverse-event rates are encouraging but cannot establish long-term safety or exclude uncommon risks. Full results will be needed to assess confidence intervals, response durability, subgroup consistency and the relationship between biomarker changes and clinical outcomes.

Overall, INTREPID supports continued evaluation of lutikizumab, while the forthcoming dataset will be important in determining its potential role in HS treatment.

References

AbbVie Announces Topline Results from the Phase 3 INTREPID Trial Showing Lutikizumab Significantly Improved Signs and Symptoms of Disease in Patients with Hidradenitis Suppurativa, AbbVie, 22 October 2026

A Study to Assess Disease Activity and Safety of Lutikizumab in Adult and Adolescent Participants with Moderate to Severe Hidradenitis Suppurativa (Intrepid), ClinicalTrials.gov ID NCT06468228