AbbVie Announces Phase 3 INTREPID Trial Results for Lutikizumab in Hidradenitis Suppurativa

AbbVie has announced topline results from the Phase 3 INTREPID study, evaluating the investigational dual-variable-domain interleukin (IL) 1α/1β antagonist lutikizumab in adults and adolescents with moderate to severe hidradenitis suppurativa (HS). According to the company, the study met its primary endpoint and eight ranked secondary endpoints.

In the trial, patients treated with lutikizumab achieved a significantly higher response rate for the primary endpoint of Hidradenitis Suppurativa Clinical Response 75 (HiSCR75) at Week 16 compared with placebo, at 31.4% versus 23.4% (p≤0.001). HiSCR75 represents at least a 75% reduction from baseline in total abscess and inflammatory nodule count, with no increase in abscesses or draining fistulas.

Key Secondary Endpoints and Findings

• Pain Reduction: At Week 8, 26.2% of patients treated with lutikizumab achieved NRS3 (at least a 3-point reduction in HS-related skin pain) compared to 15.0% on placebo (p<0.0001), with improvements reported as early as Week 1.
• Flares: Lutikizumab significantly reduced the occurrence of HS flares over the first 16 weeks compared to placebo (18.4% versus 28.1%; p<0.0001).
• Quality of Life: Significant improvements were observed in dermatology life quality index (DLQI) and hidradenitis suppurativa impact assessment (HSIA) scores.

Safety Profile and Adverse Events

According to the reported data, the safety profile of lutikizumab was consistent with prior studies, and no new safety concerns were identified. Treatment-emergent adverse event (TEAE) rates were comparable between the lutikizumab and placebo groups:

• Any adverse event: 53.4% for lutikizumab versus 53.7% for placebo.
• Serious adverse events: 3.0% versus 2.9%.
• Discontinuations due to AEs: 1.7% versus 1.9%.

The most frequent TEAEs reported with lutikizumab (≥3%) included nasopharyngitis, upper respiratory tract infections, headache, fatigue, and injection-site reactions.

Future Outlook and Next Steps

Data from the Phase 3 INTREPID study will be presented at a future medical congress. Additional results, including data from a 36-week blinded extension period, are expected in 2027 and will be used to support regulatory submissions for lutikizumab in the second half of the year. Lutikizumab remains an investigational agent and has not yet been approved by regulatory authorities.

Readers can review the official clinical trial registration under identifier NCT06468228 on ClinicalTrials.gov for more information regarding study parameters.