AbbVie posts positive Phase 3 INTREPID data

AbbVie (ABBV) announced positive topline data from the Phase 3 INTREPID trial of investigational lutikizumab in moderate to severe hidradenitis suppurativa, with the study meeting its primary endpoint. At Week 16, 31.4% of patients treated with lutikizumab achieved Hidradenitis Suppurativa Clinical Response 75 (HiSCR75), compared with 23.4% of patients receiving placebo. HiSCR75 is defined as at least a 75% reduction from baseline in total abscess and inflammatory nodule count, with no increase in abscess count and no increase in draining fistula count relative to baseline.

AbbVie said INTREPID is the first Phase 3 study including adults and adolescents with hidradenitis suppurativa to demonstrate statistically significant HiSCR75 response rates at Week 16 as the primary endpoint.

Lutikizumab met eight ranked secondary endpoints that reflected outcomes relevant to both patients and physicians. At Week 8, 36.0% of patients receiving lutikizumab achieved NRS30, defined as at least a 30% and at least a 2‑unit reduction from baseline in hidradenitis suppurativa–related skin pain, compared with 22.8% of patients receiving placebo. Over the first 16 weeks, lutikizumab significantly reduced the occurrence of disease flares, with 18.4% of treated patients experiencing flares versus 28.1% in the placebo group.

Additional pain-related outcomes also improved. At Week 8, 26.2% of patients treated with lutikizumab achieved NRS3, defined as at least a 3‑point reduction from baseline in worst skin pain, compared with 15.0% on placebo. Quality-of-life measures, including Dermatology Life Quality Index and Hidradenitis Suppurativa Impact Assessment scores, improved from baseline with p-values less than 0.0001.

Across the 16‑week placebo-controlled period, lutikizumab was generally well tolerated, and no new safety concerns were identified. Overall treatment-emergent adverse events occurred in 53.4% of patients receiving lutikizumab and 53.7% of those on placebo. Serious adverse events were reported in 3.0% of lutikizumab-treated patients versus 2.9% of placebo-treated patients, and adverse events leading to discontinuation occurred in 1.7% and 1.9% of patients, respectively.

The most frequently reported adverse events associated with lutikizumab included nasopharyngitis, upper respiratory tract infections, headache, fatigue and injection-site reactions. There were no deaths in the lutikizumab group, while one death occurred in the placebo group, and no suicidal ideation was observed in either treatment arm.

The INTREPID trial randomized 1,400 adults and adolescents with moderate to severe hidradenitis suppurativa in a 1:1 ratio to subcutaneous lutikizumab or placebo. The study includes a placebo-controlled period through Week 16, followed by blinded lutikizumab treatment from Weeks 16 to 52, and a 156‑week long-term extension period in which all patients continue lutikizumab.

Additional data from a 36‑week blinded extension period are expected in 2027 and are planned to support regulatory submissions for lutikizumab in hidradenitis suppurativa in the second half of that year. The INTREPID results also provide Phase 3 evidence supporting continued investigation of simultaneous inhibition of interleukin‑1α and interleukin‑1β as a treatment approach in this patient population.