AbbVie reports Phase 3 trial meets primary and secondary endpoints for lutikizumab in hidradenitis suppurativa
AbbVie announced that its investigational drug lutikizumab achieved the primary endpoint of a 75% reduction in lesions (HiSCR75) in 31.4% of patients versus 23.4% on placebo at week 16. The study also met eight ranked secondary endpoints, including pain reduction and fewer disease flares. Safety was comparable with placebo, with similar rates of adverse events. The company said the data will support regulatory submissions in the second half of 2027.
Why it matters
The company indicated the results will be used to file for approval of lutikizumab in hidradenitis suppurativa in late 2027, potentially adding a new product to its immunology portfolio. The comparable safety profile suggests no additional risk that could affect market perception.
Key facts
- 1Lutikizumab achieved HiSCR75 in 31.4% of patients versus 23.4% for placebo at week 16 (p≤0.001). news.abbvie.com
- 2The trial met eight ranked secondary endpoints, including a 26.2% vs 15.0% achievement of a ≥3‑point skin‑pain reduction at week 8 (p<0.0001). news.abbvie.com
- 3HS flares occurred in 18.4% of lutikizumab‑treated patients versus 28.1% on placebo (p<0.0001). news.abbvie.com
- 4Overall treatment‑emergent adverse‑event rates were 53.4% for lutikizumab and 53.7% for placebo; serious adverse events were 3.0% vs 2.9%. news.abbvie.com
- 5AbbVie plans to use the data to support regulatory submissions for lutikizumab in the second half of 2027. news.abbvie.com
Summary written by AlphAI AI Desk from 10 of 10 sources. Not investment advice. Figures are as stated by the linked sources.