EL7.AI
StocksMedium•22 October 2026•
3 min read

AbbVie reports 31.4% response rate for lutikizumab in hidradenitis suppurativa trial

Key Facts

1The response rate for the primary endpoint at week 16 was 31.4% with lutikizumab versus 23.4% with placebo.
2The study randomly assigned 1400 patients to receive the drug by subcutaneous injection or placebo.
3Disease flares occurred in 18.4% of patients receiving the drug versus 28.1% receiving placebo.
4Treatment-emergent adverse events occurred in 53.4% of patients receiving the drug versus 53.7% receiving placebo.
5AbbVie expects additional data during 2027 to support regulatory submissions planned for the second half of the same year.

AbbVie said on October 22, 2026, that its experimental drug lutikizumab met the primary endpoint in the Phase 3 INtrepid trial for hidradenitis suppurativa, with a response rate of 31.4% versus 23.4% for placebo. The company said the difference between the groups was statistically significant when response was assessed at week 16. The trial enrolled adults and adolescents with moderate to severe disease. The primary response endpoint requires at least a 75% reduction in the combined number of abscesses and inflammatory nodules from baseline. It also requires no increase in the number of abscesses or draining fistulas. Achieving a response in the trial therefore involves a reduction in inflammatory lesions while meeting conditions related to other manifestations of the disease, which can cause irreversible skin damage.

The study randomly assigned 1400 patients to receive either subcutaneous lutikizumab or placebo, according to AbbVie's statement. It used a multicentre, double-blind design and included sites in North and South America, Europe and Asia. In addition to the primary endpoint, the trial met all eight ranked secondary endpoints. These included improvements in disease-related pain, fewer flares and improvements in quality-of-life measures. During the placebo-controlled period, 18.4% of patients receiving the drug experienced disease flares, compared with 28.1% in the comparator group. Treatment-emergent adverse events occurred in 53.4% of patients receiving lutikizumab, compared with 53.7% receiving placebo. AbbVie said the safety profile was consistent with previous studies, with no new concerns.

The drug targets a disease AbbVie describes as chronic, recurrent and progressive, with manifestations including "painful cysts, abscesses and draining fistulas". Hidradenitis suppurativa can cause irreversible skin damage and may lead to disability. The U.S. Food and Drug Administration estimates that the disease affects between 1% and 4% of the U.S. population. According to AbbVie, diagnosis can take an average of between 7 and 10 years. The disease burden includes pain and recurrent flares, alongside the skin lesions whose reduction is measured by the trial's primary endpoint. Quality-of-life measures were also among the aspects the company tracked in assessing treatment outcomes.

The current trial followed a study of the drug whose results AbbVie announced in January 2024, involving 153 adult participants. Participants in that study had moderate to severe hidradenitis suppurativa. They had previously failed anti-tumour necrosis factor therapy, according to the company's statement on the earlier study. At baseline, 70.6% had severe disease classified as Hurley stage 3. Lutikizumab targets an inflammatory pathway associated with the proteins interleukin alpha and beta. AbbVie said studies had shown elevated levels of these proteins in disease lesions, providing the basis for targeting this pathway with the experimental drug.

AbbVie's results come as approved treatment options for hidradenitis suppurativa expand, including therapies for adults and younger age groups. UCB announced that its drug Bimzelx, or bimekizumab, had received U.S. Food and Drug Administration approval. That approval covers adults with moderate to severe disease, the same severity targeted in the lutikizumab trial. In younger age groups, Novartis announced U.S. approval of Cosentyx for children and adolescents aged 12 and older. The announced indication expansion for Cosentyx also covers moderate to severe hidradenitis suppurativa.

Lutikizumab remains an experimental drug without regulatory approval, while AbbVie has outlined further steps to complete its clinical programme and seek registration. The company intends to present the trial results at a future medical conference. It also expects additional data from the blinded extension period during 2027. It plans to use those data to support the drug's planned regulatory submissions. Under the timetable AbbVie announced alongside the results, those submissions are expected in the second half of the same year.