First patient dosed in global phase 3 trial of Rinvoq for hidradenitis suppurativa

Key takeaways:

• The study, Step-Up HS, will evaluate Rinvoq (upadacitinib) for the treatment of hidradenitis suppurativa in patients aged 12 years and older.
• The study will include 1,300 participants across 275 sites worldwide.

Researchers have dosed the first patient in Step-Up HS, a phase 3 study evaluating Rinvoq for moderate to severe hidradenitis suppurativa in adults and adolescents, AbbVie announced in a press release.

“Hidradenitis suppurativa is a chronic, inflammatory disease that often leads to irreversible skin damage and extreme pain for patients,” Roopal Thakkar, MD, senior vice president of development and regulatory affairs and chief medical officer of AbbVie, said in the release. "Leveraging our proven expertise in immunology and experience in HS, we continue to drive innovation and pursue advancement of care in patient populations with difficult-to-treat immune-mediated diseases that have limited therapeutic options."

Step-Up HS is the first phase 3, randomized, placebo-controlled, double-blind, multicenter study to evaluate the efficacy and safety of Rinvoq (upadacitinib), a selective Janus kinase inhibitor, in patients aged as young as 12 years with moderate to severe HS who have failed anti-tumor necrosis factor therapy.

The study is anticipated to include approximately 1,300 patients from 275 worldwide sites. Researchers will split the study into three periods. In the first, patients will be randomly assigned to 30 mg upadacitinib or placebo for 16 weeks. The second period will again randomly assign patients to either 30 mg or 15 mg of the study drug or placebo for 16 to 20 weeks. The study concludes with a long-term extension period up to week 68.

The results of this study will build upon the results from the phase 2 data that were presented at the American Academy of Dermatology Annual Meeting in March 2023 and are planned for publication in a scientific journal, according to the release.

Upadacitinib has not yet been approved for the treatment of HS.