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First Patient Receives Upadacitinib in Phase 3 Trial For Treatment of Hidradenitis Suppurativa


AbbVie announced that treatment has begun in the first randomized, placebo-controlled, double-blind, multicenter study.

AbbVie announced that the first patient has received treatment in its phase 3 Step-Up HS study.1 The study is assessing the effectiveness of upadacitinib (Rinvoq) in treating moderate to severe hidradenitis suppurativa (HS) in adults and adolescents in whom anti-tumor necrosis factor (TNF) therapy and/or one approved non-anti-TNF inhibitor therapy was unsuccessful.



The primary endpoint of Step-Up HS is the percentage of participants reaching HS clinical response (HiSCR) 50, “defined as at least a 50 percent reduction in the total abscess and inflammatory nodule (AN) count with no increase in abscess count and no increase in draining fistula count relative to baseline at week 16.”1

"Our options for patients with moderate to severe HS continue to improve, but there is still great unmet need, and there is a lot of important work underway," Alexa Kimball, MD, MPH, professor of dermatology at Harvard Medical School told Dermatology Times. She added, "Targeting the JAK1 pathway has shown significant promise in several early controlled studies and the community is looking forward to results from larger studies, including this one testing upadacitinib."

Step-Up HS is the first phase 3, randomized, placebo-controlled, double-blind, multicenter study of its kind. Researchers plan to enroll 1300 participants across 275 sites worldwide in the study that will take place over 3 periods.

Period 1 will last from weeks 0 to 16 and will evaluate the safety and efficacy of upadacitinib versus a placebo, which is the primary analysis of the study. Patients will be given either a 30 mg oral upadacitinib tablet or a placebo. During period 2, which will last from weeks 16 to 20, patients will be re-randomized to upadacitinib 30 mg, 15 mg, or a placebo, based on their clinical response. Period 3 is a long-term extension and will last until week 68.

"Hidradenitis suppurativa is a chronic, inflammatory disease that often leads to irreversible skin damage and extreme pain for patients," said Roopal Thakkar, MD, senior vice president, development and regulatory affairs and chief medical officer at AbbVie in a press release.1" 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."

Upadacitinib is a selective JAK inhibitor. The phase 2 study was completed and the results were announced at the American Academy of Dermatology Annual Meeting in March 2023.

Phase 3 trials of upadacitinib to treat ulcerative colitis, atopic dermatitis, rheumatoid arthritis, psoriatic arthritis, axial spondylarthritis, Crohn’s disease, giant cell arteritis, Takayasu arteritis, and systemic juvenile idiopathic arthritis are currently ongoing.


  1. AbbVie advanced immunology pipeline with first patient dosed in global phase 3 trial of Upadacitinib (Rinvoq) in hidradenitis suppurativa. News release. AbbVie. July 24, 2023. Accessed July 24, 2023. https://news.abbvie.com/news/press-releases/abbvie-advances-immunology-pipeline-with-first-patient-dosed-in-global-phase-3-trial-upadacitinib-rinvoq-in-hidradenitis-suppurativa.htm?view_id=15808
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