We are asking you to participate in a research program on a drug called Upadacitinib. The study drug has been approved by the regulatory authorities for the treatment of other diseases, e.g. rheumatoid arthritis, psoriatic arthritis and axial spondyloarthritis, but not yet for the treatment of moderate to severe hidradenitis suppurativa (HS). The study drug is therefore used as an investigational substance in this program.
There is already human research evaluating the efficacy and safety of upadacitinib in adult patients with moderate to severe HS, which has shown that upadacitinib leads to a reduction in signs and symptoms associated with HS in adult patients.
Aim of the study
The purpose of this study is to assess the safety and efficacy of upadacitinib compared to placebo (dummy drug) in the treatment of adults and adolescents with moderate to severe acne inversa (hidradenitis suppurativa) who have not responded to or are intolerant to anti-tumor necrosis factor (TNF) therapy.
Who can take part?
People with moderate to severe acne inversa or hidradenitis suppurativa who are at least 18 years old.
Procedure
Participation in the study is voluntary and lasts 2 years (104 weeks).
The study is divided into 3 main phases and a follow-up phase:
Phase 1 (16-week placebo-controlled, double-blind phase):
If you are eligible for participation and are enrolled at the baseline visit on Day 1, you will be randomly assigned to receive either upadacitinib 30 mg daily or placebo (a dummy drug that looks like upadacitinib but contains no active ingredient). The probability of receiving one of the two treatments is 50%. The assigned study drug is taken orally as a tablet once a day at approximately the same time each day.
Phase 2 (20-week continuation phase):
Depending on your clinical symptoms (clinical response or non-response) and the results of the tests and measures at week 16, the study will continue with one of the following options:
1) If you received placebo in phase 1, you will either continue to receive placebo (clinical response) or you will be switched to treatment with 30 mg upadacitinib once daily (clinical non-response)
2) If you received upadacitinib 30 mg in Phase 1, you will continue to receive 30 mg upadacitinib in case of clinical non-response. If there is a clinical response, you will be randomized to receive either 15 mg upadacitinib, 30 mg upadacitinib or placebo.
Phase 3 (68-week long-term continuation phase)
In phase 3 (from week 36), your treatment will continue unchanged until week 104. In Phase 3, the study will be unblinded from week 52 and as soon as all study participants on placebo have been switched to upadacitinib 30 mg as part of emergency treatment - i.e. both you and the investigator will know which study drug is being administered at this point. After unblinding of the study, the upadacitinib dose can be reduced from 30 mg to 15 mg daily if there is some improvement in your disease.
Follow-up phase (after 30 days)
The follow-up phase lasts about 30 days. You will no longer receive an investigational product in this phase. At the end of the follow-up phase (approximately 30 days after the last application of the investigational product), a final visit (or a phone call if no visit is possible) will take place.
Compensation
Original study name
M23-698: Phase 2 III randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of upadacitinib in adult and adolescent patients with moderate to severe acne inversa (hidradenitis suppurative
BASEC number
2023-01717
Sponsors