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Hidradenitis Suppurativa: Evaluation of Upadacitinib in Adult and Adolescent Subjects
EU CTIS ID: 2023-503661-28-00
What this study is testing
The primary objective is to assess the efficacy and safety of upadacitinib compared with placebo in adults and adolescents with moderate to severe HS who have failed to respond to or are intolerant of anti-tumor necrosis factor (TNF) therapy.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Subjects or their legally authorized representative (if required per local regulations) must be able to understand and be willing to adhere to all protocol requirements and voluntarily sign and date an informed consent, approved by an independent ethics committee (IEC)/institutional review board (IRB), prior to the initiation of any screening or study-specific procedures
- Subjects must be ≥ 12 years old at Screening Visit.
- Body weight must be ≥ 30 kg at the Baseline Visit for subjects between ≥ 12 and < 18 years of age
- Diagnosis of HS for at least 6 months prior to Baseline, as determined by the investigator (i.e., through medical history and interview of subject).
- Documented history of previous use of ≥ 1 TNF inhibitor for HS for at least 12 weeks and/or 1 approved nonanti-TNF biologic therapy for HS for at least 16 weeks characterized by inadequate response or for any duration characterized by intolerance as determined by the investigator
- Subject must have a total AN count of ≥ 5 at Baseline.
You likely can't join if
- Subject has history of active skin disease other than HS that could interfere with the assessment of HS, including skin infections (bacterial, fungal, or viral) requiring systemic treatment within 4 weeks of the Baseline visit.
See the full eligibility criteria
- Subjects or their legally authorized representative (if required per local regulations) must be able to understand and be willing to adhere to all protocol requirements and voluntarily sign and date an informed consent, approved by an independent ethics committee (IEC)/institutional review board (IRB), prior to the initiation of any screening or study-specific procedures
- Subjects must be ≥ 12 years old at Screening Visit.
- Body weight must be ≥ 30 kg at the Baseline Visit for subjects between ≥ 12 and < 18 years of age
- Diagnosis of HS for at least 6 months prior to Baseline, as determined by the investigator (i.e., through medical history and interview of subject).
- Documented history of previous use of ≥ 1 TNF inhibitor for HS for at least 12 weeks and/or 1 approved nonanti-TNF biologic therapy for HS for at least 16 weeks characterized by inadequate response or for any duration characterized by intolerance as determined by the investigator
- Subject must have a total AN count of ≥ 5 at Baseline.
- HS lesions must be present in at least 2 distinct anatomic areas at Baseline.
- At least 1 anatomic area of HS involvement characterized as Hurley Stage II or higher at Baseline.
- Draining fistula count of ≤ 20 at Baseline.
- Subject has history of active skin disease other than HS that could interfere with the assessment of HS, including skin infections (bacterial, fungal, or viral) requiring systemic treatment within 4 weeks of the Baseline visit.
The study team makes the final eligibility decision.
Where it's taking place
- Saudi Arabia
- Brazil
- Israel
- Colombia
- Turkey
- United Kingdom
- Korea, Republic of
- Mexico
- New Zealand
- Canada
- Singapore
- Australia
- Argentina
- Egypt
- Taiwan
- Japan
- United States
- Chile
- Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Saudi Arabia; Brazil; Israel; Colombia; Turkey; United Kingdom and 13 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.