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Study on Upadacitinib for Adults and Adolescents with Moderate to Severe Hidradenitis Suppurativa After Anti-TNF Therapy Failure

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a skin condition called Hidradenitis Suppurativa, which is a chronic inflammatory disease that causes painful lumps under the skin. The trial will evaluate a medication called Upadacitinib, which is taken as a modified-release tablet. The purpose of the study is to assess how effective and safe Upadacitinib is for adults and adolescents who have moderate to severe Hidradenitis Suppurativa and have not responded well to previous treatments known as anti-TNF therapy.

Participants in the study will be randomly assigned to receive either Upadacitinib or a placebo, which looks like the medication but does not contain the active ingredient. The study will last for a period of time, during which participants will take the medication or placebo and attend regular check-ups to monitor their condition and any changes in their symptoms. The main goal is to see if there is a significant reduction in the number of painful lumps and other symptoms associated with Hidradenitis Suppurativa after 16 weeks of treatment.

Throughout the study, participants will be asked to report on their skin condition, including any changes in pain levels and quality of life. The study aims to provide valuable information on whether Upadacitinib can be a beneficial treatment option for those suffering from this challenging skin condition. The trial is expected to continue until 2027, with recruitment starting in late 2023.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the participant will be required to sign an informed consent form. This form confirms understanding and willingness to adhere to the study requirements.

    Eligibility criteria include being at least 12 years old, having a body weight of at least 30 kg for those aged 12 to 18, and a diagnosis of hidradenitis suppurativa (HS) for at least 6 months.

  2. Step 2

    Baseline assessment

    A baseline assessment will be conducted to evaluate the participant's condition. This includes confirming the presence of HS lesions in at least two distinct areas and a total abscess and inflammatory nodule (AN) count of at least 5.

    The assessment will also check for a draining fistula count of 20 or less and at least one area of HS involvement characterized as Hurley Stage II or higher.

  3. Step 3

    Treatment phase

    Participants will be randomly assigned to receive either upadacitinib or a matching placebo. Upadacitinib is administered as a modified-release tablet taken orally.

    The primary goal is to assess the efficacy and safety of upadacitinib compared to the placebo over a period of 16 weeks.

  4. Step 4

    Primary endpoint evaluation

    The primary endpoint is the achievement of HiSCR 50 at Week 16. HiSCR 50 is defined as at least a 50% reduction in the total AN count with no increase in abscess count and no increase in draining fistula count relative to baseline.

  5. Step 5

    Secondary endpoint evaluation

    Secondary endpoints include achieving HiSCR 75, which is at least a 75% reduction in the total AN count, and NRS30, which is a reduction in skin pain by at least 30% and 2 units from baseline at Week 4.

    Other evaluations include changes in the Hidradenitis Suppurativa Symptom Assessment, Hidradenitis Suppurativa Impact Assessment, and Dermatology Life Quality Index at Week 16.

  6. Step 6

    Completion of study

    The study is estimated to end by August 1, 2027. Participants will complete the study after all assessments and evaluations are conducted.

Who can join the trial?

9 criteria

  • You or your legal representative must understand and agree to follow all study requirements and sign a consent form before any study activities begin.
  • You must be at least 12 years old at the time of the screening visit.
  • If you are between 12 and 18 years old, you must weigh at least 30 kilograms at the start of the study.
  • You must have been diagnosed with Hidradenitis Suppurativa (HS) for at least 6 months before the study begins. HS is a skin condition that causes small, painful lumps under the skin.
  • You must have previously used at least one TNF inhibitor for HS for at least 12 weeks, or one approved non-TNF biologic therapy for HS for at least 16 weeks, and either did not respond well or could not tolerate it. A TNF inhibitor is a type of medication used to reduce inflammation.
  • You must have a total AN count of at least 5 at the start of the study. AN count refers to the number of abscesses and nodules, which are types of skin lesions.
  • You must have HS lesions in at least two different areas of your body at the start of the study.
  • At least one area affected by HS must be classified as Hurley Stage II or higher at the start of the study. Hurley Stage II indicates a moderate level of disease severity.
  • You must have a draining fistula count of 20 or fewer at the start of the study. A draining fistula is an abnormal connection between two body parts that can release fluid.

Who cannot join the trial?

9 criteria

  • Patients who have not been diagnosed with Hidradenitis Suppurativa, a skin condition that causes small, painful lumps under the skin.
  • Patients who have not experienced moderate to severe symptoms of the condition.
  • Patients who have not tried or are not intolerant to anti-tumor necrosis factor (TNF) therapy, which is a treatment used to reduce inflammation.
  • Patients who are not within the specified age range for the study.
  • Patients who are not willing or able to follow the study procedures.
  • Patients who have other medical conditions that might interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who are participating in another clinical trial.
  • Patients who have a history of certain infections or diseases that could affect the study results.
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Investigated drugs

Upadacitinib is a medication being studied for its effectiveness and safety in treating moderate to severe hidradenitis suppurativa, a chronic skin condition. This trial focuses on patients who have not responded well to or cannot tolerate anti-TNF therapy, which is another type of treatment for this condition. Upadacitinib works by targeting specific pathways in the immune system to help reduce inflammation and improve symptoms.

What is already known about the treatment

Upadacitinib – This medication is administered orally and is currently being studied in clinical trials for its effectiveness in treating moderate to severe Hidradenitis Suppurativa, particularly in patients who have not responded to anti-TNF therapy. Upadacitinib is a Janus kinase (JAK) inhibitor, which works by blocking specific enzymes involved in the inflammatory process, thereby reducing inflammation and symptoms associated with the condition. It is classified as an immunosuppressant and is being evaluated for its safety and efficacy in this context.

Investigated diseases

Hidradenitis Suppurativa – Hidradenitis Suppurativa is a chronic skin condition characterized by the development of painful lumps under the skin, typically in areas where skin rubs together, such as the armpits, groin, and under the breasts. These lumps can become inflamed and may rupture, leading to the formation of abscesses and tunnels under the skin. Over time, the condition can cause scarring and the formation of sinus tracts, which are channels that connect the lumps under the skin. The disease often progresses with periods of flare-ups and remission, and the severity can vary greatly among individuals. It is not considered a rare disease and can significantly impact the quality of life due to pain and skin changes.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-503661-28-00Protocol codeM23-698Estimated enrolment1 328 patientsSponsorAbbVie Deutschland GmbH & Co. KG

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