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Study on the Long-Term Safety of Povorcitinib for Patients with Moderate to Severe Hidradenitis Suppurativa

Verified siteInvestigationalNo placebo
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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 the long-term safety and effectiveness of a medication called Povorcitinib for individuals with a skin condition known as Hidradenitis Suppurativa. Hidradenitis Suppurativa is a chronic skin disease that causes small, painful lumps to form under the skin, often in areas where skin rubs together. The study aims to understand how safe Povorcitinib is when used over an extended period.

Participants in the study will take Povorcitinib in the form of a tablet, which is taken orally. The study will last for up to 54 weeks, during which participants will be monitored for any side effects or changes in their condition. Some participants may receive a placebo, which is a tablet that looks like the medication but does not contain the active substance. The study will help determine if Povorcitinib is a safe and effective treatment option for managing the symptoms of Hidradenitis Suppurativa.

Throughout the study, researchers will collect information on any adverse events, which are any unwanted effects that occur while taking the medication. They will also assess how well the medication works in reducing the symptoms of Hidradenitis Suppurativa, such as the number of lumps and tunnels under the skin. This information will contribute to understanding the potential benefits and risks of using Povorcitinib for this condition.

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

    Participation begins after completing a previous study without safety concerns. Eligibility requires understanding and signing a consent form, compliance with previous study procedures, and agreement to use contraception.

  2. Step 2

    Medication administration

    The medication used in this study is Povorcitinib, administered in tablet form. The route of administration is oral. Specific dosage and frequency details are provided by the study team.

  3. Step 3

    Monitoring and assessments

    Regular visits are scheduled to monitor health and assess the effectiveness of the treatment. These assessments include checking for any adverse effects and measuring the reduction in symptoms of hidradenitis suppurativa.

  4. Step 4

    Evaluation of treatment response

    The study evaluates the proportion of participants experiencing adverse events and the effectiveness of the treatment in reducing symptoms. This includes measuring the reduction in abscesses and nodules.

  5. Step 5

    Quality of life assessments

    Participants complete questionnaires to assess the impact of the condition on daily life. These assessments help understand the treatment's effect on quality of life.

  6. Step 6

    Completion of the study

    The study is estimated to end by January 2027. Participants will have a final assessment to evaluate the long-term safety and effectiveness of the treatment.

Who can join the trial?

5 criteria

  • Must be able to understand and willing to sign a written document agreeing to participate in the study.
  • Must have completed a 54-week treatment period in a previous related study without any safety issues, as determined by the study doctor.
  • Must have followed the rules and procedures of the previous study, as checked by the study doctor.
  • Must agree to use birth control methods as described in the study's guidelines.
  • Must be willing and able to follow the study's rules and procedures.

Who cannot join the trial?

4 criteria

  • Patients who have a different condition than Hidradenitis Suppurativa cannot participate. This is a skin condition that causes small, painful lumps under the skin.
  • Patients who are not within the specified age range cannot participate. The age range includes both children and adults.
  • Both males and females can participate, so gender is not a reason for exclusion.
  • Patients who are considered part of a vulnerable population may be excluded. This term refers to groups of people who might be at a higher risk of harm or exploitation, such as children, pregnant women, or those with certain disabilities.
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Investigated drugs

Povorcitinib is a medication being studied for its long-term safety and effectiveness in treating moderate to severe hidradenitis suppurativa, a chronic skin condition. The trial aims to understand how well this medication works over an extended period and to monitor any potential side effects.

What is already known about the treatment

Povorcitinib – Povorcitinib is administered orally and is currently being studied in clinical trials for its long-term safety and effectiveness in treating moderate to severe Hidradenitis Suppurativa, a chronic skin condition. It is not yet widely available in medical practice as it is still under investigation. The medication works by inhibiting specific enzymes involved in the inflammatory process, helping to reduce symptoms associated with the condition. Povorcitinib belongs to the pharmacological class of Janus kinase (JAK) inhibitors, which are known for their role in managing inflammatory diseases.

Investigated diseases

Hidradenitis Suppurativa – Hidradenitis Suppurativa is a chronic skin condition characterized by the formation 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 development of sinus tracts, which are channels that connect the lumps under the skin. The disease often progresses with periods of flare-ups and remission, where symptoms may temporarily improve. The exact cause of Hidradenitis Suppurativa is not fully understood, but it is believed to involve a combination of genetic, hormonal, and environmental factors.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-507204-31-00Protocol codeINCB 54707-312Estimated enrolment960 patientsSponsorIncyte Corp.

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