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Long-term safety study of oral povorcitinib in patients with hidradenitis suppurativa, prurigo nodularis, or vitiligo who previously participated in clinical trials

Fast replyInvestigationalNo placebo
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What is this trial about?

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

This study focuses on three skin conditions: Hidradenitis Suppurativa (a painful condition causing lumps under the skin), Prurigo Nodularis (a condition causing intensely itchy bumps on the skin), and Vitiligo (a condition where patches of skin lose their color). The study uses Povorcitinib (also known as INCB054707), which is given as tablets that are taken by mouth.

The purpose of this research is to evaluate the long-term safety of Povorcitinib in people who have previously participated in other studies of this medication. The study will continue for up to 36 months, during which participants will continue taking the medication and have their condition monitored.

This is a follow-up study specifically designed for individuals who have already completed treatment with Povorcitinib in previous research studies and have shown improvement in their condition. Throughout the study, doctors will monitor how well the medication continues to work and check for any side effects that might occur with long-term use.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    You will receive povorcitinib in tablet form, which is taken orally

    Your eligibility will be confirmed based on your previous participation in a povorcitinib study

    The doctor will verify that you received benefit from the previous treatment and had no safety concerns

  2. Step 2

    Treatment period

    The study will continue from August 2025 to May 2029

    Regular monitoring will occur throughout the treatment period

    The medication will be taken as prescribed for your specific condition:

  3. Step 3

    Monitoring for skin conditions

    If you have Hidradenitis Suppurativa (a chronic skin condition with lumps), your inflammatory nodules will be counted at each visit

    If you have Vitiligo (loss of skin color), changes in the affected areas will be measured using specific assessment tools (F-VASI and T-VASI)

    If you have Prurigo Nodularis (itchy skin condition), your itch levels will be assessed using a rating scale, and the severity will be evaluated at each visit

  4. Step 4

    Safety monitoring

    Any side effects that occur during treatment will be recorded and monitored

    Regular health assessments will be conducted throughout the study period

    You must follow all safety guidelines, including pregnancy prevention measures as specified in the study requirements

Who can join the trial?

8 criteria

  • You must be able to understand and be willing to sign an Informed Consent Form (ICF) - a document that explains the study details and your rights as a participant
  • You must have completed a previous study with povorcitinib (the study medication) without any safety or health concerns
  • You must have experienced positive results from the treatment in the previous study, as determined by your doctor
  • You must have followed all requirements and instructions during the previous study
  • You must be willing to use appropriate birth control methods and avoid pregnancy or fathering children during the study
  • You must be willing and able to follow all study procedures and requirements
  • You must be an adult or adolescent (12 years or older)
  • Both men and women can participate in the study

Who cannot join the trial?

15 criteria

  • Current pregnancy or breastfeeding
  • People under 18 years of age
  • Active or chronic infections, including tuberculosis (a bacterial infection affecting the lungs)
  • History of cancer in the past 5 years (except successfully treated non-melanoma skin cancer)
  • Serious heart conditions or uncontrolled hypertension (high blood pressure)
  • Severe liver disease or abnormal liver function tests
  • Severe kidney disease or significantly reduced kidney function
  • Current treatment with other investigational drugs
  • Known allergic reactions to similar medications
  • Serious mental health conditions that could interfere with the study
  • Active substance abuse or addiction
  • Inability to follow study procedures or attend scheduled visits
  • Major surgery planned during the study period
  • Blood disorders or significant abnormalities in blood tests
  • Immunodeficiency conditions or use of medications that severely suppress the immune system
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Investigated drugs

Povorcitinib is a medication being studied for long-term safety evaluation. It is an investigational drug that works by targeting specific proteins involved in inflammation. The medication is taken orally and is being tested to understand how well it performs and how safe it is when used over an extended period. This is a continuation study for patients who have previously participated in clinical trials using this medication.

What is already known about the treatment

Povorcitinib – A novel investigational medication currently undergoing Phase 3b clinical trials for the treatment of multiple dermatological conditions including Hidradenitis Suppurativa, Prurigo Nodularis, and Vitiligo. This drug belongs to the class of Janus kinase (JAK) inhibitors and works by modulating the immune system response at the molecular level by blocking specific signaling pathways involved in inflammation. Povorcitinib is being studied as an oral medication, taken by mouth in tablet form, and its long-term safety profile is currently being evaluated through multicenter clinical trials to assess its potential as a treatment option for chronic inflammatory skin conditions.

Investigated diseases

  • Hidradenitis Suppurativa

    A chronic skin condition that causes small, painful lumps to form under the skin, typically in areas where skin rubs together. The condition commonly affects areas with sweat glands, such as armpits, groin, and under the breasts. The lumps can break open, leading to tunnels under the skin and scarring.

  • Prurigo Nodularis

    A skin condition characterized by hard, itchy lumps (nodules) that develop on the skin. These nodules typically appear on the arms, legs, and trunk of the body. The intense itching often leads to a cycle of scratching and further nodule formation.

  • Vitiligo

    A condition where patches of skin lose their color due to the destruction of pigment-producing cells called melanocytes. The depigmented patches can appear anywhere on the body, often starting on the hands, face, or areas around body openings. The patches may gradually become larger over time.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-520107-12-00Protocol codeINCB054707-801Estimated enrolment1 883 patientsSponsorIncyte Corp.

sourced from the EU Clinical Trials Register and site verification

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