Long-term safety study of oral povorcitinib in patients with hidradenitis suppurativa, prurigo nodularis, or vitiligo who previously participated in clinical trials
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.
1Initial 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
2Treatment 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:
3Monitoring 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
4Safety 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 Study?
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 Study?
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
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.
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.
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