Not recruiting

Study on the Effectiveness and Safety of Povorcitinib for Patients with Moderate to Severe Hidradenitis Suppurativa

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 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 study is testing a medication called Povorcitinib (also known by its code name INCB054707) to see how effective and safe it is for people with moderate to severe forms of this condition. Participants in the study will receive either the medication or a placebo, which is a substance with no active ingredients, to compare the effects.

The purpose of the study is to evaluate how well Povorcitinib works in reducing the symptoms of Hidradenitis Suppurativa and to monitor any side effects. The study will last for a period of up to 54 weeks, during which participants will take the medication in the form of oral tablets. Throughout the study, participants will have regular check-ups to assess their response to the treatment and any changes in their condition.

Participants will be monitored for improvements in their symptoms, such as a reduction in the number of painful lumps and overall skin condition. The study aims to provide valuable information on the potential benefits of Povorcitinib for individuals suffering from this challenging skin disease.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, you will be asked to sign a document called an informed consent form. This form confirms that you understand the study and agree to participate.
You will need to confirm that you are willing and able to follow the study procedures and that you meet the eligibility criteria, such as being 18 years or older and having a diagnosis of moderate to severe hidradenitis suppurativa for at least three months.
Step 2
Initial assessment
An initial assessment will be conducted to evaluate your condition. This includes counting the number of abscesses and inflammatory nodules you have.
Your hidradenitis suppurativa lesions must be present in at least two distinct areas of your body, with at least one area being classified as Hurley Stage II or III.
Step 3
Medication administration
You will be given **Povorcitinib** oral tablets to take as part of the study. The dosage and frequency will be determined by the study team.
It is important to follow the instructions provided for taking the medication and to avoid using certain other treatments for hidradenitis suppurativa during the study period.
Step 4
Regular check-ups
Throughout the study, you will have regular check-ups to monitor your progress. These visits will include assessments of your skin condition and any changes in your symptoms.
The study team will evaluate your response to the medication and any side effects you may experience.
Step 5
Evaluation of results
At the end of the study period, your results will be evaluated to determine the effectiveness and safety of **Povorcitinib** for treating hidradenitis suppurativa.
The primary goal is to see if there is a significant improvement in your condition, measured by the Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12.

Who can join the trial?

10 criteria

Ability to understand and willingness to sign a written consent form for the study.
Willing and able to follow the study rules and procedures.
Must be at least 18 years old at the time of signing the consent form.
Must have been diagnosed with moderate to severe Hidradenitis Suppurativa (HS) for at least 3 months before the screening visit.
Must have a total of at least 5 abscesses and inflammatory nodules at both the screening and baseline visits.
Must have HS lesions in at least 2 different body areas (such as left and right armpits or groin areas), with at least one area being at Hurley Stage II or III at both the screening and baseline visits. Hurley Stage II and III refer to more advanced stages of HS.
Must have a documented history of not responding well to at least a 3-month course of at least one conventional systemic therapy (such as oral antibiotics or biologic drugs) for HS, or must have shown intolerance or have a reason not to use such treatments.
Must agree NOT to use topical and systemic antibiotics for treating HS during the placebo-controlled period, unless specific criteria are met.
Must agree NOT to use diluted bleach baths or topical antiseptic washes containing chlorhexidine gluconate or benzoyl peroxide on areas affected by HS lesions during the placebo-controlled period. Regular soap and water are allowed.
Must agree to use contraception.

Who cannot join the trial?

9 criteria

Patients with any other skin conditions that might interfere with the study.
Patients who have had a recent infection that required treatment with antibiotics.
Patients who have a history of cancer, except for certain types of skin cancer that have been treated.
Patients who have a weakened immune system, which means their body has a harder time fighting infections.
Patients who are currently using other medications that might interfere with the study treatment.
Patients who have participated in another clinical trial recently.
Patients who are pregnant or breastfeeding.
Patients who have a history of drug or alcohol abuse.
Patients who have any other medical condition that the study doctors think might make it unsafe for them to participate.

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Verified sites

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Verified
Azienda Ospedaliera Universitaria Federico II Di Napoli
Naples, Italy
Responsive
Region Midtjylland
Aarhus, Denmark
Responsive
Uniwersytecki Szpital Kliniczny Im.Fryderyka Chopina W Rzeszowie
Rzeszow, Poland

Trial locations

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Investigated drugs

Povorcitinib is a medication being studied for its potential to help people with a skin condition called hidradenitis suppurativa. This condition causes painful lumps under the skin, often in areas like the armpits or groin. Povorcitinib works by targeting specific pathways in the body that are involved in inflammation, which is a key part of this skin condition. By reducing inflammation, the medication aims to decrease the number and severity of these painful lumps, improving the quality of life for those affected. The study is focused on understanding how effective and safe this medication is for people with moderate to severe forms of the condition.

4-[3-(Cyanomethyl)-3-(3',5'-Dimethyl-1H,1'H-[4,4'-Bipyrazol]-1-Yl)Azetidin-1-Yl]-2,5-Difluoro-N-[(2S)-1,1,1-Trifluoropropan-2-Yl]Benzamide

What is already known about the treatment

Povorcitinib – Povorcitinib is administered orally in the form of a tablet. It is currently being studied in clinical trials for its effectiveness and safety in treating moderate to severe hidradenitis suppurativa, a chronic skin condition. The medication works by inhibiting certain enzymes in the body that are involved in inflammatory processes, helping to reduce symptoms like pain and swelling. Povorcitinib belongs to a class of drugs known as Janus kinase (JAK) inhibitors, which are used to manage various inflammatory conditions.

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. The severity and frequency of these flare-ups can vary widely among individuals. The condition is thought to be related to inflammation of the hair follicles and is not contagious.