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

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What is this study about?

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 Hidradenitis Suppurativa, contributing to better treatment options in the future.

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.

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 medical history will be reviewed to ensure you have had an inadequate response to previous treatments for hidradenitis suppurativa.

3 medication administration

You will be randomly assigned to receive either the study medication, povorcitinib, or a placebo. The medication is in the form of oral tablets.

The dosage and frequency of the medication will be explained to you, and you will be required to take it as directed for the duration of the study.

4 regular check-ups

Throughout the study, you will have regular check-ups to monitor your condition and any changes in your symptoms.

These visits will include assessments of your skin condition, pain levels, and overall quality of life.

5 evaluation of results

At the end of the study period, your response to the treatment will be evaluated. This includes checking if you have achieved a significant reduction in symptoms, known as the Hidradenitis Suppurativa Clinical Response.

Your results will be compared to those of other participants to determine the effectiveness and safety of the medication.

Who Can Join the Study?

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.
Have a diagnosis of moderate to severe Hidradenitis Suppurativa (HS) for at least 3 months before the screening visit.
Have a total of at least 5 abscesses and inflammatory nodules at both the screening and baseline visits.
HS lesions must be present 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 Stages are used to describe the severity of HS.
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 have shown intolerance or have a reason not to use such treatments.
Agree not to use topical and systemic antibiotics for treating HS during the placebo-controlled period, unless specific criteria are met.
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.
Agree to use contraception.

Who Cannot Join the Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Centre Hospitalier Universitaire De Bordeaux		France
Dermedic Jacek Zdybski		Poland
Studienzentrum Dr. Beate Schwarz		Germany
Medical University Of Vienna		Austria
Centre Hospitalier Regional Et Universitaire De Brest		France
Medizinische Universitaet Innsbruck		Austria
Technische Universitaet Dresden		Germany
Katholieke Universiteit te Leuven		Belgium
Hautaerzte Zentrum Hannover GbR		Germany
Université Libre de Bruxelles – Hôpital Erasme		Belgium

Other Sites

Site Name	City	Country	Status
Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak sp.p.		Poland
Centre Hospitalier Le Mans		France
Andreas Syngros Hospital Of Venereal And Dermatological Diseases		Greece
Solumed Sp. z o.o. S.K.		Poland
General Hospital Of Thessaloniki Papageorgiou		Greece
Centre Hospitalier Universitaire De Toulouse		France
Universidade De Santiago De Compostela		Spain
Centre Hospitalier Universitaire De Nantes		France
Centre hospitalier universitaire de Liege		Belgium
Universitair Ziekenhuis Gent		Belgium
Hospital Universitario 12 De Octubre		Spain
Hospital Del Mar		Spain
Amphia Hospital		The Netherlands
Klinikum Darmstadt GmbH		Germany
AZ Sint-Lucas & Volkskliniek		Belgium
Complexo Hospitalario Universitario De Pontevedra		Spain
Hospital Universitario Virgen De Las Nieves		Spain
Beldio Research GmbH		Germany
University Hospital Ostrava		Czechia
Mtlxaak Uisasnheay Of Gcgr		Austria
Hlqowdfz ok Vyyunttv amu Snld Dthwcohs ok Trnygninqjhrwryjdpembzgfez Ovkikpz Uwhh ok Grrl Ildtoitqig		Greece
Cpxqaiqmd Utjektgdzftkpc Skotumhxt		Belgium
Fqlimica ndxguwqhh Mmidc a Hqwivwg		Czechia
Aavtgplrxg Pnzkdyhh Hdeidegy Du Pejgj		France
Avrjqjufqn Pxugpzkw Hfijzuzh Dz Mszrlnsyz		France
Ukmajjpxpilyniayvsqgy Dsbbsmebqem Aot		Germany
Erxbqkk Uffhcumrzihx Msmlsrn Cbqswdx Rfdxgrqdd (kawtewz Mfc		The Netherlands
Gvpyhb Ustydryomy Fqpxfgecu		Germany
Dznslzvnii Szr z otfy		Poland
Uhghjrbhvb Mgwjlgp Caukiy Hvboguyjbevowxjnv		Germany
Othufxxawjdgxw Llvp Gzci		Austria
Ufedbvdltsla Mrafcew Cfdtftt Gtfobfyzg		The Netherlands
Hhneueth Uygaonsqpcxtl Hoskdxfm Tvkxv y Pdvrcq Isaxytas Cozbiz dkwbikyetadorqeic (xybp		Spain
Imryibgx dy Clqrtqstezmo Hlvknezhbwc Upmopjcpblira dk Secwl Eeilerw (fobypsy		France
Ulmdqzpavt Ggoyytv Hlayjxjl Atmptrj		Greece

Trial status

Country	Status	Recruitment Start
Austria	Not recruiting	15.05.2023
Belgium	Not recruiting	15.05.2023
Czechia	Not recruiting	15.05.2023
France	Not recruiting	15.05.2023
Germany	Not recruiting	15.05.2023
Greece	Not recruiting	15.05.2023
Poland	Not recruiting	15.05.2023
Spain	Not recruiting	15.05.2023
The Netherlands	Not recruiting	15.05.2023

Trial locations

Povorcitinib is a medication being studied for its potential to help people with a skin condition called hidradenitis suppurativa, which causes painful lumps under the skin. This medication works by targeting specific pathways in the body that are involved in inflammation, which is a key part of this condition. By reducing inflammation, povorcitinib may help to decrease the number and severity of these lumps, improving the quality of life for those affected by this condition.

Investigated diseases:

Hidradenitis

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 not contagious and is believed to be related to inflammation of the hair follicles.

Trial ID:

2022-501752-29-00

Protocol code:

INCB 54707-301

NCT ID:

NCT05620823

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?