Study on the Long-Term 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 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.

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 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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Centre Hospitalier Universitaire Rouen Rouen France
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania Catania Italy
Medical Center Hera EOOD Sofia Bulgaria
Centre hospitalier universitaire de Liege Liege Belgium
Universitair Ziekenhuis Gent Gent Belgium
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
Hospital General Universitario Gregorio Maranon Madrid Spain
Hospital Universitario 12 De Octubre Madrid Spain
Hospital Del Mar Barcelona Spain
Amphia Hospital Breda The Netherlands
Katholisches Klinikum Bochum gGmbH Bochum Germany
AZ Sint-Lucas & Volkskliniek Gent Belgium
Complexo Hospitalario Universitario De Pontevedra Pontevedra Spain
Hospital Universitario Virgen De Las Nieves Granada Spain
Umbal – Prof. D-R Stoyan Kirkovich AD Stara Zagora Bulgaria
El Hospital Universitario De Gran Canaria Dr. Negrin Las Palmas De Gran Canaria Spain
Beldio Research GmbH Memmingen Germany
Staedtisches Klinikum Dessau Dessau-Roßlau Germany
Klinikum Darmstadt GmbH Darmstadt Germany
Hms GmbH Merzig Germany
HIA Sainte Anne Toulon France
Uniwersytecki Szpital Kliniczny Im.Fryderyka Chopina W Rzeszowie Rzeszow Poland
Dkc Fokus-5 Lzip OOD Sofia Bulgaria
Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak sp.p. Wroclaw Poland
General Hospital Of Thessaloniki Papageorgiou Thessaloniki Greece
Universitaetsklinikum Erlangen AöR Erlangen Germany
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico Milan Italy
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Centre Hospitalier Le Mans Le Mans France
Hospital Universitario Fundacion Jimenez Diaz Madrid Spain
Universita’ Di Pisa Pisa Italy
Universita’ Politecnica Delle Marche Ancona Italy
Universidade De Santiago De Compostela Santiago De Compostela Spain
Andreas Syngros Hospital Of Venereal And Dermatological Diseases Athens Greece
Centre Hospitalier Universitaire De Nantes Nantes France
Centre Hospitalier Universitaire De Nice Nice France
Hopital Prive D Antony Antony France
Centre Hospitalier Lyon Sud Pierre Benite France
Hopital Beaujon Clichy France
Universita Degli Studi Di Brescia Brescia Italy
Region Sjaelland Holbæk Denmark
University Hospital Ostrava Ostrava Czechia
ASMC – IPSMC – Skin And Venereal Diseases Sofia Bulgaria
CHU Bordeauxt Bordeaux France
Cbhgnkbpt Upktrtyxcntqxi Sgrqnqaxx Woluwe-Saint-Lambert Belgium
Cknacfpxe Sbbit Bezannes France
Unzwlppcjs Mmljqqa Caqukj Hgttsaramedmqycyu Hamburg Germany
Uvimwfistbet Magdpwt Civmjfk Gvmlzjsnr Groningen The Netherlands
Hprnvkie Uraxhpgchuihi Ds Lo Puoixrth Madrid Spain
Haqwldgo ox Vufgozye aty Sltd Dsindyzx ov Tciutdpnfbafzasgsyqhtonesz Oscgjke Uomi os Gvtu Ixwuodxkmw Thessaloniki Greece
Fpbnabgy nkdttmpsu Mgelu a Hztzciw Prague Czechia
Cwlsgj Hkdrmxkpxtg Udexjryhvvrsb Dg Dwdpr Dijon France
Aroytlhabt Pjeclprr Hevwmhae Dx Mjcuyfhnm Marseille France
Uxekyrcnbmtgfpkztldeh Dkncnrdpkdm Ako Duesseldorf Germany
Etwmqtj Uoraltpryynk Mxdizfr Cilmilx Rlfbucsjn (xncuqqi Mqf Rotterdam The Netherlands
Ahbqrv Uoercdxzru Hfvamdkl Aarhus Denmark
Pgplcquho Iklivbhp Mrecjttl Mvfsjrwvnbju Sahmc Wfdageidjbcj I Amimmnuofewrf Warsaw Poland
Gefxwt Umzzujrqwp Fviajtadn Frankfurt Germany
Mrnspxbw Mqglbgq Axwzgwx Pleven Bulgaria
Divwalrzfq Svr z osum Wroclaw Poland
Hwqhqnoa Ukpgnjukbnyed Hcozofzp Tzxxo y Pzzrfx Ikwzixte Csakzf dhckwtkgffvolffzt (fzpb Badalona Spain
Ljickep Sgzujirpnqwjofa Gibmnbt Dlysmackubyfmxv Lublin Poland
Imoviwfq dj Cvzkundzosmo Hzewkgpvqib Usscqzzazxlth dq Sbmga Eoemgdz (zcindst Saint Priest En Jarez France
Ungzyubyyl Gdpgmfk Hiynwhhh Azfwksd Athens Greece

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Not recruiting
04.07.2024
Belgium Belgium
Not recruiting
04.07.2024
Bulgaria Bulgaria
Not recruiting
04.07.2024
Czechia Czechia
Not recruiting
04.07.2024
Denmark Denmark
Not recruiting
04.07.2024
France France
Not recruiting
04.07.2024
Germany Germany
Not recruiting
04.07.2024
Greece Greece
Not recruiting
04.07.2024
Italy Italy
Not recruiting
04.07.2024
Poland Poland
Not recruiting
04.07.2024
Spain Spain
Not recruiting
04.07.2024
The Netherlands The Netherlands
Not recruiting
04.07.2024

Trial locations

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.

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 ID:
2023-507204-31-00
Protocol code:
INCB 54707-312
Trial Phase:
Therapeutic confirmatory (Phase III)

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