Study on Upadacitinib for Adults and Adolescents with Moderate to Severe Hidradenitis Suppurativa After Anti-TNF Therapy Failure

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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 trial will evaluate a medication called Upadacitinib, which is taken as a modified-release tablet. The purpose of the study is to assess how effective and safe Upadacitinib is for adults and adolescents who have moderate to severe Hidradenitis Suppurativa and have not responded well to previous treatments known as anti-TNF therapy.

Participants in the study will be randomly assigned to receive either Upadacitinib or a placebo, which looks like the medication but does not contain the active ingredient. The study will last for a period of time, during which participants will take the medication or placebo and attend regular check-ups to monitor their condition and any changes in their symptoms. The main goal is to see if there is a significant reduction in the number of painful lumps and other symptoms associated with Hidradenitis Suppurativa after 16 weeks of treatment.

Throughout the study, participants will be asked to report on their skin condition, including any changes in pain levels and quality of life. The study aims to provide valuable information on whether Upadacitinib can be a beneficial treatment option for those suffering from this challenging skin condition. The trial is expected to continue until 2027, with recruitment starting in late 2023.

1 joining the study

Upon joining the study, the participant will be required to sign an informed consent form. This form confirms understanding and willingness to adhere to the study requirements.

Eligibility criteria include being at least 12 years old, having a body weight of at least 30 kg for those aged 12 to 18, and a diagnosis of hidradenitis suppurativa (HS) for at least 6 months.

2 baseline assessment

A baseline assessment will be conducted to evaluate the participant’s condition. This includes confirming the presence of HS lesions in at least two distinct areas and a total abscess and inflammatory nodule (AN) count of at least 5.

The assessment will also check for a draining fistula count of 20 or less and at least one area of HS involvement characterized as Hurley Stage II or higher.

3 treatment phase

Participants will be randomly assigned to receive either upadacitinib or a matching placebo. Upadacitinib is administered as a modified-release tablet taken orally.

The primary goal is to assess the efficacy and safety of upadacitinib compared to the placebo over a period of 16 weeks.

4 primary endpoint evaluation

The primary endpoint is the achievement of HiSCR 50 at Week 16. HiSCR 50 is defined as at least a 50% reduction in the total AN count with no increase in abscess count and no increase in draining fistula count relative to baseline.

5 secondary endpoint evaluation

Secondary endpoints include achieving HiSCR 75, which is at least a 75% reduction in the total AN count, and NRS30, which is a reduction in skin pain by at least 30% and 2 units from baseline at Week 4.

Other evaluations include changes in the Hidradenitis Suppurativa Symptom Assessment, Hidradenitis Suppurativa Impact Assessment, and Dermatology Life Quality Index at Week 16.

6 completion of study

The study is estimated to end by August 1, 2027. Participants will complete the study after all assessments and evaluations are conducted.

Who Can Join the Study?

You or your legal representative must understand and agree to follow all study requirements and sign a consent form before any study activities begin.
You must be at least 12 years old at the time of the screening visit.
If you are between 12 and 18 years old, you must weigh at least 30 kilograms at the start of the study.
You must have been diagnosed with Hidradenitis Suppurativa (HS) for at least 6 months before the study begins. HS is a skin condition that causes small, painful lumps under the skin.
You must have previously used at least one TNF inhibitor for HS for at least 12 weeks, or one approved non-TNF biologic therapy for HS for at least 16 weeks, and either did not respond well or could not tolerate it. A TNF inhibitor is a type of medication used to reduce inflammation.
You must have a total AN count of at least 5 at the start of the study. AN count refers to the number of abscesses and nodules, which are types of skin lesions.
You must have HS lesions in at least two different areas of your body at the start of the study.
At least one area affected by HS must be classified as Hurley Stage II or higher at the start of the study. Hurley Stage II indicates a moderate level of disease severity.
You must have a draining fistula count of 20 or fewer at the start of the study. A draining fistula is an abnormal connection between two body parts that can release fluid.

Who Cannot Join the Study?

Patients who have not been diagnosed with Hidradenitis Suppurativa, a skin condition that causes small, painful lumps under the skin.
Patients who have not experienced moderate to severe symptoms of the condition.
Patients who have not tried or are not intolerant to anti-tumor necrosis factor (TNF) therapy, which is a treatment used to reduce inflammation.
Patients who are not within the specified age range for the study.
Patients who are not willing or able to follow the study procedures.
Patients who have other medical conditions that might interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who are participating in another clinical trial.
Patients who have a history of certain infections or diseases that could affect the study results.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country
Medical University Of Graz	Graz	Austria
Medical University Of Vienna	Vienna	Austria
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz	Mainz	Germany
Centro Hospitalar Universitario Sao Joao E.P.E.	Porto	Portugal
Katholieke Universiteit te Leuven	Leuven	Belgium
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
Bellvitge University Hospital	L'hospitalet De Llobregat	Spain
Hospital Universitario Y Politecnico La Fe	Valencia	Spain
Policlinico “Tor Vergata”, Università degli Studi di Roma TOR VERGATA	Rome	Italy
Université Libre de Bruxelles – Hôpital Erasme	Brussels	Belgium

Other Sites

Site Name	City	Country
Hospital Universitario Ramon Y Cajal	Madrid	Spain
St James’s Hospital	Dublin	Ireland
Universitaetsklinikum Regensburg AöR	Regensburg	Germany
University Hospital Galway	Galway	Ireland
Fakultni Nemocnice Kralovske Vinohrady	Prague	Czechia
Andreas Syngros Hospital Of Venereal And Dermatological Diseases	Athens	Greece
Klinikum rechts der Isar der TU Muenchen AöR	Munich	Germany
Azienda USL Toscana Centro	Florence	Italy
Centre Hospitalier Universitaire De Nice	Nice	France
Specijalna Bolnica Medico	Rijeka	Croatia
Hopital Prive D Antony	Antony	France
Poliklinika Solmed d.o.o.	Zagreb	Croatia
401 General Military Hospital Of Athens	Athens	Greece
Vilniaus universiteto ligonine Santaros klinikos VšĮ	Vilnius	Lithuania
Hms GmbH	Merzig	Germany
University Of Pecs	Pecs	Hungary
Centro Hospitalar Universitario Lisboa Central E.P.E.	Lisbon	Portugal
KBC Zagreb	Zagreb	Croatia
Hospital De Manises	Manises	Spain
University Of Debrecen	Debrecen	Hungary
Somogy Varmegyei Kaposi Mor Oktato Korhaz	Kaposvar	Hungary
University Teaching Hospital Markusovszky	Szombathely	Hungary
Dkc Fokus-5 Lzip OOD	Sofia	Bulgaria
General Hospital Of Thessaloniki Papageorgiou	Thessaloniki	Greece
Obudai Egeszseguegyi Centrum Kft.	Dunaújváros	Hungary
Universitaetsklinikum Erlangen AöR	Erlangen	Germany
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico	Milan	Italy
Centre Hospitalier Universitaire De Toulouse	Toulouse	France
Karolinska University Hospital	Solna	Sweden
Semmelweis University	Budapest	Hungary
Universita’ Di Pisa	Pisa	Italy
Medical Center – University Of Freiburg	Freiburg Im Breisgau	Germany
KBC Split	Split	Croatia
Azienda Ospedaliero Universitaria Di Modena	Modena	Italy
Centre hospitalier universitaire de Liege	Liege	Belgium
Universitair Ziekenhuis Gent	Gent	Belgium
Children’s Hospital Zagreb	Zagreb	Croatia
St. Josef-Hospital	Bochum	Germany
Hospital Edouard Herriot	Lyon	France
Hospital Universitario Puerta De Hierro De Majadahonda	Majadahonda	Spain
Vrije Universiteit Brussel	Jette	Belgium
Amphia Hospital	Breda	The Netherlands
Universita Degli Studi Di Brescia	Brescia	Italy
Universita’ Degli Studi Di Ferrara	Ferrara	Italy
Queen Silvia Childrens Hospital – Sahlgrenska University Hospital – Vaestra Goetalandsregionen	Gothenburg	Sweden
Karlovarska krajska nemocnice a.s.	Karlovy Vary	Czechia
University Hospital Waterford	Waterford	Ireland
Univerzitna Nemocnica Martin	Martin	Slovakia
Fakultna Nemocnica Trnava	Trnava	Slovakia
Hospital Cuf Descobertas S.A.	Lisbon	Portugal
Oulu University Hospital	Oulu	Finland
Hospital Universitario Virgen De Las Nieves	Granada	Spain
Ippokratio General Hospital Of Thessaloniki	Thessaloniki	Greece
Umbal – Prof. D-R Stoyan Kirkovich AD	Stara Zagora	Bulgaria
Hospital General De Granollers	Granollers	Spain
South Infirmary Victoria University Hospital	Cork	Ireland
NAFTALAN specijalna bolnica za medicinsku rehabilitaciju	Ivanic-Grad	Croatia
Derma-B Kft.	Debrecen	Hungary
Fakultna Nemocnica S Poliklinikou Nove Zamky	Nove Zamky	Slovakia
Havelklinik GmbH & Co. KG	Berlin	Germany
University Of Szeged	Szeged	Hungary
W-N Med Kft.	Budapest	Hungary
ASMC – IPSMC – Skin And Venereal Diseases	Sofia	Bulgaria
CHU Bordeauxt	Bordeaux	France
Courlancy Sante	Reims	France
Hospital Hotel Dieu	Nantes	France
BAG Dres. med. Quist PartG	Mainz	Germany
Suomen Terveystalo Oy	Tampere	Finland
Cjvkvy Hffjfrwulb Uvbzjqknhduuw Da Pkyvw Elhuwz	Porto	Portugal
Truxrpnmftv ure Slahyxbhwti Brjigtmm Gxgg	Bad Bentheim	Germany
Aqrnjsf Sqjkgqaqc Lamxks Ajzdoybk Stjmpwp Lnvlrbgkardnps	L'aquila	Italy
Gcsxo Hqkyenv Dz Cgqxoiobm	Gerpinnes	Belgium
Uiymtdqbvif nszrqnnkk Ls Pdptzifu	Kosice	Slovakia
Ccigrwgbc Uxndbqbzejekkh Snbvvdjqj	Woluwe-Saint-Lambert	Belgium
Upcejlpzap Hntsyvog Bxumxdtgrb	Bratislava	Slovakia
Farqxccs nitustbyf Mdtby a Hgdbaut	Prague	Czechia
Uytsqlyppnnofbrxpbbay Dkyfmtjwlxa Aja	Duesseldorf	Germany
Gektzx Uchmpotaqq Fvkoawtvx	Frankfurt	Germany
Uhnzcjvkdnuxayzpwnjcb Wsueyszem Aao	Wuerzburg	Germany
Huhxlhlc Dc Lr Svprf Clky I Sejn Pkl	Barcelona	Spain
Ubfhrsdoiayp Mgtsbge Cerxzue Gpwzverbm	Groningen	The Netherlands
Iddplbcs Upm	Kaunas	Lithuania
Svy Vyikawqwqafdlqi Uphkukvsqd Hfugifag	Dublin	Ireland
Uwjwqpueka Gutpfss Haigisyp Adeylab	Athens	Greece

Trial status

Country	Status	Recruitment Start
Austria	Recruiting	23.10.2023
Belgium	Recruiting	23.10.2023
Bulgaria	Recruiting	23.10.2023
Croatia	Recruiting	23.10.2023
Czechia	Recruiting	23.10.2023
Finland	Recruiting	23.10.2023
France	Recruiting	23.10.2023
Germany	Recruiting	23.10.2023
Greece	Recruiting	23.10.2023
Hungary	Recruiting	23.10.2023
Ireland	Recruiting	23.10.2023
Italy	Recruiting	23.10.2023
Lithuania	Recruiting	23.10.2023
Portugal	Recruiting	23.10.2023
Slovakia	Recruiting	23.10.2023
Spain	Recruiting	23.10.2023
Sweden	Recruiting	23.10.2023
The Netherlands	Recruiting	23.10.2023

Trial locations

Investigated drugs:

Upadacitinib

Upadacitinib is a medication being studied for its effectiveness and safety in treating moderate to severe hidradenitis suppurativa, a chronic skin condition. This trial focuses on patients who have not responded well to or cannot tolerate anti-TNF therapy, which is another type of treatment for this condition. Upadacitinib works by targeting specific pathways in the immune system to help reduce inflammation and improve symptoms.

Hidradenitis Suppurativa – Hidradenitis Suppurativa is a chronic skin condition characterized by the development 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 formation of sinus tracts, which are channels that connect the lumps under the skin. The disease often progresses with periods of flare-ups and remission, and the severity can vary greatly among individuals. It is not considered a rare disease and can significantly impact the quality of life due to pain and skin changes.

Trial ID:

2023-503661-28-00

Protocol code:

M23-698

NCT ID:

NCT05889182

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Upadacitinib for Adults and Adolescents with Moderate to Severe Hidradenitis Suppurativa After Anti-TNF Therapy Failure

What is this study about?

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