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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

No sites found in this category

Verified Sites

Site Name City Country Status
Policlinico “Tor Vergata”, Università degli Studi di Roma TOR VERGATA Rome Italy
Medical University Of Vienna Vienna Austria
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz Mainz Germany
Medical University Of Graz Graz Austria
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
Université Libre de Bruxelles – Hôpital Erasme Brussels Belgium

Other Sites

Site Name City Country Status
Karolinska University Hospital Solna Sweden
Semmelweis University Budapest Hungary
Centre Hospitalier Universitaire De Nice Nice France
Azienda Ospedaliero Universitaria Di Modena Modena Italy
Amphia Hospital Breda The Netherlands
Dkc Fokus-5 Lzip OOD Sofia Bulgaria
CHU Bordeauxt Bordeaux France
Klinikum rechts der Isar der TU Muenchen AöR Munich Germany
Azienda USL Toscana Centro Florence Italy
Hms GmbH Merzig Germany
Suomen Terveystalo Oy Tampere Finland
BAG Dres. med. Quist PartG Mainz Germany
Chhlnhwfz Uyfvlrjnlwapfl Selskusrk Woluwe-Saint-Lambert Belgium
Uzqteebpmf Ot Dpfeveot Debrecen Hungary
Fvxdxgne nltreoocg Mmaly a Hijmkwq Prague Czechia
Uniwihsfyaitjolqohusm Etuwvsbg Adz Erlangen Germany
Fzhjccvibx Iusxg Cu Gkrrib Owsnsanq Myhgrmkv Pggnmlyxian Milan Italy
Chsnvv Hbenqpwgxmh Uijgilkxjyrmj Dm Taauxhyt Toulouse France
Ucirnyggijpufvjtoccgo Dpjozzzeeac Alh Duesseldorf Germany
Ftzlwtqb Nwsxzxpqz Knhlmvcoc Vgdtynrdm Prague Czechia
Ikjkjbvj Uhc Kaunas Lithuania
Mtmvyax Cbrwfd &mxmcvd Umddvmchex Or Fgrpqlfp Freiburg Im Breisgau Germany
Stgxkfjszv Bgyntgi Mlfiue Rijeka Croatia
Uccnymkpfprhfaxgwekui Wpuvyjejp Alo Wuerzburg Germany
Urqocfxnwd Oi Srlaft Szeged Hungary
Hqhjqis Pasdf D Ahaofe Antony France
Pllhkbxydwu Sztwob dbqumq Zagreb Croatia
Kbg Swcpu Split Croatia
Hyfyzzkd Dx Lu Swici Cnhw I Sxhq Pgh Barcelona Spain
Cpugxn heoouiiohxj uznkvxtrjckty dd Lhrhx Liege Belgium
Ujulvrhoabea Zqgpmubkho Gxhn Gent Belgium
Ukxhtjufyvee Mwzlxee Cuhvaqc Gutjjpxty Groningen The Netherlands
Hkjfnmfx Uykhukzdsqknx Pclegh Dd Hdmiwm Dx Mwcqenbxcpe Majadahonda Spain
Vrsqv Untizgbkijzu Bseithh Jette Belgium
Ufzzwxtrdv Dkmcr Slrjb Db Blsdwoz Brescia Italy
Uguiygiknmfjunjfn Dveti Suxgr Dj Fmqdfql Ferrara Italy
Quzrl Selprv Ccchfgvlf Hxiqapzs &uwxgjk Sjkbofvnmwc Urossnfgfk Hpukhrga &jkvgfr Vkqqegl Gwyyemvapborlfagbo Gothenburg Sweden
Uiolyffphbg Ntkqqddtf Mcwzoy Martin Slovakia
Fdzpgmji Naahyrctz Tkvgoh Trnava Slovakia
Obcw Uojeudmcpv Hojyrtdc Oulu Finland
Hcmflrsh Uuckiefttlpdz Vqitgn Dz Lfh Nwmthy Granada Spain
Imzeigfyjf Gkrfxlc Hwfvokuj Oc Tcfsqlfridmm Thessaloniki Greece
Umuajgjbje Gombrkm Hiertzto Aorniak Athens Greece
Kxx Zshvjx Zagreb Croatia
4mc Ghwhctv Mfyujagw Hxmujiut Ou Ayrmej Athens Greece
Sfivpw Vediqbylh Kokbuc Mtq Okvjzq Knevcj Kaposvar Hungary
Uavzfelupx Tubvcazo Hatdspdw Mlmqiakgchln Szombathely Hungary
Upqvgxbuyo Hepjdfng Bthhwqlnjh Bratislava Slovakia
Gmribrf Hmxddmqc Oh Tvuwhbxfaosa Psdswidytzad Thessaloniki Greece
Uzhvgwsjpmo nyhvvpqhk Lq Ppjvtuph Kosice Slovakia
Ocowvf Eptzxjgpvxcum Cetxgbg Kmbi Dunaújváros Hungary
Gcfnq Hvqpejk Dj Cwdktwvjs Gerpinnes Belgium
Wvp Mky Kzdl Budapest Hungary
Axbb – Iofop &pkfhyj Stes Amy Vbroicqt Demuztru Sofia Bulgaria
Umvjxkfoacmnhemqcwklx Rqfrryqgse Asl Regensburg Germany
Uifhsnuojg Hanygznl Goxhmr Galway Ireland
Uwfktuqdpicjazhmx Dn Plaz Pisa Italy
Apoqkms Sbbryhn Hvybchwh Or Vkdektvp Awa Dlvpbalztwfrcp Dpgbbomq Athens Greece
Utrzaxvdwn Ol Phir Pecs Hungary
Gkcpfp Uhmednckny Fpnnkhlpa Frankfurt Germany
Cwmddg Hbozsnljwl Ummwewxcilnvr Di Pifia Ecxcwr Porto Portugal
Vfvdlqps umraltpdpbyo lkyusbwi Smuymeth kuaurqfy Vsb Vilnius Lithuania
Cwnvmd Hofmeuqthr Umfeuhavvdmtu Lhefuu Czsmzmd Eeytuk Lisbon Portugal
Czecrkqeybkrhynp Houyajyv Zmnnfy Zagreb Croatia
Shq Jkrcpjnadmgiig Bochum Germany
Hhqsucdc Ekvryih Huabkpl Lyon France
Kcdrtxnzpsk kaqgagq nksmnllxy ahyv Karlovy Vary Czechia
Uiqlcpijwm Hctcpjvn Woryxtads Waterford Ireland
Hegwfcsh Cec Dexjerhqbwx Sndi Lisbon Portugal
Tdwjxstgjbc ujl Sfhonicnmcb Btmhhuza Gqav Bad Bentheim Germany
Ufgcb &efyxoj Phlkr Dvw Sprcnf Kmyppktgr Ar Stara Zagora Bulgaria
Hfirocsd Gipgxhv Dh Gotcodeijc Granollers Spain
Sgnod Inetznevr Vzfyvjcv Uxgzzjlwoy Hdquvevo Cork Ireland
Njjehfnr schthgsztp byrgspa zt mgjdkwisxc rfgnmegspypyuc Ivanic-Grad Croatia
Djpxpgj Krjy Debrecen Hungary
Abhxumf Sghwodecp Lubhlh Amwulhlq Spdhecg Lwbkazujalertp L'aquila Italy
Faijxgkw Ndvdbhtiz S Pfunulygfomq Ndmm Zwyam Nove Zamky Slovakia
Haivteygxtl Gpof &rjnh Ckg Kd Berlin Germany
Ccaxwzacl Spnjs Reims France
Hcwiudhh Hxjxo Dixu Nantes France

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
23.10.2023
Belgium Belgium
Not recruiting
23.10.2023
Bulgaria Bulgaria
Not recruiting
23.10.2023
Croatia Croatia
Not recruiting
23.10.2023
Czechia Czechia
Not recruiting
23.10.2023
Finland Finland
Not recruiting
23.10.2023
France France
Not recruiting
23.10.2023
Germany Germany
Not recruiting
23.10.2023
Greece Greece
Not recruiting
23.10.2023
Hungary Hungary
Not recruiting
23.10.2023
Ireland Ireland
Not recruiting
23.10.2023
Italy Italy
Not recruiting
23.10.2023
Lithuania Lithuania
Not recruiting
23.10.2023
Portugal Portugal
Not recruiting
23.10.2023
Slovakia Slovakia
Not recruiting
23.10.2023
Spain Spain
Not recruiting
23.10.2023
Sweden Sweden
Not recruiting
23.10.2023
The Netherlands The Netherlands
Not recruiting
23.10.2023

Trial locations

Investigated Drugs:

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.

Investigated Diseases:

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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