Study on Dose Flexibility of Upadacitinib for Adults with Moderate to Severe Atopic Dermatitis

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What is this study about?

This clinical trial is focused on studying Atopic Dermatitis, a condition that causes the skin to become red, itchy, and inflamed. The study is testing a medication called Upadacitinib, which is a type of drug known as a small molecule JAK inhibitor. This medication is taken orally in the form of a modified-release tablet, which means it is designed to release the drug slowly over time.

The purpose of the study is to evaluate how flexible the dosing of Upadacitinib can be for adults with moderate to severe Atopic Dermatitis. Participants will start with a specific dose of the medication, and depending on their response, the dose may be adjusted. The study will explore two main approaches: increasing the dose for those who do not see enough improvement and reducing the dose for those who achieve significant improvement. The study will last for a period of 24 weeks, during which participants will be monitored for changes in their condition.

Throughout the study, the effectiveness and safety of the medication will be assessed by looking at improvements in the severity of the skin condition and the level of itching experienced by participants. The goal is to find the most effective and safe dosing strategy for managing Atopic Dermatitis with Upadacitinib.

1 initial treatment phase

Begin taking upadacitinib at a dose of 15 mg once daily. This medication is in the form of a modified-release tablet and is taken orally.

Continue this dosage for a period of 12 weeks. The goal during this phase is to assess the initial response to the treatment.

2 evaluation and adjustment phase

After 12 weeks, the effectiveness of the treatment is evaluated using the Eczema Area and Severity Index (EASI).

If the EASI 90 score is not achieved, the dose may be increased to 30 mg once daily. This adjustment aims to improve the treatment response.

If the EASI 90 score is achieved, the dose may be reduced to 15 mg once daily to maintain the treatment effect while minimizing potential side effects.

3 continued treatment and monitoring

Continue the adjusted dosage for an additional 12 weeks, completing a total of 24 weeks of treatment.

Throughout this period, regular assessments are conducted to monitor the effectiveness and safety of the treatment.

4 final assessment

At the end of the 24-week period, a final evaluation is performed to determine the overall success of the treatment.

The primary goal is to achieve an EASI 90 score, indicating a significant reduction in the severity of atopic dermatitis.

Who Can Join the Study?

  • Participants must be male or female and between 18 and 64 years old at the time of the screening visit.
  • Participants should have chronic atopic dermatitis (AD), which means they have had symptoms for at least 3 years before the start of the study. They must also meet the Hanifin and Rajka criteria, which are specific guidelines used to diagnose atopic dermatitis.
  • Participants must be considered a candidate for systemic treatment, which means they may need medication that affects the entire body, not just the skin.

Who Cannot Join the Study?

  • Patients who have a history of severe allergic reactions to the study medication.
  • Patients with other skin conditions that might interfere with the study results.
  • Patients who are currently participating in another clinical trial.
  • Patients who have used certain medications that could affect the study within a specific time frame before the study starts.
  • Patients with certain medical conditions that the study doctors believe could make participation unsafe.
  • Patients who are pregnant or breastfeeding.
  • Patients who have a history of drug or alcohol abuse.
  • Patients who have not followed the study instructions in the past.
  • Patients who have certain infections that could affect the study.
  • Patients who have had a recent surgery that could interfere with the study.
  • Patients who have a history of cancer, except for some types of skin cancer.
  • Patients who have a weakened immune system.
  • Patients who have certain blood disorders.
  • Patients who have a history of heart problems.
  • Patients who have uncontrolled high blood pressure.
  • Patients who have liver or kidney problems.
  • Patients who have a history of mental health issues that could affect participation.
  • Patients who are unable to attend all study visits or follow study procedures.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
IRCCS Humanitas Research Hospital Rozzano Italy
Centro Hospitalar Universitario Sao Joao E.P.E. Porto Portugal
Technische Universitaet Dresden Dresden Germany
Bellvitge University Hospital L'hospitalet De Llobregat Spain
Royalderm Agnieszka Nawrocka Warsaw Poland
Dermed Centrum Medyczne Sp. z o.o. Lodz Poland

Other Sites

Site Name City Country Status
Amphia Hospital Breda The Netherlands
Alergologia Plus Sp. z o.o. Poznan Poland
Clinexpert Kft. Budapest Hungary
BeneDerma s.r.o. Dubravka Slovakia
Gyongyosi Bugat Pal Korhaz Gyongyos Hungary
Tokuda Hospital Sofia Bulgaria
AZ Sint-Lucas & Volkskliniek Gent Belgium
Silmedic Sp. z o.o. Katowice Poland
Mtuyelngo Ibwgdatidt Cwuffvcn Sbejmwxc Sdh z oeur Warsaw Poland
Czlrdpgcv Unposinoxyspqj Schzrvszm Woluwe-Saint-Lambert Belgium
Ghccb Hwapyzy Do Cokibuhds Charleroi Belgium
Dzgihmfrhoacczbnrrtwxpi cmxicc “nidpaovlbqpoajk Eams Sofia Bulgaria
Vgxhni doz Rszkk Ukiidhqzxb Hhpswkzb Sevilla Spain
Fjgpszfaxa Ixrhn Cy Gcwazh Obkffhdq Mbbzivmh Poturbouqrm Milan Italy
Uoylxpcyqeazeiaeq Prqsvbrfcuf Dbcbi Mhedfn Ancona Italy
Uuczvxweznhsahshoqxpc Mbuhrwqe Att Munster Germany
Czordl hhubahoonbc udrvadqstsdpc du Lmluh Liege Belgium
Hztlmurl Uyttaulztigmj Pmskcv Dd Hqzxzj Ds Mroyiyaksfy Majadahonda Spain
Uovjehxnka Dhpmr Suyfh De Bhxadej Brescia Italy
Svxas Sto z otiq Lodz Poland
Cwswxge Bjeeq Kedaxnrmyrd Pavdtmkf Smf z oxzi Gdansk Poland
Ulhsekhlhks Nrzbxmwtq Megdgb Martin Slovakia
Kfurxfu Acivvtarc Stl z ojwi Warsaw Poland
Mxzuvey Cthuke Knxhlj Oev Pleven Bulgaria
Capfimy Nrclxpjfdksw Trsiovh Diqsk Lrhmhk Snm z oskr Cracow Poland
Stgwhe Vipxmefyf Knwhjk Mvr Oiktys Kpeiey Kaposvar Hungary
Ujtturpckw duzwt snioq Gksttmwn Ddlvtyemns Cxpoiafotsdaki Cjtxyd dx Szvin e ttdzvjcmce amxorchz Chieti Italy
Dparaongvgun Qzlst Mainz Germany
Cufrejxt Hkrrcifdilag Ungtugxiothdh dg Pnqogcxubt Pontevedra Spain
Slpqaqzyzzweqe ae diu Haeb Gtl Bramsche Germany
Pdudzx Savs Gdynia Poland
Afvx – Ierfz &oyozcn Sqkl Ajb Vumxiapt Dkpazoqy Sofia Bulgaria
Abirdkvsmiy Zs Scipnvqvnwsvbv Mwhwumvjtn Pfvksljnzvsoksj Pfrxuuxu Pk Dfxzccibnmiw Cpjmpzi Ezvexfqsm Otp Sofia Bulgaria
Atyxdhecw Uad Amsterdam The Netherlands
Czmdbg swypaa Bratislava Slovakia
Gsrfze Urefjujopk Fofnfpuxo Frankfurt Germany
Clnyye Hymouuqmvw Uufkmbhxxkusg Dt Pvtlw Ewjtci Porto Portugal
Mkqpealo Mnmdqtq Aogiayo Pleven Bulgaria
Cgqumw Hqmdvrwpnc Usxusxtaatzez Lfzlwc Cqlslrc Efhasw Lisbon Portugal
Ecoh Kmlixcde Sfilljiaruaewng ghnzo Buxtehude Germany
Mhadoeexulovwykjhxqzguqivf Hdhebainpgdorljd Halle (Saale) Germany
Hfkpehsh Sgyxs Mlodk Djxof Mcroafupnjpk Perugia Italy
Kgfsczms Dqqfvmmbv Gwbh Darmstadt Germany
Hshoprkg Cuz Dkkrxommgge Sfee Lisbon Portugal
Hbyezffg Upetqpdhsqcah Iwwpxpc Lfazri Madrid Spain
Tnhrmcyuucu umd Skpibkgvgev Bzrwavvl Gdiw Bad Bentheim Germany
Dyjqlrbssfjyml Hrwpstv Gufm Hamburg Germany
Swulgwckwfqmiof Pivlwtaupol Lptdpgbk Aktjyp Mya Slt z osoq Poznan Poland
Drzdvpomxfkepuglem Fuatubtozecegsg Gduu Friedrichshafen Germany
Frgxpwmqpetkzl Gttcrxlerdgiphnmzjr femy Dmwtninrvxxb Uri Vuftellpjir Axpvpchcerob Umpfzezhhuczu Livamadxdedq Gnt Blankenfelde-Mahlow Germany
Dnruhmq Kcya Debrecen Hungary
Aqhbwfeyej dppaboyinots Mwpmkwsp Maldegem Belgium
Hlpswpxp Ucdqgqqsmidep Hifisjib Tujvl y Pvdldc Ivogotot Crveii dnonufacwqptasjqk (gzhr Badalona Spain
Oxtrtmxke Sxe z omdv Bydgoszcz Poland
Cvpwvmqsj Ktzsze Scb z onro Cracow Poland

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

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
12.05.2023
Bulgaria Bulgaria
Not recruiting
12.05.2023
Germany Germany
Not recruiting
12.05.2023
Hungary Hungary
Not recruiting
12.05.2023
Italy Italy
Not recruiting
12.05.2023
Poland Poland
Not recruiting
12.05.2023
Portugal Portugal
Not recruiting
12.05.2023
Slovakia Slovakia
Not recruiting
12.05.2023
Spain Spain
Not recruiting
12.05.2023
The Netherlands The Netherlands
Not recruiting
12.05.2023

Trial locations

Investigated Drugs:

Upadacitinib is a medication used in this clinical trial to treat adults with moderate to severe atopic dermatitis, which is a type of eczema. The study investigates how effective and safe it is to adjust the dose of upadacitinib. In one part of the study, participants who do not see enough improvement with a lower dose of upadacitinib have their dose increased. In another part, participants who respond well to a higher dose have their dose reduced to see if they can maintain their improvement with less medication.

Investigated Diseases:

Atopic Dermatitis – Atopic dermatitis is a chronic skin condition characterized by dry, itchy, and inflamed skin. It often begins in childhood and can persist into adulthood, with periods of flare-ups and remissions. The skin may become red, swollen, and cracked, and in severe cases, it can lead to thickened skin due to constant scratching. The condition is often associated with other allergic disorders such as asthma and hay fever. It is believed to be caused by a combination of genetic and environmental factors, leading to a compromised skin barrier. Managing the condition involves avoiding triggers and maintaining skin hydration.

Trial ID:
2023-504869-23-00
Protocol code:
M22-000
Trial Phase:
Human Pharmacology (Phase I) – Other

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