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
Dermed Centrum Medyczne Sp. z o.o. Lodz Poland
Royalderm Agnieszka Nawrocka Warsaw Poland

Other Sites

Site Name City Country Status
Cliniq s.r.o. Bratislava Slovakia
BeneDerma s.r.o. Dubravka Slovakia
Tokuda Hospital Sofia Bulgaria
Grand Hopital De Charleroi Charleroi Belgium
Centro Hospitalar Universitario Lisboa Central E.P.E. Lisbon Portugal
Somogy Varmegyei Kaposi Mor Oktato Korhaz Kaposvar Hungary
Clinexpert Kft. Budapest Hungary
Università degli studi Gabriele D’Annunzio Chieti-Pescara Centro di Studi e tecnologie avanzate Chieti Italy
Diagnostic-consultative center “Aleksandrovska” EOOD Sofia Bulgaria
Virgen del Rocío University Hospital Sevilla Spain
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico Milan Italy
Universita’ Politecnica Delle Marche Ancona Italy
Gyongyosi Bugat Pal Korhaz Gyongyos Hungary
Centre hospitalier universitaire de Liege Liege Belgium
Elbe Kliniken Stade-Buxtehude gGmbH Buxtehude Germany
Hospital Universitario Puerta De Hierro De Majadahonda Majadahonda Spain
Hospital Santa Maria Della Misericordia Perugia Italy
Amphia Hospital Breda The Netherlands
Universita Degli Studi Di Brescia Brescia Italy
Klinikum Darmstadt GmbH Darmstadt Germany
Alergologia Plus Sp. z o.o. Poznan Poland
Santa Sp. z o.o. Lodz Poland
AZ Sint-Lucas & Volkskliniek Gent Belgium
Univerzitna Nemocnica Martin Martin Slovakia
Hospital Cuf Descobertas S.A. Lisbon Portugal
Hospital Universitario Infanta Leonor Madrid Spain
Silmedic Sp. z o.o. Katowice Poland
Dermatologikum Hamburg GmbH Hamburg Germany
Specjalistyczna Przychodnia Lekarska Alergo Med Sp. z o.o. Poznan Poland
Derma-Study-Center Friedrichshafen GmbH Friedrichshafen Germany
Fachaerztliche Gemeinschaftspraxis fuer Dermatologie Und Venerologie Allergologie Umweltmedizin Lasermedizin GbR Blankenfelde-Mahlow Germany
Derma-B Kft. Debrecen Hungary
Associatie dermatologie Maldegem Maldegem Belgium
Klinika Ambroziak Sp. z o.o. Warsaw Poland
Centrum Nowoczesnych Terapii Dobry Lekarz Sp. z o.o. Cracow Poland
ASMC – IPSMC – Skin And Venereal Diseases Sofia Bulgaria
Ambulatoria Za Specializirana Medicinska Pomosht-Grupova Praktika Po Dermatologia Clinica Evroderma OOD Sofia Bulgaria
Oftalmika Sp. z o.o. Bydgoszcz Poland
Centermed Krakow Sp. z o.o. Cracow Poland
Pjaszs Sfvs Gdynia Poland
Ceyltl Hpdedhghhc Ujbgqcvfspdog De Pdckh Eskvaw Porto Portugal
Mwzocjsjm Iyyftjmmam Cdmrcicb Slyjtcao Soi z ocmm Warsaw Poland
Crpnixgbc Ugzrtmmrnimqim Sbgbgbnrv Woluwe-Saint-Lambert Belgium
Sbqdpjrpacolhb ai drg Hfkg Gte Bramsche Germany
Uipzjqiovahqhwtgeulkj Myeyiuoi Ady Munster Germany
Aogborwon Udy Amsterdam The Netherlands
Gbrlxj Uablranhvh Fgyoczsai Frankfurt Germany
Mcgiakob Meoeuva Anjfucq Pleven Bulgaria
Mphouxdpxunegkonpwgvxaiqnp Hwzbrngtcrbauatv Halle (Saale) Germany
Cfvrbno Bxiab Kghfsuulfwe Pcuzaivo Sky z oglb Gdansk Poland
Tnybjyelbhk ujx Sghpjlkbrcd Byyytima Gvww Bad Bentheim Germany
Msjxyfu Cabkra Kqjolp Ope Pleven Bulgaria
Holebgib Uwouloppesvfo Hefkybtn Txrwt y Pogecw Ihhpmtpb Cattbk dpaxqtudwpkxjvprx (xvcm Badalona Spain
Dvojwurahjit Qivww Mainz Germany

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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