Study of Upadacitinib for Adolescents and Adults with Moderate to Severe Eczema

3 1

What is this study about?

This clinical trial is focused on studying the effects of a medication called Upadacitinib on individuals with moderate to severe Atopic Dermatitis, commonly known as eczema. Eczema is a condition that causes the skin to become itchy, red, and inflamed. The study involves both adolescents and adults who are experiencing significant symptoms of this skin condition. The purpose of the study is to evaluate how effective and safe Upadacitinib is for treating these symptoms. Upadacitinib is a type of medication known as a Janus kinase (Jak) 1 inhibitor, which works by blocking certain enzymes in the body that contribute to inflammation.

Participants in the study will be randomly assigned to receive either Upadacitinib or a placebo, which is a substance with no active medication. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo. This helps ensure that the results are not influenced by expectations. The study will last for a period of time, during which participants will take the medication orally in the form of a modified-release tablet. The goal is to observe any changes in the severity of eczema symptoms and overall skin condition over the course of the study.

Throughout the study, participants will be monitored for any improvements in their eczema symptoms, such as reduced itching and inflammation, as well as any potential side effects. The study aims to provide valuable information on whether Upadacitinib can be an effective treatment option for those suffering from moderate to severe eczema. By participating in this study, researchers hope to gain insights that could lead to better management and treatment options for individuals with this challenging skin condition.

1 joining the study

Upon joining the study, eligibility is confirmed based on age (12-75 years) and the presence of moderate to severe atopic dermatitis.

Candidates must be suitable for systemic therapy or have recently required it for atopic dermatitis.

2 initial assessment

An initial assessment is conducted to establish baseline measurements for the severity of atopic dermatitis using various scales such as EASI (Eczema Area Severity Index) and IGA (Investigator’s Global Assessment).

Other assessments may include the Worst Pruritus Numerical Rating Scale and the Patient Oriented Eczema Measure.

3 treatment phase

Participants receive either upadacitinib or a placebo. Upadacitinib is administered orally in the form of a modified-release tablet.

The dosage of upadacitinib is either 15 mg or 30 mg, taken once daily.

The treatment phase lasts for 16 weeks.

4 monitoring and follow-up

Throughout the study, regular monitoring is conducted to assess the effectiveness and safety of the treatment.

Primary outcomes include achieving a significant reduction in atopic dermatitis severity by Week 16, as measured by the vIGA-AD and EASI 75 scales.

Secondary outcomes involve improvements in pruritus, quality of life, and other related symptoms.

5 completion of the study

At the end of the 16-week treatment period, a final assessment is conducted to evaluate the overall impact of the treatment.

Participants may be asked to provide feedback on their experience and any changes in their condition.

Who Can Join the Study?

  • Participants must be male or female and between the ages of 12 and 75.
  • Participants must have active moderate to severe atopic dermatitis. This is a skin condition that causes red, itchy, and inflamed skin. It is measured by specific tools like EASI (Eczema Area and Severity Index), IGA (Investigator’s Global Assessment), BSA (Body Surface Area), and pruritus (itchiness).
  • Participants must be candidates for systemic therapy or have recently needed systemic therapy for their atopic dermatitis. Systemic therapy means treatment that affects the entire body, not just the skin.

Who Cannot Join the Study?

  • Patients with other skin conditions that might interfere with the study.
  • Patients who have had a recent infection that required treatment.
  • Patients who have a history of certain serious diseases, like cancer.
  • Patients who are pregnant or breastfeeding.
  • Patients who have used certain medications recently that might affect the study results.
  • Patients who have participated in another clinical trial recently.
  • Patients with a known allergy to the study medication.
  • Patients who have a history of drug or alcohol abuse.
  • Patients who have a condition that the study doctor believes would make it unsafe for them to participate.

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
SYNEXUS Magyarorszag Kft. Budapest Hungary
401 General Military Hospital Of Athens Athens Greece
Noe LGA Gesundheit Region Mitte GmbH St. Poelten Austria
Somogy Varmegyei Kaposi Mor Oktato Korhaz Kaposvar Hungary
Clinexpert Kft. Budapest Hungary
General Hospital Of Thessaloniki Papageorgiou Thessaloniki Greece
Ambulatoria Za Specializirana Medicinska Izvanboln Pomosht0medicinski Centar Sveti Panteleimon EOOD Sofia Bulgaria
Fakultni Nemocnice Plzen Plzen Czechia
University Hospital Galway Galway Ireland
Hospital General Universitario De Valencia Valencia Spain
Andreas Syngros Hospital Of Venereal And Dermatological Diseases Athens Greece
Borsod-Abauj-Zemplen Varmegyei Koezponti Korhaz Es Egyetemi Oktatokorhaz Miskolc Hungary
University Of Pecs Pecs Hungary
Groupe Hospitalier Bretagne Sud Lorient France
251 Air Force General Hospital Athens Greece
Hopital Prive D Antony Antony France
Vseobecna Fakultni Nemocnice V Praze Prague Czechia
Gyongyosi Bugat Pal Korhaz Gyongyos Hungary
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer Barcelona Spain
Azienda Ospedaliero Universitaria Di Modena Modena Italy
Centre hospitalier universitaire de Liege Liege Belgium
Hospital Sant Joan De Deu Barcelona Esplugues De Llobregat Spain
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
Klinik Donaustadt Vienna Austria
Hospital General Universitario Gregorio Maranon Madrid Spain
Universita Degli Studi Di Brescia Brescia Italy
Klinikum Darmstadt GmbH Darmstadt Germany
Hospital Cuf Descobertas S.A. Lisbon Portugal
Hospital Universitario Infanta Leonor Madrid Spain
CCAB Centro Clinico Academico Braga Associacao Braga Portugal
DRC Kft. Balatonfured Hungary
Fachaerztliche Gemeinschaftspraxis fuer Dermatologie Und Venerologie Allergologie Umweltmedizin Lasermedizin GbR Blankenfelde-Mahlow Germany
NAFTALAN specijalna bolnica za medicinsku rehabilitaciju Ivanic-Grad Croatia
Consorci Mar Parc De Salut De Barcelona Barcelona Spain
Medicinski Centar Doverie AD Sofia Bulgaria
Azienda Ospedaliera Universitaria Di Cagliari Monserrato Italy
Zealand University Hospital Koege Denmark
Djecja bolnica Srebrnjak Zagreb Croatia
Uniklinikum Salzburg Salzburg Austria
Ctumicmmh Ubvudoramkisls Ssnhssikh Woluwe-Saint-Lambert Belgium
Bewahq Zgbbpzuekv Bergen Op Zoom The Netherlands
Hxzsv umn Lbujgwvvaqeo Huzgatord Dkelijnufoyucaat Subvtlqjzzbapg Simmern Germany
Hyctxnmwevmnfr Dh Myt Mxmhmayg Hpjkqytt Witten Germany
Aqaqkwbkcn Pucqpivk Hvsxssrz Da Pdhes Paris France
Amyvun Ubaxugpddm Hnwsjjfr Aarhus Denmark
Cbrsid Hmjwqzcqtj Dh Lxrfqj Eddlaz Leiria Portugal
Ckexlb Hltwxwidtv Uyujgeurpsjoi Dw Paozz Enrxbj Porto Portugal
Myiupfqq Mvczixc Azuboqr Pleven Bulgaria
Impptq Iaxunpxv Fkstvvtnufrdd Odztcejcimn Rome Italy
Oukdftobwzcqor Lijl Gjeu Linz Austria
Uqufzqabxvfl Mhlrstp Ctmxqjd Gpouqvfqe Groningen The Netherlands
Awrzxya Somocdlzf Lkojjy Avxbpddf Skeffjd Lycqgthnttcqtn L'aquila Italy

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
31.01.2019
Belgium Belgium
Not recruiting
31.01.2019
Bulgaria Bulgaria
Not recruiting
31.01.2019
Croatia Croatia
Not recruiting
31.01.2019
Czechia Czechia
Not recruiting
31.01.2019
Denmark Denmark
Not recruiting
31.01.2019
France France
Not recruiting
31.01.2019
Germany Germany
Not recruiting
31.01.2019
Greece Greece
Not recruiting
31.01.2019
Hungary Hungary
Not recruiting
31.01.2019
Ireland Ireland
Not recruiting
31.01.2019
Italy Italy
Not recruiting
31.01.2019
Portugal Portugal
Not recruiting
31.01.2019
Spain Spain
Not recruiting
31.01.2019
The Netherlands The Netherlands
Not recruiting
31.01.2019

Trial locations

Investigated drugs:

Upadacitinib is a medication being studied for its effectiveness and safety in treating moderate to severe atopic dermatitis, a type of eczema, in both adolescents and adults. It is intended for patients who may need systemic therapy, which means treatment that affects the entire body rather than just the skin.

Investigated diseases:

Atopic Dermatitis – Atopic Dermatitis is a chronic skin condition characterized by dry, itchy, and inflamed skin. It often begins in childhood but can occur at any age. The disease progresses with periods of flare-ups, where symptoms worsen, followed by periods of remission. The skin may become thickened and cracked due to persistent scratching. Environmental factors, allergens, and stress can trigger or exacerbate symptoms. It is commonly associated with other allergic conditions such as asthma and hay fever.

Trial ID:
2022-502936-38-00
Protocol code:
M18-891
Trial Phase:
Therapeutic confirmatory (Phase III)

Other Trials to Consider

  • Testing two moisturizing creams with urea, propylene glycol, and propylene glycol alone for preventing flare-ups in patients with atopic dermatitis

    Recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    Norway Sweden
  • Long-Term Safety and Efficacy of Lebrikizumab in Children and Adolescents With Moderate-to-Severe Atopic Dermatitis

    Recruiting

    3 1
    Investigated diseases:
    Investigated drugs:
    Czechia France Germany Poland Spain