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

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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 candidates for systemic therapy, which means they may need treatment that affects the entire body rather than just the skin.

The purpose of the study is to evaluate the effectiveness and safety of Upadacitinib, which is a type of medication known as a Janus Kinase (Jak) 1 Inhibitor. This medication is taken orally in the form of a modified-release tablet, which means it is designed to release the active ingredient slowly over time. Participants in the study will receive either Upadacitinib or a placebo, which is a substance with no active medication, to compare the outcomes.

Throughout the study, participants will be monitored to see how their eczema symptoms change over time. The study will last for several months, and participants will have regular check-ups to assess their skin condition and overall health. The goal is to determine if Upadacitinib can significantly improve the symptoms of eczema and enhance the quality of life for those affected by this condition.

1 initial visit

Upon joining the study, an initial visit is conducted to confirm eligibility. This involves a review of medical history and a physical examination.

Participants are informed about the study procedures, potential risks, and benefits. Consent is obtained before proceeding.

2 randomization

Participants are randomly assigned to receive either the study medication, upadacitinib, or a placebo. This process is double-blind, meaning neither the participant nor the study team knows which treatment is being administered.

3 medication administration

Participants take the assigned medication orally in the form of a modified-release tablet. The dosage and frequency are determined by the study protocol.

The duration of medication administration is up to 16 weeks, with regular monitoring throughout this period.

4 follow-up visits

Regular follow-up visits are scheduled to monitor the participant’s health and response to the treatment. These visits include physical examinations and assessments of atopic dermatitis symptoms.

Participants are required to report any side effects or changes in their condition during these visits.

5 final assessment

At the end of the 16-week period, a final assessment is conducted to evaluate the effectiveness and safety of the treatment.

This includes a comprehensive review of the participant’s health status and any changes in atopic dermatitis symptoms.

Who Can Join the Study?

Participants must be male or female and between 12 to 75 years old.
Participants must have active moderate to severe atopic dermatitis. This is a skin condition that can cause redness, swelling, and itching. It is measured by specific tools: 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 atopic dermatitis. Systemic therapy means treatment that affects the entire body, not just the skin.

Who Cannot Join the Study?

Patients with any other skin conditions that might interfere with the study results.
Patients who have had a serious infection in the past 12 weeks.
Patients who have been treated with certain medications that affect the immune system in the past 4 weeks.
Patients with a history of cancer, except for certain types of skin cancer that have been treated.
Patients who are pregnant or breastfeeding.
Patients with a history of severe allergic reactions to the study medication or similar medications.
Patients with certain heart conditions that are not well controlled.
Patients with liver disease or abnormal liver function tests.
Patients with a history of drug or alcohol abuse in the past year.
Patients who have participated in another clinical trial in the past 4 weeks.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Azienda Ospedaliera Universitaria Federico II Di Napoli	Naples	Italy
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz	Mainz	Germany
Medizinische Hochschule Hannover	Hanover	Germany
Kuopio University Hospital	Kuopio	Finland
CABINET MEDICAL DE DERMATO VENEROLOGIE Prof.Dr. ORASAN R. REMUS IOAN	Cluj Napoca	Romania

Other Sites

Site Name	City	Country
Centre Hospitalier Le Mans	Le Mans	France
Tartu University Hospital	Tartu	Estonia
Mehilaeinen Oy	Helsinki	Finland
Klinika Za Djecje Bolesti Zagreb	Zagreb	Croatia
KBC Zagreb	Zagreb	Croatia
Centre Hospitalier Universitaire Rouen	Rouen	France
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania	Catania	Italy
Spitalul Clinic Colentina Bucuresti	Bucharest	Romania
Arstikeskus Confido AS	Tallin	Estonia
Diagnostic-consultative center “Aleksandrovska” EOOD	Sofia	Bulgaria
Centre Hospitalier Universitaire De Toulouse	Toulouse	France
Universita’ Di Pisa	Pisa	Italy
Universita’ Politecnica Delle Marche	Ancona	Italy
Centre Hospitalier Universitaire De Nantes	Nantes	France
Gentofte Hospital	Hellerup	Denmark
KBC Split	Split	Croatia
Centre Hospitalier Lyon Sud	Pierre Benite	France
TFS Trial Form Support GmbH	Hamburg	Germany
Du Docteur Ruer S.E.L.A.R.L.	Martigues	France
North Estonia Medical Centre Foundation	Tallin	Estonia
Suomen Terveystalo Oy	Tampere	Finland
Usglpafwbx Mtkzsuvgzpkr Hwmpdtps fyt Aktuon Tlioexybw Svwad Mvqdnv &epaikr Pppzpc	Pleven	Bulgaria
Afuncw Uvrbtwysdt Hdbeftxj	Aarhus	Denmark
Ucmhztxuwnojvrqgrkuxz Mesqcrse Awo	Munster	Germany
Acrzvzm Uuldc Smugwggnk Lisxxv Dd Bkzffuu	Bologna	Italy

Trial status

Country	Status	Recruitment Start
Bulgaria	Not recruiting	31.08.2018
Croatia	Not recruiting	31.08.2018
Denmark	Not recruiting	31.08.2018
Estonia	Not recruiting	31.08.2018
Finland	Not recruiting	31.08.2018
France	Not recruiting	31.08.2018
Germany	Not recruiting	31.08.2018
Italy	Not recruiting	31.08.2018
Romania	Not recruiting	31.08.2018

Trial locations

Investigated drugs:

Upadacitinib

Upadacitinib is a medication being studied for its potential to help people with moderate to severe atopic dermatitis, which is a type of skin condition that causes red, itchy, and inflamed skin. This medication works by targeting specific pathways in the immune system that are involved in causing inflammation. By doing so, it aims to reduce the symptoms of atopic dermatitis, such as itching and skin rashes, and improve the overall condition of the skin. The goal of using upadacitinib in this trial is to see if it can effectively and safely help people who need more than just topical treatments for their skin condition.

Investigated diseases:

Dermatitis atopic

Atopic Dermatitis – Atopic Dermatitis is a chronic inflammatory skin condition characterized by dry, itchy, and inflamed skin. It often begins in childhood but can occur at any age. The disease progresses through periods of flare-ups, where symptoms worsen, and remissions, where symptoms improve or disappear. The skin may become thickened and cracked over time due to persistent scratching. It is commonly associated with other atopic conditions such as asthma and hay fever. The exact cause is unknown, but it involves a combination of genetic, environmental, and immune system factors.

Trial ID:

2022-502938-30-00

Protocol code:

M16-045

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

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