Study on the Safety and Effectiveness of Upadacitinib and Dupilumab for Children Aged 2 to 12 with Moderate to Severe Atopic Dermatitis

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What is this study about?

This clinical trial is focused on studying the treatment of Atopic Dermatitis, a condition commonly known as eczema, which causes the skin to become itchy, red, and inflamed. The study involves two treatments: Upadacitinib, which is taken as an oral solution or a modified-release tablet, and Dupilumab, which is given as a solution for injection. The purpose of the study is to compare the safety and effectiveness of these two treatments in children aged 2 to less than 12 years who have moderate to severe atopic dermatitis.

Participants in the study will receive either Upadacitinib or Dupilumab. The study will last for several weeks, during which the children will be monitored to see how their skin condition improves and to check for any side effects. The study aims to find out which treatment works better in reducing the symptoms of atopic dermatitis, such as the extent and severity of the eczema, and to ensure that the treatments are safe for use in children.

Throughout the study, the children will have regular check-ups to assess their progress. The main goal is to see if there is a significant reduction in the eczema symptoms by the end of the study period. This research is important for understanding how these treatments can help manage atopic dermatitis in young children and improve their quality of life.

1 joining the study

Upon joining the study, you will be assigned to receive either upadacitinib or dupilumab. These medications are used to treat moderate to severe atopic dermatitis, a skin condition characterized by red, itchy, and inflamed skin.

2 medication administration

If you are assigned to upadacitinib, you will take it as an oral solution or a modified-release tablet. The specific dosage and frequency will be determined by the study team.

If you are assigned to dupilumab, it will be administered as a subcutaneous injection. The dosage and frequency will be according to the study protocol.

3 treatment duration

The treatment will continue for a specified period, with regular assessments to monitor your response to the medication and any side effects. The primary assessment will occur at week 16.

4 regular assessments

Throughout the study, you will undergo regular assessments to evaluate the effectiveness of the treatment. This includes measuring the reduction in eczema area and severity index score (EASI) and other health indicators.

5 end of treatment evaluation

At the end of the treatment period, a final evaluation will be conducted to assess the overall effectiveness and safety of the medication. This will help determine the percentage of participants achieving significant improvement in their condition.

Who Can Join the Study?

  • The child must be between 2 and less than 12 years old at the start of the study.
  • The child must weigh at least 10 kg and have a weight and height above the 5th percentile for their age based on local growth charts.
  • The child must have a certain level of disease activity, which includes:
    • An EASI score of 16 or higher. (EASI is a tool used to measure the severity of eczema.)
    • A vIGA-AD score of 3 or higher. (vIGA-AD is a scale used to assess the severity of eczema.)
    • At least 10% of the body surface area affected by eczema.
    • A weekly average score of 4 or higher on a daily itch scale reported by the child or caregiver.
  • The child must meet at least one of the following criteria:
    • For children in countries other than the US: A history of not responding well or having a bad reaction to topical treatments like creams or ointments, or if these treatments are not suitable for them.
    • For children who have not used dupilumab before: A history of not responding well to other systemic treatments (treatments that affect the whole body) for eczema, or if these treatments are not suitable for them.
    • A history of not responding well to at least two courses of oral corticosteroid therapy (a type of medication) given for 14 days or more within 6 months before the study, or if symptoms returned within 4 months after stopping the medication.
    • For children who have used dupilumab before: Prior use of dupilumab without a history of not responding well or having a bad reaction, but stopped for non-medical reasons like insurance issues.
    • For children who did not respond well or had a bad reaction to dupilumab, or if dupilumab is not suitable for them, and have a history of not responding well or having a bad reaction to topical treatments.
  • If the child has eczema around the eyes, they must be willing to have an eye examination before starting the study.

Who Cannot Join the Study?

  • Patients who have any other skin conditions that might interfere with the study.
  • Patients who have a history of severe allergic reactions to any of the study medications.
  • Patients who are currently participating in another clinical trial.
  • Patients who have received certain treatments for their skin condition within a specific time frame before the study starts.
  • Patients who have any serious health conditions that could affect their participation in the study.
  • Patients who are unable to follow the study procedures or attend the required visits.
  • Patients who have a history of certain infections that could be worsened by the study medications.
  • Patients who are pregnant or breastfeeding.
  • Patients who have a history of alcohol or drug abuse.
  • Patients who have been vaccinated with certain vaccines within a specific time frame before the study starts.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Technische Universitaet Dresden Dresden Germany
University Hospital Of Clermont-Ferrand Clermont Ferrand France
Poliklinika Vlatka Cavka d.o.o. Zagreb Croatia
Medical University Of Vienna Vienna Austria
Medical University Of Graz Graz Austria
Centro Hospitalar Universitario Sao Joao E.P.E. Porto Portugal
Oncopole Claudius Regaud Toulouse France
Royalderm Agnieszka Nawrocka Warsaw Poland

Other Sites

Site Name City Country Status
Centre Hospitalier Victor Dupouy Argenteuil France
Hospital Sant Joan De Deu Barcelona Esplugues De Llobregat Spain
Hospital General Universitario Gregorio Maranon Madrid Spain
Pellegrin Hospital Bordeaux France
Alergologia Plus Sp. z o.o. Poznan Poland
Univerzitna Nemocnica Martin Martin Slovakia
Fakultna Nemocnica Trnava Trnava Slovakia
Clinical Research Group Sp. z o.o. Warsaw Poland
Klinika Ambroziak Sp. z o.o. Warsaw Poland
Centrum Nowoczesnych Terapii Dobry Lekarz Sp. z o.o. Cracow Poland
Narodny Ustav Detskych Chorob Bratislava Slovakia
University Of Debrecen Debrecen Hungary
Univerzitna nemocnica L. Pasteura Kosice Kosice Slovakia
Klinika Za Djecje Bolesti Zagreb Zagreb Croatia
Diagnostic-consultative center “Aleksandrovska” EOOD Sofia Bulgaria
Universitaetsklinikum Erlangen AöR Erlangen Germany
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Hospital General Universitario De Valencia Valencia Spain
Centre Hospitalier Universitaire De Nantes Nantes France
Specijalna Bolnica Medico Rijeka Croatia
Centre Hospitalier Universitaire Amiens Picardie Amiens France
Poliklinika Solmed d.o.o. Zagreb Croatia
Centro Hospitalar Universitario De Santo Antonio E.P.E. Porto Portugal
KBC Split Split Croatia
Hopital Beaujon Clichy France
Ospedale Pediatrico Bambino Gesu’ Rome Italy
University Of Szeged Szeged Hungary
Uniklinikum Salzburg Salzburg Austria
DermaMed Research Kft. Oroshaza Hungary
Klinika Osipowicz & Turkowski Sp. z o.o. Warsaw Poland
Cfxsjmo Bqnsq Krfnmwdydof Ppjgamaw Sjr z oglj Gdansk Poland
Tyelgyusenz uhc Sqqsekdrclx Bkxkotcm Gekk Bad Bentheim Germany
Ajrbdg scjmjt Kosice Slovakia
Mtycwsp Cqpxzo Kryafj Ope Pleven Bulgaria
Mccvvbdke Iddxknctzq Ciafirlk Sdqclrfc Snv z ozzu Warsaw Poland
Nuhi Sxjtbbvm Olznnji Daddkupuptvvcnw Dmppaj Bialystok Poland
Awfrhougt Uxs Amsterdam The Netherlands
Edyxfid Uawtejtemsqs Meacggc Camqrlv Ruiuwruar (awoyfmp Mtv Rotterdam The Netherlands
Uurwhcjigjnupkrkxbkik Mladwfdj Ask Munster Germany
Cwau Dx Nrhyr Vandoeuvre Les Nancy France
Aldixxc Ukqwx Shhleammf Llgdme Dk Bysuxha Bologna Italy
Pcdoyas Sha z osny Katowice Poland
Fdmgjqqhv Pwtm Lx Iwrljjwjwdugd Bwaitfsev Dko Hwinazlt Uzkpujlatnmvs Lo Pfg Madrid Spain

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

Trial status

Country Status Recruitment Start
Austria Austria
Recruiting
21.11.2024
Bulgaria Bulgaria
Not recruiting
21.11.2024
Croatia Croatia
Recruiting
21.11.2024
France France
Recruiting
21.11.2024
Germany Germany
Recruiting
21.11.2024
Hungary Hungary
Recruiting
21.11.2024
Italy Italy
Recruiting
21.11.2024
Poland Poland
Recruiting
21.11.2024
Portugal Portugal
Recruiting
21.11.2024
Slovakia Slovakia
Recruiting
21.11.2024
Spain Spain
Recruiting
21.11.2024
The Netherlands The Netherlands
Recruiting
21.11.2024

Trial locations

Investigated drugs:

Upadacitinib is a medication used in this clinical trial to help treat children with moderate to severe atopic dermatitis, which is a type of eczema. It works by targeting specific pathways in the immune system that are involved in causing inflammation and itching in the skin. By doing so, it aims to reduce the symptoms of atopic dermatitis, such as redness, swelling, and itching, making the skin feel more comfortable and improving the quality of life for the children participating in the trial.

Dupilumab is another medication being tested in this trial for children with moderate to severe atopic dermatitis. It is designed to block certain proteins in the body that can cause inflammation and lead to the symptoms of eczema. By blocking these proteins, dupilumab helps to decrease the inflammation and itching associated with atopic dermatitis, potentially leading to clearer skin and relief from discomfort for the children involved in the study.

Investigated diseases:

Atopic Dermatitis – Atopic dermatitis is a chronic inflammatory skin condition characterized by itchy, red, and swollen skin. It often begins in childhood and can persist into adulthood. The skin may become dry, cracked, and prone to infections due to frequent scratching. Flare-ups can occur, leading to more intense symptoms and discomfort. The condition is associated with a malfunction in the skin barrier and immune system, which can be influenced by genetic and environmental factors. Over time, the skin may thicken and develop a leathery texture due to repeated irritation and inflammation.

Trial ID:
2023-504713-76-00
Protocol code:
M17-380
Trial Phase:
Therapeutic confirmatory (Phase III)

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