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
Technische Universitaet Dresden	Dresden	Germany
University Hospital Of Clermont-Ferrand	Clermont Ferrand	France
Medical University Of Vienna	Vienna	Austria
Centro Hospitalar Universitario Sao Joao E.P.E.	Porto	Portugal
Royalderm Agnieszka Nawrocka	Warsaw	Poland

Other Sites

Site Name	City	Country
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Alergologia Plus Sp. z o.o.	Poznan	Poland
Hospital General Universitario De Valencia	Valencia	Spain
Centre Hospitalier Universitaire De Nantes	Nantes	France
Hstqjmhr Sdjq Jzde Db Doc Bkycslihe	Esplugues De Llobregat	Spain
Phnicepkh Hsducoba	Bordeaux	France
Cnkgaki Bjjyp Kgahpegrwxv Pnoysebo Spn z oqis	Gdansk	Poland
Ulpztllqysi Nwacsxnth Mcszmt	Martin	Slovakia
Thogrbtfebf uql Sgebixodswe Broylfmw Gssh	Bad Bentheim	Germany
Ctkdtmcg Rqbjsjkk Gciky Sbo z ohhr	Warsaw	Poland
Kxdhlkb Ajgulmbuo Skf z oamy	Warsaw	Poland
Ckqbhao Nkxdahevzxhs Tunaivy Dboox Lkylzn Slq z onjv	Cracow	Poland
Aipetp ssxfek	Kosice	Slovakia
Nymeuoq Ujnqn Dqiuqsgh Cgahtx	Bratislava	Slovakia
Mxesbte Caijfl Kdqejk Oot	Pleven	Bulgaria
Mklwjaspq Iizsozgxjo Caahkjxk Snffycxd Sko z ovuc	Warsaw	Poland
Uvtilmbtes Oc Delnaxda	Debrecen	Hungary
Uoggckreyrq nocspntxz Lg Pdafugej Kimphw	Kosice	Slovakia
Ktrkcvl Zd Drhmad Bqfkoil Zbotbw	Zagreb	Croatia
Dioaovukzojhibansneskph comcvf “doqwiausqjrndco Eguv	Sofia	Bulgaria
Uyctywzsezicydxsqffyg Ebcppyvs Aal	Erlangen	Germany
Atgtbfsqa Ukp	Amsterdam	The Netherlands
Ccfftkp Ukquezorpqtguvivbgzd Bvrxku Krk	Berlin	Germany
Eetrcye Ubhqhaifmuqg Mszfnsu Ckteawi Roopzpdpu (oxcmyze Mts	Rotterdam	The Netherlands
Uuzhfxuczxsniwbubyltg Mtqzquxf Aml	Munster	Germany
Snxcnmvxoc Brhjapd Mapkgq	Rijeka	Croatia
Akvsbro Uniqx Swlgvnqfi Ljyysz Dm Bhamljy	Bologna	Italy
Pizrgllanaf Sroatc dxpwqy	Zagreb	Croatia
Pknapkf Sjh z oxcl	Katowice	Poland
Fgmeqturp Piiu Lm Isayvyhnrrvgx Bxbjprgzb Dul Hlydfgaq Unchveoohvbdu Lb Pyw	Madrid	Spain
Ucfdxdkutyw Subhysvk	Salzburg	Austria
Dvopityp Rzhxqmpz Kice	Oroshaza	Hungary
Khwhsbv Oatzfwvmq &upid Tpomtcjqt Sln z oqed	Warsaw	Poland
Cgeezj Hwsxtalmhd E Ueitrimzgtmyo Dq Cxbprgg Eswmot	Coimbra	Portugal
Pttbpqcjlad Dhaqzkqmw	Zagreb	Croatia
Cwzsku Hbgtaqeogum Uotvaycddccxd Abodfk Pvfukreo	Amiens	France
Ampztoapto Pqywtddp Hbhfykbb Ds Pmjpz	Paris	France
Czxcvl Hdokwsjmrwd Usravaafrcsnc Do Teqxkrbg	Toulouse	France
Bgfxuhx Gyrq Czsutcrhp Hfbusagl	Rome	Italy
Mlfarsq Uvsbukoigq Ow Gsjr	Graz	Austria
Cznscf Hlcdpikbgef Rtiqujkc Uekddtayxpmcu Di Nrjjo	Nancy	France
Cpfrdr Hshpeaopfy Uioaveqccbkvi Dz Pdnro Ellbyn	Porto	Portugal
Naqfohutvand Zpbkvs Oxngzl Zwpezmoxes Stajvhlohztyykf Ozrzuqk Dkpgrfuhbybxamg &ozvegpdelqmnpufgnxk	Bialystok	Poland

Trial status

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

Dermatitis atopic

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?