Study on Rocatinlimab for Adolescents Aged 12-17 with Moderate-to-Severe Atopic Dermatitis

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What is this study about?

This clinical trial is focused on studying Atopic Dermatitis (AD), a skin condition that causes red, itchy, and inflamed skin. The study is specifically for adolescents aged 12 to 18 years who have moderate-to-severe forms of this condition. The treatment being tested is called Rocatinlimab, also known by its code name AMG 451. This medication is given as a solution for injection under the skin.

The purpose of the study is to understand how safe and tolerable Rocatinlimab is for adolescents with moderate-to-severe Atopic Dermatitis. Participants in the study will receive the treatment over a period of 52 weeks. During this time, researchers will monitor the participants to see how they respond to the treatment and to check for any side effects. Some participants may receive a placebo, which is a substance with no active medication, to compare the effects of the treatment.

This study aims to provide valuable information about the safety and potential benefits of Rocatinlimab for young people dealing with this challenging skin condition. By participating, researchers hope to gather data that could lead to better treatment options for adolescents with Atopic Dermatitis in the future.

1 initial visit

Upon joining the study, you will attend an initial visit. During this visit, your eligibility for the trial will be confirmed based on specific criteria, such as age, weight, and the severity of your atopic dermatitis.

You will receive information about the study, and your legally authorized representative will provide informed consent if you are under the legal age. You will also provide written assent if required.

2 screening assessments

Screening assessments will be conducted to evaluate your condition. This includes measuring the extent of your atopic dermatitis and assessing your medical history.

Your body surface area (BSA) affected by atopic dermatitis and your Eczema Area and Severity Index (EASI) score will be recorded.

3 treatment phase

If eligible, you will enter the treatment phase, which lasts for 52 weeks. During this time, you will receive the medication rocatinlimab.

The medication is administered as a solution for injection under the skin (subcutaneous use). The dosage and frequency will be explained to you by the study team.

4 regular follow-up visits

Throughout the study, you will attend regular follow-up visits. These visits are important for monitoring your health and the effects of the medication.

During these visits, you will undergo various assessments to check the safety and tolerability of the treatment.

5 end of study visit

At the end of the 52-week treatment period, you will have a final visit. This visit will include a comprehensive assessment of your condition and any changes observed during the study.

The study team will discuss the results with you and provide guidance on the next steps for managing your atopic dermatitis.

Who Can Join the Study?

The person responsible for the patient must give permission for the patient to join the study if the patient is too young to decide for themselves. The patient must also agree in writing to participate.
The patient must have a vIGA-AD score of 3 or higher. This score measures the severity of the skin condition, with 3 being moderate and 4 being severe.
The patient must have at least 10% of their body surface area affected by the skin condition at the start of the study.
If the patient is receiving treatment for mental health issues, their treatment must be stable for at least 2 months before starting the study.
The patient must be between 12 and 17 years old.
The patient must have been diagnosed with Atopic Dermatitis (AD) for at least 6 months before joining the study.
The patient must weigh at least 40 kg (about 88 pounds) at the start of the study.
The patient must have previously tried a treatment called Topical Corticosteroids (TCS) of medium or higher strength and not had a good enough response. This means the treatment did not clear the skin or reduce the disease to a mild state, even after using it daily for at least 28 days or as recommended.
The patient must have an EASI score of 16 or higher. This score measures the extent and severity of the skin condition.

Who Cannot Join the Study?

Patients with any other skin conditions that might interfere with the study.
Patients who have had a serious allergic reaction to any medication in the past.
Patients who are currently participating in another clinical trial.
Patients who have used certain medications that might affect the study results.
Patients with a history of certain chronic diseases that could affect their safety during the study.
Patients who are pregnant or breastfeeding.
Patients who have a history of drug or alcohol abuse.
Patients with any condition that the study doctors believe 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

Site Name	City	Country
Diamond Clinic Sp. z o.o.	Cracow	Poland
Medical University Of Graz	Graz	Austria
Centro Hospitalar Universitario Lisboa Central E.P.E.	Lisbon	Portugal
Centro Hospitalar Universitario Sao Joao E.P.E.	Porto	Portugal

Other Sites

Site Name	City	Country
Klinika Ambroziak Sp. z o.o.	Warsaw	Poland
University Of Debrecen	Debrecen	Hungary
Clinexpert Kft.	Budapest	Hungary
Universitaetsklinikum Erlangen AöR	Erlangen	Germany
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico	Milan	Italy
Rheinische Friedrich-Wilhelms-Universitaet Bonn	Bonn	Germany
Suomen Terveystalo Oy	Helsinki	Finland
Gentofte Hospital	Hellerup	Denmark
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Hospital Del Mar	Barcelona	Spain
Hospital Santa Maria Della Misericordia	Perugia	Italy
Hospital Cuf Descobertas S.A.	Lisbon	Portugal
Oulu University Hospital	Oulu	Finland
Unidade Local De Saude Do Alto Ave E.P.E.	Guimaraes	Portugal
Cnsivgxt Boih Siussvfiv Sgk z ogrk Slbu	Lublin	Poland
Hlaubaqr Dx Lg Sqyak Chxt I Stnx Pwj	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Austria	Not yet recruiting	03.04.2023
Denmark	Not yet recruiting	03.04.2023
Finland	Not yet recruiting	03.04.2023
Germany	Not yet recruiting	03.04.2023
Hungary	Not yet recruiting	03.04.2023
Italy	Not yet recruiting	03.04.2023
Poland	Not yet recruiting	03.04.2023
Portugal	Not yet recruiting	03.04.2023
Spain	Not yet recruiting	03.04.2023

Trial locations

Investigated drugs:

Rocatinlimab

Rocatinlimab (AMG 451) 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 is designed to work by targeting specific parts of the immune system that are involved in causing the symptoms of atopic dermatitis. The goal of using rocatinlimab is to reduce the severity of the skin condition and improve the quality of life for those affected by it. In this clinical trial, researchers are focusing on understanding how safe and tolerable this medication is for adolescents, as well as how effective it is in managing their symptoms over a period of 52 weeks.

Atopic Dermatitis – Atopic Dermatitis is a chronic inflammatory skin condition characterized by dry, itchy, and red skin. It often begins in childhood and can persist into adulthood, with periods of flare-ups and remissions. The skin may become thickened and cracked due to persistent scratching. It is commonly associated with other allergic conditions such as asthma and hay fever. The exact cause is unknown, but it involves a combination of genetic, environmental, and immune system factors. The condition can significantly impact the quality of life due to its persistent itchiness and visible skin changes.

Trial ID:

2022-501535-16-00

Protocol code:

20210263

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Rocatinlimab for Adolescents Aged 12-17 with Moderate-to-Severe Atopic Dermatitis

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