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Long-Term Safety Study of Dupilumab for Children and Teens with Atopic Dermatitis

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the long-term safety of a medication called Dupilumab in children and teenagers who have a skin condition known as Atopic Dermatitis. Atopic Dermatitis, often referred to as eczema, is a condition that makes the skin red, inflamed, and itchy. The medication being tested, Dupilumab, is given as an injection under the skin and is available in different forms, such as a pre-filled syringe or pen. Dupilumab is also known by its code name, REGN668.

The purpose of this study is to understand how safe Dupilumab is when used over a long period in young patients with Atopic Dermatitis. The study will also include an optional sub-study for children aged 2 to 12 years, which will look at how the body processes the medication when given using a pre-filled pen. Participants in the study will receive regular injections of Dupilumab and will be monitored for any side effects or changes in their condition. The study will help gather important information about the safety and effectiveness of Dupilumab in managing Atopic Dermatitis in children and teenagers.

Throughout the study, participants will have regular check-ups to monitor their health and the condition of their skin. The study aims to provide valuable insights into how Dupilumab can be used safely in young patients with Atopic Dermatitis, potentially improving their quality of life by managing the symptoms of this chronic skin condition. The study is expected to continue for several years to gather comprehensive data on the long-term use of Dupilumab in this patient group.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
The study is designed for individuals aged 6 months to less than 18 years who have previously participated in a dupilumab study for atopic dermatitis and completed all required visits and assessments.
Participants must meet specific criteria, such as age and body weight, to be eligible for the optional sub-study involving a pre-filled pen.
Step 2
Treatment administration
The medication used in this study is dupilumab, administered as a solution for injection.
The injections are given subcutaneously, which means they are administered under the skin.
The available forms of the medication include a 200 mg solution in a pre-filled syringe, a 200 mg solution in a pre-filled pen, a 300 mg solution in a pre-filled syringe, and a 300 mg solution in a pre-filled pen.
Step 3
Monitoring and assessments
Participants will be monitored for any treatment-emergent adverse events (TEAEs) throughout the study.
The study will also assess the long-term safety of dupilumab, including the incidence of serious adverse events (SAEs).
For those in the optional sub-study, additional assessments will include the pharmacokinetics of dupilumab, which involves measuring the concentration of the drug in the body over time.
Step 4
Study duration
The study is expected to continue until September 7, 2026.
Participants will have regular in-clinic visits to assess the effectiveness and safety of the treatment.

Who can join the trial?

6 criteria

The patient must be a boy or girl who is at least 6 months old but younger than 18 years old at the time of screening.
The patient must have participated in a previous study with the medication called dupilumab for children with Atopic Dermatitis (a skin condition that causes itchy and inflamed skin) and must have completed all required visits and assessments in that study.
For the Pre-filled Pen (PFP) Sub-study, the patient must be at least 2 years old but younger than 12 years old at the time of screening.
For the PFP Sub-study, the patient must weigh at least 5 kg (about 11 pounds) but less than 60 kg (about 132 pounds) at the time of screening.
For the PFP Sub-study, the patient must have received the same dose of dupilumab that will be used in the PFP sub-study during the previous 12 weeks in the main study using a prefilled syringe.
Other specific criteria defined in the study protocol may also apply.

Who cannot join the trial?

10 criteria

Patients who have a history of severe allergic reactions to the study medication or its ingredients.
Patients who have other skin conditions that might interfere with the study results.
Patients who are currently participating in another clinical trial.
Patients who have a serious illness that could affect their ability to participate in the study.
Patients who are unable to follow the study procedures or attend the required visits.
Patients who have received certain medications that might interfere with the study results.
Patients who have a history of drug or alcohol abuse.
Patients who are pregnant or breastfeeding.
Patients who have been diagnosed with certain infections that could affect the study.
Patients who have had a recent vaccination that might interfere with the study results.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Centrum Medyczne Plejady Magdalena Celinska Loewenhoff Michal Zolnowski sp.k.
Cracow, Poland
Verified
Copernicus Podmiot Leczniczy Sp. z o.o.
Gdansk, Poland
Verified
Dermedic Jacek Zdybski
Ostrowiec Swietokrzyski, Poland

Trial locations

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Investigated drugs

Dupilumab is a medication used in this clinical trial to treat children and adolescents with atopic dermatitis, which is a type of eczema. The study aims to evaluate the long-term safety and effectiveness of this medication in patients aged 6 months to under 18 years. Dupilumab works by targeting specific pathways in the immune system to reduce inflammation and improve skin condition.

Dupilumab

What is already known about the treatment

Dupilumab – Dupilumab is administered as an injection, typically under the skin, using a pre-filled pen or syringe. It is currently being studied in clinical trials for its long-term safety and effectiveness in treating atopic dermatitis, particularly in children aged 6 months to under 18 years. The main therapeutic use of dupilumab is to manage symptoms of atopic dermatitis, a chronic skin condition. At the molecular level, dupilumab works by blocking certain proteins that cause inflammation, helping to reduce skin irritation and itching. It is classified as a monoclonal antibody, which targets specific pathways in the immune system to alleviate symptoms.

Investigated diseases

Atopic Dermatitis – Atopic Dermatitis is a chronic skin condition characterized by dry, itchy, and inflamed skin. It often begins in childhood and can persist into adulthood, though the severity and specific symptoms can vary widely among individuals. The skin may become red, swollen, and cracked, and in some cases, blisters may form. It is commonly associated with other allergic conditions such as asthma and hay fever. The condition tends to flare up periodically, with symptoms worsening at times and then improving. Environmental factors, stress, and irritants can trigger or exacerbate these flare-ups.