Study on Nemolizumab for Children Aged 2-11 with Moderate-to-Severe Atopic Dermatitis Not Controlled by Topical Treatments

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What is this study about?

This clinical trial is focused on studying Atopic Dermatitis, a skin condition that causes red, itchy, and inflamed skin. The trial will use a treatment called Nemolizumab, which is a solution for injection. Nemolizumab is also known by the code name CD14152 or CIM331. The purpose of the study is to assess how the body processes Nemolizumab, as well as its safety and effectiveness when used alongside topical corticosteroids, which are creams or ointments applied to the skin, in children aged 2 to 11 years who have moderate-to-severe atopic dermatitis that is not well controlled with topical treatments alone.

Participants in the study will receive Nemolizumab through an injection under the skin. The study will monitor the levels of Nemolizumab in the blood at various points over a period of time, specifically at weeks 4, 8, 12, 16, 32, and 52. The study will also track any side effects or adverse events that may occur during the trial. The goal is to understand how well Nemolizumab works in reducing the symptoms of atopic dermatitis and to ensure it is safe for use in children.

The trial will last for a period of up to 52 weeks, during which the participants’ skin condition will be regularly assessed to see if there is an improvement in the severity and extent of their atopic dermatitis. The study will also evaluate how many participants achieve significant improvement in their skin condition, defined as a reduction in the severity of their symptoms. This information will help determine the potential benefits of Nemolizumab for children with this challenging skin 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.

The study team will explain the trial procedures, and informed consent will be obtained from the caregiver and assent from the participant.

2 baseline assessment

A baseline assessment is performed to evaluate the severity of atopic dermatitis. This includes measuring the eczema area and severity index (EASI) and the investigator’s global assessment (IGA) score.

The participant’s pruritus numeric rating scale (PP NRS) score is also recorded to assess itch severity.

3 treatment initiation

The participant begins treatment with nemolizumab, administered as a solution for injection under the skin (subcutaneous use).

The dosage and frequency of administration are determined by the study protocol and the participant’s age group.

4 ongoing treatment and monitoring

Throughout the study, the participant continues to receive nemolizumab injections at specified intervals.

Regular visits are scheduled to monitor the participant’s response to treatment and to assess any side effects. Blood samples may be taken to measure nemolizumab levels in the body.

5 use of topical treatments

Participants are required to apply a moisturizer daily and use authorized topical corticosteroids (TCS) as needed, as determined by the investigator.

The use of these topical treatments is monitored throughout the study.

6 follow-up assessments

Follow-up assessments are conducted at various points during the study to evaluate changes in the EASI and IGA scores.

The participant’s itch severity is also reassessed using the PP NRS score.

7 end of study

At the end of the study, a final assessment is performed to evaluate the overall effectiveness and safety of the treatment.

The participant and caregiver are provided with information about the study results and any further steps if necessary.

Who Can Join the Study?

Children aged 7 to 11 years can join the study. Children aged 2 to 6 years may join later, depending on safety checks.
Must have had atopic dermatitis for at least 6 months if aged 2-6 years, or at least 1 year if aged 7-11 years.
Must have a skin condition score of 16 or higher on the Eczema Area and Severity Index (EASI), which measures the extent and severity of eczema.
Must have a score of 3 or higher on the Investigator’s Global Assessment (IGA), which rates the overall severity of the skin condition.
Must have at least 10% of the body affected by atopic dermatitis.
Must have a Pruritus Numeric Rating Scale (PP NRS) score of at least 4, which measures itchiness on a scale from 0 to 10.
Must have a history of not responding well to current skin treatments or needing stronger treatments.
Must agree to use a moisturizer daily and apply prescribed skin treatments as directed by the study doctor.
If a girl has started menstruating and is sexually active, she must agree to use effective birth control or not engage in sexual activity during the study and for 12 weeks after the last treatment.
Must be willing and able to follow all study instructions and attend all study visits.
Must understand and sign a consent form, and if applicable, a form for children to agree to participate.

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 used any investigational drug within the last 30 days.
Patients who have a known infection that requires treatment with antibiotics.
Patients who have a weakened immune system, which means their body has a harder time fighting infections.
Patients who have any serious health conditions that the study doctor thinks might make it unsafe for them to participate.
Patients who are pregnant or breastfeeding.
Patients who have used certain medications that might interfere with the study results.
Patients who have a history of drug or alcohol abuse within the past year.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Dermed Centrum Medyczne Sp. z o.o.	Lodz	Poland
Dermedic Jacek Zdybski	Ostrowiec Swietokrzyski	Poland

Other Sites

Site Name	City	Country
Hospital Sant Joan De Deu Barcelona	Esplugues De Llobregat	Spain
Klinika Ambroziak Sp. z o.o.	Warsaw	Poland
Wromedica I Bielicka A Strzalkowska s.c.	Wroclaw	Poland
Obudai Egeszseguegyi Centrum Kft.	Dunaújváros	Hungary
Uniwersytecki Szpital Kliniczny Im.Fryderyka Chopina W Rzeszowie	Rzeszow	Poland
Lrpwlcv Setdmwepaosxviv Gfmovmh Dcuvxcgjbbckyfj	Lublin	Poland

Trial status

Country	Status	Recruitment Start
Hungary	Not recruiting	16.12.2021
Poland	Not recruiting	16.12.2021
Spain	Not recruiting	16.12.2021

Trial locations

Investigated drugs:

Nemolizumab

Nemolizumab is a medication being studied for its effects on children with moderate-to-severe atopic dermatitis, which is a type of eczema that causes itchy and inflamed skin. This medication works by targeting a specific protein in the body that is involved in causing inflammation and itching. The goal of using nemolizumab in this trial is to see how it moves through the body, how safe it is, and how well it helps improve the skin condition when used alongside other treatments.

Topical Corticosteroids are creams or ointments applied directly to the skin to help reduce inflammation and relieve itching. They are commonly used to treat atopic dermatitis and other skin conditions. In this trial, topical corticosteroids are used together with nemolizumab to see if the combination is more effective in managing the symptoms of atopic dermatitis in children.

Investigated diseases:

Dermatitis atopic

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. The disease progresses through periods of flare-ups, where symptoms worsen, and remissions, where symptoms improve or disappear. The skin barrier is compromised, leading to increased sensitivity and susceptibility to infections. Environmental factors, allergens, and stress can trigger or exacerbate symptoms. Over time, repeated scratching can lead to thickened skin and further irritation.

Trial ID:

2024-514405-65-00

Protocol code:

RD.06.SPR.118126

NCT ID:

NCT04921345

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Nemolizumab for Children Aged 2-11 with Moderate-to-Severe Atopic Dermatitis Not Controlled by Topical Treatments

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?