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Pharmacokinetics, Safety and Efficacy of Nemolizumab in Infants 6–23 Months with Moderate-to-Severe Atopic Dermatitis

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What is this trial about?

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

The study focuses on infants and toddlers who have moderate-to-severe Atopic Dermatitis that has not improved enough with creams or ointments applied to the skin. The medication being tested is called Nemolizumab, which is given by a small injection under the skin (subcutaneous route). The main goal of the trial is to evaluate how the drug moves through the body (pharmacokinetics) and to check that it is safe, looking especially at any adverse events that may occur. Blood samples will be taken to measure the drug’s level in the blood (serum concentrations) at several time points.

Participants will receive the study medication at scheduled visits over about one year, with regular doctor appointments to monitor health and record any side effects. The effectiveness of the treatment will be judged by several simple skin‑health scores: the EASI score, which rates the extent and severity of the rash; the IGA rating, which classifies the overall appearance of the skin; and a pruritus rating that measures how much itching the child experiences. Additional assessments include the SCORAD index that combines redness, swelling and other signs, as well as questionnaires that ask parents about the child’s daily comfort and quality of life, such as the IDQOL and the POEM.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Baseline visit and first dose
On the day you join the study you will attend a baseline visit at the clinic. during this visit you will complete questionnaires about your skin condition and quality of life, and a small amount of blood will be drawn to measure your baseline levels of the drug and antibodies.
You will receive the first nemolizumab dose as a subcutaneous injection. the medication is supplied as a solution for injection; the exact amount is determined by the study protocol and recorded in the trial documents.
Step 2
Week 4 follow‑up
Four weeks after the first dose you will return for a follow‑up visit. a blood sample will be taken to check the amount of nemolizumab in your bloodstream.
The study staff will ask about any side effects, record any adverse events, and repeat the skin‑condition questionnaires and physical assessments.
Step 3
Week 16 follow‑up and antibody testing
At week 16 another blood sample will be collected. this sample is used for both drug concentration measurement and testing for anti‑drug antibodies, which are proteins your body might make against the medication.
You will also be examined for safety, and the same questionnaires about skin severity, itch intensity, and quality of life will be completed.
Step 4
Week 32 follow‑up
At week 32 you will have a further clinic visit. a blood sample will be drawn to measure drug levels, and the study team will assess any new or continuing side effects.
Efficacy assessments, including the eczema severity score and itch rating, will be repeated.
Step 5
Week 52 final visit and study completion
One year after the first dose (week 52) you will attend the final scheduled visit. a blood sample will be taken for drug concentration and anti‑drug antibody testing.
The study staff will perform the last safety evaluation, record any adverse events that occurred during the study, and repeat all efficacy questionnaires and skin assessments.
After this visit the administration of nemolizumab in the study ends.
Step 6
Unscheduled safety visits (if needed)
If you experience any concerning symptoms or side effects at any time, the investigator may ask you to come in for an additional safety visit. during such a visit additional blood tests or examinations may be performed.
Step 7
Use of rescue therapy
Throughout the study you may be allowed to use standard topical treatments as rescue therapy if your skin condition worsens. any use of rescue therapy will be recorded by the study team.

Who can join the trial?

10 criteria

Child must be at least 6 months old but younger than 24 months when screened.
Parent or caregiver must agree to put on a moisturizer every day and, if a prescription steroid cream (topical corticosteroid) was used before the study, keep using the same amount throughout the study.
Child must have a doctor‑confirmed diagnosis of atopic dermatitis (AD) based on the American Academy of Dermatology guidelines.
Child must have an Eczema Area and Severity Index (EASI) score of 16 or higher at both the screening visit and the start of the study; this score measures how widespread and severe the rash is.
Child must have an Investigator Global Assessment (IGA) score of 3 or higher at both the screening visit and the start of the study; this is a doctor’s overall rating of the rash severity.
At least 10% of the child’s body surface area (BSA) must be affected by AD at both the screening visit and the start of the study; BSA is the total skin area of the body.
Parent or caregiver must rate the child’s itch as 4 or higher on a 0‑to‑10 Parent‑Patient Numeric Rating Scale (PP‑NRS) at both screening and baseline; the rating is recorded for the 24‑hour period before screening and as an average of daily scores for the week before baseline.
Doctor must have recorded that the child did not get enough relief from current skin creams or any systemic (whole‑body) medicines for AD within the past 6 months.
Parent or caregiver must be willing and able to follow all study visit times and procedures.
Parent or caregiver must read, understand, and sign the study’s informed consent form before any study procedures are done.

Who cannot join the trial?

14 criteria

Body weight less than 5 kg (about 11 pounds) – children who weigh less than this cannot join the study.
Child in care – a child who is under the legal protection of a government or court agency (such as foster care) is excluded.
Skin infection within 1 week before the first visit, or any infection that required oral (taken by mouth) or injected antibiotics, antivirals, antiparasitics, or antifungal medicines within 2 weeks before the first visit.
Rescue therapy needed for eczema during the screening period or expected to be needed within 2 weeks after the baseline visit.
Positive test results for blood‑borne viruses: hepatitis B (HBsAg or HBcAb), hepatitis C (HCV antibody with confirmatory PCR test), or HIV antibody.
After a full 16‑week course of the eczema medicine dupilumab, the child’s eczema got worse or did not improve by at least 10 % on standard severity scales.
History of lymphoproliferative disease (abnormal growth of certain white‑blood cells) or any type of cancer at any time before screening.
History of severe allergy (hypersensitivity), including a life‑threatening reaction called anaphylaxis, to antibody medicines (such as monoclonal antibodies) or any ingredients used in the study drug.
Known or suspected primary immunodeficiency – a condition where the immune system does not work properly from birth.
Other skin conditions that could interfere with study assessments, such as Netherton syndrome, psoriasis, contact dermatitis, dermatitis herpetiformis, erythroderma, ichthyosis, or scabies.
Any serious medical condition affecting the heart, liver, lungs (including uncontrolled asthma), or blood, or any significant laboratory abnormality that the doctor believes puts the child at high risk or makes study measurements difficult (for example, difficulty finding a vein for blood draws or fear of needles).
Planned or expected major surgery during the time of the study.
Planned or anticipated use of any medication that is not allowed in the study.
Currently participating in, or having participated in, another clinical trial of an experimental drug or device within the past 8 weeks (or longer if the previous drug stays in the body for an extended period).

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Verified sites

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

Centrum Zdrowia Dziecka I Rodziny Im. Jana Pawla II W Sosnowcu Sp. z o.o.
Responsive
Sosnowiec, Poland
Copernicus Podmiot Leczniczy Sp. z o.o.
Verified
Gdansk, Poland
Uniwersytecki Szpital Kliniczny Im.Fryderyka Chopina W Rzeszowie
Responsive
Rzeszow, Poland

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Investigated drugs

Nemolizumab is an injectable medicine that is given under the skin. It is a type of biologic drug that works by blocking a specific pathway in the immune system that can cause itching and inflammation in the skin. In this study, the medicine is being tested to see how it moves through the bodies of very young children with moderate‑to‑severe atopic dermatitis that has not improved enough with regular creams or ointments. The goal is to learn whether the drug is safe for this age group and how well it helps control the skin condition.

Nemolizumab

What is already known about the treatment

Nemolizumab - Nemolizumab is given as a subcutaneous injection of a clear solution. It is an experimental drug that is still being studied in clinical trials and has not yet received full market approval. It is being tested to treat moderate‑to‑severe atopic dermatitis, a skin condition that causes itching and rash. Nemolizumab works by blocking the IL‑31 receptor, which reduces the signals that cause itch and inflammation, and it belongs to the class of monoclonal antibody therapies.

Investigated diseases

Atopic Dermatitis - Atopic dermatitis is a chronic inflammatory skin condition that causes itchy, red, and scaly patches. It often begins in early childhood and can affect various parts of the body. The itching leads to scratching, which can worsen the rash and cause skin thickening over time. Flare-ups may occur intermittently, with periods of relative calm between them. The disease can spread or become more widespread as the child ages. Skin changes may become more pronounced with repeated inflammation.