At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Tralokinumab + TCS (drug), Placebo + TCS (drug)
- How long the study runs
- Study runs about 46 months (dates as stated)
- About the drug or intervention
- Tralokinumab + TCS — drug: The trial medication will be given under the skin (SC). · Placebo + TCS — drug: The trial medication will be given under the skin (SC).
- Patient visit burden
- "There will be visits every 2 weeks for the first year and every 6 weeks thereafter." (as stated by sponsor)
In plain English
This trial, run by LEO Pharma, is testing whether a medicine called tralokinumab, given alongside topical corticosteroids (cream or ointment steroids applied to the skin), is effective and safe for children and infants with moderate-to-severe atopic dermatitis (a type of long-term eczema). The study is looking at babies from 6 months old up to children under 12 years.
Who can take part
- Aged 6 months to under 12 years at screening
- Weighs at least 9 kg at screening
- Has a diagnosis of atopic dermatitis (eczema) using standard criteria
- Has had eczema for at least 12 months (for children aged 6 or over) or at least 3 months (for children aged 6 months to under 6)
- Has not responded well enough to medium-strength steroid creams within 6 months before screening
- Has eczema covering at least 10% of the body surface at screening and baseline
- Has moderate-to-severe eczema scores (Eczema Area and Severity Index of 16 or more, and an Investigator's Global Assessment of 3 or more) at screening and baseline
- Has significant itching (a weekly average score of 4 or more on an itch or scratching scale) in the week before baseline
Who may not be able to
- Used steroid creams or other eczema skin treatments (including calcineurin inhibitors, PDE-4 inhibitors, or JAK inhibitor creams) within 1 week before baseline
- Had bleach baths within 1 week before baseline
- Taken medicines that suppress or change the immune system (for example methotrexate or cyclosporine) or steroid tablets/injections within 4 weeks before baseline
- Used tanning beds or light therapy within 4 weeks before baseline
- Had any vaccine (live or non-live) within 30 days before the baseline visit
- Has other skin conditions that could confuse the eczema diagnosis or affect assessments, such as seborrheic dermatitis, active skin infection, scabies, cutaneous T cell lymphoma, or psoriasis
- Has a significant infection needing antibiotic, antiviral, antifungal, or antiprotozoal treatment within 2 weeks before baseline
- Has or has had hepatitis B or hepatitis C, including a positive test at screening
What taking part involves
- • Tralokinumab given together with topical corticosteroids (steroid treatment applied to the skin)
Time commitment: Not stated — ask the trial team
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 6 Months to 11 Years
- Who
- All
- Number of participants
- 195
- Started
- 2024-06-10
- Last checked
- 2026-07
Plain English Summary
What is this study?
- • Testing a new treatment for atopic dermatitis
- • Phase3 - 195 participants
- • The purpose of this trial is to test whether treatment with tralokinumab (administered subcutaneous injections \[SC\]) in combination with topical corticosteroids (TCS) is safe and effective to treat moderate-to-severe atopic dermatitis (AD) in children and infants
Who can take part?
- • Ages 6 Months to 11 Years
- • Diagnosed with atopic dermatitis
Where?
- • Lincoln - Leo Pharma Investigational site
- • London - Leo Pharma Investigational site
- • Sheffield - Leo Pharma Investigational site
- • Southampton - Leo Pharma Investigational site
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
The purpose of this trial is to test whether treatment with tralokinumab (administered subcutaneous injections \[SC\]) in combination with topical corticosteroids (TCS) is safe and effective to treat moderate-to-severe atopic dermatitis (AD) in children and infants. This will be judged by a range of assessments that rate the severity and extent of atopic dermatitis and its symptoms, as well as general health status and quality of life. The trial will last for up to 4 years. There will be visits every 2 weeks for the first year and every 6 weeks thereafter. Some of the visits will be conducted by phone. The study involves two different age groups: children aged 2 to under 12 years and infants aged 6 months to under 2 years. This trial compares tralokinumab +TCS to placebo + TCS for children with moderate-to-severe AD and evaluates tralokinumab + TCS for infants with moderate-to-severe AD. Infants will not receive placebo. All subjects will go through a screening process, which is the first part of the trial and will last up to 4 weeks. During this period, it will be checked if the child or infant meets the criteria to participate in the trial. The children will be randomly assigned to receive tralokinumab + TCS or placebo + TCS for the initial 16 weeks, with the treatment being double-blinded. During the first 16 weeks, children will have a 2 out of 3 chance of getting tralokinumab and a 1 out of 3 chance of getting placebo. Thereafter, all subjects will receive tralokinumab + TCS. The infants will receive tralokinumab + TCS as open-label treatment for the entire treatment period, meaning that the participants will know they are receiving tralokinumab. After stopping treatment, all participants will enter a 4-week safety follow-up period.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 6 Months - 11 Years
- Who can join: All genders
Biomarkers mentioned
What the study is looking for
- ✓Age 6 months to \<12 years at screening.
- ✓Body weight ≥9 kg at screening.
- ✓Diagnosis of AD as defined by the Hanifin and Rajka (1980) criteria for AD.
- ✓History of AD for: ≥12 months for subjects aged ≥6 years at screening and ≥3 months for subjects aged 6 months to...
- ✓Documented inadequate response to mid-strength TCS within 6 months before the screening visit.
Who cannot take part
- ✗Treatment with bleach baths within 1 week prior to baseline.
- ✗Use of tanning beds or phototherapy within 4 weeks prior to baseline.
- ✗Treatment with a live (attenuated) or non-live vaccine within 30 days prior to the baseline visit.
- ✗Clinically significant active chronic or acute infection requiring treatment with systemic antibiotics, antivirals,...
- ✗History of past or current hepatitis B or C including a positive hepatitis B or C test at screening.
See the full criteria
Where Is This Study? (4 UK sites)
Leo Pharma Investigational site
Lincoln LN2 5QY, United Kingdom
Leo Pharma Investigational site
London WC1N 3JH, United Kingdom
Leo Pharma Investigational site
Sheffield S10 2TH, United Kingdom
Leo Pharma Investigational site
Southampton SO16 6YD, United Kingdom
How to Get in Touch
Clinical Disclosure
Sponsor contactCONTACT