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A Trial to Evaluate the Efficacy and Safety of Tralokinumab in Combination With Topical Corticosteroids in Children and Infants With Moderate-to-severe Atopic Dermatitis

RecruitingPhase 3Ages 6 Months - 11 YearsAllLEO Pharma
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: * 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 \<6 years at screening. * Documented inadequate response to mid-strength TCS within 6 months before the screening visit. * AD involvement of ≥10% body surface area at screening and baseline according to component A of SCORAD. * An EASI score of ≥16 at screening and baseline. * An IGA score of ≥3 at screening and baseline. * A Child Worst Itch NRS average score of ≥4 (subjects aged ≥6 years at screening) or a Scratch ObsRO average score of ≥4 (subjects aged \<6 years at screening) during the week prior to baseline. Exclusion Criteria: * Treatment with the topical corticosteroids (TCS), topical calcineurin inhibitors (TCI), topical phosphodiesterase-4 inhibitors (PDE-4), and topical Janus kinase inhibitors (JAK) within 1 week prior to baseline. * Treatment with bleach baths within 1 week prior to baseline. * Treatment with the immunomodulatory medications systemic immunosuppressive/immunomodulating drugs (e.g. methotrexate, cyclosporine, azathioprine, mycophenolate mofetil, Janus kinase inhibitors) and systemic corticosteroids (excludes inhaled, ophthalmic, or intranasal delivery) within 4 weeks 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. * Active dermatologic conditions that may confound the diagnosis of AD or would interfere with assessment of treatment such as seborrheic dermatitis, active skin infection, scabies, cutaneous T cell lymphoma, or psoriasis. * Clinically significant active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antifungals or antiprotozoal within 2 weeks before the baseline visit. * History of past or current hepatitis B or C including a positive hepatitis B or C test at screening.
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What it tests

  • Tralokinumab + TCS
  • Placebo + TCS
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Where

72 sites
Leo Pharma Investigational site
Birmingham, United States
Leo Pharma Investigational site
North Little Rock, United States
Leo Pharma Investigational site
Palo Alto, United States
Leo Pharma Investigational site
Sacramento, United States
Leo Pharma Investigational site
San Diego, United States
Leo Pharma Investigational site
San Diego, United States
Leo Pharma Investigational site
Jacksonville, United States
Leo Pharma Investigational site
Miami, United States

…and 64 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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