Evaluating Tralokinumab with Corticosteroids for Atopic Dermatitis in Children

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial aims to assess the safety and efficacy of tralokinumab, a subcutaneous injection, in combination with topical corticosteroids for treating moderate-to-severe atopic dermatitis in children and infants. The study will involve two age groups: children aged 2 to under 12 years and infants aged 6 months to under 2 years. Participants will be monitored over a period of up to 4 years, with assessments every two weeks for the first year and every six weeks thereafter. The effectiveness of the treatment will be evaluated through various measures of dermatitis severity, symptoms, and overall health status.

Why it matters

Who can join: the full rules

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.

Where it's running

• Leo Pharma Investigational site
  Birmingham, Alabama, United States Recruiting
• Leo Pharma Investigational site
  North Little Rock, Arkansas, United States Recruiting
• Leo Pharma Investigational site
  Palo Alto, California, United States Recruiting
• Leo Pharma Investigational site
  Sacramento, California, United States Recruiting
• Leo Pharma Investigational site
  San Diego, California, United States Recruiting
• Leo Pharma Investigational site
  Jacksonville, Florida, United States Recruiting

+22 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Clinical Disclosure
• Email: disclosure@leo-pharma.com
• Phone: +45 4494 5888

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.