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

Launched by LEO PHARMA · Mar 8, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for moderate-to-severe atopic dermatitis (a common skin condition that causes itchy, inflamed skin) in children and infants. The researchers want to see if a medicine called tralokinumab, given as an injection along with topical corticosteroids (creams applied to the skin), is safe and effective. The trial will last up to four years, with regular check-ins every two weeks for the first year and then every six weeks. Participants will be divided into two groups: one will receive the tralokinumab treatment, while the other will get a placebo (a dummy treatment) along with the topical corticosteroids for the first 16 weeks. After that, everyone will receive the active treatment.

To be eligible for the trial, children must be between 6 months and 12 years old and have had atopic dermatitis for at least three months. They should also have had a poor response to regular topical treatments and have a specific level of skin involvement. The trial aims to help improve the understanding of how well tralokinumab works and how it affects the quality of life for young patients with this skin condition. Participants will undergo screening to ensure they meet the criteria and will have close monitoring throughout the study, including a safety follow-up after treatment ends.

Gender

ALL

Eligibility criteria

• 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.