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

Recruiting Phase 3 Interventional Study
Atopic Dermatitis
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
6 Months – 11
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
195 (estimated)
Sponsor
LEO Pharma · Industry
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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 gen…
Trial Locations
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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 year…
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Clinical Disclosure

+45 4494 5888

disclosure@leo-pharma.com

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