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.
Official registry: https://clinicaltrials.gov/study/NCT06311682 · LEO Pharma · enrollment listed as 195
Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
If you join, the listed intervention(s) are Tralokinumab + TCS, or Placebo + TCS. The registry lists allocation as randomized. 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.
They plan to enroll about 195 people at 61 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
A Phase 3 Multi-center Trial to Evaluate the Efficacy and Safety of Tralokinumab in Combination With Topical Corticosteroids in Children (Age 2 to <12 Years) and Infants (Age 6 Months to <2 Years) With Moderate-to-severe Atopic Dermatitis. The Trial is Randomized, Double-blind, Placebo-controlled, and Parallel-group for Children (Age 2 to <12 Years) and Open-label and Single-group for Infants (Age 6 Months to <2 Years)
Interventions: Tralokinumab + TCS, Placebo + TCS
Primary outcome (registry wording): Investigator's Global Assessment for atopic dermatitis (IGA 0/1) score of 0 (clear) or 1 (almost clear) in subjects aged 2 to <12 years at screening.
Clinical Disclosure
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
+ 47 sites outside the US on the same record
This is a tissue, urine, and blood banking protocol for cutaneous t-cell lymphoma (CTCL), eczema, and atopic dermatitis patients for current and future research.
NCT00177268 · Official ClinicalTrials.gov record · University of Pittsburgh
This study will examine microbes (e.g., bacteria, fungi, viruses) that live on human skin and how microbes contribute to health and disease. It will analyze healthy human skin and how the these microorganisms might change in patients with atopic dermatitis (AD), a skin condition also known as eczema.
NCT00605878 · Official ClinicalTrials.gov record · National Human Genome Research Institute (NHGRI)
Background: \- Atopic dermatitis, or eczema, is a chronic skin disorder. Patients sometimes have infections with S.
NCT01631617 · Official ClinicalTrials.gov record · National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
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