Condition: Atopic Dermatitis · Sponsor: LEO Pharma
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. Infants will not receive placebo. All subjects will go through a screening process, which is the first part of the trial and will last up to 4 weeks. During this period, it will be checked if the child or infant meets the criteria to participate in the trial. The children will be randomly assigned to receive tralokinumab + TCS or placebo + TCS for the initial 16 weeks, with the treatment being double-blinded. During the first 16 weeks, children will have a 2 out of 3 chance of getting tralokinumab and a 1 out of 3 chance of getting placebo. Thereafter, all subjects will receive tralokinumab…
This description comes directly from the study's public registry record.
Clinical Disclosure · +45 4494 5888 · disclosure@leo-pharma.com
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| 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| Leo Pharma Investigational site | San Diego, California, United States | Withdrawn |
| Leo Pharma Investigational site | San Diego, California, United States | Recruiting |
| Leo Pharma Investigational site | Jacksonville, Florida, United States | Recruiting |
| Leo Pharma Investigational site | Miami, Florida, United States | Recruiting |
| Leo Pharma Investigational site | Tampa, Florida, United States | Recruiting |
| Leo Pharma Investigational site | Macon, Georgia, United States | Recruiting |
| Leo Pharma Investigational site | Waterford, Michigan, United States | Recruiting |
| Leo Pharma Investigational site | Tulsa, Oklahoma, United States | Recruiting |
+ 60 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT06311682