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 + TCS. The infants will receive tralokinumab + TCS as open-label treatment for the entire treatment period, meaning that the participants will know they are receiving tralokinumab. After stopping treatment, all participants will enter a 4-week safety follow-up period.
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.
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.
Parallel
Tralokinumab + TCS
DrugThe trial medication will be given under the skin (SC). Dose and dosing frequency for each subject will depend on the subject's body weight. Subjects who will receive treatment every two weeks will receive a loading dose corresponding to a double dose at baseline. Subjects who will receive treatment every 4 weeks will receive a staggered loading dose at baseline and Week 2. After the loading dose, they will continue to receive treatment every 4 weeks. The dose and dosing frequency will be adjusted according to the subject's body weight at weeks 16, 32, 52, 64, 88, 112, 136, 160, and 184.
Placebo + TCS
DrugThe trial medication will be given under the skin (SC). Dose and dosing frequency for each subject will depend on the subject's body weight. Subjects who will receive treatment every two weeks will receive a loading dose corresponding to a double dose at baseline. Subjects who will receive treatment every 4 weeks will receive a staggered loading dose at baseline and Week 2. After the loading dose, they will continue to receive treatment every 4 weeks. The dose and dosing frequency will be adjusted according to the subject's body weight at weeks 16, 32, 52, 64, 88, 112, 136, 160, and 184.
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.
The IGA is an instrument used in clinical trials to rate the severity of the subject's global AD and is based on a 5-point scale ranging from 0 (clear) to 4 (severe).
Having at least 75% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 2 to <12 years at screening.
The EASI is a validated measure to assess the severity and extent of atopic dermatitis. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.
Having at least 90% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 2 to <12 years at screening.
The EASI is a validated measure to assess the severity and extent of atopic dermatitis. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.
Having at least 90% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 6 month to <2 years at screening.
The EASI is a validated measure to assess the severity and extent of atopic dermatitis. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.
Investigator's Global Assessment for atopic dermatitis (IGA 0/1) score of 0 (clear) or 1 (almost clear) in subjects aged 6 month to <2 years at screening.
The IGA is an instrument used in clinical trials to rate the severity of the subject's global AD and is based on a 5-point scale ranging from 0 (clear) to 4 (severe).
Having at least 75% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 6 month to <2 years at screening.
The EASI is a validated measure to assess the severity and extent of atopic dermatitis. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.
