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
Phase 3
195
about 3.9 years
0.5–11
15 sites in AL, AR, CA +7
What this study is about
Researchers are testing whether a treatment with tralokinumab (given by injection) combined with topical corticosteroids is safe and effective for children and infants with moderate-to-severe atopic dermatitis. The trial will last up to 4 years, involving visits every few weeks initially, followed by less frequent visits. It compares tralokinumab + TCS to placebo + TCS for children with moderate-to-severe AD and evaluates tralokinumab + TCS for infants with moderate-to-severe AD.
Simplified from trial records by PatientMatch.
What you may be asked to do
- 1.Take Placebo + TCS
- 2.Take Tralokinumab + TCS
Participation Burden
What's physically and logistically required of participants.
Requires travel to a study site
How treatment is administered
You may get a placebo/standard care, and you won't know which.
Extracted study details
Pulled from the trial record to show what is being tested and what the study is measuring.
tralokinumab
Secondary: Change in Child Worst Itch NRS (weekly average) for subjects aged 6 to <12 years at screening., Number of treatment-emergent adverse events (AEs) per subject aged 2 to <12 years at screening., Number of treatment-emergent adverse events (AEs) per subject aged 6 month to <2 years at screening., Reduction in Child Worst Itch numeric rating score (NRS) (weekly average) ≥4 for subjects aged 6 to <12 years at screening., Reduction of ≥4 in Child Worst Itch NRS (weekly average) for subjects aged 6 to <12 years at screening or Scratch ObsRO (weekly average) for subjects aged 2 to <6 years at screening.
Dermatology