Tralokinumab Monotherapy for Children With Moderate-to-severe Atopic Dermatitis - TRAPEDS 1 (TRAlokinumab PEDiatric Trial no. 1)

• Status: Not yet recruiting
• Trial end date: 2025-11-28

Summary

The main purpose of this trial is to investigate what happens to the trial drug in the body and to confirm that it is safe to use and effective for treating atopic dermatitis (AD) in children.

The trial will last up to 88 weeks, and there will be up to 40 visits, 13 of which may be conducted via telephone if appropriate. The visits will typically be every second week.

The first part of the trial is called a screening period and will last between 2 and 6 weeks. After the screening period, the trial drug will be adminstered to the child by subcutaneous (SC) injection. The treatment period with tralokinumab is divided in 2 parts: 1.) initial treatment period for 16 weeks and 2.) open-label treatment period for 52 weeks. The last part of the trial is called a safety follow-up period where the child is of the drug for 14 weeks.

All children will use an emollient twice daily (or more) for at least 14 days prior to start of treatment and will continue this treatment throughout the trial. If medically necessary, rescue treatment for AD is allowed at the discretion of the trial doctor.

• Phase: Phase 2

Details

• Lead Sponsor: LEO Pharma