TRAPEDS 1

• Research type

  Research Study

• Full title

  A single (assessor) blinded, randomised, parallel-group, monotherapy trial to evaluate the pharmacokinetic and safety of tralokinumab in children (age 2 to <12 years) with moderate-to-severe atopic dermatitis.

• IRAS ID

  1005083

• Contact name

  Ana Tenreiro da Cruz

• Contact email

  ancru@leo-pharma.com

• Sponsor organisation

  LEO Pharma A/S

• Eudract number

  2021-005573-12

• Clinicaltrials.gov Identifier

  NCT05355818

• Research summary

  Atopic Dermatitis (AD) is a type of eczema that may affect up to 20% of children and up to 10% of adults. In its severe form, AD is characterized by widespread skin lesions, itch, poor quality of life and a higher risk of bacterial, viral and fungal skin infections.
  In AD patients, an immune response is activated. Tralokinumab is a human antibody, a type of systemic biological drug, which binds to a human protein called interleukin-13 (IL-13). IL-13 is involved in the body's immune responses to fight diseases but also increases skin cell production and decreased barrier function, leading to itch. By binding to IL-13, tralokinumab may improve or clear the symptoms of AD.
  Tralokinumab has already been tested in 26 clinical trials with more than 4,700 persons exposed to tralokinumab, including more than 300 adolescents. 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 when used in children.
  After a 2 to 6 week screening period, at least 48 subjects will be randomised (1:1) to receive either a low dose or a high dose of tralokinumab by injection under the skin. There will be 2 cohorts based on age (6-<12 years and 2 to <6 years). Cohort 2 will begin after data from cohort 1 has been analysed. After 16 weeks all subjects will roll over to open label treatment for 52 weeks. After treatment ends, a safety follow-up period of 16 weeks will be completed

• REC name

  Yorkshire & The Humber - Sheffield Research Ethics Committee

• REC reference

  22/YH/0098

• Date of REC Opinion

  8 Jun 2022

• REC opinion

  Further Information Favourable Opinion