A Phase 2/3 study of Dupilumab in children aged 6m-6ys with severe AD

• Research type

  Research Study

• Full title

  A Phase 2/3 Study Investigating the Pharmacokinetics, Safety, and Efficacy of Dupilumab In Patients Aged ≥6 Months to <6 Years With Severe Atopic Dermatitis

• IRAS ID

  222882

• Contact name

  Michael Cork

• Contact email

  m.j.cork@sheffield.ac.uk

• Sponsor organisation

  Regeneron Pharmaceuticals, Inc.

• Eudract number

  2016-000955-28

• Duration of Study in the UK

  4 years, 1 months, 2 days

• Research summary

  This study is a phase II/III study for children aged between 6 months and 6 years of age who have a diagnosis of severe Atopic Dermatitis (AD).
  The study involves a study drug, Dupilumab, which is a targeted drug that can regulate the immune system in particular the cells that are known to cause AD. The study will be conducted in 2 parts. Both parts of the study will assess safety and how the body responds to the study drug. Part A will be a single dose of study drug while Part B will compare the effectiveness of 2 different doses of study drug against placebo when used with standard Topical Corticosteroids (TCS).
  
  Part A of the study is a randomized, open label study, meaning both patient/parent and study staff know which treatment is given. Part B is randomised, double blind, parallel group, placebo controlled study meaning neither patient/parent nor study doctor will know which treatment the participant is receiving, the treatment will have 2 regimens vs a placebo and both parts will be grouped into age groups. Part A will involve 40 patients and Part B will involve 240 patients, both parts will be recruited for across 52 research sites in 6 countries. Participants in Part A will not be allowed to enrol in Part B.

  Part’s A&B will last for up to 8 or 28 weeks, respectively, and participants will be expected to undertake up to 8 or 21 visits, respectively, to the research site within this period including procedures for screening.
  Various blood tests, physiology tests, questionnaires and diary entries will be asked of the participant/parents throughout the length of the trial.
  Eligible patients must be ≥6 Months to <6 Years old, have a diagnosis of AD and fit other specific criteria.

• REC name

  Yorkshire & The Humber - Sheffield Research Ethics Committee

• REC reference

  17/YH/0389

• Date of REC Opinion

  9 Nov 2017

• REC opinion

  Favourable Opinion