ADvantage

• Research type

  Research Study

• Full title

  A Randomised, Double-Blind, Placebo-Controlled Phase 3 Clinical Trial to Assess the Efficacy and Safety of Lebrikizumab in Combination With Topical Corticosteroids in Adult and Adolescent Patients With Moderate-To-Severe Atopic Dermatitis That Are Not Adequately Controlled With Cyclosporine or For Whom Cyclosporine is Not Medically Advisable.

• IRAS ID

  304283

• Contact name

  Richard Warren

• Contact email

  Richard.Warren@manchester.ac.uk

• Sponsor organisation

  Almirall, S.A.

• Eudract number

  2021-002967-23

• ISRCTN Number

  ISRCTN00000000

• Clinicaltrials.gov Identifier

  NCT00000000

• Duration of Study in the UK

  2 years, 3 months, 1 days

• Research summary

  Atopic dermatitis (AD) is a skin disorder condition that causes the skin to become itchy, dry and cracked. AD is one of the most common inflammatory skin disorders, affecting up to 20% of children and 10% of adults in high-income countries.
  The purpose of this study is to learn more about a possible treatment for AD called Lebrikizumab. Lebrikizumab works by binding to and blocking a type of protein in the skin (called “interleukin-13 cytokine”), which prevents the signalling pathway (series of chemical reactions in cells) responsible for AD symptoms.
  The main goal of this study is to learn how well the study drug, Lebrikizumab works and how safe the study drug is in combination with topical corticosteroids (a type of steroid medicine applied directly to the skin to reduce inflammation) compared with a placebo. A placebo is an inactive material that looks like the study drug but does not have any active study drug. Researchers use a placebo to see if the study drug works better or is safer than taking nothing.
  The study is divided into 4 time periods: a screening period, an induction period, a maintenance period, and a follow-up period. The induction period will be double blind, which means that both participants and the study team will not know who is receiving the study drug or placebo. The maintenance period will be open label, which means that both participants and the study team will be aware that all participants will receive the study drug.
  Study procedures include: medical examination, details of medical history and previous therapy, vital signs, blood and urine tests, completing an eDiary, questionnaires, AD assessments and administration of the study drug.
  This study will run in approximately 70 study centres in 8 countries with about 312 participants with AD participating.

• REC name

  North West - Greater Manchester South Research Ethics Committee

• REC reference

  21/NW/0291

• Date of REC Opinion

  7 Feb 2022

• REC opinion

  Further Information Favourable Opinion