* CQGE031G12301

• Research type

  Research Study

• Full title

  A 52 week, multi-center, randomized, double-blind placebo-controlled study to assess the clinical efficacy and safety of ligelizumab (QGE031) in decreasing the sensitivity to peanuts in patients with peanut allergy

• IRAS ID

  1005125

• Contact name

  Sarah Brunner

• Contact email

  sarah-1.brunner@novartis.com

• Sponsor organisation

  Novartis Pharma AG

• Eudract number

  2020-005339-56

• ISRCTN Number

  ISRCTN04984876

• Clinicaltrials.gov Identifier

  NCT04984876

• Research summary

  Food allergy affects people of all ages and nations and, given its prevalence and the costs associated to the disease, it represents an emerging population health priority. The purpose of the study is to determine if ligelizumab improves allergic reaction to peanuts.
  Ligelizumab is a protein made in a laboratory that looks like some that are produced by the body (a monoclonal antibody). In this study we want to find out if ligelizumab is safe and useful in treatment of peanut allergy.
  Approximately 486 people with peanut allergy between the ages of 6 and 55 years are being invited to join this study. Participants will be in the study for about 18 months and during that time, will need to visit the Study Doctor about 24 times. Every study participant will receive ligelizumab for at least 36 weeks but may also receive placebo (no active treatment) during the study. Treatment will be given by subcutaneous (under your skin) injection once per month.

• REC name

  North East - Tyne & Wear South Research Ethics Committee

• REC reference

  22/NE/0141

• Date of REC Opinion

  25 Apr 2022

• REC opinion

  Further Information Favourable Opinion