CQGE031A2208:Phase II multi-center trial- adults with peanut allergy

• Research type

  Research Study

• Full title

  A phase II, randomized, double-blind, placebo controlled, parallel design, dose ranging, multi-center trial of four levels of exposure of QGE031 s.c. for 16 weeks in subjects aged 18 years and older with peanut allergy

• IRAS ID

  86539

• Contact name

  Amr Radwan

• Sponsor organisation

  Novartis Pharma Services AG

• Eudract number

  2011-000631-92

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  Peanut allergy is a reaction which occurs soon after exposure to peanuts or peanut products. The body view??s the protein in a peanut as an invader and the immune system overcompensates releasing immunoglobulin E (IgE) allergy antibodies against the peanut proteins. This leads to overload of histamines in the body causing symptoms such as a runny nose, itchy eyes, hives, general swelling, vomiting, diarrhoea, trouble breathing, quickened heart rate and in extreme cases loss of consciousness because of a drop in the person??s blood pressure (anaphylaxis). Currently the only available treatment is strict avoidance of the peanut protein. However, accidental ingestion is common and patients may need to use rescue medications such as self-injectable adrenaline. QGE031 is a humanized monoclonal antibody which acts against human IgE. This study will assess how well several different doses of the study drug QGE031 is in decreasing the body??s sensitivity against peanut allergen. This change in sensitivity will be measured by oral food challenges before and after a 16-week treatment period. The results from this study will support the dose and regimen selection for later studies. Eligible patients will be randomly allocated to receive either one of four different doses of the study drug QGE031 or placebo (dummy - no active drug). Injections will be given bi-weekly on 8 occasions. There will be a 1 in 5 chance of receiving placebo. Neither doctor nor patient will know which treatment has been allocated. Patients will visit the hospital clinic 18 times in total over approximately a 30 week period. Assessments include skin prick tests, physical examinations, blood pressure, pulse, temperature, breathing rate, blood tests, oral food challenges, completion of health-related questionnaires and injection site local symptom pages. The study will involve approximately 110 adult patients worldwide (15 from UK) with a confirmed diagnosis of acute peanut allergy.

• REC name

  East Midlands - Leicester Central Research Ethics Committee

• REC reference

  11/EM/0343

• Date of REC Opinion

  8 Nov 2011

• REC opinion

  Further Information Favourable Opinion