VAK694 for the treatment of seasonal allergic rhinitis

• Research type

  Research Study

• Full title

  Randomized, double-blind, placebo-controlled trial to determine the capacity of VAK694 to elicit long term immune tolerance when combined with subcutaneous allergen immunotherapy for the treatment of seasonal allergic rhinitis.

• IRAS ID

  31028

• Sponsor organisation

  Novartis

• Eudract number

  2009-013429-40

• ISRCTN Number

  N/A

• Research summary

  Allergen immunotherapy involves repeated injections of an allergen extract into the skin of hayfever sufferers in order to reduce their symptoms and need for anti-allergic drugs during the pollen season. This study is designed to see if VAK694 when given with allergen immunotherapy (allergy "shots"), will provide better long term protection against seasonal rhinitis (hayfever) than the allergen extract alone. The study will recruit approximately 39 subjects with seasonal allergic rhinitis. The subjects will be randomly assigned to one of three treatments. The three treatments are: VAK694 subcutaneous allergen immunotherapy (SCIT); VAK694 placebo SCIT; or VAK694 placebo SCIT placebo. One dose of VAK694 or placebo will be administered every 4 weeks for 13 weeks. SCIT or placebo will be administered weekly for 13 weeks. The study will have a maximum of a 120 day screening window, 30 day window for the baseline visit, treatment period lasting 13 weeks with a follow up period lasting up to 11 months from the last dose to the clinical endpoint. If efficacy from VAK694 is observed in season 1, subjects will be invited to return for a further assessment of their symptoms the following year, season 2, to determine if the response to VAK694 extends for greater than one year. Each subject will be required to attend 24 study visits (with an option of additional visit in season 2) from screening to study completion. Study completion will be at visit 24, or visit 27 if the study is extended to a second season and the patient agrees to participate. The overall duration of the study from screening to study completion evaluation will be approximately 18 months for the main study, or approximately 21 months if subjects participate in the optional grass pollen allergy season.

• REC name

  East Midlands - Derby Research Ethics Committee

• REC reference

  09/H0405/46

• Date of REC Opinion

  15 Oct 2009

• REC opinion

  Further Information Favourable Opinion