Safety of ToleroMune Ragweed to Treat Ragweed Allergy in Ragweed Allergic Subjects With Rhinoconjunctivitis
Condition: Allergy
MeSH terms: Hypersensitivity
Study type: Interventional
Phase: Phase 2

Summary: 
      It is estimated that 36 million Americans suffer from seasonal allergies and that ragweed is
      the primary cause of autumn allergies, 87% of patients with ragweed allergy suffer
      rhinoconjunctivitis. ToleroMune Ragweed is a novel, synthetic, allergen-derived peptide
      desensitising vaccine, currently being developed for the treatment of ragweed allergy.

      The purpose of the present study is to evaluate the safety and tolerability of multiple
      ascending doses of ToleroMune Ragweed in subjects in subjects with a documented history of
      allergic rhinoconjunctivitis on exposure to ragweed pollen. The efficacy of ToleroMune
      Ragweed will also be explored in these subjects using the Late Phase Skin Response, Early
      Phase Skin Response and Conjunctival Provocation Test.
    

Detailed description: 
      This study is designed as a randomised, double-blind, placebo-controlled study to evaluate
      the safety and tolerability of escalating multiple doses of ToleroMune Ragweed in subjects
      with a documented history of allergic rhinoconjunctivitis on exposure to ragweed pollen. The
      efficacy of ToleroMune Ragweed will also be explored in these subjects using the LPSR, EPSR,
      CPT and levels of ragweed specific IgE. A single centre will be initiated first, with a
      second centre included as a backup, if needed, to enable recruitment numbers to be met.

      The study will consist of 3 study periods. In Period 1, Screening will be performed up to a
      maximum of 8 weeks before randomisation and may consist of one or two visits to the clinic,
      at the Investigator's discretion. Baseline Challenge will consist of a single visit 1 to 4
      weeks before randomisation.

      Period 2 (Treatment Period) will consist of 4 visits (Visits 3A-3D) two weeks apart (14±2
      days). Subjects who comply with the inclusion/exclusion criteria will be assigned to one of 5
      dose groups. The first dose group will receive 4 administrations of ToleroMune Ragweed.
      Successive dose groups will increasing doses given as 4 administrations of ToleroMune
      Ragweed, provided the first administration of the previous dose was safe and well tolerated.

      In Period 3, Post-treatment Challenge will take place 19-25 weeks after the first
      administration in the Treatment Period and will be timed to be outside the Ragweed season.
      However in the event that the Ragweed season lasts beyond 26th October 2009, the PTC will
      take place 22-28 weeks after the first administration in the Treatment Period. Assessments
      performed will be identical to those at the Baseline Challenge. Follow-up will be conducted
      3-10 days after PTC.
    

Intervention name(s): ToleroMune Ragweed; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): ToleroMune Ragweed dose 1x4 administrations 2 weeks apart; Placebo comparator, 1x4 administrations 2 weeks apart
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Ragweed allergy; Immunotherapy; Rhinoconjunctivitis; Toleromune Ragweed