Safety of ToleroMune House Dust Mite (HDM) to Treat House Dust Mite Allergy in HDM Allergic Subjects With Rhinoconjunctivitis
Condition: Allergy
MeSH terms: Dust Mite Allergy; Hypersensitivity
Study type: Interventional
Phase: Phase 2

Summary: 
      The prevalence of allergic sensitisation to House Dust Mite (HDM) varies from region to
      region and depends on the regional prevalence of HDM. In the third National Health and
      Nutrition Examination Surveys, 54.3% of the US population had positive test responses to one
      or more allergens, with the prevalence for HDM being 27.5%. Like many other allergens,
      exposure to HDMA in sensitised patients is associated with poorer lung function, greater
      medication requirements and more asthma symptoms as well as chronic rhinosinusitis symptoms.

      ToleroMune HDM is a novel, synthetic, allergen-derived peptide desensitising vaccine,
      currently being developed for the treatment of Houst Dust Mite allergy.

      The purpose of the present study is to evaluate the safety and tolerability of multiple
      ascending doses of ToleroMune HDM in subjects in subjects with a documented history of
      allergic rhinoconjunctivitis on exposure to house dust mite. The efficacy of ToleroMune HDM
      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 HDM in subjects with a
      documented history of allergic rhinoconjunctivitis on exposure to house dust mite. The
      efficacy of ToleroMune HDM will also be explored in these subjects using the LPSR, EPSR, CPT
      and levels of HDM 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) four weeks apart (28±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 HDM.
      Successive dose groups will increasing doses given as 4 administrations of ToleroMune HDM,
      provided the first administration of the previous dose was safe and well tolerated.

      In Period 3, Post-treatment Challenge will take place 18-22 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 HDM; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): ToleroMune HDM dose 1x4 administrations 4 weeks apart; Placebo comparator, 1x4 administrations 4 weeks apart
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: House Dust Mite Allergy; Immunotherapy; Rhinoconjunctivitis; Toleromune HDM