Allergy Clinical Trial
Official title:
An Escalating, Multiple-dose Study in Grass Allergic Subjects to Assess the Safety of Intradermal Injection of ToleroMune Grass
Grass pollen allergens are universally recognised as a major cause of allergic diseases in
humans and animals, including asthma, allergic rhinitis, conjunctivitis and dermatitis.
Worldwide, at least 40% of allergic patients are sensitized to grass pollen allergens and
between 50-90% of hayfever or seasonal allergy sufferers are allergic to grass pollen.
ToleroMune Grass is a novel, synthetic, allergen-derived peptide desensitising vaccine,
currently being developed for the treatment of grass allergy.
The purpose of the present study is to evaluate the safety and tolerability of multiple
ascending doses of ToleroMune Grass in subjects allergic to grass.
This study is designed as a randomised, double-blind, placebo-controlled study to evaluate
the safety and tolerability of escalating multiple doses of ToleroMune Grass in subjects
with a documented history of allergic rhinoconjunctivitis on exposure to grass. The efficacy
of ToleroMune HDM will also be explored LPSR, EPSR, CPT and levels of grass specific IgE.
The study will consist of 3 study periods. In Period 1, Screening will be performed up to a
maximum of 6 weeks before randomisation.
Period 2 (Treatment Period) will consist of 4 visits (Visits 3A-3D) four weeks apart. The
first cohort will receive the lowest dose and successive dose groups will increasing doses
of ToleroMune Grass, provided the first administration of the previous dose was safe and
well tolerated.
In Period 3, 2 Post-treatment Challenge visits will take place, the first will be 2 weeks
after the last administration in the Treatment Period and the second will be 17 weeks after
the first administration. Follow-up will be conducted 3-10 days after the second PTC.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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