NCT01949441

ToleroMune House Dust Mite (HDM) Tolerability Study

A Multi-Centre, Double-Blind, Randomised, Placebo-Controlled Parallel-Group Study to Assess the Tolerability of ToleroMune House Dust Mite in Subjects With Controlled Asthma and House Dust Mite-Induced Rhinoconjunctivitis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Circassia Limited · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

House Dust Mites (HDMs) are arachnids that infest bedding, carpet, upholstered furniture and fabric. 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. In contrast to other allergens, there is evidence that HDMA leads to the development of asthma, in addition to exacerbating pre-existing asthma in HDM-sensitised patients. ToleroMune House Dust Mite (TM-HDM), a combination of seven Synthetic Peptide Immuno-Regulatory Epitopes, is being developed for the treatment of HDM allergy. This study to assess the tolerability of ToleroMune House Dust Mite in subjects with controlled asthma and house dust mite-induced rhinoconjunctivitis.

Detailed description

A multi-centre, randomised, double-blind, placebo-controlled, parallel-group, multiple dose study to evaluate the tolerability of four intradermal doses of TM-HDM in subjects with controlled asthma and HDM-induced rhinoconjunctivitis.

Conditions

• Rhinoconjunctivitis

Interventions

Type	Name	Description
BIOLOGICAL	ToleroMune HDM	Intradermal injection 1 x 4 administrations 4 weeks apart
BIOLOGICAL	Placebo	Intradermal injection 1 x 4 administrations 4 weeks apart

Timeline

• Start date: 2013-09-01
• Primary completion: 2014-05-01
• Completion: 2014-05-01
• First posted: 2013-09-24
• Last updated: 2014-06-11

Locations

1 site across 1 country: Canada