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Safety of ToleroMune House Dust Mite (HDM) to Treat House Dust Mite Allergy in HDM Allergic Subjects With Rhinoconjunctivitis

NCT01008332 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2010-11-10

No results posted yet for this study

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.

Conditions

  • Allergy

Interventions

BIOLOGICAL

Toleromune HDM

ToleroMune HDM dose 1x4 administrations 4 weeks apart

BIOLOGICAL

Placebo

Placebo comparator, 1x4 administrations 4 weeks apart

Sponsors & Collaborators

  • Adiga Life Sciences, Inc.

    collaborator INDUSTRY

  • Circassia Limited

    lead INDUSTRY

Principal Investigators

  • Jacques Hebert, MD · Centre de Recherche Appliqué en Allergie de Québec

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2010-08-31
Completion
2010-08-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01008332 on ClinicalTrials.gov