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An Optional Investigation of Biomarkers of Efficacy

NCT01949415 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 105

Last updated 2014-05-21

No results posted yet for this study

Summary

House Dust Mites (HDM) 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) is being developed for the treatment of HDM allergy.

Study TH002 evaluated the efficacy, safety and tolerability of TM-HDM. This study will identify cellular, proteomic or genetic biomarkers of efficacy to TM-HDM treatment in TH002 study participants

Conditions

  • Rhinoconjunctivitis

Sponsors & Collaborators

  • Adiga Life Sciences, Inc.

    collaborator INDUSTRY

  • Topstone Research

    collaborator UNKNOWN

  • Circassia Limited

    lead INDUSTRY

Eligibility

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

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2014-04-30
Completion
2014-04-30

Countries

  • Canada

Study Locations

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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 NCT01949415 on ClinicalTrials.gov