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OpenTrials
Completed

NCT Number: NCT01949415

An Optional Investigation of Biomarkers of Efficacy

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

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Key information

Conditions

Rhinoconjunctivitis

Age range

16 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Topstone Research

Toronto, Ontario, M9C 4Z5, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Previously randomised into study TH002, completed the study and received either placebo or the 12 nmol dose in TH002.

Exclusion criteria

  • Subjects who have received allergen or peptide immunotherapy during the last 12 months (other than TM-HDM)

Treatment and study plan

Primary outcomes

  1. To identify cellular, proteomic or genetic biomarkers of efficacy to ToleroMune House Dust Mite (TM-HDM) treatment in TH002 study participants.

    Time frame: 1 Day

Sponsors and collaborators

Lead sponsor

Circassia Limited

Industry

Collaborators

  • Adiga Life Sciences, Inc.
  • Topstone Research

Registry information

Official study title

An Optional Investigation of Biomarkers of Efficacy in TH002 Clinical Study Subjects.

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Sep 24, 2013
Registry last updated
May 21, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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