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NCT01949415 Clinical Trial

An Optional Investigation of Biomarkers of Efficacy

Rhinoconjunctivitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01949415
Other study ID # RES-008
Secondary ID
Status Completed
Phase N/A
First received September 20, 2013
Last updated May 20, 2014
Start date September 2013
Est. completion date April 2014

Study information
Verified date May 2014
Source Circassia Limited
Contact n/a
Is FDA regulated No
Health authority Canada: Health Canada
Study type Observational

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 105
Est. completion date April 2014
Est. primary completion date April 2014
Accepts healthy volunteers No
Gender Both
Age group 16 Years to 65 Years
Eligibility 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)

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Canada Topstone Research Toronto Ontario

Sponsors (3)
Lead Sponsor Collaborator
Circassia Limited Adiga Life Sciences, Inc., Topstone Research

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary To identify cellular, proteomic or genetic biomarkers of efficacy to ToleroMune House Dust Mite (TM-HDM) treatment in TH002 study participants. 1 Day No
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