An Optional Investigation of Biomarkers of Efficacy

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01949415

Enrollment

105

Registered

2013-09-24

Start date

2013-09-30

Completion date

2014-04-30

Last updated

2014-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rhinoconjunctivitis

Keywords

House Dust Mite, Rhinoconjunctivitis, ToleroMune

Brief 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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

16 Years to 65 Years

Healthy volunteers

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)

Design outcomes

Primary

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

Countries

Canada

Outcome results