An Optional Investigation of Biomarkers of Efficacy

Completed

• Conditions: Rhinoconjunctivitis

• Registration Number: NCT01949415
• Lead Sponsor: Circassia Limited

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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2013-09-20
• Study First Submitted QC: 2013-09-20
• Study First Posted: 2013-09-24
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-20
• Last Update Posted: 2014-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 105

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

Topstone Research; 🇨🇦 Toronto, Ontario, Canada