An Optional Investigation of Biomarkers of Efficacy

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

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

Study Overview

• Status: Completed
• Conditions: Rhinoconjunctivitis

• Study Type: Observational
• Enrollment (Anticipated): 105

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M9C 4Z5
      • Topstone Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of subjects who completed TH002 and have been dosed with either placebo or the 12 nmol dose in the TH002 study.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Circassia Limited
• Collaborators: Adiga Life Sciences, Inc.; Topstone Research

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Actual): April 1, 2014
• Study Completion (Actual): April 1, 2014

Study Registration Dates

• First Submitted: September 20, 2013
• First Submitted That Met QC Criteria: September 20, 2013
• First Posted (Estimate): September 24, 2013

Study Record Updates

• Last Update Posted (Estimate): May 21, 2014
• Last Update Submitted That Met QC Criteria: May 20, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Keywords: Rhinoconjunctivitis; House Dust Mite; ToleroMune
• Additional Relevant MeSH Terms: Eye Diseases; Conjunctival Diseases; Conjunctivitis
• Other Study ID Numbers: RES-008