An Optional Investigation of Biomarkers of Efficacy
1 other identifier
observational
105
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Sep 2013
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2013
CompletedFirst Submitted
Initial submission to the registry
September 20, 2013
CompletedFirst Posted
Study publicly available on registry
September 24, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2014
CompletedMay 21, 2014
May 1, 2014
7 months
September 20, 2013
May 20, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To identify cellular, proteomic or genetic biomarkers of efficacy to ToleroMune House Dust Mite (TM-HDM) treatment in TH002 study participants.
1 Day
Eligibility Criteria
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.
You may qualify if:
- Previously randomised into study TH002, completed the study and received either placebo or the 12 nmol dose in TH002.
You may not qualify if:
- Subjects who have received allergen or peptide immunotherapy during the last 12 months (other than TM-HDM)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Circassia Limitedlead
- Adiga Life Sciences, Inc.collaborator
- Topstone Researchcollaborator
Study Sites (1)
Topstone Research
Toronto, Ontario, M9C 4Z5, Canada
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 20, 2013
First Posted
September 24, 2013
Study Start
September 1, 2013
Primary Completion
April 1, 2014
Study Completion
April 1, 2014
Last Updated
May 21, 2014
Record last verified: 2014-05