ToleroMune House Dust Mite Follow on Study

Completed

• Conditions: House Dust Mite Allergy; Rhinoconjunctivitis

• Registration Number: NCT01923792
• 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 HDM allergens 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 HDM is currently being developed for the treatment of HDM allergy.

The Purpose of this optional observational follow-on study is to evaluate the continued efficacy of TM-HDM in HDM allergic subjects based on change in TRSS from TH002 baseline approximately two years after the completion of the baseline EEC visit in TH002 following challenge with HDM allergen in an EEC.

Detailed Description

Subjects who completed all dosing visits and the post treatment challenge (PTC) in study TH002 will be invited to attend the Screening visit for TH002a. Subjects will attend for 3 visits to the EEU on successive days. Following the last EEC visit a follow-up visit will be performed 3-10 days later.

Study Timeline

• Study First Submitted: 2013-07-16
• Study First Submitted QC: 2013-08-14
• Study First Posted: 2013-08-16
• Study Start: 2013-09
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-14
• Last Update Posted: 2014-05-15

Recruitment & Eligibility

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

Inclusion Criteria

• previously randomised in study TH002, completed all dosing visits and the PTC

Exclusion Criteria

• "Partly controlled" and "uncontrolled" asthma
• History of anaphylaxis to House Dust Mite allergen
• FEV1 <80% of predicted.
• Symptoms of a clinically relevant illness
• Subjects who cannot tolerate allergen challenge in the EEC

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Total Rhinoconjunctivitis Symptom Scores	2 years post after the completion of the baseline environmental exposure chamber (EEC) visit in TH002

Secondary Outcome Measures

Name	Time	Method
Total Non Nasal Symptom Scores (TNNSS)	Two years after the completion of the baseline EEC visit in TH002
Der P Specific IgE	Two years after the completion of the baseline EEC visit in TH002
Total Nasal Symptom Scores (TNSS)	Two years after the completion of the baseline EEC visit in TH002
Der p specific IgG4	Two years after the completion of the baseline EEC visit in TH002
Der p Specific IgA	Two years after the completion of the baseline EEC visit in TH002