ToleroMune House Dust Mite Follow on Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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An Optional Follow-Up Study to Evaluate the Continued Efficacy of ToleroMune HDM in House Dust Mite Allergic Subjects Following Challenge With House Dust Mite Allergen in an Environmental Exposure Chamber

Conditions
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House Dust Mite Allergy, Rhinoconjunctivitis

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo<br>Subjects previously randomised to receive placebo in study TH002 | |
| ToleroMune HMD Group 1<br>Subjects previously randomised to receive ToleroMune HDM in study TH002 | |
| ToleroMune HDM Group 2<br>Subjects previously randomised to receive ToleroMune HDM in study TH002 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Rhinoconjunctivitis Symptom Scores |  | 2 years post after the completion of the baseline environmental exposure chamber (EEC) visit in TH002 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Nasal Symptom Scores (TNSS) |  | 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 | 
| 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 | 
| Der p specific IgG4 |  | Two years after the completion of the baseline EEC visit in TH002 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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House Dust Mite Allergy, Rhinoconjunctivitis, Environmental Exposure Unit, Immunotherapy, ToleroMune HDM