ToleroMune House Dust Mite (HDM) Tolerability Study

Study Overview
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Brief Summary
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House Dust Mites (HDMs) 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), a combination of seven Synthetic Peptide Immuno-Regulatory Epitopes, is being developed for the treatment of HDM allergy. This study to assess the tolerability of ToleroMune House Dust Mite in subjects with controlled asthma and house dust mite-induced rhinoconjunctivitis.

Detailed Description
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A multi-centre, randomised, double-blind, placebo-controlled, parallel-group, multiple dose study to evaluate the tolerability of four intradermal doses of TM-HDM in subjects with controlled asthma and HDM-induced rhinoconjunctivitis.

Official Title
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A Multi-Centre, Double-Blind, Randomised, Placebo-Controlled Parallel-Group Study to Assess the Tolerability of ToleroMune House Dust Mite in Subjects With Controlled Asthma and House Dust Mite-Induced Rhinoconjunctivitis

Conditions
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Rhinoconjunctivitis

Intervention / Treatment
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* Biological: ToleroMune HDM
* Biological: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female, aged 18-65 years. Asthma controlled by Step 1 or Step 2 treatment as defined by GINA in the four weeks prior to randomisation. Asthma controlled by Step 1 or Step 2 treatment as defined by GINA in the four weeks prior to randomisation. No change in asthma controller treatment (dose, frequency) in the four weeks prior to randomisation. A reliable history consistent with rhinoconjunctivitis on exposure to HDM for at least 1 year that has required symptomatic treatment on at least one occasion during the year prior to randomisation Positive skin prick test to Dermatophagoides pteronyssinus with an average wheal diameter at least 5 mm larger than that produced by the negative control. ImmunoCAP® Dermatophagoides pteronyssinus-specific Immunoglobulin E ≥ 0.35 kU/L. Exclusion Criteria: History of life-threatening asthma Asthma exacerbation in the 12 weeks prior to randomisation Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) < 80 % of predicted, regardless of the cause. Post-bronchodilator FEV1/Forced Vital Capacity ratio of < 0.7. Concurrent respiratory disease that would confound study participation or affect subject safety. Non-HDM allergy that may significantly interfere with the results of this study. 7. Previous immunotherapy treatment with any HDM allergen for more than 1 month within 5 years prior to screening.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ToleroMune HDM<br> | Biological: ToleroMune HDM<br>* Intradermal injection 1 x 4 administrations 4 weeks apart<br>|
| Placebo Comparator: Placebo<br> | Biological: Placebo<br>* Intradermal injection 1 x 4 administrations 4 weeks apart<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events |  | Up to 19 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FEV1 and FVC |  | Up to 19 Weeks | 
| Peak Expiratory Flow Rate |  | Up to 19 Weeks | 
| VAS Breathlessness |  | Up to 19 weeks | 
| Asthma Exacerbations |  | Up to 19 weeks | 
| Systemic Allergic Reactions |  | Up to 19 Weeks | 
| Injection Site Examinations |  | Up to 19 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HDM Allergy, Rhinoconjunctivitis, Immunotherapy, ToleroMune HDM