Safety and Clinical Tolerability of hdmASIT+TM Peptides Administered in HDM-induced Allergic Patients

Study Overview
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Brief Summary
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hdmASIT+TM product is based on highly purified allergen fragments from house dust mites. The purpose of this study is to assess the safety and clinical tolerability of subcutaneous immunotherapy with hdmASIT+TM in patients with house dust mite-induced allergic rhinoconjunctivitis compared to placebo.

Official Title
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Assessment of Safety and Clinical Tolerability of hdmASIT+TM Administered Subcutaneously in House Dust Mite-induced Allergic Rhinoconjunctivitis Patients

Conditions
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House Dust Mite Allergy

Intervention / Treatment
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* Biological: Placebo solution
* Biological: hdmASIT+TM


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A medical history of moderate to severe allergic rhinoconjunctivitis for house dust mite for at least 12 months (definition of allergy severity according to ARIA (Bousquet et al., 2001)) A positive skin prick test to house dust mite Dermatophagoides pteronyssinus Specific IgE against house dust mite Dermatophagoides pteronyssinus ≥ 0.7 kU/L Positive response to Conjunctival Provocation Test (CPT) Being treated with anti-allergic medication for at least 12 months prior to enrollment For asthmatic patients: confirmed diagnosis of controlled asthma according to Global Initiative for Asthma (GINA) guidelines (steps 1-3, GINA 2014), FEV1 ≥ 80% of the patient's reference value Exclusion Criteria: Previous immunotherapy with house dust mite allergens within the last 5 years Ongoing immunotherapy with house dust mite allergens or any other allergens History of severe systemic reactions and/or anaphylaxis, including to food (e.g. peanut, marine animals) or to Hymenoptera venom (e.g. bee, wasp stings) or to medication (e.g. penicillin), etc. Partly controlled or uncontrolled asthma according to GINA guidelines (GINA 2014) Chronic asthma or emphysema, particularly with a forced expiratory volume in 1 second (FEV1) < 80% of the patient's reference value (ECSC) History of a respiratory tract infection and/or exacerbation of asthma within 4 weeks before the screening

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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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Biological: Placebo solution<br>* 15 injections over 7 weeks<br>|
| Experimental: hdmASIT+TM<br> | Biological: hdmASIT+TM<br>* 15 injections over 7 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Solicited adverse events | Local reactions at the injection site Allergic systemic reactions | up to 7 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Unsolicited adverse events and serious adverse events (SAEs) |  | up to 12 weeks | 
| Physical examinations (body systems) and vital signs (heart rate, systolic and diastolic blood pressure) |  | up to 12 weeks | 
| Laboratory investigations (haematology, clinical biochemistry, immunological parameters) |  | up to 12 weeks | 
| Pulmonary functions (FEV1) for asthmatic patients |  | up to 7 weeks |