Dose Ranging Study of SLIT Tablets of House Dust Mite Allergen Extracts (HDM) in Adults With HDM-associated Allergic Asthma

Study Overview
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Brief Summary
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The purpose of this study is to investigate the efficacy and safety of different doses of sublingual tablets of house dust mite allergen extracts as compared to placebo in adults with house dust mite-associated allergic asthma.

Official Title
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A Dose Ranging Study Investigating the Efficacy and Safety of Sublingual Immunotherapy Tablets of House Dust Mite Allergen Extracts in Adults With House Dust Mite-associated Allergic Asthma

Conditions
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Asthma, House Dust Mite Allergy

Intervention / Treatment
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* Biological: SLIT tablets of HDM allergen extracts, 3 different doses (A)
* Biological: SLIT tablets of HDM allergen extracts, 3 different doses (B)
* Biological: SLIT tablets of HDM allergen extracts, 3 different doses (C)
* Biological: Placebo matching the SLIT tablets of HDM allergen extracts


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent. Male or female from 18 to 50 years of age. Diagnosed asthma and rhinitis with medical history consistent with HDM-induced allergic asthma and rhinitis. Positive SPT to HDM and and HDM-specific IgE serum value ≥ 0.7 kU/L. Stable asthma therapies. Spirometry (pre-bronchodilator) with best FEV1 ≥ 70% of the predicted value. Spirometry with reversibility in FEV1 of ≥ 12% and ≥ 200 mL. Asthma Control Test™ (ACT) score ≤ 19. Exclusion Criteria: Former smoker with > 10 pack year history or current smoker. Patient with a urine level of cotinine ≥ 500 ng/mL. Co-sensitisation to any allergen possibly leading to clinically relevant symptoms likely to significantly change the asthma symptoms of the subject during the study. Patient who received allergen immunotherapy for HDM within the past 10 years. Ongoing immunotherapy for an aeroallergen other than house dust mite. Patient with any oral condition that could confound the safety assessments or planning to have a dental extraction during the study. Patient treated with beta-blockers, tricyclic antidepressants or monoamine oxidase inhibitors (MAOIs). Pregnant women or breast-feeding/lactating. Women with childbearing potential who are not using a medically accepted birth control method. Patient with a past or current disease, which as judged by the Investigator, may affect the patient's participation in, or the outcome of this study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 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 |
| --- | --- |
| Experimental: SLIT (A)<br>SLIT tablets of HDM allergen extracts, 3 different doses (A) | Biological: SLIT tablets of HDM allergen extracts, 3 different doses (A)<br>* Two sublingual tablets daily for 13 months<br>* Other names: Sublingual immunotherapy tablet;|
| Experimental: SLIT (B)<br>SLIT tablets of HDM allergen extracts, 3 different doses (B) | Biological: SLIT tablets of HDM allergen extracts, 3 different doses (B)<br>* Two sublingual tablets daily for 13 months<br>* Other names: Sublingual immunotherapy tablet;|
| Experimental: SLIT (C)<br>SLIT tablets of HDM allergen extracts, 3 different doses (C) | Biological: SLIT tablets of HDM allergen extracts, 3 different doses (C)<br>* Two sublingual tablets daily for 13 months<br>* Other names: Sublingual immunotherapy tablet;|
| Placebo Comparator: Placebo<br>Placebo matching the SLIT tablets of HDM allergen extracts | Biological: Placebo matching the SLIT tablets of HDM allergen extracts<br>* Two sublingual tablets daily for 13 months<br>* Other names: Sublingual placebo tablet;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect on the Asthma control test (ACT) score | Assessment of the effect of one year of treatment of 3 different doses of sublingual immunotherapy tablets of house dust mite (HDM) allergen extracts as compared to placebo on the Asthma Control Test™ (ACT) score, in adults with HDM-associated allergic asthma | 13 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number and percentage of subjects with treatment-emergent AEs |  | Measured during 13 months |