A Study Investigating the Immunologic Effects and Safety of 60-day Treatment of the ALK HDM Tablets in Adult Subjects With HDM-Induced Allergic Rhinitis and/or Atopic Asthma

Study Overview
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Brief Summary
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To demonstrate superiority of ALK HDM tablets versus placebo in immune response, measured as change of D.farinae specific immunoglobulin G4 (IgG4) from baseline to end of treatment with ALK HDM tablets given once daily over 60 days.

Detailed Description
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To demonstrate superiority of ALK HDM tablets versus placebo in the immune response, measured as change of D. Farinae specific IgG4 from baseline to end of treatment with ALK HDM tablets given once daily over 60 days To evaluate the immune response, measured as change of D. pteronyssinus, D. farinae specific immunoglobulin E (IgE) and D. pteronyssinus specific IgG4 from baseline to end of treatment with ALK HDM tablets given once daily over 60 days, compared to placebo To evaluate in patients with HDM-allergic respiratory disease the safety and tolerability of 60-day treatment with ALK HDM tablets compared to placebo

Official Title
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A Randomized, Double-blind, Placebo-controlled Study Investigating the Immunologic Effects and Safety of 60-day Treatment of the ALK HDM Tablets in Adult Subjects With Allergic Rhinitis and/or Atopic Asthma Induced by House Dust Mites

Conditions
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Allergy, Asthma, Rhinitis

Intervention / Treatment
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* Drug: Mitizax
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent obtained before entering the study Patients 18-65 years of age, with a clinical history consistent with HDM-induced allergic rhinitis or allergic rhinoconjunctivitis with or without HDM-induced allergic atopic asthma for more than 1 year Use of symptomatic treatment of HDM-induced allergic rhinitis and/or HDM-induced atopic asthma, i.e. antihistamines, nasal decongestants, nasal and/or inhaled corticosteroid for more than 1 year if HDM-induced atopic asthma is present, it should be of mild to moderate severity, controlled on treatment corresponding to steps 1-3 of The Global initiative for asthma (GINA) Positive skin prick test response (wheal diameter ≥3 mm) to D pteronyssinus and/or D.farinae Moderate or higher level of D.pteronyssinus and/or D.farinae specific IgE (defined as ≥IgE Class 2; or ≥0.70 kilo unit (kU)/L) Patient one of the following: Male Female, infertile Female, with a negative pregnancy test and willingness to practice appropriate contraceptive methods until treatment with study drug has been discontinued. Patient willing and able to comply with study protocol Exclusion Criteria: Previous treatment with HDM immunotherapy for more than 1 month within the last 5 years Ongoing treatment with any allergen-specific immunotherapy product Reduced lung function (defined as Forced expiratory volume in 1 second (FEV1) < 70% of predicted value after adequate pharmacologic treatment) measured at Visit 1 and Visit 2 Clinical history of uncontrolled asthma within 3 months prior to the screening visit Having experienced a severe asthma exacerbation within 3 months prior to screening visit Symptoms of or treatment for upper respiratory tract infection, acute sinusitis, acute otitis media or other relevant infectious process at randomization Inflammatory conditions in the oral cavity with severe symptoms such as oral lichen planus with ulcerations or severe oral mycosis at randomization History of anaphylaxis with cardiorespiratory symptoms (immunotherapy, exercise-induced, food allergy, drugs or an idiopathic reaction) History of recurrent generalized urticaria (defined as two or more episodes) during the last 2 years A history of drug induced (incl. immunotherapy) facial angioedema or a family (parents and siblings) history of hereditary angioedema Any chronic disease (e.g. cystic fibrosis, malignancy, malabsorption or malnutrition, renal or hepatic abnormality or any other diseases that in the opinion of the investigator would interfere with the study evaluations or the safety of the subject) Systemic disease affecting the immune system (e.g. autoimmune disease, immune complex disease, or immune deficiency disease whether acquired or not) Immunosuppressive treatment (ATC code L04 or L01) within 3 months prior to the screening visit Currently treated with tricyclic antidepressants; catecholamine-O-methyltransferase (COMT) inhibitors and mono amine oxidase inhibitors (MAOIs) and beta-blockers including topical administration Use of medication at the screening visit which at the time of skin prick test (SPT) can interfere with the result (i.e. antihistamines) Use of an investigational drug within 30 days/5 half-lives of the drug (which ever longest) prior to the screening visit History of allergy, hypersensitivity or intolerance to a excipient in the investigational medicinal product (except D.Pteronyssinus and D.farinae) Being immediate family of the investigator or study staff, defined as the investigator's/staff's spouse, parent, child, grandparent or grandchild Severe mental disorders that in the opinion of the investigator would interfere with the study evaluations or the safety of the subject Cardiovascular conditions in which complications are possible when using adrenaline Women who are pregnant or breastfeeding

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mitizax ALK HDM tablet<br>Standardised allergen extract from the house dust mites Dermatophagoides pteronyssinus and Dermatophagoides farinae developmental unit, dose standard for ALK HDM tablets (12DU) | Drug: Mitizax<br>* Allergen extract<br>* Other names: allergen extract;|
| Placebo Comparator: Placebo tablet<br>Placebo tablet | Drug: Placebo<br>* Placebo tablet<br>* Other names: Placebo tablet;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| D. Farinae Specific IgG4 Change From Baseline to End of Treatment | primary efficacy endpoint of D. Farinae specific IgG4 change from baseline to end of treatment | 60 days from baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| D. Pteronyssinus Specific IgG4 Change From Baseline to End of Treatment | secondary endpoint of D. pteronyssinus specific IgG4 change from baseline to end of treatment | 60 days from baseline | 
| D. Farinae Specific IgE Change From Baseline to End of Treatment | the secondary endpoint of D. farinae specific IgE change from baseline to end of treatment compared to placebo | 60 days from baseline | 
| D. Pteronyssinus Specific IgE Change From Baseline to End of Treatment | the secondary endpoint of D. pteronyssinus specific IgE change from baseline to end of treatment compared to placebo | 60 days from baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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House Dust Mite