A Study to Investigate an Immunomodulatory Therapy in Adult Patients With Perennial Allergic Rhinoconjunctivitis

Study Overview
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Brief Summary
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The purpose of the study is to test the efficacy of the combination treatment AllQbG10 in patients with perennial allergic rhinoconjunctivitis due to house dust mite allergy in a double-blind, placebo-controlled setting

Official Title
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Double Blind Placebo Controlled Study to Assess Efficacy and Safety of a Combined Allergen Vaccine (CYT005-AllQbG10) and Its Single Components in Patients With House Dust Mite Allergy

Conditions
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Perennial Allergic Rhinoconjunctivitis, House Dust Mite Allergy

Intervention / Treatment
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* Drug: CYT005-AllQbG10 (combination of house dust mite allergen extract with CYT003-QbG10)
* Drug: House dust mite allergen extract in combination with CYT003-QbG10-placebo
* Drug: CYT003-AllQbG10 in combination with house dust mite allergen extract placebo
* Drug: CYT003-QbG10-placebo in combination with house dust mite allergen extract placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Mild to moderate perennial allergic rhinoconjunctivitis due to hypersensitization towards house dust mite allergens Exclusion Criteria: Clinically relevant other allergies (perennial or seasonal) that could potentially interfere with the patient's study treatment schedule or assessments Use of any concomitant medication that could affect the patient's study treatment response or assessment results

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: CYT005-AllQbG10 (combination of house dust mite allergen extract with CYT003-QbG10)<br>* subcutaneous injections at 6 visits<br>|
| Placebo Comparator: 2<br> | Drug: House dust mite allergen extract in combination with CYT003-QbG10-placebo<br>* subcutaneous injections at 6 visits<br>|
| Experimental: 3<br> | Drug: CYT003-AllQbG10 in combination with house dust mite allergen extract placebo<br>* subcutaneous injections at 6 visits<br>|
| Placebo Comparator: 4<br> | Drug: CYT003-QbG10-placebo in combination with house dust mite allergen extract placebo<br>* subcutaneous injections at 6 visits<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Conjunctival Provocation Test (CPT) With House Dust Mite Allergen Solutions. Change of Median Individual Allergen Tolerance Compared to Baseline (Factor of Increase in Allergen Concentration to Induce a Threshold CPT Score ≥ 2) | The outcome measure is a conjunctival provocation test (CPT) with house dust mite allergen solutions. CPT score was measured as a sum of the following assessed symptoms: conjunctival hyperemia, tearing, itching, burning and swelling of eyelids. Each of the assessed symptom could be absent (0), mild (1 point), moderate (2 points) or severe (3 points). The provocation tests started with the maximal dilution of the allergen 1:1000. If the sum of the reached CPT score was <10 points, the test continued with the next dilution step 1:100. This procedure was repeated until patients reached the CPT score ≥ 10 points or the provocation solution reached the maximal concentration 1:1 (undiluted). The outcome is then given as the change of median individual allergen tolerance at month two compared to baseline. The change is expressed as a factor of increase in allergen concentration to induce a threshold CPT score ≥ 2. | baseline versus 2 months after baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and Tolerability of the Study Treatment by Collection of Adverse Events |  | about 30 min. at each visit |