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
Overview
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Cytos Biotechnology AG
- Enrollment
- 40
- Primary Endpoint
- 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)
Overview
Brief Summary
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
1
Intervention: CYT005-AllQbG10 (combination of house dust mite allergen extract with CYT003-QbG10) (Drug)
2
Intervention: House dust mite allergen extract in combination with CYT003-QbG10-placebo (Drug)
3
Intervention: CYT003-AllQbG10 in combination with house dust mite allergen extract placebo (Drug)
4
Intervention: CYT003-QbG10-placebo in combination with house dust mite allergen extract placebo (Drug)
Outcomes
Primary Outcomes
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)
Time Frame: baseline versus 2 months after baseline
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.
Secondary Outcomes
- Safety and Tolerability of the Study Treatment by Collection of Adverse Events(about 30 min. at each visit)