NCT00800332
Completed
Phase 2
Double-blind, Placebo-controlled Dose-finding Study With CYT003-QbG10 in Adult Patients With Rhinoconjunctivitis Due to House Dust Mite Allergy
Overview
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Cytos Biotechnology AG
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- Rhinoconjunctivitis symptom and medication scores
Overview
Brief Summary
The purpose of the study is to test whether vaccinations with CYT003-QbG10 can improve allergy symptoms in patients with house dust mite allergy. The active treatment will be compared against placebo.
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
- •Perennial allergic rhinoconjunctivitis due to clinically relevant allergy towards house dust mite allergens
- •Further criteria as defined in the study protocol
Exclusion Criteria
- •Clinically manifested seasonal allergy/-ies which is/are expected to interfere with the patient's study treatment schedule and/or assessments
- •Clinically relevant perennial allergy/-ies other than house dust mites allergy
- •Contraindication to any study test or procedure
- •Further criteria as defined in the study protocol
Arms & Interventions
1
Experimental
Intervention: CYT003-QbG10 (Drug)
2
Experimental
Intervention: CYT003-QbG10 (Drug)
3
Placebo Comparator
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Rhinoconjunctivitis symptom and medication scores
Time Frame: Pre- / Post-Treatment
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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