NCT00574223
Completed
Phase 2
Double-Blind, Placebo-Controlled Study to Investigate Safety, Tolerability, Immunogenicity and Clinical Efficacy of a Specific Immunotherapy Combining Allergen With CYT003-QbG10 (CYT005-AllQbG10) in Adult Patients With Perennial Allergic Rhinoconjunctivitis Due to House Dust Mite Allergy
Overview
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Cytos Biotechnology AG
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Conjunctival provocation test with allergen and rhinoconjunctivitis symptoms in daily life
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 rhinoconjunctivits 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
Arm 1
Experimental
Intervention: CYT005-AllQbG10 (combination of house dust mite allergen extract with CYT003-QbG10) (Drug)
Arm 2
Placebo Comparator
Intervention: House dust mite allergen extract in combination with CYT003-QbG10-placebo (Drug)
Outcomes
Primary Outcomes
Conjunctival provocation test with allergen and rhinoconjunctivitis symptoms in daily life
Time Frame: about 1.5 hours on 4 occasions over 1 year
Secondary Outcomes
- Safety and tolerability of the study treatment by collection of adverse events(about 30 min. at each visit)
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Completed
Phase 2
A Study to Investigate an Immunomodulatory Therapy in Adult Patients With Perennial Allergic RhinoconjunctivitisPerennial Allergic RhinoconjunctivitisHouse Dust Mite AllergyNCT00574704Cytos Biotechnology AG40
Completed
Phase 2
CYT003-QbG10 for Treatment of Allergic Asthma BronchialAllergic Bronchial AsthmaNCT00890734Cytos Biotechnology AG63
Active, not recruiting
Phase 2
Phase 2 Estimation Study of Fixed Dose Drugs Combination Type of PolypillAlzheimer DiseaseNCT06597058Noah Pharmaceuticals, Inc.103
Completed
Phase 1
Safety and Efficacy Study of a New Treatment for Symptoms of Urinary IncontinenceUrinary IncontinenceNCT01340066Beech Tree Labs, Inc.94
Unknown
Phase 2
Clinical Study to Evaluate the Efficacy of HUDC_VT in Patients With Bacterial VaginosisBacterial VaginosisHUDC_VTHaudongchunNCT03357666Haudongchun Co., Ltd.150