Back to resultsA Study to Investigate an Immunomodulatory Therapy in Adult Patients With Perennial Allergic Rhinoconjunctivitis
Primary Purpose
Perennial Allergic Rhinoconjunctivitis, House Dust Mite Allergy
Status
Completed
Phase
Phase 2
Locations
Switzerland
Study Type
Interventional
Intervention
CYT005-AllQbG10 (combination of house dust mite allergen extract with CYT003-QbG10)
House dust mite allergen extract in combination with CYT003-QbG10-placebo
Sponsored by
About this trial
This is an interventional treatment trial for Perennial Allergic Rhinoconjunctivitis
Eligibility Criteria
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
Sites / Locations
- Cytos Biotechnology (Sponsor's Headquarter)
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Arm 1
Arm 2
Arm Description
Outcomes
Primary Outcome Measures
Conjunctival provocation test with allergen and rhinoconjunctivitis symptoms in daily life
Secondary Outcome Measures
Safety and tolerability of the study treatment by collection of adverse events
Full Information
NCT ID
NCT00574223
First Posted
December 14, 2007
Last Updated
April 24, 2009
Sponsor
Cytos Biotechnology AG
1. Study Identification
Unique Protocol Identification Number
NCT00574223
Brief Title
A Study to Investigate an Immunomodulatory Therapy in Adult Patients With Perennial Allergic Rhinoconjunctivitis
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2009
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Cytos Biotechnology AG
4. Oversight
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Perennial Allergic Rhinoconjunctivitis, House Dust Mite Allergy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Experimental
Arm Title
Arm 2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
CYT005-AllQbG10 (combination of house dust mite allergen extract with CYT003-QbG10)
Intervention Description
subcutaneous injections at 8 visits
Intervention Type
Drug
Intervention Name(s)
House dust mite allergen extract in combination with CYT003-QbG10-placebo
Intervention Description
subcutaneous injections at 8 visits
Primary Outcome Measure Information:
Title
Conjunctival provocation test with allergen and rhinoconjunctivitis symptoms in daily life
Time Frame
about 1.5 hours on 4 occasions over 1 year
Secondary Outcome Measure Information:
Title
Safety and tolerability of the study treatment by collection of adverse events
Time Frame
about 30 min. at each visit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philipp Mueller, MD
Organizational Affiliation
Cytos Biotechnology
Official's Role
Study Director
Facility Information:
Facility Name
Cytos Biotechnology (Sponsor's Headquarter)
City
Schlieren
ZIP/Postal Code
CH-8952
Country
Switzerland
12. IPD Sharing Statement
Learn more about this trial
A Study to Investigate an Immunomodulatory Therapy in Adult Patients With Perennial Allergic Rhinoconjunctivitis
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