- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00574223
A Study to Investigate an Immunomodulatory Therapy in Adult Patients With Perennial Allergic Rhinoconjunctivitis
April 24, 2009 updated by: Cytos Biotechnology AG
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
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 Overview
Status
Completed
Study Type
Interventional
Enrollment (Anticipated)
100
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Schlieren, Switzerland, CH-8952
- Cytos Biotechnology (Sponsor's Headquarter)
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm 1
|
subcutaneous injections at 8 visits
|
Placebo Comparator: Arm 2
|
subcutaneous injections at 8 visits
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Conjunctival provocation test with allergen and rhinoconjunctivitis symptoms in daily life
Time Frame: about 1.5 hours on 4 occasions over 1 year
|
about 1.5 hours on 4 occasions over 1 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Safety and tolerability of the study treatment by collection of adverse events
Time Frame: about 30 min. at each visit
|
about 30 min. at each visit
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Philipp Mueller, MD, Cytos Biotechnology
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2007
Primary Completion (Actual)
March 1, 2009
Study Completion (Actual)
March 1, 2009
Study Registration Dates
First Submitted
December 14, 2007
First Submitted That Met QC Criteria
December 14, 2007
First Posted (Estimate)
December 17, 2007
Study Record Updates
Last Update Posted (Estimate)
April 27, 2009
Last Update Submitted That Met QC Criteria
April 24, 2009
Last Verified
April 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CYT005-AllQbG10 04
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on House Dust Mite Allergy
-
ALK-Abelló A/SCompletedHouse Dust Mite AllergyFrance
-
Allergopharma GmbH & Co. KGCompletedHouse Dust Mite AllergyGermany
-
Universitas AirlanggaNot yet recruiting
-
ASIT Biotech S.A.CompletedHouse Dust Mite AllergyGermany
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Circassia LimitedAdiga Life Sciences, Inc.; Inflamax Research IncorporatedCompletedRhinoconjunctivitis | House Dust Mite Allergy
-
Probelte Pharma S.L.U.RecruitingHouse Dust Mite AllergySpain
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HAL AllergyCompleted
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Cytos Biotechnology AGCompletedHouse Dust Mite Allergy | Perennial Allergic Rhinoconjunctivitis
-
T-Balance Therapeutics GmbHCompletedAllergic Asthma | Allergy to House Dust MiteGermany
-
Johann Wolfgang Goethe University HospitalCompletedHouse Dust Mite Allergy | Bronchial HyperresponsivenessGermany
Clinical Trials on CYT005-AllQbG10 (combination of house dust mite allergen extract with CYT003-QbG10)
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Cytos Biotechnology AGCompletedHouse Dust Mite Allergy | Perennial Allergic Rhinoconjunctivitis
-
John SundyTerminatedHealthy | Atopic AsthmaUnited States
-
Oslo University HospitalUniversity of OsloUnknown