A Study to Investigate an Immunomodulatory Therapy in Adult Patients With Perennial Allergic Rhinoconjunctivitis
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
1 other identifier
interventional
100
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Nov 2007
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2007
CompletedFirst Submitted
Initial submission to the registry
December 14, 2007
CompletedFirst Posted
Study publicly available on registry
December 17, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2009
CompletedApril 27, 2009
April 1, 2009
1.3 years
December 14, 2007
April 24, 2009
Conditions
Outcome Measures
Primary Outcomes (1)
Conjunctival provocation test with allergen and rhinoconjunctivitis symptoms in daily life
about 1.5 hours on 4 occasions over 1 year
Secondary Outcomes (1)
Safety and tolerability of the study treatment by collection of adverse events
about 30 min. at each visit
Study Arms (2)
Arm 1
EXPERIMENTALArm 2
PLACEBO COMPARATORInterventions
subcutaneous injections at 8 visits
subcutaneous injections at 8 visits
Eligibility Criteria
You may qualify if:
- Mild to moderate perennial allergic rhinoconjunctivits due to hypersensitization towards house dust mite allergens
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cytos Biotechnology (Sponsor's Headquarter)
Schlieren, CH-8952, Switzerland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Philipp Mueller, MD
Cytos Biotechnology
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
December 14, 2007
First Posted
December 17, 2007
Study Start
November 1, 2007
Primary Completion
March 1, 2009
Study Completion
March 1, 2009
Last Updated
April 27, 2009
Record last verified: 2009-04