Dose Finding Study With CYT003-QbG10 in Patients With House Dust Mite Allergy
Double-blind, Placebo-controlled Dose-finding Study With CYT003-QbG10 in Adult Patients With Rhinoconjunctivitis Due to House Dust Mite Allergy
1 other identifier
interventional
300
6 countries
8
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2008
8 active sites
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, 2008
CompletedFirst Submitted
Initial submission to the registry
December 1, 2008
CompletedFirst Posted
Study publicly available on registry
December 2, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2010
CompletedNovember 15, 2010
November 1, 2010
1.4 years
December 1, 2008
November 11, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rhinoconjunctivitis symptom and medication scores
Pre- / Post-Treatment
Study Arms (3)
1
EXPERIMENTAL2
EXPERIMENTAL3
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Perennial allergic rhinoconjunctivitis due to clinically relevant allergy towards house dust mite allergens
- Further criteria as defined in the study protocol
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Cytos Investigator Sites
Paide, Tartu, Tallin, Rakvere, Estonia
Cytos Investigator Sites
Fulda, Dresden, Ulm, Rodgau, Kassel, Eisenach, Germany
Cytos Investigator Sites
Wiesbaden, Frankfurt/M, Leipzig, Jena, Hamburg, Dulmen, Germany
Cytos Investigator Sites
N. Faliro, Hiraklion, Athens, Greece
Cytos Investigator Sites
Riga, Rezekne, Latvia
Cytos Investigator Sites
Vilnius, Kaunas, Klaipeda, Lithuania
Cytos Investigator Sites
Galati, Cluj Napoca, Bahia Mare, Brasov, Piesti, Romania
Cytos Investigator Sites
Targu Mures, Bukarest, Craiova, Iasi, Romania
Related Publications (1)
Klimek L, Willers J, Hammann-Haenni A, Pfaar O, Stocker H, Mueller P, Renner WA, Bachmann MF. Assessment of clinical efficacy of CYT003-QbG10 in patients with allergic rhinoconjunctivitis: a phase IIb study. Clin Exp Allergy. 2011 Sep;41(9):1305-12. doi: 10.1111/j.1365-2222.2011.03783.x. Epub 2011 Jun 14.
PMID: 21672053DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
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 1, 2008
First Posted
December 2, 2008
Study Start
November 1, 2008
Primary Completion
April 1, 2010
Study Completion
November 1, 2010
Last Updated
November 15, 2010
Record last verified: 2010-11