Dose Finding Study With CYT003-QbG10 in Patients With House Dust Mite Allergy

This study has been completed.

First Received on December 1, 2008. Last Updated on November 11, 2010 History of Changes

Sponsor:	Cytos Biotechnology AG
Information provided by:	Cytos Biotechnology AG
ClinicalTrials.gov Identifier:	NCT00800332

Purpose

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.

Condition	Intervention	Phase
Rhinoconjunctivitis Allergies	Drug: CYT003-QbG10 Drug: Placebo	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Double-blind, Placebo-controlled Dose-finding Study With CYT003-QbG10 in Adult Patients With Rhinoconjunctivitis Due to House Dust Mite Allergy

Resource links provided by NLM:

MedlinePlus related topics: Allergy

U.S. FDA Resources

Further study details as provided by Cytos Biotechnology AG:

Primary Outcome Measures:

Rhinoconjunctivitis symptom and medication scores [ Time Frame: Pre- / Post-Treatment ] [ Designated as safety issue: No ]

Estimated Enrollment:	300
Study Start Date:	November 2008
Study Completion Date:	November 2010
Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	Drug: CYT003-QbG10 subcutaneous injection
Experimental: 2	Drug: CYT003-QbG10 subcutaneous injection
Placebo Comparator: 3	Drug: Placebo subcutaneous injection

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Perennial allergic rhinoconjunctivitis due to clinically relevant allergy towards house dust mite allergens
Further criteria as defined in the study protocol

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00800332

Locations

Estonia
Cytos Investigator Sites
Paide, Tartu, Tallin, Rakvere, Estonia
Germany
Cytos Investigator Sites
Fulda, Dresden, Ulm, Rodgau, Kassel, Eisenach, Germany
Cytos Investigator Sites
Wiesbaden, Frankfurt/M, Leipzig, Jena, Hamburg, Dulmen, Germany
Greece
Cytos Investigator Sites
N. Faliro, Hiraklion, Athens, Greece
Latvia
Cytos Investigator Sites
Riga, Rezekne, Latvia
Lithuania
Cytos Investigator Sites
Vilnius, Kaunas, Klaipeda, Lithuania
Romania
Cytos Investigator Sites
Galati, Cluj Napoca, Bahia Mare, Brasov, Piesti, Romania
Cytos Investigator Sites
Targu Mures, Bukarest, Craiova, Iasi, Romania

Sponsors and Collaborators

Cytos Biotechnology AG

More Information

No publications provided by Cytos Biotechnology AG

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. Epub 2011 Jun 14.

Responsible Party:	Clinical Development, Cytos Biotechnology
ClinicalTrials.gov Identifier:	NCT00800332 History of Changes
Other Study ID Numbers:	CYT003-QbG10 09
Study First Received:	December 1, 2008
Last Updated:	November 11, 2010
Health Authority:	Estonia: The State Agency of Medicine

Keywords provided by Cytos Biotechnology AG:

Rhinoconjunctivitis due to house dust mite allergy

Additional relevant MeSH terms:

Hypersensitivity
Conjunctivitis
Immune System Diseases
Conjunctival Diseases
Eye Diseases

ClinicalTrials.gov processed this record on May 23, 2012