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

This study has been completed.
Sponsor:
Information provided by:
Cytos Biotechnology AG
ClinicalTrials.gov Identifier:
NCT00800332
First received: December 1, 2008
Last updated: November 11, 2010
Last verified: November 2010
History of Changes
  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):

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 22, 2013