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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00800332
First Posted: December 2, 2008
Last Update Posted: November 15, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Cytos Biotechnology AG
December 1, 2008
December 2, 2008
November 15, 2010
November 2008
April 2010   (Final data collection date for primary outcome measure)
Rhinoconjunctivitis symptom and medication scores [ Time Frame: Pre- / Post-Treatment ]
Same as current
Complete list of historical versions of study NCT00800332 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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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
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Rhinoconjunctivitis
  • Allergies
  • Drug: CYT003-QbG10
    subcutaneous injection
  • Drug: Placebo
    subcutaneous injection
  • Experimental: 1
    Intervention: Drug: CYT003-QbG10
  • Experimental: 2
    Intervention: Drug: CYT003-QbG10
  • Placebo Comparator: 3
    Intervention: Drug: Placebo
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
300
November 2010
April 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Estonia,   Germany,   Greece,   Latvia,   Lithuania,   Romania
 
 
NCT00800332
CYT003-QbG10 09
No
Not Provided
Not Provided
Clinical Development, Cytos Biotechnology
Cytos Biotechnology AG
Not Provided
Not Provided
Cytos Biotechnology AG
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP