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A Study to Investigate an Immunomodulatory Therapy in Adult Patients With Perennial Allergic Rhinoconjunctivitis

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.
 
ClinicalTrials.gov Identifier: NCT00574223
Recruitment Status : Completed
First Posted : December 17, 2007
Last Update Posted : April 27, 2009
Sponsor:
Information provided by:
Cytos Biotechnology AG

Tracking Information
First Submitted Date  ICMJE December 14, 2007
First Posted Date  ICMJE December 17, 2007
Last Update Posted Date April 27, 2009
Study Start Date  ICMJE November 2007
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 17, 2008)
Conjunctival provocation test with allergen and rhinoconjunctivitis symptoms in daily life [ Time Frame: about 1.5 hours on 4 occasions over 1 year ]
Original Primary Outcome Measures  ICMJE
 (submitted: December 14, 2007)
Conjunctival provocation test and skin prick test with house dust mite allergen solutions [ Time Frame: about 1.5 hours on 4 occasions over 1 year ]
Change History Complete list of historical versions of study NCT00574223 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 14, 2007)
Safety and tolerability of the study treatment by collection of adverse events [ Time Frame: about 30 min. at each visit ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Investigate an Immunomodulatory Therapy in Adult Patients With Perennial Allergic Rhinoconjunctivitis
Official Title  ICMJE 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
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Perennial Allergic Rhinoconjunctivitis
  • House Dust Mite Allergy
Intervention  ICMJE
  • Drug: CYT005-AllQbG10 (combination of house dust mite allergen extract with CYT003-QbG10)
    subcutaneous injections at 8 visits
  • Drug: House dust mite allergen extract in combination with CYT003-QbG10-placebo
    subcutaneous injections at 8 visits
Study Arms  ICMJE
  • Experimental: Arm 1
    Intervention: Drug: CYT005-AllQbG10 (combination of house dust mite allergen extract with CYT003-QbG10)
  • Placebo Comparator: Arm 2
    Intervention: Drug: House dust mite allergen extract in combination with CYT003-QbG10-placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: December 14, 2007)
100
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2009
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Mild to moderate perennial allergic rhinoconjunctivits due to hypersensitization towards house dust mite allergens

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00574223
Other Study ID Numbers  ICMJE CYT005-AllQbG10 04
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Philipp Mueller, MD, Head of Clinical Development, EVP, Cytos Biotechnology AG
Study Sponsor  ICMJE Cytos Biotechnology AG
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Philipp Mueller, MD Cytos Biotechnology
PRS Account Cytos Biotechnology AG
Verification Date April 2009

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