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

This study has been completed.
Sponsor:
Information provided by:
Cytos Biotechnology AG
ClinicalTrials.gov Identifier:
NCT00574223
First received: December 14, 2007
Last updated: April 24, 2009
Last verified: April 2009

December 14, 2007
April 24, 2009
November 2007
March 2009   (final data collection date for primary outcome measure)
Conjunctival provocation test with allergen and rhinoconjunctivitis symptoms in daily life [ Time Frame: about 1.5 hours on 4 occasions over 1 year ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00574223 on ClinicalTrials.gov Archive Site
Safety and tolerability of the study treatment by collection of adverse events [ Time Frame: about 30 min. at each visit ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study to Investigate an Immunomodulatory Therapy in Adult Patients With Perennial Allergic Rhinoconjunctivitis
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

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

Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Perennial Allergic Rhinoconjunctivitis
  • House Dust Mite Allergy
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
March 2009
March 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT00574223
CYT005-AllQbG10 04
Not Provided
Philipp Mueller, MD, Head of Clinical Development, EVP, Cytos Biotechnology AG
Cytos Biotechnology AG
Not Provided
Study Director: Philipp Mueller, MD Cytos Biotechnology
Cytos Biotechnology AG
April 2009

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