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

House Dust Mite Allergy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00574223
• Other study ID #: CYT005-AllQbG10 04
• Status: Completed
• Phase: Phase 2
• First received: December 14, 2007
• Last updated: April 24, 2009
• Start date: November 2007
• Est. completion date: March 2009

Study information

• Verified date: April 2009
• Source: Cytos Biotechnology AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Paul-Ehrlich-Institut
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Conjunctivitis
• Conjunctivitis, Allergic
• House Dust Mite Allergy
• Perennial Allergic Rhinoconjunctivitis

Intervention

Drug:
• CYT005-AllQbG10 (combination of house dust mite allergen extract with CYT003-QbG10)
subcutaneous injections at 8 visits
• House dust mite allergen extract in combination with CYT003-QbG10-placebo
subcutaneous injections at 8 visits

Locations

Country	Name	City	State
Switzerland	Cytos Biotechnology (Sponsor's Headquarter)	Schlieren

Sponsors (1)

Lead Sponsor	Collaborator
Cytos Biotechnology AG

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Conjunctival provocation test with allergen and rhinoconjunctivitis symptoms in daily life		about 1.5 hours on 4 occasions over 1 year	No
Secondary	Safety and tolerability of the study treatment by collection of adverse events		about 30 min. at each visit	No