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

NCT00574223 — Phase 2, Completed, 100 participants, Cytos Biotechnology AG

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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

Registry	NCT00574223
Status	Completed
Phase	Phase 2
Study type	Interventional; randomized, parallel, masking: quadruple, treatment
Enrollment	100 (Estimated)
Sponsor	Cytos Biotechnology AG (Industry)
Conditions	Perennial Allergic Rhinoconjunctivitis, House Dust Mite Allergy
Interventions	CYT005-AllQbG10 (combination of house dust mite allergen extract with CYT003-QbG10), House dust mite allergen extract in combination with CYT003-QbG10-placebo (Drug)
Dates	start 2007-11-01, primary completion 2009-03-01, completion 2009-03-01, first posted 2007-12-17, last updated 2009-04-27
Locations	1 site in Switzerland

-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

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+Arms and interventions

Arm	Type	Interventions	Description
Arm 1	Experimental	Drug: CYT005-AllQbG10 (combination of house dust mite allergen extract with CYT003-QbG10)
Arm 2	Placebo comparator	Drug: House dust mite allergen extract in combination with CYT003-QbG10-placebo

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

+Outcome measures

Primary outcomes

Conjunctival provocation test with allergen and rhinoconjunctivitis symptoms in daily life [about 1.5 hours on 4 occasions over 1 year]

Secondary outcomes

Safety and tolerability of the study treatment by collection of adverse events [about 30 min. at each visit]

+Eligibility

Sex: All, ages: 18 Years to 65 Years

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

+Locations (1)

Facility	City	Country	Status
Cytos Biotechnology (Sponsor's Headquarter)	Schlieren	Switzerland

+Investigators

Philipp Mueller, MD, Study director, Cytos Biotechnology