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

Phase 2

Completed

• Conditions: Perennial Allergic Rhinoconjunctivitis; House Dust Mite Allergy
• Interventions: Drug: CYT005-AllQbG10 (combination of house dust mite allergen extract with CYT003-QbG10); Drug: House dust mite allergen extract in combination with CYT003-QbG10-placebo

• Registration Number: NCT00574223
• Lead Sponsor: Cytos Biotechnology AG

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 available

Study Timeline

• Study Start: 2007-11
• Study First Submitted: 2007-12-14
• Study First Submitted QC: 2007-12-14
• Study First Posted: 2007-12-17
• Primary Completion: 2009-03
• Study Completion: 2009-03
• Status Verified: 2009-04
• Last Update Submitted: 2009-04-24
• Last Update Posted: 2009-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	CYT005-AllQbG10 (combination of house dust mite allergen extract with CYT003-QbG10)	-
Arm 2	House dust mite allergen extract in combination with CYT003-QbG10-placebo	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Safety and tolerability of the study treatment by collection of adverse events	about 30 min. at each visit

Trial Locations

Locations (1)

Cytos Biotechnology (Sponsor's Headquarter); 🇨🇭 Schlieren, Switzerland