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

Phase 2

Completed

• Conditions: Perennial Allergy to House Dust Mite and/or Cat
• Interventions: Drug: CYT003-QbG10

• Registration Number: NCT00575003
• Lead Sponsor: Cytos Biotechnology AG

Brief Summary

The purpose of the study is to test the efficacy of a vaccine against house dust mite and/or cat allergy compared to placebo in adult patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-12
• 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: 64

Inclusion Criteria

• Mild to moderate perennial allergic rhinoconjunctivitis due to hypersensitization towards house dust mite and/or cat allergens

Exclusion Criteria

• Clinical 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.
• Any clinically relevant concomitant disease as judged by the investigator.
• Pregnancy or female planning to become pregnant during the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	CYT003-QbG10	-
2	CYT003-QbG10	-

Primary Outcome Measures

Name	Time	Method
Conjunctival provocation test with allergen and rhinoconjunctivitis symptoms in daily life	on 4 occations over 1 year

Secondary Outcome Measures

Name	Time	Method
Safety and tolerability of the vaccine by collection of adverse events	at each visit

Trial Locations

Locations (7)

Tartu University Clinic, Lungs Clinic; 🇪🇪 Tartu, Estonia

The centre of the investigation in treatment of allergic disease; 🇱🇻 Riga, Latvia

Kaunas Medical University Hospital, Department of Pulmonology and Immunology; 🇱🇹 Kaunas, Lithuania

SNC Uniclinica; 🇱🇻 Riga, Latvia

Kaunas County Hospital, Department of Pulmonology and Allergology; 🇱🇹 Kaunas, Lithuania

Tartu University Clinic, Out-Patients Department; 🇪🇪 Tartu, Estonia

Vilnius University Hospital, Centre of Pulmonology and Allergology; 🇱🇹 Vilnius, Lithuania