Dose Finding Study With CYT003-QbG10 in Patients With House Dust Mite Allergy

Phase 2

Completed

• Conditions: Rhinoconjunctivitis; Allergies
• Interventions: Drug: CYT003-QbG10; Drug: Placebo

• Registration Number: NCT00800332
• Lead Sponsor: Cytos Biotechnology AG

Brief Summary

The purpose of the study is to test whether vaccinations with CYT003-QbG10 can improve allergy symptoms in patients with house dust mite allergy. The active treatment will be compared against placebo.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11
• Study First Submitted: 2008-12-01
• Study First Submitted QC: 2008-12-01
• Study First Posted: 2008-12-02
• Primary Completion: 2010-04
• Status Verified: 2010-11
• Study Completion: 2010-11
• Last Update Submitted: 2010-11-11
• Last Update Posted: 2010-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Perennial allergic rhinoconjunctivitis due to clinically relevant allergy towards house dust mite allergens
• Further criteria as defined in the study protocol

Exclusion Criteria

• Clinically manifested seasonal allergy/-ies which is/are expected to interfere with the patient's study treatment schedule and/or assessments
• Clinically relevant perennial allergy/-ies other than house dust mites allergy
• Contraindication to any study test or procedure
• Further criteria as defined in the study protocol

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Rhinoconjunctivitis symptom and medication scores	Pre- / Post-Treatment

Trial Locations

Locations (1)

Cytos Investigator Sites; 🇷🇴 Targu Mures, Bukarest, Craiova, Iasi, Romania