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

Rhinoconjunctivitis Clinical Trial

Official title:

Double-blind, Placebo-controlled Dose-finding Study With CYT003-QbG10 in Adult Patients With Rhinoconjunctivitis Due to House Dust Mite Allergy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00800332
• Other study ID #: CYT003-QbG10 09
• Status: Completed
• Phase: Phase 2
• First received: December 1, 2008
• Last updated: November 11, 2010
• Start date: November 2008
• Est. completion date: November 2010

Study information

• Verified date: November 2010
• Source: Cytos Biotechnology AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Estonia: The State Agency of Medicine
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: November 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Allergies
• Conjunctivitis
• Hypersensitivity
• Rhinoconjunctivitis

Intervention

Drug:
• CYT003-QbG10
subcutaneous injection
• Placebo
subcutaneous injection

Locations

Country	Name	City	State
Estonia	Cytos Investigator Sites	Paide, Tartu, Tallin, Rakvere
Germany	Cytos Investigator Sites	Fulda, Dresden, Ulm, Rodgau, Kassel, Eisenach
Germany	Cytos Investigator Sites	Wiesbaden, Frankfurt/M, Leipzig, Jena, Hamburg, Dulmen
Greece	Cytos Investigator Sites	N. Faliro, Hiraklion, Athens
Latvia	Cytos Investigator Sites	Riga, Rezekne
Lithuania	Cytos Investigator Sites	Vilnius, Kaunas, Klaipeda
Romania	Cytos Investigator Sites	Galati, Cluj Napoca, Bahia Mare, Brasov, Piesti
Romania	Cytos Investigator Sites	Targu Mures, Bukarest, Craiova, Iasi

Sponsors (1)

Lead Sponsor	Collaborator
Cytos Biotechnology AG

Countries where clinical trial is conducted

Estonia,  Germany,  Greece,  Latvia,  Lithuania,  Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rhinoconjunctivitis symptom and medication scores		Pre- / Post-Treatment	No