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

November 11, 2010 updated by: Cytos Biotechnology AG

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: CYT003-QbG10
subcutaneous injection
Experimental: 2
Drug: CYT003-QbG10
subcutaneous injection
Placebo Comparator: 3
Drug: Placebo
subcutaneous injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rhinoconjunctivitis symptom and medication scores
Time Frame: Pre- / Post-Treatment
Pre- / Post-Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cytos Biotechnology AG

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Actual)

April 1, 2010

Study Completion (Actual)

November 1, 2010

Study Registration Dates

First Submitted

December 1, 2008

First Submitted That Met QC Criteria

December 1, 2008

First Posted (Estimate)

December 2, 2008

Study Record Updates

Last Update Posted (Estimate)

November 15, 2010

Last Update Submitted That Met QC Criteria

November 11, 2010

Last Verified

November 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CYT003-QbG10 09

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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