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

• Sponsor: Cytos Biotechnology AG (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00800332
• Collaborator: (none)
• Enrollment: 300
• Locations: 8
• Arms: 3
• Duration (Months): 24
• Patients Per Site: 37.5
• Patients Per Site Per Month: 1.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Rhinoconjunctivitis; Allergies	Drug: CYT003-QbG10; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 300 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Double-blind, Placebo-controlled Dose-finding Study With CYT003-QbG10 in Adult Patients With Rhinoconjunctivitis Due to House Dust Mite Allergy
• Study Start Date: Nov 1, 2008
• Actual Primary Completion Date: Apr 1, 2010
• Actual Study Completion Date: Nov 1, 2010

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Rhinoconjunctivitis symptom and medication scores [Pre- / Post-Treatment]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

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

Sponsors and Collaborators

• Cytos Biotechnology AG

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00800332
• Other Study ID Numbers: CYT003-QbG10 09
• First Posted: Dec 2, 2008
• Last Update Posted: Nov 15, 2010
• Last Verified: Nov 1, 2010

• Keywords provided by , ,: Rhinoconjunctivitis due to house dust mite allergy
• Additional relevant MeSH terms: Conjunctivitis; Hypersensitivity

Study Results

No Results Posted as of Nov 15, 2010