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

Primary Purpose

Rhinoconjunctivitis, Allergies

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
CYT003-QbG10
Placebo
Sponsored by
Cytos Biotechnology AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rhinoconjunctivitis focused on measuring Rhinoconjunctivitis due to house dust mite allergy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cytos Investigator Sites
  • Cytos Investigator Sites
  • Cytos Investigator Sites
  • Cytos Investigator Sites
  • Cytos Investigator Sites
  • Cytos Investigator Sites
  • Cytos Investigator Sites
  • Cytos Investigator Sites

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

1

2

3

Arm Description

Outcomes

Primary Outcome Measures

Rhinoconjunctivitis symptom and medication scores

Secondary Outcome Measures

Full Information

First Posted
December 1, 2008
Last Updated
November 11, 2010
Sponsor
Cytos Biotechnology AG
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1. Study Identification

Unique Protocol Identification Number
NCT00800332
Brief Title
Dose Finding Study With CYT003-QbG10 in Patients With House Dust Mite Allergy
Official Title
Double-blind, Placebo-controlled Dose-finding Study With CYT003-QbG10 in Adult Patients With Rhinoconjunctivitis Due to House Dust Mite Allergy
Study Type
Interventional

2. Study Status

Record Verification Date
November 2010
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
November 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Cytos Biotechnology AG

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rhinoconjunctivitis, Allergies
Keywords
Rhinoconjunctivitis due to house dust mite allergy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Experimental
Arm Title
3
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
CYT003-QbG10
Intervention Description
subcutaneous injection
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
subcutaneous injection
Primary Outcome Measure Information:
Title
Rhinoconjunctivitis symptom and medication scores
Time Frame
Pre- / Post-Treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Cytos Investigator Sites
City
Paide, Tartu, Tallin, Rakvere
Country
Estonia
Facility Name
Cytos Investigator Sites
City
Fulda, Dresden, Ulm, Rodgau, Kassel, Eisenach
Country
Germany
Facility Name
Cytos Investigator Sites
City
Wiesbaden, Frankfurt/M, Leipzig, Jena, Hamburg, Dulmen
Country
Germany
Facility Name
Cytos Investigator Sites
City
N. Faliro, Hiraklion, Athens
Country
Greece
Facility Name
Cytos Investigator Sites
City
Riga, Rezekne
Country
Latvia
Facility Name
Cytos Investigator Sites
City
Vilnius, Kaunas, Klaipeda
Country
Lithuania
Facility Name
Cytos Investigator Sites
City
Galati, Cluj Napoca, Bahia Mare, Brasov, Piesti
Country
Romania
Facility Name
Cytos Investigator Sites
City
Targu Mures, Bukarest, Craiova, Iasi
Country
Romania

12. IPD Sharing Statement

Citations:
PubMed Identifier
21672053
Citation
Klimek L, Willers J, Hammann-Haenni A, Pfaar O, Stocker H, Mueller P, Renner WA, Bachmann MF. Assessment of clinical efficacy of CYT003-QbG10 in patients with allergic rhinoconjunctivitis: a phase IIb study. Clin Exp Allergy. 2011 Sep;41(9):1305-12. doi: 10.1111/j.1365-2222.2011.03783.x. Epub 2011 Jun 14.
Results Reference
derived

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

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