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

NCT ID: NCT00800332

Last Updated: 2010-11-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2010-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Rhinoconjunctivitis Allergies

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Rhinoconjunctivitis due to house dust mite allergy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Group Type EXPERIMENTAL

CYT003-QbG10

Intervention Type DRUG

subcutaneous injection

2

Group Type EXPERIMENTAL

CYT003-QbG10

Intervention Type DRUG

subcutaneous injection

3

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

subcutaneous injection

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

CYT003-QbG10

subcutaneous injection

Intervention Type DRUG

Placebo

subcutaneous injection

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Cytos Biotechnology AG

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Cytos Biotechnology

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Cytos Investigator Sites

Paide, Tartu, Tallin, Rakvere, , Estonia

Site Status

Cytos Investigator Sites

Fulda, Dresden, Ulm, Rodgau, Kassel, Eisenach, , Germany

Site Status

Cytos Investigator Sites

Wiesbaden, Frankfurt/M, Leipzig, Jena, Hamburg, Dulmen, , Germany

Site Status

Cytos Investigator Sites

N. Faliro, Hiraklion, Athens, , Greece

Site Status

Cytos Investigator Sites

Riga, Rezekne, , Latvia

Site Status

Cytos Investigator Sites

Vilnius, Kaunas, Klaipeda, , Lithuania

Site Status

Cytos Investigator Sites

Galati, Cluj Napoca, Bahia Mare, Brasov, Piesti, , Romania

Site Status

Cytos Investigator Sites

Targu Mures, Bukarest, Craiova, Iasi, , Romania

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Estonia Germany Greece Latvia Lithuania Romania

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 21672053 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CYT003-QbG10 09

Identifier Type: -

Identifier Source: org_study_id