NCT00652223

Brief Summary

The purpose of the study is to test the safety, tolerability, immunogenicity and clinical efficacy of the combination treatment AllQbG10 in patients with rhino-conjunctivitis and asthma due to house dust mite allergy in a single-center, open-label setting.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Mar 2005

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2005

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2005

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

April 1, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 3, 2008

Completed
Last Updated

April 9, 2008

Status Verified

April 1, 2008

First QC Date

April 1, 2008

Last Update Submit

April 4, 2008

Conditions

Perennial Allergic RhinoconjunctivitisAllergic Asthma

Study Arms (1)

1

EXPERIMENTAL
Biological: CYT005-AllQbG10

Interventions

CYT005-AllQbG10BIOLOGICAL

Immunomodulator CYT003-QbG10 in combination with commercial house dust mite extract as used for routine SIT

1

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Mild to moderate perennial allergic rhinoconjunctivitis due to sensitization against house dust mites
  • Mild asthma
  • Females only if non-reproductive or agree to practice an effective and accepted method of contraception

You may not qualify if:

  • Relevant cardiovascular, renal, pulmonary or endocrine disease
  • History of autoimmune disease
  • Severe allergies
  • History of active infectious disease
  • Current diagnosis or history of malignancy
  • Relevant neurological or psychiatric disorder
  • Pregnancy or lactation
  • History of alcohol abuse or other recreational drugs
  • Use of an investigational drug within three month before enrolment
  • Blood donation within 30 days before enrolment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Zurich, Department of Dermatology

Zurich, Canton of Zurich, 8091, Switzerland

Location

Study Officials

  • Philipp Mueller, MD

    Cytos Biotechnology AG

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 1, 2008

First Posted

April 3, 2008

Study Start

March 1, 2005

Study Completion

November 1, 2005

Last Updated

April 9, 2008

Record last verified: 2008-04

Locations

CH(1)