NCT00890734

Brief Summary

The purpose of the study is to test whether treatment with CYT003-QbG10 can improve asthma symptoms in patients with allergic bronchial asthma. The active treatment will be compared against placebo.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
63

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Apr 2009

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

April 28, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 30, 2009

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
Last Updated

February 13, 2012

Status Verified

February 1, 2012

Enrollment Period

1 year

First QC Date

April 28, 2009

Last Update Submit

February 10, 2012

Conditions

Allergic Bronchial Asthma

Outcome Measures

Primary Outcomes (1)

  • Markers for inflammation and asthma

    1-3 months

Study Arms (2)

1

EXPERIMENTAL
Drug: CYT003-QbG10

2

PLACEBO COMPARATOR
Drug: Placebo

Interventions

CYT003-QbG10DRUG

subcutaneous injection

1
PlaceboDRUG

subcutaneous injection

2

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Persistent allergic asthma bronchial requiring long-term treatment with inhaled corticosteroids
  • Further criteria as defined in the study protocol

You may not qualify if:

  • Use of oral corticosteroids within past 3 months
  • Hospitalization for asthma exacerbation within past 6 months
  • Uncontrolled asthma
  • Contraindication to any study test or procedure
  • Further criteria as defined in the study protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cytos Investigator Sites

Luebeck, Berlin, Wiesbaden, Rodgau, Eisenach, Germany

Location

Related Publications (1)

  • Beeh KM, Kanniess F, Wagner F, Schilder C, Naudts I, Hammann-Haenni A, Willers J, Stocker H, Mueller P, Bachmann MF, Renner WA. The novel TLR-9 agonist QbG10 shows clinical efficacy in persistent allergic asthma. J Allergy Clin Immunol. 2013 Mar;131(3):866-74. doi: 10.1016/j.jaci.2012.12.1561. Epub 2013 Feb 4.

    PMID: 23384679DERIVED

MeSH Terms

Interventions

CYT003-QbG10

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 28, 2009

First Posted

April 30, 2009

Study Start

April 1, 2009

Primary Completion

April 1, 2010

Study Completion

November 1, 2010

Last Updated

February 13, 2012

Record last verified: 2012-02

Locations

DE(1)