CYT003-QbG10, a TLR9-agonist, for Treatment of Uncontrolled Moderate to Severe Allergic Asthma

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Cytos Biotechnology AG
ClinicalTrials.gov Identifier:
NCT01673672
First received: August 23, 2012
Last updated: November 20, 2013
Last verified: November 2013
  Purpose

The purpose of this study is to assess the therapeutic potential and safety/tolerability of study drug (CYT003) at 3 dose levels versus placebo in patients with persistent moderate to severe allergic asthma not sufficiently controlled on current standard controller therapy.

Altogether 360 patients randomized to 4 treatment groups will be included. The study compares three dose strength with placebo. Each patient receives 7 injections of study drug or undistinguishable placebo. Key outcome measures are patient reported parameters on their asthma.


Condition Intervention Phase
Moderate to Severe Allergic Asthma
Biological: CYT003
Biological: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Placebo-Controlled, Phase IIb Dose-Finding Study of CYT003-QbG10, a TLR9-Agonist, in Patients With Moderate to Severe Allergic Asthma Not Sufficiently Controlled on Current Standard Therapy (GINA Steps 3+4)

Resource links provided by NLM:


Further study details as provided by Cytos Biotechnology AG:

Primary Outcome Measures:
  • Asthma Control Questionnaire [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 360
Study Start Date: November 2012
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
7 weekly/biweekly injections of a placebo buffer
Biological: Placebo
7 subcutaneous injections, weekly/biweekly within 10 weeks
Experimental: CYT003 low dose
7 weekly/biweekly injections of CYT003 low dose
Biological: CYT003
7 subcutaneous injections, weekly/biweekly within 10 weeks
Experimental: CYT003 medium dose
7 weekly/biweekly injections of CYT003 medium dose
Biological: CYT003
7 subcutaneous injections, weekly/biweekly within 10 weeks
Experimental: CYT003 high dose
7 weekly/biweekly injections of CYT003 high dose
Biological: CYT003
7 subcutaneous injections, weekly/biweekly within 10 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Able and willing to provide written informed consent
  • Able and willing to complete all protocol requirements
  • Between 18 to 65 years of age
  • Presence of persistent asthma for at least 6 months according to GINA 2011 guidelines at step 3 or 4 of treatment who has been on stable controller therapy for at least 4 weeks, and symptoms are not sufficiently controlled with medium to high doses of inhaled corticosteroid (ICS) (>250 to ≤1000 µg/day fluticasone or equivalent) in combination with or without long acting beta agonist (LABA), insufficient control will be based on asthma control questionnaire (ACQ) score ≥1.5 points. Use of stable doses of other controller therapies according to GINA steps 3 and 4 (leukotriene modifiers, sustained release theophylline) are also acceptable, but NOT treatment with anti immunoglobulin E (IgE) antibodies within the past 6 months
  • Stable but insufficiently controlled baseline conditions as documented by ACQ ≥1.5 at the screening and the baseline visits.
  • Positive skin prick test (SPT) or radioallergosorbent test (RAST) to at least 1 aero-allergen during the screening period
  • Forced expiratory volume in one second (FEV1)≥40 to ≤90% of predicted value
  • Reversibility of airway obstruction as demonstrated by:

    • FEV1 improvement by >12% , and
    • By ≥200 mL after inhaled β2-agonist (400 µg salbutamol or equivalent). If a subject does not meet reversibility criteria at the screening visit, reversibility may be retested once prior to run-in as long as the test is performed at least 5 days prior to the beginning of the run-in phase

Exclusion Criteria:

  • Failure to meet at least 80% compliance with completion of asthma symptoms and medication diaries at the baseline visit, after initial instruction at the screening visit and where necessary additional training at the 2-weeks run-in visit. . An additional maximum 2-weeks training period may be added in such patients.
  • Treatment or hospitalization for asthma exacerbation within past 2 months.
  • Current use or use of systemic corticosteroids within past 2 months.
  • Current smokers.
  • Ex-smokers with a smoking history of >10 pack years (1 package per day for 10 years).
  • Pregnancy or female planning to become pregnant during the study period.
  • Ongoing or planned specific immunotherapy (SIT) during the whole study period or SIT completed within the last 3 years.
  • Treatment with IgE antibodies (Xolair®) within past 6 months.
  • Use of investigational unapproved drugs within 30 days or within 5 half-lives of the investigational drug, whichever is longer, or planned use during the whole study period.
  • Use of investigational biologics within the last 6 months.
  • Previous participation in a clinical study with a virus like particle (VLP) Qb-based vaccine.
  • Possible dependency of the patient on sponsor and/or investigator.
  • Women of child bearing potential
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01673672

  Show 34 Study Locations
Sponsors and Collaborators
Cytos Biotechnology AG
Investigators
Study Chair: Thomas B Casale, Professor Creighton University, Omaha (NE)
  More Information

No publications provided

Responsible Party: Cytos Biotechnology AG
ClinicalTrials.gov Identifier: NCT01673672     History of Changes
Other Study ID Numbers: CYT003-QbG10 12, 2012-003070-39
Study First Received: August 23, 2012
Last Updated: November 20, 2013
Health Authority: United States: Food and Drug Administration
Germany: Paul-Ehrlich-Institut

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on April 16, 2014