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

This study has been terminated.
(primary endpoint missed)
Sponsor:
Information provided by (Responsible Party):
Cytos Biotechnology AG
ClinicalTrials.gov Identifier:
NCT01673672
First received: August 23, 2012
Last updated: May 13, 2014
Last verified: May 2014
  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 ]

Enrollment: 365
Study Start Date: November 2012
Study Completion Date: May 2014
Primary Completion Date: May 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: May 13, 2014
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 September 18, 2014