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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01673672
Recruitment Status : Terminated (primary endpoint missed)
First Posted : August 28, 2012
Last Update Posted : May 14, 2014
Sponsor:
Information provided by (Responsible Party):
Cytos Biotechnology AG

Brief Summary:

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 or disease Intervention/treatment Phase
Moderate to Severe Allergic Asthma Biological: CYT003 Biological: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 365 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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)
Study Start Date : November 2012
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Asthma Control Questionnaire [ Time Frame: 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01673672


Locations
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United States, California
Cytos Investigator Sites
Los Angeles, Huntington Beach, San Jose, California, United States
Cytos Investigator Sites
Walnut Creek, San Diego, Riverside, Fountain Valley, California, United States
United States, Colorado
Cytos Investigator Sites
Colorado Springs, Denver, Colorado, United States
United States, Connecticut
Cytos Investigator Sites
Waterbury, Connecticut, United States
United States, Florida
Cytos Investigator Sites
Miami, Tallahassee, Florida, United States
United States, Georgia
Cytos Investigator Sites
Albany, Georgia, United States
United States, Indiana
Cytos Investigator Sites
South Bend, Indiana, United States
United States, Louisiana
Cytos Investigator Sites
Metairie, Louisiana, United States
United States, Maine
Cytos Investigator Sites
Bangor, Maine, United States
United States, Maryland
Cytos Investigator Sites
Bethesda, Maryland, United States
United States, Massachusetts
Cytos Investigator Sites
North Dartmouth, Massachusetts, United States
United States, Missouri
Cytos Investigator Sites
St. Louis, Missouri, United States
United States, Nebraska
Cytos Investigator Sites
Ohmaha, Bellevue, Nebraska, United States
United States, New York
Cytos Investigator Sites
Rochester, New York, United States
United States, Ohio
Cytos Investigator Sites
Cincinnati, Ohio, United States
United States, Oklahoma
Cytos Investigator Sites
Oklahoma City, Oklahoma, United States
United States, Oregon
Cytos Investigator Sites
Eugene, Medford, Oregon, United States
United States, Rhode Island
Cytos Investigator Sites
Providence, Warwick, Rhode Island, United States
United States, South Carolina
Cytos Investigator Sites
Spartanburg, Summerville, South Carolina, United States
United States, Texas
Cytos Investigator Sites
San Antonio, Texas, United States
United States, Virginia
Cytos Investigator Sites
Richmond, Virginia, United States
Czech Republic
Cytos Investigator Sites
Kyjov, Czech Republic
Cytos Investigator Sites
Olomouc, Praha, Tabor, Ostrava, Hradec Kralove, Plzen, Brno, Czech Republic
Germany
Cytos Investigator Sites
Bad Woerishofen, Leipzig, Magdeburg, Germany
Cytos Investigator Sites
Frankfurt aM, Delitzsch, Bonn, Berlin, Ruedersdorf, Germany
Hungary
Cytos Investigator Sites
Szazhalombatta, Komaron, Hungary
Cytos Investigator Sites
Tatabanya, Szombathely, Csorna, Budapest, Balassagyarmat, Hungary
Israel
Cytos Investigator Sites
Haifa, Zerifin, Israel
Cytos Investigator Sites
Rehovot, Petach Tikva, Ramat Gan, Jerusalem, Ashkelon, Afula, Israel
Poland
Cytos Investigator Sites
Slupsk, Lodz, Tarnow, Pila, Poznan, Wroclaw, Poland
Russian Federation
Cytos Investigator Sites
Ekaterinburg, Russian Federation
Cytos Investigator Sites
Tomsk,St.Petersburg,Yaroslavl,Novosibirsk,Smolensk,Barnaul, Russian Federation
Ukraine
Cytos Investigator Sites
Donetsk, Kharkiv, Kiew, Chernivtsi, Zaporizhzhya, Mykolayiv, Ukraine
Cytos Investigator Sites
Vinnytsya, Ivano-Frankivsk, Ukraine
Sponsors and Collaborators
Cytos Biotechnology AG
Investigators
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Study Chair: Thomas B Casale, Professor Creighton University, Omaha (NE)
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Responsible Party: Cytos Biotechnology AG
ClinicalTrials.gov Identifier: NCT01673672    
Other Study ID Numbers: CYT003-QbG10 12
2012-003070-39 ( EudraCT Number )
First Posted: August 28, 2012    Key Record Dates
Last Update Posted: May 14, 2014
Last Verified: May 2014
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases