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CYT003 in Patients With Mild to Moderate Allergic Asthma Not Sufficiently Controlled on Inhaled Glucocorticosteroids

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ClinicalTrials.gov Identifier: NCT02087644
Recruitment Status : Withdrawn (Sponsor decision)
First Posted : March 14, 2014
Last Update Posted : May 14, 2014
Sponsor:
Information provided by (Responsible Party):
Cytos Biotechnology AG

Brief Summary:

A phase IIb study in patients to evaluate CYT003- QbG10 versus placebo, in patients with mild to moderate allergic asthma not sufficiently controlled on inhaled steroid.

Altogether 170 patients, randomized to two treatment groups will be included. Key outcome measures are patient reported parameters on their asthma


Condition or disease Intervention/treatment Phase
Asthma Biological: CYT003 Biological: Placebo Phase 2

Detailed Description:

A phase IIb study in patients to evaluate CYT003- QbG10 versus placebo, in patients with mild to moderate allergic asthma not sufficiently controlled on inhaled steroid.

Altogether 170 patients, randomized to two treatment groups will be included. Key outcome measures are patient reported parameters on their asthma at the time of primary endpoint and throughout the study.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 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 Study of CYT003-QbG10 (CYT003), a TLR9 Agonist, in Patients With Mild to Moderate Allergic Asthma Not Sufficiently Controlled on Inhaled Glucocorticosteroids
Study Start Date : May 2014
Actual Primary Completion Date : May 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Experimental: CYT003
Injections of CYT003
Biological: CYT003
Injections

Placebo Comparator: Placebo
Injections of placebo
Biological: Placebo
Injections




Primary Outcome Measures :
  1. Asthma Control Questionnaire (ACQ) [ Time Frame: 12 weeks ]


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:

  1. Provide written informed consent.
  2. Complete all protocol requirements.
  3. Between 18 to 65 years of age.
  4. Persistent allergic asthma patients
  5. Forced expiratory volume in one second (FEV1) ≥60% to ≤ 90% of predicted value
  6. Reversibility of airway obstruction
  7. Patients meeting the contraception requirements
  8. At baseline: Patients treated with ICS and insufficiently controlled
  9. Blood eosinophil count above a certain level

Exclusion Criteria:

  1. Failure to meet at least 80% compliance of use of the patient e-diary/ peak expiratory flow (PEF) meter (AM3 device) at the baseline visit
  2. Treatment or hospitalization for asthma exacerbation within past 2 months
  3. Current use or use of systemic corticosteroids within past 2 months
  4. Current smokers.
  5. Ex-smokers for less than 1 year, with a tobacco smoking history of >10 pack years
  6. Major surgery within 3 months prior to signing the ICF or anticipated during study
  7. Presence or history of clinically relevant cardiovascular, renal, pulmonary (e.g. COPD), endocrine, autoimmune, dermatological, neurological, psychiatric, or ocular disease as judged by the investigator.
  8. Any malignancy within the previous 5 years
  9. Presence of suspicious lymphadenopathy or splenomegaly on physical examination.
  10. Confirmed or suspected current infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV).
  11. Presence of active infectious disease as judged by the investigator
  12. Active autoimmune diseases or prior diagnosis of autoimmune disease including but not limited to rheumatoid arthritis, lupus and ulcerative colitis.
  13. Pregnancy (based on positive urine test at screening visit) or lactation.
  14. Female planning to become pregnant during the study period.
  15. Patients with any history of abuse of alcohol or other recreational drugs.
  16. Ongoing or planned specific immunotherapy (SIT) during the whole study period or SIT completed within the last 3 years.
  17. BMI >40
  18. Use of investigational or approved biologics/immune-modulators within the last 6 months.

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): NCT02087644


Locations
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United States, Florida
University of South Florida
Tampa, Florida, United States, 33612-4799
Sponsors and Collaborators
Cytos Biotechnology AG
Investigators
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Principal Investigator: Thomas Casale, MD University of South Florida
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Responsible Party: Cytos Biotechnology AG
ClinicalTrials.gov Identifier: NCT02087644    
Other Study ID Numbers: CYT003-QbG10 13
First Posted: March 14, 2014    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