CYT003 in Patients With Mild to Moderate Allergic Asthma Not Sufficiently Controlled on Inhaled Glucocorticosteroids
NCT ID: NCT02087644
Last Updated: 2014-05-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE2
INTERVENTIONAL
2014-05-31
Brief Summary
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Altogether 170 patients, randomized to two treatment groups will be included. Key outcome measures are patient reported parameters on their asthma
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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CYT003
Injections of CYT003
CYT003
Injections
Placebo
Injections of placebo
Placebo
Injections
Interventions
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CYT003
Injections
Placebo
Injections
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
65 Years
ALL
No
Sponsors
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Cytos Biotechnology AG
INDUSTRY
Responsible Party
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Principal Investigators
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Thomas Casale, MD
Role: PRINCIPAL_INVESTIGATOR
University of South Florida
Locations
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University of South Florida
Tampa, Florida, United States
Countries
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Other Identifiers
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CYT003-QbG10 13
Identifier Type: -
Identifier Source: org_study_id
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