Back to resultsCYT003 in Patients With Mild to Moderate Allergic Asthma Not Sufficiently Controlled on Inhaled Glucocorticosteroids
Primary Purpose
Asthma
Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
CYT003
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Asthma
Eligibility Criteria
Inclusion Criteria:
- Provide written informed consent.
- Complete all protocol requirements.
- Between 18 to 65 years of age.
- Persistent allergic asthma patients
- Forced expiratory volume in one second (FEV1) ≥60% to ≤ 90% of predicted value
- Reversibility of airway obstruction
- Patients meeting the contraception requirements
- At baseline: Patients treated with ICS and insufficiently controlled
- Blood eosinophil count above a certain level
Exclusion Criteria:
- 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
- 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 for less than 1 year, with a tobacco smoking history of >10 pack years
- Major surgery within 3 months prior to signing the ICF or anticipated during study
- 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.
- Any malignancy within the previous 5 years
- Presence of suspicious lymphadenopathy or splenomegaly on physical examination.
- Confirmed or suspected current infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV).
- Presence of active infectious disease as judged by the investigator
- Active autoimmune diseases or prior diagnosis of autoimmune disease including but not limited to rheumatoid arthritis, lupus and ulcerative colitis.
- Pregnancy (based on positive urine test at screening visit) or lactation.
- Female planning to become pregnant during the study period.
- Patients with any history of abuse of alcohol or other recreational drugs.
- Ongoing or planned specific immunotherapy (SIT) during the whole study period or SIT completed within the last 3 years.
- BMI >40
- Use of investigational or approved biologics/immune-modulators within the last 6 months.
Sites / Locations
- University of South Florida
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
CYT003
Placebo
Arm Description
Injections of CYT003
Injections of placebo
Outcomes
Primary Outcome Measures
Asthma Control Questionnaire (ACQ)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02087644
Brief Title
CYT003 in Patients With Mild to Moderate Allergic Asthma Not Sufficiently Controlled on Inhaled Glucocorticosteroids
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 Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Withdrawn
Why Stopped
Sponsor decision
Study Start Date
May 2014 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cytos Biotechnology AG
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CYT003
Arm Type
Experimental
Arm Description
Injections of CYT003
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Injections of placebo
Intervention Type
Biological
Intervention Name(s)
CYT003
Intervention Description
Injections
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Injections
Primary Outcome Measure Information:
Title
Asthma Control Questionnaire (ACQ)
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Provide written informed consent.
Complete all protocol requirements.
Between 18 to 65 years of age.
Persistent allergic asthma patients
Forced expiratory volume in one second (FEV1) ≥60% to ≤ 90% of predicted value
Reversibility of airway obstruction
Patients meeting the contraception requirements
At baseline: Patients treated with ICS and insufficiently controlled
Blood eosinophil count above a certain level
Exclusion Criteria:
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
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 for less than 1 year, with a tobacco smoking history of >10 pack years
Major surgery within 3 months prior to signing the ICF or anticipated during study
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.
Any malignancy within the previous 5 years
Presence of suspicious lymphadenopathy or splenomegaly on physical examination.
Confirmed or suspected current infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV).
Presence of active infectious disease as judged by the investigator
Active autoimmune diseases or prior diagnosis of autoimmune disease including but not limited to rheumatoid arthritis, lupus and ulcerative colitis.
Pregnancy (based on positive urine test at screening visit) or lactation.
Female planning to become pregnant during the study period.
Patients with any history of abuse of alcohol or other recreational drugs.
Ongoing or planned specific immunotherapy (SIT) during the whole study period or SIT completed within the last 3 years.
BMI >40
Use of investigational or approved biologics/immune-modulators within the last 6 months.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Casale, MD
Organizational Affiliation
University of South Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612-4799
Country
United States
12. IPD Sharing Statement
Learn more about this trial
CYT003 in Patients With Mild to Moderate Allergic Asthma Not Sufficiently Controlled on Inhaled Glucocorticosteroids
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