- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02937168
An Imaging Study Using PET/CT to Characterize the Effect of Intravenous Reslizumab on Airway Inflammation (DEAR)
Distribution of Eosinophils in Asthma After Reslizumab (DEAR). A 7-Week, Placebo-Controlled, Double-Blinded, Parallel-Group, Imaging Study Using Positron Emission Tomography/Computer Tomography (PET/CT) to Characterize the Effect of Intravenous Reslizumab on Airway Inflammation in Patients With Eosinophilic Asthma
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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New Jersey
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New Brunswick, New Jersey, United States, 08901
- Teva Investigational Site 13808
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Male or female, 18 through 50 years of age.
- Females that are either surgically sterile, are 2 years postmenopausal, or have a negative pregnancy test at screening.
- Females of childbearing potential (not surgically sterile or 2 years postmenopausal), have to use a medically accepted method of contraception and have to agree to continue to use of this method for the duration of the study and for 5 months after study drug administration.
- Participants with less that 10-pack year history of smoking.
- Have a previous diagnosis of asthma.
- Participants taking inhaled fluticasone at a dosage of at least 440 micrograms (mcg) daily, or equivalent.
- The participant's baseline asthma therapy must be stable for 30 days prior to screening and judged by their treating physician to be able to continue without dosage changes throughout the study.
Participants with a blood eosinophil level of at least 400 cells/microliter (cells/μL) at screening. Participants with a blood eosinophil level below 400 cells/μL will be given 2 additional screening opportunities to determine blood eosinophil levels.
- Additional criteria apply; please contact the investigator for more information.
Exclusion Criteria:
- Participants requiring treatment with oral, intramuscular, or IV corticosteroids within 6 weeks of the Part 1 baseline visit for an asthma exacerbation.
- Participants with any other confounding underlying lung disorder including but not limited to: bronchiectasis, chronic obstructive pulmonary disorder, smoking greater than or equal to (≥)10 pack year history, pulmonary fibrosis, emphysema, cystic fibrosis, and lung cancer.
- Participants diagnosed with diabetes mellitus.
- Participants with pulmonary conditions and blood eosinophilia other than eosinophilic asthma.
- Participants with clinically meaningful comorbidity that can interfere with the study schedule or procedures, or compromise the participant's safety.
- Participants that are current smokers (that is, have smoked within the last 12 months prior to screening).
Participants using systemic immunosuppressive, immunomodulating, or other biologic agents (including, but not limited to, anti-IgE mAb, methotrexate, cyclosporin, interferon-α, or anti-tumor necrosis factor mAb) within 6 months prior to screening. Participants whose treatment with anti-IgE mAb therapy (omalizumab) is considered ineffective by their physician may be included as potential participants when:
- The omalizumab (Xolair) therapy has been discontinued.
- The participant's blood eosinophil level meets inclusion criteria.
Participants who have previously received an anti-hIL-5 mAb (for example, reslizumab, mepolizumab [Nucala]) or anti-IL-5 receptor mAb (eg, benralizumab). Participants whose treatment with mepolizumab or benralizumab is considered ineffective by their physician may be included as potential participants when:
- The mepolizumab or benralizumab therapy has been discontinued.
- The participant's blood eosinophil level meets inclusion criteria.
- Participants who had concurrent infection or disease that may preclude assessment of active asthma.
- Participants with a history of concurrent immunodeficiency (human immunodeficiency virus or acquired immunodeficiency syndrome or congenital immunodeficiency).
- Participants that had an active parasitic infection within 6 months prior to screening.
- Participants with any disorder that may interfere with drug absorption, distribution, metabolism, or excretion (including gastrointestinal surgery).
- Known hypersensitivity to study drug or to FDG/contrast agents
- Treatment with metformin.
Compromised renal function.
- Additional criteria apply; please contact the investigator for more information.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: Part 1: PET/CT Scan
Healthy participants will have 2 PET/CT scan in Part 1: within 7 days of eligibility being confirmed, and 7 days after the first PET/CT scan.
Participants will receive Fluorodeoxyglucose F-18 (FDG) as part of the PET/CT procedures and will provide sputum/blood samples.
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FDG will be administered by IV infusion prior to each PET/CT scan.
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EXPERIMENTAL: Part 2: Reslizumab
Reslizumab 3.0 milligrams/kilogram (mg/kg) will be administered by intravenous (IV) infusion, over 20 to 50 minutes, at Baseline (Day 1) of Part 2. PET/CT scan will be done on Weeks 2, 4 and 6.
Participants will receive FDG as part of the PET/CT procedures and will provide sputum/blood samples.
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FDG will be administered by IV infusion prior to each PET/CT scan.
Reslizumab will be administered as per the dose and schedule specified in the arm.
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PLACEBO_COMPARATOR: Part 2: Placebo
Matching placebo will be administered by IV infusion at Baseline (Day 1) of Part 2. PET/CT scan will be done on Weeks 2, 4 and 6.
Participants will receive FDG as part of the PET/CT procedures and will provide sputum/blood samples.
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FDG will be administered by IV infusion prior to each PET/CT scan.
Placebo matching to reslizumab will be administered as per the schedule specified in the arm.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Part 1: Average Global Lung Glycolysis (GLG) at Baseline (Day 1)
Time Frame: Baseline (Day 1) of Part 1
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GLG is the total FDG uptake in the whole lung.
A region of interest (ROI) was drawn around lung boundary in each axial slice.
Standardized uptake value (SUV) mean and area of each ROI was recorded.
Using the formula: area*slice thickness the volume of each slice was calculated.
Then the SUVmean of each slice was multiplied by the volume of the corresponding slice, which represented the total FDG uptake in one slice.
This number for each slice was summed together to provide GLG of that lung.
Average between GLG of right lung and GLG of left lung was reported.
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Baseline (Day 1) of Part 1
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Part 1: Average Global Lung Glycolysis (GLG) at Day 8
Time Frame: Day 8
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GLG is the total FDG uptake in the whole lung.
ROI was drawn around lung boundary in each axial slice.
SUV mean and area of each ROI was recorded.
Using the formula: area*slice thickness the volume of each slice was calculated.
Then the SUVmean of each slice was multiplied by the volume of the corresponding slice, which represented the total FDG uptake in one slice.
This number for each slice was summed together to provide GLG of that lung.
Average between GLG of right lung and GLG of left lung was reported.
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Day 8
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Part 2: Change From Baseline to Week 4 in GLG
Time Frame: Baseline, Week 4
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Baseline, Week 4
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Part 2: Change From Baseline to Week 4 in Lung Parenchyma (LP) SUV Mean
Time Frame: Baseline, Week 4
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Baseline, Week 4
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Part 2: Change From Baseline to Week 4 in Blood Eosinophil Counts
Time Frame: Baseline, Week 4
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Baseline, Week 4
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Change From Baseline to Week 4 in Forced Expiratory Volume in 1 Second (FEV1)
Time Frame: Baseline, Week 4
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Baseline, Week 4
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Change From Baseline to Week 4 in Fractional Exhaled Nitric Oxide (FeNO)
Time Frame: Baseline, Week 4
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Baseline, Week 4
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Change From Baseline to Week 4 in Asthma Quality of Life Questionnaire (AQLQ) Score
Time Frame: Baseline, Week 4
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Baseline, Week 4
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Number of Participants With Adverse Events (AEs)
Time Frame: 21 days
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An AE was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug.
SAEs included death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized the participant and required medical intervention to prevent 1 of the outcomes listed in this definition.
A summary of serious and non-serious AEs regardless of causality is located in 'Reported Adverse Events module'.
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21 days
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Respiratory Tract Diseases
- Immune System Diseases
- Lung Diseases
- Hypersensitivity, Immediate
- Bronchial Diseases
- Lung Diseases, Obstructive
- Respiratory Hypersensitivity
- Hypersensitivity
- Inflammation
- Asthma
- Molecular Mechanisms of Pharmacological Action
- Radiopharmaceuticals
- Anti-Asthmatic Agents
- Respiratory System Agents
- Fluorodeoxyglucose F18
- Reslizumab
Other Study ID Numbers
- C38072-AS-40105
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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