An Imaging Study Using PET/CT to Characterize the Effect of Intravenous Reslizumab on Airway Inflammation
Status: | Terminated |
---|---|
Conditions: | Asthma |
Therapuetic Areas: | Pulmonary / Respiratory Diseases |
Healthy: | No |
Age Range: | 18 - 50 |
Updated: | 9/2/2018 |
Start Date: | March 1, 2017 |
End Date: | July 11, 2018 |
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
This is an exploratory study with the primary objectives to 1) establish that PET/CT of the
lung can reliably distinguish healthy, non-asthmatic volunteers from patients with asthma and
an eosinophilic phenotype and 2) to examine the utility of PET/CT for demonstrating that
reslizumab produces a reduction in lung inflammation in patients with severe asthma and an
eosinophilic phenotype .
lung can reliably distinguish healthy, non-asthmatic volunteers from patients with asthma and
an eosinophilic phenotype and 2) to examine the utility of PET/CT for demonstrating that
reslizumab produces a reduction in lung inflammation in patients with severe asthma and an
eosinophilic phenotype .
Inclusion Criteria:
- 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.
- Subjects and patients with less that 10-pack year history of smoking.
- Have a previous diagnosis of asthma.
- Patients taking inhaled fluticasone at a dosage of at least 440 mcg daily, or
equivalent.
- The patient'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.
- Patients with a blood eosinophil level of at least 300 cells/μL at screening or a
historical blood eosinophil level of at least 300 cells/μL within the last year.
- Additional criteria apply, please contact the investigator for more information
Exclusion Criteria:
- Patients requiring treatment with oral, intramuscular, or iv corticosteroids within 6
weeks of the Part 1 baseline visit for an asthma exacerbation.
- Patients with any other confounding underlying lung disorder including but not limited
to:
bronchiectasis, chronic obstructive pulmonary disorder, smoking ≥10 pack year history,
pulmonary fibrosis, emphysema, cystic fibrosis, and lung cancer.
- Patients diagnosed with diabetes mellitus.
- Patients with pulmonary conditions and blood eosinophilia other than eosinophilic
asthma
- Patients with clinically meaningful comorbidity that can interfere with the study
schedule or procedures, or compromise the patient's safety.
- Patients that are current smokers (ie, have smoked within the last 12 months prior to
screening).
- Patients 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. Patients whose
treatment with anti-IgE mAb therapy (omalizumab) is considered ineffective by their
physician may be included as potential subjects when:
1. The omalizumab (Xolair) therapy has been discontinued.
2. The patient's blood eosinophil level meets inclusion criteria.
- Patients who have previously received an anti-hIL-5 mAb (eg, reslizumab, mepolizumab
[Nucala]) or anti-IL-5 receptor mAb (eg, benralizumab). Patients whose treatment with
mepolizumab or benralizumab is considered ineffective by their physician may be
included as potential subjects when:
1. The mepolizumab or benralizumab therapy has been discontinued.
2. The patient's blood eosinophil level meets inclusion criteria.
- Patients who had concurrent infection or disease that may preclude assessment of
active asthma.
- Patients with a history of concurrent immunodeficiency (human immunodeficiency virus
or acquired immunodeficiency syndrome or congenital immunodeficiency).
- Patients that had an active parasitic infection within 6 months prior to screening.
- Patients 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
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