An Imaging Study Using PET/CT to Characterize the Effect of Intravenous Reslizumab on Airway Inflammation

NCT ID: NCT02937168

Last Updated: 2021-11-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-08
• Study Completion Date: 2017-05-24

Brief Summary

This is an exploratory study with the following primary objectives: 1) to establish that PET/CT of the lung can reliably distinguish healthy, non-asthmatic participants from participants with severe 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 participants with severe asthma and an eosinophilic phenotype .

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Fludeoxyglucose F 18 (FDG)

Intervention Type: DRUG

FDG will be administered by IV infusion prior to each PET/CT scan.

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.

Group Type: EXPERIMENTAL

Reslizumab

Intervention Type: DRUG

Reslizumab will be administered as per the dose and schedule specified in the arm.

Fludeoxyglucose F 18 (FDG)

Intervention Type: DRUG

FDG will be administered by IV infusion prior to each PET/CT scan.

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.

Group Type: PLACEBO_COMPARATOR

Fludeoxyglucose F 18 (FDG)

Intervention Type: DRUG

FDG will be administered by IV infusion prior to each PET/CT scan.

Placebo

Intervention Type: DRUG

Placebo matching to reslizumab will be administered as per the schedule specified in the arm.

Interventions

Reslizumab

Reslizumab will be administered as per the dose and schedule specified in the arm.

Intervention Type: DRUG

Fludeoxyglucose F 18 (FDG)

FDG will be administered by IV infusion prior to each PET/CT scan.

Intervention Type: DRUG

Placebo

Placebo matching to reslizumab will be administered as per the schedule specified in the arm.

Intervention Type: DRUG

Eligibility Criteria

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.

• 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:

1. The mepolizumab or benralizumab therapy has been discontinued.

• 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.

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:

1. The omalizumab (Xolair) therapy has been discontinued.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Teva Branded Pharmaceutical Products R&D, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Teva Medical Expert, MD

Role: STUDY_DIRECTOR

Teva Branded Pharmaceutical Products R&D, Inc.

Locations

Teva Investigational Site 13808

New Brunswick, New Jersey, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

C38072-AS-40105

Identifier Type: -

Identifier Source: org_study_id