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

NCT02937168 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2021-11-09

Study results available
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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

Interventions

DRUG

Reslizumab

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

DRUG

Fludeoxyglucose F 18 (FDG)

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

DRUG

Placebo

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

Sponsors & Collaborators

  • Teva Branded Pharmaceutical Products R&D, Inc.

    lead INDUSTRY

Principal Investigators

  • Teva Medical Expert, MD · Teva Branded Pharmaceutical Products R&D, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-05-08
Primary Completion
2017-05-24
Completion
2017-05-24
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02937168 on ClinicalTrials.gov