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A Trial of Mepolizumab Adjunctive Therapy for the Prevention of Asthma Exacerbations in Urban Children

NCT03292588 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 335

Last updated 2022-07-20

Study results available
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Summary

The purpose of this study is to see if treatment with a medication called Nucala® (mepolizumab), given along with standard asthma care, makes children less likely to have asthma attacks.

Conditions

Interventions

BIOLOGICAL

Mepolizumab

Mepolizumab administered every 4 weeks by subcutaneous injection at a dose of: * 100 mg for participants ≥12 years of age and * 40 mg for participants ages 6 to 11 years and weighing ≥40 kg. Note: Participants 6 to 11 years of age and weighing ≥40 kg who were enrolled in the study under previous versions of the protocol and were initially assigned a 100 mg dose will have their dose reduced to 40 mg. Participants 11 years of age will increase to the 100 mg dose if they become age 12 years during the study.

DRUG

Placebo

Placebo administered every 4 weeks by subcutaneous injection at a dose of: * 100 mg for participants ≥12 years of age and * 40 mg for participants ages 6 to 11 years and weighing ≥40 kg. Note: Participants 6 to 11 years of age and weighing ≥40 kg who were enrolled in the study under previous versions of the protocol and were initially assigned a 100 mg dose will have their dose reduced to 40 mg. Participants 11 years of age will increase to the 100 mg dose if they become age 12 years during the study.

Sponsors & Collaborators

  • Inner-City Asthma Consortium

    collaborator NETWORK

  • GlaxoSmithKline

    collaborator INDUSTRY

  • Rho Federal Systems Division, Inc.

    collaborator INDUSTRY

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Daniel J Jackson, MD · University of Wisconsin, Madison

  • William W Busse, MD · University of Wisconsin, Madison

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-07
Primary Completion
2021-04-20
Completion
2021-04-20
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

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 NCT03292588 on ClinicalTrials.gov