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

PHASE2CompletedINTERVENTIONAL
Enrollment

335

Participants

Timeline

Start Date

November 7, 2017

Primary Completion Date

April 20, 2021

Study Completion Date

April 20, 2021

Conditions
Asthma
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."

Trial Locations (9)

10032

Columbia University Medical Center, New York

20010

Children's National Medical Center, Washington D.C.

45229

Cincinnati Children's Hospital, Cincinnati

48202

Henry Ford Health System, Detroit

60611

Ann and Robert Lurie Children's Hospital of Chicago, Chicago

63110

St. Louis Children's Hospital, St Louis

75390

University of Texas Southwestern Medical Center, Dallas

80045

Children's Hospital Colorado, Aurora

02118

Boston Medical Center, Boston

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Inner-City Asthma Consortium

NETWORK

collaborator

GlaxoSmithKline

INDUSTRY

collaborator

Rho Federal Systems Division, Inc.

INDUSTRY

lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH