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A Trial of Mepolizumab Adjunctive Therapy for the Prevention of Asthma Exacerbations in Urban Children (MUPPITS-2)

Primary Purpose

Asthma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Mepolizumab
Placebo
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring urban setting, children and adolescents, double-masked, placebo-controlled randomized trial, asthma exacerbations (attacks), mepolizumab adjunctive therapy, asthma exacerbations prevention, difficult-to-control exacerbation-prone asthma

Eligibility Criteria

6 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Study applicant(s) that fulfill all of the inclusion criteria and none of the exclusion criteria are eligible for the study-

  • Participant and/or parent guardian must be able to understand and provide informed consent and age-appropriate assent;
  • Must have a primary place of residence in one of the pre-selected recruitment census tracts as outlined in the study's Manual of Procedures (MOP);
  • Has had a diagnosis of asthma made >1 year prior to recruitment;

    --Those who received an asthma diagnosis by a clinician ≤1 year prior to recruitment must report that their respiratory symptoms were present for more than 1 year prior to recruitment.

  • Has had ≥2 asthma exacerbations in the prior year (defined as a requirement for systemic corticosteroids and/or hospitalization);
  • At Visit 0 (Screening), has the following requirement for asthma controller medication:

    • For those ages 6 to 11 years, treatments with at least fluticasone 250 mcg dry powder inhaler (DPI) one puff twice daily or its equivalent and,
    • For those ≥12 years of age, treatment with at least Advair 250/50 mcg dry powder inhaler (DPI), one puff twice daily or its equivalent.
  • Has peripheral blood eosinophils ≥150 cells/µl obtained at Visit 0 (Screening) or in another Inner-City Asthma Consortium (ICAC) clinical research study within 6 months;
  • Is able to perform spirometry at randomization (Visit for treatment assignment);
  • Has documentation of current medical insurance with prescription coverage at randomization; and
  • Has had varicella or the varicella vaccination.

Exclusion Criteria:

Individual(s) who meets any of the following criteria are not eligible for enrollment or randomization-

  • Is not able or willing to give written informed consent or comply with the study protocol;
  • Has concurrent (existing) medical problems that would require systemic corticosteroids or other immunomodulator treatments during the study;
  • Is currently receiving immunotherapy;
  • Is currently receiving treatment with omalizumab or has had omalizumab treatment within 6 months prior to planned participant randomization to treatment assignment;
  • Is currently requiring greater than fluticasone 500 mcg administered twice daily plus a long-acting beta agonist (LABA) one puff twice daily or its equivalent, and/or

    --Individuals using oral corticosteroids daily or every other day for more than 14 days at the time of Visit 0 (Screening).

  • Is currently pregnant or lactating, or plans to become pregnant during the time of study participation

    --Note: Females of child-bearing potential (post-menarche) must be abstinent or use a medically acceptable birth control method throughout the study (e.g. oral subcutaneous, mechanical, or surgical contraception).

  • Has a known, pre-existing clinically important lung condition other than asthma;
  • Has a current malignancy or previous history of cancer in remission for less than 12 months prior to randomization;
  • Has known, pre-existing, unstable liver disease;
  • Is a current smoker or has a smoking history of 10 or more pack years;
  • Has a known immunodeficiency disease;
  • Has other conditions that could lead to elevated eosinophils such as hypereosinophilic syndromes, including eosinophilic granulomatosis with polyangiitis;
  • Has a known, active pre-existing parasitic infestation or is undergoing treatment for a parasitic infestation

    --Note: Once the individual has been successfully treated, the interested study applicant may be reevaluated for study eligibility.

  • Positive for use of investigational drugs within 4 weeks of randomization;
  • Has a past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the study clinician,

    • May pose additional risks from participation in this study,
    • May interfere with the participant's ability to comply with study requirements, or
    • May impact the quality or interpretation of the data obtained from the study.
  • In the event that the study applicant will not allow the study clinician, an asthma specialist, to manage their disease for the duration of the study or who are not willing to change their asthma medications to follow the protocol;
  • Has a known history of allergic reaction to previous biologic therapy for asthma; or
  • Has had a life threatening asthma exacerbation in the last 2 years requiring intubation, mechanical ventilation or resulting in a hypoxic seizure.

Sites / Locations

  • Children's Hospital Colorado
  • Children's National Medical Center
  • Ann and Robert Lurie Children's Hospital of Chicago
  • Boston Medical Center
  • Henry Ford Health System
  • St. Louis Children's Hospital
  • Columbia University Medical Center
  • Cincinnati Children's Hospital
  • University of Texas Southwestern Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Mepolizumab

Placebo

Arm Description

Intervention: Mepolizumab plus guidelines-based standard of care asthma treatment.

Intervention: Placebo for mepolizumab plus guidelines-based standard of care asthma treatment.

Outcomes

Primary Outcome Measures

Number of Asthma Exacerbations During the Treatment Period
Exacerbations were defined as a prescription of a course of systemic corticosteroids by a clinician, initiation of a course of systemic corticosteroids by a participant, or as a hospitalization for asthma. If a participant initiated and completed a course of systemic corticosteroids without clinician involvement, this course was counted only if the study clinician agreed the treatment was warranted, and it met the following dosage: the course for prednisone, prednisolone, or methylprednisolone was at least 20 mg daily dose for 3 of 5 consecutive days. The course for dexamethasone was at least a 10 mg single daily dose. If a corticosteroid burst for the treatment of an asthma exacerbation was prescribed by a non-ICAC clinician, it was counted regardless of dose.

Secondary Outcome Measures

Composite Asthma Severity Index (CASI)
Composite Asthma Severity Index (CASI) scores included 5 domains: day symptoms and albuterol use, night symptoms and albuterol use, controller treatment, lung function measures, and exacerbations. The minimum composite score was 0 while the maximum was 20. The higher the score the more allergy symptoms a subject has.
Participant Quality of Life Measured Using the Physician Global Assessment Tool
The Physician Global Assessment Tool was used to assess the quality of life of the subjects during treatment. The questionnaire is one question that asks the physician to evaluate how the participant's quality of life changed over the course of treatment. There are seven possible options ranging from significantly worse to significantly improved.
Participant Quality of Life Measured Using the Patient Global Assessment, at Visit 14
The Patient Global Assessment Tool was used to assess the quality of life of the subjects during treatment. The questionnaire is one question that asks the participant to evaluate how their quality of life changed over the course of treatment. There are seven possible options ranging from significantly worse to significantly improved.
Lung Function as Assessed by Spirometry
A generalized mixed model was used to analyze spirometry parameter at each visit where the lung function was collected. The ratio of the forced expiratory volume to the forced vital capacity of the lungs (FEV1/FVC) is the outcome that measured lung function.
Lung Function as Assessed by Impulse Oscillometry
A generalized mixed model was used to analyze impulse oscillometry parameter at each visit where the lung function was collected. The Percent Predicted FEV1 (%) is the outcome that measured lung function.
Rate of Exacerbations (Mepolizumab vs. Placebo) During the Treatment Period for Participants Who Did Not Fit the FDA-approved Dosing Table for Omalizumab Therapy.
Looking at the rate of exacerbations similarly to the primary endpoint. This outcome measure also took into consideration FDA- approved dosing of omalizumab. The FDA-approved dosing table is based off of age, weight and pre-treatment Serum IGE
Rate of Exacerbations (Mepolizumab vs. Placebo) During the Treatment Period for Participants Who Fit the FDA-approved Dosing Table.
Looking at the rate of exacerbations similarly to the primary endpoint. This outcome measure also took into consideration FDA- approved dosing of omalizumab. The FDA-approved dosing table is based off of age, weight and pre-treatment Serum IGE
Time to First Asthma Exacerbation
A Cox PH model was also used to model the time to first asthma exacerbation during the treatment period. The Cox PH model included treatment arm as the primary exposure but was also adjusted for study site, number of exacerbations in year prior to study (2 or 3+), peripheral blood eosinophils (above or below 400 cells/μl), BMI (above or below 95th percentile for age) and total serum IgE (above or below 540 kUA/L).
Number of Reported Adverse Events (AEs), Including Their Severity
The number of AEs by severity was used to assess safety. Please refer to the Adverse Event tables for specifics.
Number of Reported Adverse Events (AEs), Including Their Treatment Relatedness
The number of AEs by relationship to study drug was used to assess safety. Please refer to the Adverse Event tables for specifics.
Number of Reported Serious Adverse Events (SAEs) Inclusive of Severity. Please Refer to the Adverse Event Tables for Specifics.
The number of SAEs by severity and relationship to study drug was used to assess safety.
Number of Reported Serious Adverse Events (SAEs) Inclusive of Treatment Relatedness. Please Refer to the Adverse Event Tables for Specifics.
The number of SAEs by relationship to study drug was used to assess safety.

Full Information

First Posted
September 20, 2017
Last Updated
June 23, 2022
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Inner-City Asthma Consortium, GlaxoSmithKline, Rho Federal Systems Division, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03292588
Brief Title
A Trial of Mepolizumab Adjunctive Therapy for the Prevention of Asthma Exacerbations in Urban Children
Acronym
MUPPITS-2
Official Title
Mechanisms Underlying Asthma Exacerbations Prevented and Persistent With Immune-Based Therapy: A Systems Approach Phase 2 (ICAC-30)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
November 7, 2017 (Actual)
Primary Completion Date
April 20, 2021 (Actual)
Study Completion Date
April 20, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Inner-City Asthma Consortium, GlaxoSmithKline, Rho Federal Systems Division, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed Description
Asthma is a growing problem, especially in children. It causes frequent wheezing, shortness of breath, chest tightness, and cough. Asthma attacks, or exacerbations, are problems for children with asthma. The purpose of this study is to see if treatment with a medication called mepolizumab (Nucala®), given along with standard asthma care, makes children less likely to have asthma attacks. Mepolizumab is a new drug that is approved by the Food and Drug Administration (FDA) for use in children with asthma who are aged 12 years and older. Mepolizumab is given by injection. It is being studied by other researchers in children aged 6-11 years. All participants will be prescribed standard asthma medications by a clinician who is trained in asthma care. Medications will include controller medications, a rescue medication, and a medication for severe asthma attacks (prednisone). The amount of medication that participants receive may be increased or decreased during the study based on their symptoms and breathing test results. Study clinicians will treat all participants according to the same guidelines. These treatment guidelines are based on recommendations from a group of national experts in asthma. This study has been designed this way so that all participants will have safe and effective standard asthma care. In order to enroll in this study, participants must be willing to have their asthma managed by the study clinician during the entire study period. Participants must also be willing to bring study medications to all study visits. This study will include up to 20 study visits. Participant involvement in the study will endure for approximately 1 year. During the treatment period, participants will be placed in one of two treatment groups: Mepolizumab injection and guidelines-based asthma care or Placebo injection and guidelines-based asthma care. Participants will not be able to choose which group they are assigned. This assignment is random and by chance, much like flipping a coin. Participants will not know if they are receiving mepolizumab or placebo. Investigators will compare the study results between the participants of each group.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
urban setting, children and adolescents, double-masked, placebo-controlled randomized trial, asthma exacerbations (attacks), mepolizumab adjunctive therapy, asthma exacerbations prevention, difficult-to-control exacerbation-prone asthma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
335 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mepolizumab
Arm Type
Experimental
Arm Description
Intervention: Mepolizumab plus guidelines-based standard of care asthma treatment.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Intervention: Placebo for mepolizumab plus guidelines-based standard of care asthma treatment.
Intervention Type
Biological
Intervention Name(s)
Mepolizumab
Other Intervention Name(s)
Nucala®, anti-Interleukin 5 (IL5) antagonist monoclonal antibody
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Placebo for Mepolizumab
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Asthma Exacerbations During the Treatment Period
Description
Exacerbations were defined as a prescription of a course of systemic corticosteroids by a clinician, initiation of a course of systemic corticosteroids by a participant, or as a hospitalization for asthma. If a participant initiated and completed a course of systemic corticosteroids without clinician involvement, this course was counted only if the study clinician agreed the treatment was warranted, and it met the following dosage: the course for prednisone, prednisolone, or methylprednisolone was at least 20 mg daily dose for 3 of 5 consecutive days. The course for dexamethasone was at least a 10 mg single daily dose. If a corticosteroid burst for the treatment of an asthma exacerbation was prescribed by a non-ICAC clinician, it was counted regardless of dose.
Time Frame
Up to 12 months
Secondary Outcome Measure Information:
Title
Composite Asthma Severity Index (CASI)
Description
Composite Asthma Severity Index (CASI) scores included 5 domains: day symptoms and albuterol use, night symptoms and albuterol use, controller treatment, lung function measures, and exacerbations. The minimum composite score was 0 while the maximum was 20. The higher the score the more allergy symptoms a subject has.
Time Frame
Week 12, 24, 36, 48, 52 after randomization
Title
Participant Quality of Life Measured Using the Physician Global Assessment Tool
Description
The Physician Global Assessment Tool was used to assess the quality of life of the subjects during treatment. The questionnaire is one question that asks the physician to evaluate how the participant's quality of life changed over the course of treatment. There are seven possible options ranging from significantly worse to significantly improved.
Time Frame
Week 56
Title
Participant Quality of Life Measured Using the Patient Global Assessment, at Visit 14
Description
The Patient Global Assessment Tool was used to assess the quality of life of the subjects during treatment. The questionnaire is one question that asks the participant to evaluate how their quality of life changed over the course of treatment. There are seven possible options ranging from significantly worse to significantly improved.
Time Frame
Week 56
Title
Lung Function as Assessed by Spirometry
Description
A generalized mixed model was used to analyze spirometry parameter at each visit where the lung function was collected. The ratio of the forced expiratory volume to the forced vital capacity of the lungs (FEV1/FVC) is the outcome that measured lung function.
Time Frame
Weeks 12, 24, 36, 48, 52 after randomization
Title
Lung Function as Assessed by Impulse Oscillometry
Description
A generalized mixed model was used to analyze impulse oscillometry parameter at each visit where the lung function was collected. The Percent Predicted FEV1 (%) is the outcome that measured lung function.
Time Frame
Weeks 12, 24, 36, 48, 52 after randomization
Title
Rate of Exacerbations (Mepolizumab vs. Placebo) During the Treatment Period for Participants Who Did Not Fit the FDA-approved Dosing Table for Omalizumab Therapy.
Description
Looking at the rate of exacerbations similarly to the primary endpoint. This outcome measure also took into consideration FDA- approved dosing of omalizumab. The FDA-approved dosing table is based off of age, weight and pre-treatment Serum IGE
Time Frame
Up to 12 months
Title
Rate of Exacerbations (Mepolizumab vs. Placebo) During the Treatment Period for Participants Who Fit the FDA-approved Dosing Table.
Description
Looking at the rate of exacerbations similarly to the primary endpoint. This outcome measure also took into consideration FDA- approved dosing of omalizumab. The FDA-approved dosing table is based off of age, weight and pre-treatment Serum IGE
Time Frame
Up to 12 months
Title
Time to First Asthma Exacerbation
Description
A Cox PH model was also used to model the time to first asthma exacerbation during the treatment period. The Cox PH model included treatment arm as the primary exposure but was also adjusted for study site, number of exacerbations in year prior to study (2 or 3+), peripheral blood eosinophils (above or below 400 cells/μl), BMI (above or below 95th percentile for age) and total serum IgE (above or below 540 kUA/L).
Time Frame
Up to 12 months
Title
Number of Reported Adverse Events (AEs), Including Their Severity
Description
The number of AEs by severity was used to assess safety. Please refer to the Adverse Event tables for specifics.
Time Frame
Week 4 (Treatment Initiation) to Week 56 (Completion of Treatment)
Title
Number of Reported Adverse Events (AEs), Including Their Treatment Relatedness
Description
The number of AEs by relationship to study drug was used to assess safety. Please refer to the Adverse Event tables for specifics.
Time Frame
Week 4 (Treatment Initiation) to Week 56 (Completion of Treatment)
Title
Number of Reported Serious Adverse Events (SAEs) Inclusive of Severity. Please Refer to the Adverse Event Tables for Specifics.
Description
The number of SAEs by severity and relationship to study drug was used to assess safety.
Time Frame
Week 4 (Treatment Initiation) to Week 56 (Completion of Treatment)
Title
Number of Reported Serious Adverse Events (SAEs) Inclusive of Treatment Relatedness. Please Refer to the Adverse Event Tables for Specifics.
Description
The number of SAEs by relationship to study drug was used to assess safety.
Time Frame
Week 4 (Treatment Initiation) to Week 56 (Completion of Treatment)
Other Pre-specified Outcome Measures:
Title
EXPLORATORY: Time to First Respiratory Virus-Induced Exacerbation
Description
As measured by an exacerbation associated with a respiratory virus detected using nasal mucus samples obtained at the time of an exacerbation.
Time Frame
Week 4 (Treatment Initiation) to Week 56 (Completion of Treatment)
Title
EXPLORATORY:Number of Respiratory Virus-Induced Exacerbations
Description
Measured by an exacerbation associated with a respiratory virus detected using nasal mucus samples obtained at the time of an exacerbation.
Time Frame
Week 4 (Treatment Initiation) to Week 56 (Completion of Treatment)
Title
EXPLORATORY:Childhood Asthma Control Test (ACT)/c-ACT
Description
A validated tool to assess overall asthma control (over the last 4 weeks) in participants.
Time Frame
Visits (V) 4 (Week 4 Treatment Initiation) , V4 (Week 16), V7 (Week 28), V10 (Week 40), V13 (Week 52) and V14 (Week 56, Completion of Treatment)
Title
EXPLORATORY:Maximum Number of Asthma Symptom Days
Description
Defined as the highest value among the following variables over a two-week period: number of days with wheezing, tightness in the chest, or cough; number of nights with disturbed sleep as a result of asthma; and number of days on which the participant had to slow down or discontinue play/physical activities.
Time Frame
Week 4 (Treatment Initiation) to Week 56 (Completion of Treatment)
Title
EXPLORATORY:Bronchodilator Responsiveness
Description
A measure to determine whether mepolizumab improves pulmonary outcomes.
Time Frame
Baseline (prior to treatment initiation), Week 56 (Completion of Treatment)
Title
EXPLORATORY: Gene Expression in Nasal Lavage Samples
Description
Whole genome transcriptomics of nasal lavage samples to identify inflammatory pathways affected by mepolizumab.
Time Frame
Visits (V) 1 (Week 4 Treatment Initiation) , V3(Week 12), and V14 (Week 56, Completion of Treatment)
Title
EXPLORATORY: Gene Expression in Whole Blood RNA Samples
Description
Whole genome transcriptomics of whole blood RNA samples to identify inflammatory pathways affected by mepolizumab..
Time Frame
Visits (V) 1 (Week 4 Treatment Initiation) , V3(Week 12), and V14 (Week 56, Completion of Treatment)
Title
EXPLORATORY:Levels of Antibody to Mepolizumab
Description
An assay for detection/measurement of levels of antibody to mepolizumab. Analysis will include participants randomized to mepolizumab.
Time Frame
Visit (V) 1 (Week 4, prior to treatment initiation), V3 (Week 12), and Visit 14 (Week 56, Completion of Treatment)
Title
EXPLORATORY:Other Potential Biomarkers Not Specified to Date
Description
Plasma, nasal samples, RNA and DNA will be banked for possible future study of potential biomarkers associated with asthma and asthma exacerbations.
Time Frame
Visit (V) 1 (Week 4, prior to treatment initiation), V3 (Week 12), and Visit 14 (Week 56, Completion of Treatment)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Study applicant(s) that fulfill all of the inclusion criteria and none of the exclusion criteria are eligible for the study- Participant and/or parent guardian must be able to understand and provide informed consent and age-appropriate assent; Must have a primary place of residence in one of the pre-selected recruitment census tracts as outlined in the study's Manual of Procedures (MOP); Has had a diagnosis of asthma made >1 year prior to recruitment; --Those who received an asthma diagnosis by a clinician ≤1 year prior to recruitment must report that their respiratory symptoms were present for more than 1 year prior to recruitment. Has had ≥2 asthma exacerbations in the prior year (defined as a requirement for systemic corticosteroids and/or hospitalization); At Visit 0 (Screening), has the following requirement for asthma controller medication: For those ages 6 to 11 years, treatments with at least fluticasone 250 mcg dry powder inhaler (DPI) one puff twice daily or its equivalent and, For those ≥12 years of age, treatment with at least Advair 250/50 mcg dry powder inhaler (DPI), one puff twice daily or its equivalent. Has peripheral blood eosinophils ≥150 cells/µl obtained at Visit 0 (Screening) or in another Inner-City Asthma Consortium (ICAC) clinical research study within 6 months; Is able to perform spirometry at randomization (Visit for treatment assignment); Has documentation of current medical insurance with prescription coverage at randomization; and Has had varicella or the varicella vaccination. Exclusion Criteria: Individual(s) who meets any of the following criteria are not eligible for enrollment or randomization- Is not able or willing to give written informed consent or comply with the study protocol; Has concurrent (existing) medical problems that would require systemic corticosteroids or other immunomodulator treatments during the study; Is currently receiving immunotherapy; Is currently receiving treatment with omalizumab or has had omalizumab treatment within 6 months prior to planned participant randomization to treatment assignment; Is currently requiring greater than fluticasone 500 mcg administered twice daily plus a long-acting beta agonist (LABA) one puff twice daily or its equivalent, and/or --Individuals using oral corticosteroids daily or every other day for more than 14 days at the time of Visit 0 (Screening). Is currently pregnant or lactating, or plans to become pregnant during the time of study participation --Note: Females of child-bearing potential (post-menarche) must be abstinent or use a medically acceptable birth control method throughout the study (e.g. oral subcutaneous, mechanical, or surgical contraception). Has a known, pre-existing clinically important lung condition other than asthma; Has a current malignancy or previous history of cancer in remission for less than 12 months prior to randomization; Has known, pre-existing, unstable liver disease; Is a current smoker or has a smoking history of 10 or more pack years; Has a known immunodeficiency disease; Has other conditions that could lead to elevated eosinophils such as hypereosinophilic syndromes, including eosinophilic granulomatosis with polyangiitis; Has a known, active pre-existing parasitic infestation or is undergoing treatment for a parasitic infestation --Note: Once the individual has been successfully treated, the interested study applicant may be reevaluated for study eligibility. Positive for use of investigational drugs within 4 weeks of randomization; Has a past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the study clinician, May pose additional risks from participation in this study, May interfere with the participant's ability to comply with study requirements, or May impact the quality or interpretation of the data obtained from the study. In the event that the study applicant will not allow the study clinician, an asthma specialist, to manage their disease for the duration of the study or who are not willing to change their asthma medications to follow the protocol; Has a known history of allergic reaction to previous biologic therapy for asthma; or Has had a life threatening asthma exacerbation in the last 2 years requiring intubation, mechanical ventilation or resulting in a hypoxic seizure.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel J Jackson, MD
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
William W Busse, MD
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Study Chair
Facility Information:
Facility Name
Children's Hospital Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Children's National Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Ann and Robert Lurie Children's Hospital of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
St. Louis Children's Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Cincinnati Children's Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Facility Name
University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Participant level data access and additional relevant materials will be made available upon completion of the trial.
IPD Sharing Time Frame
After completion of the trial, within 24 months status post database lock.
IPD Sharing Access Criteria
Registration is available for the Immunology Database and Analysis Portal (ImmPort) at: https://www.immport.org/registration. Submit a rationale for the purpose of requesting study data access. ImmPort is a long-term archive of clinical and mechanistic data, a National Institute of Allergy and Infectious Diseases Division of Allergy, Immunology and Transplantation (NIAID DAIT)-funded data repository. This archive is in support of the NIH mission to share data with the public. Data shared through ImmPort is provided by NIH-funded programs, other research organizations and individual scientists, ensuring these discoveries will be the foundation of future research.
IPD Sharing URL
https://www.immport.org/home
Citations:
PubMed Identifier
35964610
Citation
Jackson DJ, Bacharier LB, Gergen PJ, Gagalis L, Calatroni A, Wellford S, Gill MA, Stokes J, Liu AH, Gruchalla RS, Cohen RT, Makhija M, Khurana Hershey GK, O'Connor GT, Pongracic JA, Sherenian MG, Rivera-Spoljaric K, Zoratti EM, Teach SJ, Kattan M, Dutmer CM, Kim H, Lamm C, Sheehan WJ, Segnitz RM, Dill-McFarland KA, Visness CM, Becker PM, Gern JE, Sorkness CA, Busse WW, Altman MC; US National Institute of Allergy and Infectious Disease's Inner City Asthma Consortium. Mepolizumab for urban children with exacerbation-prone eosinophilic asthma in the USA (MUPPITS-2): a randomised, double-blind, placebo-controlled, parallel-group trial. Lancet. 2022 Aug 13;400(10351):502-511. doi: 10.1016/S0140-6736(22)01198-9.
Results Reference
derived
Links:
URL
https://www.niaid.nih.gov/
Description
National Institute of Allergy and Infectious Diseases (NIAID) website
URL
https://www.niaid.nih.gov/about/dait
Description
Division of Allergy, Immunology, and Transplantation (DAIT) website

Learn more about this trial

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

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