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Prevention of Asthma Exacerbations Using Dupilumab in Urban Children and Adolescents

NCT05347771 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2026-01-20

No results posted yet for this study

Summary

This is a multi-center, double-blind, placebo-controlled, randomized trial of dupilumab adjunctive therapy for prevention of asthma exacerbations in urban children and adolescents with T2-high exacerbation-prone asthma.

Conditions

Interventions

DRUG

Dupilumab

Dupilumab is a recombinant DNA-derived humanized IgG4ĸ monoclonal antibody that selectively binds to anti IL-4R monoclonal antibody (mAb).

DRUG

Placebo

The composition of the placebo for dupilumab is the same as the active study drug without the dupilumab.

Sponsors & Collaborators

  • Childhood Asthma in Urban Settings (CAUSE)

    collaborator UNKNOWN

  • Regeneron Pharmaceuticals

    collaborator INDUSTRY

  • Rho Federal Systems Division, Inc.

    collaborator INDUSTRY

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Daniel J. Jackson, M.D. · University of Wisconsin School of Medicine and Public Health; Division of Allergy & Immunology

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
2022-05-04
Primary Completion
2026-12-31
Completion
2027-03-15
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 NCT05347771 on ClinicalTrials.gov