Prevention of Asthma Exacerbations Using Dupilumab in Urban Children and Adolescents

Part of paid clinical trials in Aurora, Colorado.

Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Study ID
NCT05347771
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
6 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Dupilumab — DRUG
    Dupilumab is a recombinant DNA-derived humanized IgG4ĸ monoclonal antibody that selectively binds to anti IL-4R monoclonal antibody (mAb).
  • Placebo — DRUG
    The composition of the placebo for dupilumab is the same as the active study drug without the dupilumab.

Study Details

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.

Key Dates

Start date
May 4, 2022
Status verified
Jan 2026
Primary completion
Dec 31, 2026
Completion
Mar 15, 2027

Study Design

Enrollment
240 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Dupilumab
    Participants between 12-17 years of age will receive an initial dose of 600 mg (two 300 mg injections) followed by 300 mg given every other week (Q2W). Participants between 6-11 years of age will not complete a loading dose and will receive injections based on their body weight: Those weighing 15 kg to less than 30 kg will receive 300 mg every four weeks (Q4W). Participants in this weight category who were randomized before July 1, 2024, were assigned to a 100mg Q2W and will not be transitioned to the Q4W dosing schedule. Those with a body weight of 30 kg or more will receive 200 mg Q2W.
  • Placebo Comparator: Placebo
    Participants between 12-17 years of age will receive an initial dose of placebo (two injections) followed by a placebo injection given every other week (Q2W). Participants between 6-11 years of age will not receive an initial loading dose of placebo and will receive injections Q2W or Q4W based on their body weight and date of randomization.: The injection volume of placebo will be matched to the corresponding dupilumab dose based on participant body weight.

Primary Outcome Measure

Number of asthma exacerbations during the 12-month treatment period [ Time Frame: Week 4 (Treatment initiation) - Week 54 (Completion of treatment) ]

Locations (8)

FacilityCityStateZIPSite coordinators
Children's Hospital Colorado: Allergy ProgramAuroraColorado80045-
Children's National Medical Center: Children's Research InstituteWashington D.C.District of Columbia20010-
Ann & Robert H. Lurie Children's Hospital of Chicago: Division of Allergy and ImmunologyChicagoIllinois60611-
Boston Children's Hospital: Department of ImmunologyBostonMassachusetts02215-
Washington University at St. LouisSt LouisMissouri63110-
Columbia University Medical Center: Division of Pediatric PulmonologyNew YorkNew York10032-
Icahn School of Medicine at Mount Sinai: Division of Clinical Immunology, Immunology InstituteNew YorkNew York10029-
Cincinnati Children's Hospital Medical Center: Asthma CenterCincinnatiOhio45229-

Find similar trials in Aurora, CO

By condition
Asthma
By specialty
PulmonologyLung disease
By research site
Children's Hospital Colorado: Allergy Program· Aurora, COChildren's National Medical Center: Children's Research Institute· Washington D.C., DCAnn & Robert H. Lurie Children's Hospital of Chicago: Division of Allergy and Immunology· Chicago, ILBoston Children's Hospital: Department of Immunology· Boston, MAWashington University at St. Louis· St Louis, MOColumbia University Medical Center: Division of Pediatric Pulmonology· New York, NY

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