Investigating Dupilumab's Effect in Asthma by Genotype

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Boston Children's Hospital
Study ID
NCT03694158
Phase
PHASE4
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
12 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dupilumab — DRUG
    anti-IL4 receptor antagonist
  • Placebo — OTHER
    Placebo for Dupilumab (packaged/administered the same as the active drug)

Study Details

The Goal of this study is to investigate if individuals ages 12 years and older, carrying the IL-4RαR576 gene variant, will have a greater response to therapy acting directly on the anti-IL-4R. This will be conducted by examining the effect of a 48 week therapy with dupilumab on the rate of asthma exacerbations.

Key Dates

Start date
Sep 8, 2021
Status verified
Feb 2026
Primary completion
Jan 31, 2027
Completion
Mar 31, 2027

Study Design

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

Arms

  • Experimental: Treatment group
    Dupilumab (Dupixent®) administered subcutaneously every two weeks. An initial dose of 600 mg (two 300 mg injections) followed by 300 mg given every other week.
  • Placebo Comparator: Placebo group
    Placebo (preparation, administration, packaging, and labeling all equivalent to the treatment) administered subcutaneously every two weeks.

Primary Outcome Measure

The rate of asthma exacerbations [ Time Frame: 48 week treatment period ]

Locations (6)

FacilityCityStateZIPSite coordinators
Boston Children's HospitalBostonMassachusetts02115-
Brigham and Women's HospitalBostonMassachusetts02115-
Henry Ford Health SystemDetroitMichigan48202-
Montefiore Einstein Clinical Research CenterThe BronxNew York10467-
MetroHealth SystemClevelandOhio44109-
University of PennsylvaniaPhiladelphiaPennsylvania19104-

Find similar trials in Boston, MA

By condition
Asthma
By specialty
PulmonologyLung disease
By research site
Boston Children's Hospital· Boston, MABrigham and Women's Hospital· Boston, MAHenry Ford Health System· Detroit, MIMontefiore Einstein Clinical Research Center· The Bronx, NYMetroHealth System· Cleveland, OHUniversity of Pennsylvania· Philadelphia, PA

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