Dupilumab in Eosinophilic Gastritis

Part of paid clinical trials in Aurora, Colorado.

Sponsor
Children's Hospital Medical Center, Cincinnati
Study ID
NCT03678545
Phase
PHASE2
Status
Completed

Conditions

  • Eosinophilic Gastritis
  • Eosinophilic Gastroenteritis

Eligibility Criteria

Sex
ALL
Age
12 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Dupilumab (blinded) — DRUG
    Subcutaneous injection every two weeks as follows: 600 mg initial dose, and 300 mg subsequent doses for a total of 6 injections.
  • Placebo (blinded) — DRUG
    Placebo is matched to the active drug (dupilumab), and is given in the same manner: a subcutaneous injection every two weeks for a total of 6 injections.

Study Details

40 participants with Eosinophilic Gastritis 12-70 years of age will be randomly assigned with dupilumab or placebo subcutaneous injections every two weeks for a total of 12 weeks. Study subjects who complete the 12-week treatment phase, may continue into an open label extension study, where dupilumab will be administered every two weeks for a total of 24 weeks.

Key Dates

Start date
May 15, 2021
Status verified
Mar 2025
Primary completion
Mar 4, 2024
Completion
Nov 13, 2024

Study Design

Enrollment
41 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Dupilumab
  • Placebo Comparator: Placebo

Primary Outcome Measure

Relative Change of Peak Eosinophil Counts in the Stomach [ Time Frame: 12 weeks after randomization ]

Locations (12)

FacilityCityStateZIPSite coordinators
Children's Hospital ColoradoAuroraColorado80045-
University of Colorado Denver and HospitalAuroraColorado80045-
Northwestern Medicine Digestive Health CenterChicagoIllinois60611-
Riley Children's HospitalIndianapolisIndiana46202-
Tufts Medical CenterBostonMassachusetts02111-
Icahn School of Medicine at Mount SinaiNew YorkNew York10029-
University of North Carolina School of MedicineChapel HillNorth Carolina27599-
Cincinnati Children's Hospital Medical CenterCincinnatiOhio45229-
The Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19104-
University of PennsylvaniaPhiladelphiaPennsylvania19104-
Texas Children's HospitalHoustonTexas77030-
University of Utah HospitalSalt Lake CityUtah84132-

Find similar trials in Aurora, CO

By research site
Children's Hospital Colorado· Aurora, COUniversity of Colorado Denver and Hospital· Aurora, CONorthwestern Medicine Digestive Health Center· Chicago, ILRiley Children's Hospital· Indianapolis, INTufts Medical Center· Boston, MAIcahn School of Medicine at Mount Sinai· New York, NY

Related Studies