Dupilumab in Eosinophilic Gastritis
A Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Efficacy of Dupilumab (Anti-IL4a) in Subjects With Eosinophilic Gastritis
2 other identifiers
interventional
41
1 country
12
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started May 2021
Typical duration for phase_2
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 6, 2018
CompletedFirst Posted
Study publicly available on registry
September 19, 2018
CompletedStudy Start
First participant enrolled
May 15, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 4, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
November 13, 2024
CompletedResults Posted
Study results publicly available
November 4, 2025
CompletedNovember 4, 2025
March 1, 2025
2.8 years
August 6, 2018
March 5, 2025
October 10, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Relative Change of Peak Eosinophil Counts in the Stomach
We will determine the Relative change from baseline of the peak eosinophil counts in the 5 most eosinophil dense HPFs in the gastric antrum and/or body between drug vs placebo at 12 weeks will be the primary measurement endpoint.
12 weeks after randomization
Study Arms (2)
Dupilumab
ACTIVE COMPARATORPlacebo
PLACEBO COMPARATORInterventions
Subcutaneous injection every two weeks as follows: 600 mg initial dose, and 300 mg subsequent doses for a total of 6 injections.
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.
Eligibility Criteria
You may qualify if:
- Participant and/or parent guardian must be able to understand and provide informed consent and/or assent.
- Willing and able to comply with study visits and activities
- Age ≥ 12 and \< 71 years at study enrollment
- Histologically active EG at time of screening, with a peak gastric count of ≥ 30 eos/hpf in at least 5 hpfs in the gastric antrum and/or body.
- History (by patient report) of moderate to severe EG symptoms
- Stable medical management of EG.
- Willing to maintain current dietary regimen throughout the course of the study. Diet must have been stable for 8 weeks prior to baseline endoscopy.
- If have asthma and/or any other chronic allergic conditions they must be willing to maintain their pretrial medications until the end of study. Medication dose can be increased if there is a deterioration in the condition.
- Score on Asthma Control Test (ACTTM) ≥ 20
You may not qualify if:
- Inability or unwillingness of a participant to give written informed consent or comply with study protocol.
- Current active H. pylori infection.
- Systemic gastrointestinal disorders such as Crohn's disease, inflammatory bowel disease, or Celiac disease.
- Known or suspected active colitis in the Principal Investigator's opinion or by biopsy.
- Hypereosinophilic syndrome.
- History of cancer
- Current or recent use of biological agents.
- Leukocyte count has not returned to the relevant lower limit of normal after discontinuing cell depleting biological agents.
- Current or recent use of any investigational drug.
- Current use of systemic steroids with daily dose \> 10 mg for any reason or steroid burst for \> 3 days within 1 month of screening.
- Prior exposure to dupilumab.
- History of anaphylaxis to any biologic therapy.
- Current pregnancy or breastfeeding.
- Ocular disorder.
- Individuals who have required use of a systemic corticosteroid for asthma.
- +15 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
Children's Hospital Colorado
Aurora, Colorado, 80045, United States
University of Colorado Denver and Hospital
Aurora, Colorado, 80045, United States
Northwestern Medicine Digestive Health Center
Chicago, Illinois, 60611, United States
Riley Children's Hospital
Indianapolis, Indiana, 46202, United States
Tufts Medical Center
Boston, Massachusetts, 02111, United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
University of North Carolina School of Medicine
Chapel Hill, North Carolina, 27599, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Texas Children's Hospital
Houston, Texas, 77030, United States
University of Utah Hospital
Salt Lake City, Utah, 84132, United States
Related Publications (1)
Sia T, Bacchus L, Tanaka R, Khuda R, Mallik S, Leung J. Dupilumab Can Induce Remission of Eosinophilic Gastritis and Duodenitis: A Retrospective Case Series. Clin Transl Gastroenterol. 2024 Jan 1;15(1):e00646. doi: 10.14309/ctg.0000000000000646.
PMID: 37753954DERIVED
MeSH Terms
Conditions
Interventions
Results Point of Contact
- Title
- Regina Yearout
- Organization
- Cincinnati Children's Hospital Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
Marc Rothenberg
Children's Hospital Medical Center, Cincinnati
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 6, 2018
First Posted
September 19, 2018
Study Start
May 15, 2021
Primary Completion
March 4, 2024
Study Completion
November 13, 2024
Last Updated
November 4, 2025
Results First Posted
November 4, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will not share
data will be collected from 14 different sites and kept in a secure electronic database supported by the NIH: Rare Diseases Data Management and Coordinating Center. Information such as test results, eligibility and patient reported outcomes can be accessed by authorized personnel from each site. staff from each site will only have access to the data collect by that site. The main site, CCHMC, will have full access to all data collected from all sites.