Eosinophilic GastritisPhase 2NCT03678545
Dupilumab in Eosinophilic Gastritis
A Phase 2 study testing Dupilumab (blinded) in people with Eosinophilic Gastritis and Eosinophilic Gastroenteritis, run by Children's Hospital Medical Center, Cincinnati at 12 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 70 years
- Conditions the study is for
- Eosinophilic Gastritis, Eosinophilic Gastroenteritis
- What is being tested?
- Dupilumab (blinded)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 12 sitesUnited States
- Study dates
- 15 May 2021to 13 Nov 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Show all 9Show fewer
- 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
Who cannot join
- 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
Show all 30Show fewer
- 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.
- Received live vaccine 30 days prior to screening or planning on receiving a live vaccine during the time period that he/she is participating in the study.
- Any esophageal stricture unable to be passed with a standard, diagnostic upper endoscope.
- History of bleeding disorders or esophageal varices.
- Active parasitic infection.
- History of alcohol or drug abuse within 6 months prior to screening.
- Participant or his/her immediate family is a member of the investigational team.
- Planned or anticipated major surgical procedure during the study.
- Initiation, discontinuation or addition of allergens to subcutaneous immunotherapy (SCIT) within 12 months prior to screening.
- Treatment with sublingual immunotherapy (SLIT) within 6 months prior to screening.
- Treatment with oral immunotherapy (OIT) within 6 months prior to screening.
- Chronic or acute infection requiring treatment with systemic antibiotics, antivirals or antifungals within 2 weeks before the baseline visit
- Known or suspected immunodeficiency disorder, including human immunodeficiency disorder (HIV).
- Planned or anticipated use of any prohibited medications and procedures during the study.
- Initiation, discontinuation or change in the dosage regimen of the following Proton pump inhibitors (PPIs) Leukotriene inhibitors Nasal and/or inhaled corticosteroids
- Women of childbearing potential who are unwilling to practice highly effective contraception.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Children's Hospital Colorado
Aurora, Colorado, 80045
University of Colorado Denver and Hospital
Aurora, Colorado, 80045
Tufts Medical Center
Boston, Massachusetts, 02111
University of North Carolina School of Medicine
Chapel Hill, North Carolina, 27599
Northwestern Medicine Digestive Health Center
Chicago, Illinois, 60611
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Texas Children's Hospital
Houston, Texas, 77030
Riley Children's Hospital
Indianapolis, Indiana, 46202
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
University of Utah Hospital
Salt Lake City, Utah, 84132
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Efficacy of Dupilumab (Anti-IL4a) in Subjects With Eosinophilic Gastritis
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.
Read the detailed description
This is a phase 2, multi-center, randomized, double-blind, placebo-controlled trial testing the efficacy of dupilumab vs. placebo in EG. Qualifying subjects will be randomized 1:1 to either study drug (dupilumab) or placebo, and will receive 600 mg once followed by 300 mg doses every two weeks of study treatment for a total of 6 injections. After the 6th injection subjects may continue into an open-label treatment phase in which dupilumab will be administered every two weeks for a total of 24 weeks.
Approximately 14 sites associated with the Consortium of Eosinophilic Gastrointestinal Disease Researchers (CEGIR) will take part in the study.
The primary objective of this study is to assess the efficacy of repeat subcutaneous (SC) doses of dupilumab, compared with placebo, to reduce eosinophilic inflammation in the gastrointestinal tract of patients with EG.
- Being tested
- Dupilumab (blinded), Placebo (blinded)
- Medical subject headings
- Eosinophilic enteropathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 group | Role | What they receive |
|---|---|---|
| Dupilumab | Active comparator | Not described Receives: Drug: Dupilumab (blinded) |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo (blinded) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2018
- Study start15 May 2021
- Primary completion4 Mar 2024
- Study completion13 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Eosinophilic GastritisStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are assigned to either drug or placebo, followed by an open label extension
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- Regeneron Pharmaceuticals, National Institute of Allergy and Infectious Diseases (NIAID)
- Responsible party
- Sponsor
- Investigators
- Marc Rothenberg, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03678545
- Sponsor's protocol ID
- 2020-0798
- Other IDs
- U54AI117804
- Status last verified
- Mar 2025
- First submitted
- 6 Aug 2018
- Last updated
- 4 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
Gonsalves NP, Dellon ES, Kliewer KL, Shoda T, Yearout R, Aceves SS, Arva NC, Besse JA, Caldwell JM, Chehade M, Coleman A, Collins MH, Anvari S, Falk GW, Gupta SK, Hiremath G, Katzka DA, Khoury P, Leung J, Menard-Katcher C, Menard-Katcher P, Peterson KA, Pletneva MA, Spergel AKR, Spergel JM, Vaysman T, Wechsler JB, Wright BL, Yang GY, Zhang X, Zhou M, Bansal A, Raphael BP, Radwan A, Maloney J, Martin A, Deniz Y, Furuta GT, Martin LJ, Rothenberg ME; Consortium of Eosinophilic Gastrointestinal Disease Researchers (CEGIR) Investigators. Dupilumab versus placebo in adults and adolescents with eosinophilic gastritis (DEGAS): a double-blind, placebo-controlled, phase 2, multicentre, randomised controlled trial. Lancet Gastroenterol Hepatol. 2026 Aug;11(8):672-688. doi: 10.1016/S2468-1253(26)00116-0. Epub 2026 Jun 24.
PubMed 42341804Sia 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.
PubMed 37753954
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Efficacy of Dupilumab (Anti-IL4a) in Subjects With Eosinophilic Gastritis
- ClinicalTrials.gov ID
- NCT03678545
- Acronym / sponsor ID
- 2020-0798
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Collaborators
- Regeneron Pharmaceuticals, National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 15 May 2021 (actual)
- Primary completion
- 4 Mar 2024 (actual)
- Study completion
- 13 Nov 2024 (actual)
- First posted
- 19 Sep 2018 (actual)
- Results
- Posted 4 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a phase 2, multi-center, randomized, double-blind, placebo-controlled trial testing the efficacy of dupilumab vs. placebo in EG. Qualifying subjects will be randomized 1:1 to either study drug (dupilumab) or placebo, and will receive 600 mg once followed by 300 mg doses every two weeks of study treatment for a total of 6 injections. After the 6th injection subjects may continue into an open-label treatment phase in which dupilumab will be administered every two weeks for a total of 24 weeks.
Approximately 14 sites associated with the Consortium of Eosinophilic Gastrointestinal Disease Researchers (CEGIR) will take part in the study.
The primary objective of this study is to assess the efficacy of repeat subcutaneous (SC) doses of dupilumab, compared with placebo, to reduce eosinophilic inflammation in the gastrointestinal tract of patients with EG.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Participants are assigned to either drug or placebo, followed by an open label extension
| Arm | Type | Receives |
|---|---|---|
| Dupilumab | Active comparator | Drug: Dupilumab (blinded) |
| Placebo | Placebo comparator | Drug: Placebo (blinded) |
Who may qualify
- Ages
- 12 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (30 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dupilumab (blinded)Subcutaneous injection every two weeks as follows: 600 mg initial dose, and 300 mg subsequent doses for a total of 6 injections. | Drug | Dupilumab |
| Placebo (blinded)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. | Drug | Placebo |
Primary outcome
Relative Change of Peak Eosinophil Counts in the Stomach
Time frame: 12 weeks after randomization
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42341804Gonsalves NP, Dellon ES, Kliewer KL, Shoda T, Yearout R, Aceves SS, Arva NC, Besse JA, Caldwell JM, Chehade M, Coleman A, Collins MH, Anvari S, Falk GW, Gupta SK, Hiremath G, Katzka DA, Khoury P, Leung J, Menard-Katcher C, Menard-Katcher P, Peterson KA, Pletneva MA, Spergel AKR, Spergel JM, Vaysman T, Wechsler JB, Wright BL, Yang GY, Zhang X, Zhou M, Bansal A, Raphael BP, Radwan A, Maloney J, Martin A, Deniz Y, Furuta GT, Martin LJ, Rothenberg ME; Consortium of Eosinophilic Gastrointestinal Disease Researchers (CEGIR) Investigators. Dupilumab versus placebo in adults and adolescents with eosinophilic gastritis (DEGAS): a double-blind, placebo-controlled, phase 2, multicentre, randomised controlled trial. Lancet Gastroenterol Hepatol. 2026 Aug;11(8):672-688. doi: 10.1016/S2468-1253(26)00116-0. Epub 2026 Jun 24.
- Derived from this study: PubMed 37753954Sia 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.
- Individual participant dataSharing planned: No. 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.
Related trials for Eosinophilic Gastritis
Recruiting
The Esophageal String Test as a Diagnostic Screening Tool for Eosinophilic Esophagitis Among Africans With Dysphagia in Mali and the United States
Dysphagia, Eosinophilic Esophagitis
Active, not recruitingPhase 3
Efficacy and Safety of Tezepelumab in Patients With Eosinophilic Esophagitis
Eosinophilic Esophagitis
RecruitingObservational study
Natural History and Genetics of Food Allergy and Related Conditions
Food Allergy, Loeys-Dietz Syndrome
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Active, not recruiting
Patient-Centered Decision Support for Eosinophilic Esophagitis
Eosinophilic Esophagitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc Rothenberg principal investigator
Children's Hospital Medical Center, Cincinnati
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dupilumab (blinded) in people with Eosinophilic Gastritis and Eosinophilic Gastroenteritis, run by Children's Hospital Medical Center, Cincinnati at 12 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relative Change of Peak Eosinophil Counts in the Stomach (time frame: 12 weeks after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03678545, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2025.