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DEGS - Dupilumab for Eosinophilic Gastritis Study

Study Purpose

40 participants with Eosinophilic Gastritis 18-60 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.

Recruitment Criteria

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Accepts Healthy Volunteers
No

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Study Type
Interventional
Eligible Ages 18 Years - 70 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Able to give written informed consent - Willing and able to comply with study visits and activities.
  • - Age 18-70 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, with no other known cause for gastric eosinophilia; involvement of eosinophilic inflammation in other gastrointestinal segments will be allowed but not required or sufficient.
  • - Ongoing clinical symptoms (i.e., abdominal pain, bloating, vomiting, diarrhea) prior to enrollment that are not adequately managed by current therapeutic regimen, in the opinion of the patient and investigator.
  • - Stable medical management of EG (and other eosinophilic disorders, if applicable) including stable dosage of medications in the 30 days prior to study enrolment.
Subjects may be on baseline anti-EG therapy (such as elimination diet, elemental diet, proton pump inhibitors, topical or systemic glucocorticoids, immunosuppressive agents, cromolyn, and anti-histamines) as long as there is agreement not to change their dosage unless medically indicated.
  • - Willing to maintain current dietary regimen throughout the course of the study.
  • - Women of childbearing potential (WOCBP) and male subjects who are sexually active and non-sterile must agree to use an acceptable method of contraception from Screening until 16 weeks after their last dose.

Exclusion Criteria:

  • - Concurrent H.
pylori gastritis or parasitic infection
  • - Other gastrointestinal disorders such as Crohn's disease, inflammatory bowel disease, or Celiac disease - Hypereosinophilic syndrome, defined by multiple organ involvement (with the exception of atopic disease or EGID) and persistent blood absolute eosinophil count ≥1500/mcL.
  • - History of cancer: Subjects who have had basal cell carcinoma, localized squamous cell carcinoma of the skin, or in situ carcinoma of the cervix are eligible provided that the subject is in remission and curative therapy was completed at least 12 months prior to the date informed consent was obtained.
Subjects who have had other malignancies are eligible provided that the subject is in remission and curative therapy was completed at least 5 years prior to the date informed consent was obtained. - Current or recent use of biological agents (<5 half-lives prior to screening) - Current or recent use of any investigational drug (30 days or 5 half-lives, whichever is longer, prior to screening) - History of anaphylaxis to any biologic therapy or vaccine - Current pregnancy or breastfeeding - A history of known immunodeficiency disorder including a positive human immunodeficiency virus (HIV) test - Receipt of immunoglobulin or blood products within 30 days prior to the date informed consent is obtained - Any other medical illness that precludes study involvement

Trial Details

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

Trial ID:
NCT03678545

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase
Phase 2

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Lead Sponsor
Children's Hospital Medical Center, Cincinnati

The person who is responsible for the scientific and technical direction of the entire clinical study.

Principal Investigator
N/A
Principal Investigator Affiliation N/A

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Agency Class
OtherIndustry
Overall Status Not yet recruiting
Countries United States

The disease, disorder, syndrome, illness, or injury that is being studied.

Conditions
Eosinophilic Gastritis, Eosinophilic Gastroenteritis
Additional Details

This is a phase 2, multi-center, randomized, double-blind, placebo-controlled trial testing the efficacy of dupilumab vs.#46; 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 nine 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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Cincinnati, Ohio

Status

Address

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229

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