Save

A Study to Learn How Well Dupilumab Works in Adult and Adolescent Participants With Eosinophilic Gastritis With or Without Eosinophilic Duodenitis and the Side Effects it May Have

PHASE2RECRUITING

This study is researching an experimental drug called dupilumab. The study is focused on participants with active eosinophilic gastritis (EoG) with or without eosinophilic duodenitis (EoD). Participants with EoD only are not eligible for enrollment.

EoG and EoD are uncommon, persistent, allergic/immune diseases in which eosinophils (a type of white blood cell) gather in large numbers in the stomach and small intestine and cause inflammation and damage. The aim of the study is to evaluate the effect of dupilumab on relieving EoG (with or without EoD) symptoms and reducing inflammation in the stomach and, if applicable, small intestine in adults and adolescents aged 12 years and older after at least 24 weeks (about 6 months) and up to 52 weeks (1 year) of treatment. The study is looking at several other research questions, including: * What side effects may happen from taking the study drug * How much study drug is in the blood at different times * Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects).

Simpliy with AI

Study details:

This study has 2 parts and a 12-week (about 3 months) Follow-up Period for all participants. * Part A is an open-label treatment period lasting up to 24 weeks (up to 6 months). "Open-label" means that you and the study doctors and the staff staff will know that you are taking the study drug.

* Part C is an open-label extended treatment period lasting up to 28 weeks (about 7 months). "Extended Treatment Period" means that you will take the study drug for 28 weeks if you are eligible to take part in this part of the study.

Simplify with AI

Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

Adolescent participants will only be enrolled at study sites in countries/regions as permitted by local regulatory authorities and ethic committees (ECs)

Documented endoscopic biopsy supporting a pathologic diagnosis of Eosinophilic gastritis (EoG) at least 3 months prior to screening

Screening endoscopic biopsies with a demonstration of eosinophilic infiltration for a diagnosis of EoG, as defined in the protocol

Completed at least 11 of 14 days of EoG/EoD-SQ eDiary data entry in the 2 weeks prior to the baseline visit

History (by participant report) of at least 2 episodes of EoG (with or without EoD) symptoms per week in 8 weeks before screening, as defined in the protocol

An average TSS of ≥ 20 calculated using data collected via the EoG/EoD-SQ eDiary per week for the 2 weeks prior to baseline. An average severity score of ≥4 (on a scale of 0-10) per week for the 2 weeks prior to baseline for at least 2 of the 6 symptoms, as defined in the protocol.

Exclusion criteria

Body weight less than 40 kg at screening

Prior participation in a dupilumab clinical trial, or past or current treatment with dupilumab

Helicobacter pylori infection

Any esophageal stricture unable to be passed with a standard, diagnostic, upper endoscope or any critical esophageal stricture that requires dilation at screening

History of achalasia, Crohn's disease, eosinophilic colitis, ulcerative colitis, celiac disease, and prior gastric or duodenal surgery, as defined in the protocol

Other causes of gastric and, if applicable, duodenal eosinophilia or the following conditions: eosinophilic granulomatosis with polyangiitis (Churg-Strauss syndrome) or hyper-eosinophilic syndrome

History of bleeding disorders, esophageal or gastric varices that, in the opinion of the investigator, would put the participant at undue risk for significant complications from an endoscopy procedure

Initiation or change of a food-elimination diet regimen or re-introduction of a previously eliminated food group in the 4 weeks prior to the screening visit. Participants on a food-elimination diet must remain on the same diet throughout the study

Planned or anticipated use of any prohibited medications and procedures during the study

Planned or anticipated major surgical procedure during the study

Receiving tube feeding or parenteral nutritional at screening

Simplify with AI

Eligibility

Age eligible for study : 12 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2023-05-03

Primary completion: 2026-06-17

Study completion finish: 2027-03-24

Study type

TREATMENT

Phase

PHASE2

Trial ID

NCT05831176

Intervention or treatment

DRUG: Dupilumab Dose 1

DRUG: Dupilumab Dose 2

DRUG: Matching Placebo

Conditions

• Eosinophilic Gastritis
• Eosinophilic Duodenitis
• Eosinophilic Gastrointestinal Disease

Condition: Eosinophilic Gastritis, Eosinophilic Duodenitis and more
DRUG: Dupilumab Dose 1 and other drugs
Kingswood, New South Wales, Australia and more
Sponsor: Regeneron Pharmaceuticals

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

Nepean Clinical School

Research sites nearby

Select from list below to view details:

Nepean Clinical School
Kingswood, New South Wales, Australia
Mater Research Ltd
South Brisbane, Queensland, Australia
The University of Queensland - Princess Alexandra Hospital (PAH)
Woolloongabba, Queensland, Australia
St. Vincent's Hospital
Fitzroy, Not Specified, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Part A: Phase 2 Randomized 1:1	DRUG: Dupilumab Dose 1 Administered subcutaneously (SC) once weekly (QW)
EXPERIMENTAL: Part B: Phase 3 Randomized 1:1:1	DRUG: Dupilumab Dose 1 Administered subcutaneously (SC) once weekly (QW)
EXPERIMENTAL: Part C: Extended Active Treatment Period Eligible participants from Part A and Part B will enter Part C. Part A participants will get Dose 1. Part B participants who received Dose 1 or Dose 2 will remain on Dose 1 or Dose 2. Part B placebo participants will be randomized 1:1 to receive Dose 1 or Dose 2.	DRUG: Dupilumab Dose 1 Administered subcutaneously (SC) once weekly (QW)

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
Proportion of participants achieving a peak gastric eosinophil count of ≤6 eosinophils/high power field (eos/hpf)	Part A and Part B	At Week 24
Absolute change in the Eosinophilic Gastritis/Eosinophilic Duodenitis Symptom Questionnaire (EoG/EoD-SQ) Total Symptom Score (TSS)	Part B Only EoG/EoD-SQ is a patient reported outcome (PRO) collected daily via an eDiary. Symptoms are assessed using an 11-point numerical rating scale (0 through 10). Higher scores indicate a higher symptom burden. Symptom scores are summed on each day with a maximum daily score of 60. The TSS is calculated by averaging daily sum scores over 7 days, with a maximum TSS of 60.	Baseline to Week 24

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
Proportion of participants achieving both a peak gastric eosinophil count of ≤6 eos/hpf and a peak duodenal eosinophil count of ≤15 eos/hpf	Part A, Part B and Part C	At Week 24 and At Week 52
Proportion of participants achieving a peak duodenal eosinophil count of ≤15 eos/hpf	Part A, Part B and Part C	At Week 24 and At Week 52
Absolute change in the EoG/EoD-SQ TSS	Part A and Part C EoG/EoD-SQ is a PRO collected daily via an eDiary. Symptoms are assessed using an 11-point numerical rating scale (0 through 10). Higher scores indicate a higher symptom burden. Symptom scores are summed on each day with a maximum daily score of 60. The TSS is calculated by averaging daily sum scores over 7 days, with a maximum TSS of 60.	Baseline to Week 24 and Baseline to Week 52
Percent change in the EoG/EoD-SQ TSS	Part A, Part B and Part C EoG/EoD-SQ is a PRO collected daily via an eDiary. Symptoms are assessed using an 11-point numerical rating scale (0 through 10). Higher scores indicate a higher symptom burden. Symptom scores are summed on each day with a maximum daily score of 60. The TSS is calculated by averaging daily sum scores over 7 days, with a maximum TSS of 60.	Baseline to Week 24 and Baseline to Week 52
Percent change in peak gastric tissue eosinophil count (eos/hpf)	Part A, Part B and Part C	Baseline to Week 24 and Baseline to Week 52
Proportion of participants achieving a peak gastric tissue eosinophil count of <30 eos/hpf	Part A, Part B and Part C	At Week 24 and At Week 52
Percent change in peak duodenal tissue eosinophil count (eos/hpf)	Part A, Part B and Part C: Assessed for only those with duodenal involvement	Baseline to Week 24 and Baseline to Week 52
Proportion of participants achieving a peak duodenal tissue eosinophil count of <30 eos/hpf	Part A, Part B and Part C: Assessed for only those with duodenal involvement	At Week 24 and At Week 52
Absolute change in EoG scores from the EoG Histology Scoring System (EoGHSS)	Part A, Part B and Part C EoGHSS scores evaluate 11 features of gastric tissue. Total score is the sum of features scores divided by the maximum possible score for the biopsy. Total scores range from 0 - 1.	Baseline to Week 24 and Baseline to Week 52
Change in frequency of diarrhea epispodes	Assessed for only those with diarrhea at baseline.	Baseline at Week 24 and Baseline at Week 52
Change in frequency of vomiting episodes	Assessed for only those with vomiting at baseline	Baseline at Week 24 and Baseline at Week 52
Change in the Normalized Enrichment Scores (NES) for the type 2 inflammation transcriptome signature	Part A, Part B and Part C: Assessed on gastric tissue Normalized Enrichment Score (NES) reflects the degree to which the activity level of a set of transcripts is overrepresented at the extremes (top or bottom) of the entire ranked list of transcripts within a sample and is normalized by accounting for the number of transcripts in the set.	Baseline to Week 24 and Baseline to Week 52
Change in the NES for the type 2 inflammation transcriptome signature	Part A, Part B and Part C: Assessed on duodenal tissue from participants with EoD NES reflects the degree to which the activity level of a set of transcripts is overrepresented at the extremes (top or bottom) of the entire ranked list of transcripts within a sample and is normalized by accounting for the number of transcripts in the set.	Baseline to Week 24 and Baseline to Week 52
Change in the NES for the EoG disease (EoG diagnostic panel (EGDP]) transcriptome signature	Part A, Part B and Part C: Assessed on gastric tissue NES reflects the degree to which the activity level of a set of transcripts is overrepresented at the extremes (top or bottom) of the entire ranked list of transcripts within a sample and is normalized by accounting for the number of transcripts in the set.	Baseline to Week 24 and Baseline to Week 52
Proportion of participants who receive rescue medications or procedures	Part A, Part B and Part C	At Week 24 and At Week 52
Proportion of participants achieving a peak gastric eosinophil count of ≤6 eos/hpf	Part C	At Week 52
Incidence of treatment-emergent adverse events (TEAEs)	Part A, Part B and Part C A TEAE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment.	Up to Week 52
Incidence of treatment-emergent serious adverse events (SAEs)	Part A, Part B and Part C An SAE is any untoward medical occurrence that at any dose: * Results in death - includes all deaths, even those that appear to be completely unrelated to study drug (eg, a car accident in which a patient is a passenger) * Is life-threatening * Requires in-patient hospitalization or prolongation of existing hospitalization * Results in persistent or significant disability/incapacity * Is a congenital anomaly/birth defect * Is an important medical event	Up to Week 52
Incidence of treatment-emergent adverse events of special interest (AESIs)	Part A, Part B and Part C An AESI (serious or non-serious) is one of scientific and medical concern specific to the sponsor's product or program, for which ongoing monitoring and rapid communication by the Investigator to the sponsor can be appropriate. Such an event might warrant further investigation in order to characterize and understand it	Up to Week 52
Incidence of TEAEs leading to permanent discontinuation of study treatment	Part A, Part B and Part C A TEAE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment.	Up to Week 52
Incidence of anti-drug antibody (ADA)	Part A, Part B and Part C Immunogenicity will be characterized per drug molecule by ADA and NAb status	Up to Week 52
Titer of ADA	Part A, Part B and Part C Immunogenicity will be characterized per drug molecule by ADA and NAb status	Up to Week 52
Incidence of neutralizing antibody (Nab) to dupilumab	Part A, Part B and Part C Immunogenicity will be characterized per drug molecule by ADA and NAb status	Up to Week 52
Concentrations of functional dupilumab in serum at each assessment time point from baseline to end of study	The concentrations of functional dupilumab over time will be summarized by descriptive statistics by study arm for the overall population and for adolescent patients.	Baseline to Week 64

Frequently Asked Questions

Please note: some questions and answers are submitted by anonymous patients or using AI, and have not been verified by Clinrol

No questions submitted. Be the first to ask a question!

You may be eligible to participate in this trial based on your search.Apply for study

Are you running this trial? If you're a clinic or sponsor, you can claim this study.Claim this trial

References

Clinical Trials Gov: A Study to Learn How Well Dupilumab Works in Adult and Adolescent Participants With Eosinophilic Gastritis With or Without Eosinophilic Duodenitis and the Side Effects it May Have