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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
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).
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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
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
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
| DRUG: Dupilumab Dose 1
|
EXPERIMENTAL: Part B: Phase 3
| DRUG: Dupilumab Dose 1
|
EXPERIMENTAL: Part C: Extended Active Treatment Period
| DRUG: Dupilumab Dose 1
|
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 |
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