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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-500795-62-00 | Registry Identifier | EUCT Number |
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| Name | Class |
|---|---|
| Sanofi | INDUSTRY |
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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:
This study has 2 parts and a 12-week (about 3 months) Follow-up Period for all participants
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dupilumab | Experimental | Part A: Treatment Period Part C: Extended Treatment Period Eligible participants from Part A will enter Part C |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dupilumab | Drug | Administered as described in the protocol |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent change in peak gastric eosinophil count eosinophils/high power field (eos/hpf) | Baseline up to 24 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percent change in peak gastric eosinophil count eosinophils/high power field (eos/hpf) | Baseline up to 52 Weeks | |
| Proportion of participants achieving a peak gastric eosinophil count of ≤20 eos/hpf | Up to 52 Weeks |
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Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other Protocol Defined Inclusion / Exclusion Criteria Apply
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Management | Regeneron Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phoenix Childrens Hospital | Phoenix | Arizona | 85016 | United States | ||
| Om Research LLC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37753954 | Derived | 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. |
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All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.
When Regeneron has:
Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf
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| Proportion of participants achieving a peak gastric eosinophil count of ≤30 eos/hpf | Up to 52 Weeks |
| Proportion of participants achieving both a peak gastric eosinophil count of ≤20 eos/hpf and a peak duodenal eosinophil count of ≤30 eos/hpf | Up to 52 Weeks |
| Proportion of participants achieving a peak duodenal eosinophil count of ≤30 eos/hpf | Assessed for only those with duodenal involvement | Up to 52 Weeks |
| Absolute change in the EoG/EoD-SQ Total Symptom Score (TSS) | 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 up to 52 Weeks |
| Percent change in the EoG/EoD-SQ TSS | Baseline up to 52 Weeks |
| Percent change in peak duodenal tissue eosinophil count (eos/hpf) | Assessed for only those with duodenal involvement | Baseline up to 52 Weeks |
| Absolute change in EoG scores from the EoG Histology Scoring System (EoGHSS) | 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 up to 52 Weeks |
| Change in frequency of diarrhea episodes | Assessed for only those with diarrhea at baseline | Baseline up to 52 Weeks |
| Change in frequency of vomiting episodes | Assessed for only those with vomiting at baseline | Baseline up to 52 Weeks |
| Change in the Normalized Enrichment Scores (NES) for the type 2 inflammation transcriptome signature | 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 up to 52 Weeks |
| Change in the NES for the type 2 inflammation transcriptome signature | 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 up to 52 Weeks |
| Change in the NES for the EoG disease (EoG diagnostic panel (EGDP]) transcriptome signature | 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 up to 52 Weeks |
| Proportion of participants who receive rescue medications or procedures | Up to 52 Weeks |
| Incidence of treatment-emergent adverse events (TEAEs) | 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 52 Weeks |
| Incidence of treatment-emergent serious adverse events (SAEs) | An SAE is any untoward medical occurrence that at any dose:
| Up to 52 Weeks |
| Incidence of treatment-emergent adverse events of special interest (AESIs) | 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 52 Weeks |
| Incidence of TEAEs leading to permanent discontinuation of study treatment | 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 52 Weeks |
| Incidence of anti-drug antibody (ADA) | Immunogenicity will be characterized per drug molecule by ADA status | Up to 52 Weeks |
| Titer of ADA | Immunogenicity will be characterized per drug molecule by ADA status | Up to 52 Weeks |
| Incidence of neutralizing antibody (NAb) to dupilumab | Immunogenicity will be characterized per drug molecule by NAb status | Up to 52 Weeks |
| Concentrations of functional dupilumab in serum at each assessment time point | 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 up to 64 Weeks |
| Apple Valley |
| California |
| 92307 |
| United States |
| Scripps Clinic | La Jolla | California | 92037 | United States |
| Om Research LLC | Lancaster | California | 93534 | United States |
| University of California - Los Angeles (UCLA) | Los Angeles | California | 90024 | United States |
| University of Southern California Keck School of Medicine | Los Angeles | California | 90033 | United States |
| GastroIntestinal BioSciences | Los Angeles | California | 90067 | United States |
| United Medical Doctors | Murrieta | California | 92563 | United States |
| Ucsf Medical Center (Benioff Childrens Hospital) | San Francisco | California | 94158 | United States |
| University of Colorado Anschutz Health Science Building (AHSB) CU Research Pharmacy | Aurora | Colorado | 80045 | United States |
| Connecticut Clinical Research Institute | Bristol | Connecticut | 06010 | United States |
| UConn Health | Farmington | Connecticut | 06030 | United States |
| Encore Borland-Groover Clinical Research | Jacksonville | Florida | 32256 | United States |
| Northwestern University | Chicago | Illinois | 60611 | United States |
| University Of Kansas | Kansas City | Kansas | 66103 | United States |
| Beth Israel Deaconess Medical Center (BIDMC) Harvard Medical School | Boston | Massachusetts | 02215 | United States |
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| MNGI Digestive Health P.A. | Plymouth | Minnesota | 55446 | United States |
| Mayo Clinic Hospital Rochester | Rochester | Minnesota | 55905 | United States |
| Advanced Research Institute | Reno | Nevada | 89511 | United States |
| Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | United States |
| Northwell Health | Great Neck | New York | 11021 | United States |
| Icahn School of Medicine at Mount Sinai (ISMMS) - The Mount Sinai Hospital (MSH) | New York | New York | 10029 | United States |
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
| Charlotte Gastroenterology & Hepatology, PLLC | Charlotte | North Carolina | 28207 | United States |
| Duke University | Durham | North Carolina | 27710 | United States |
| ESI Medical Research, PLLC | Kinston | North Carolina | 28513 | United States |
| University of Cincinnati Medical Center-Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | United States |
| Ohio State University Medical Center | Columbus | Ohio | 43210 | United States |
| Allergy, Asthma and Clinical Research Center | Oklahoma City | Oklahoma | 73120 | United States |
| The Oregon Clinic - Gastroenterology East | Portland | Oregon | 97220 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| TDDC dba GI Alliance Research | Mansfield | Texas | 76063 | United States |
| University of Utah | Salt Lake City | Utah | 84132 | United States |
| Seattle Children's Home Health Company | Seattle | Washington | 98105 | United States |
| Froedtert Hospital | Milwaukee | Wisconsin | 53226 | United States |
| Stollery Children's Hospital - University of Alberta | Edmonton | Alberta | T6G 1C9 | Canada |
| Humanitas Research Hospital | Rozzano | Milan | 20089 | Italy |
| AOOR Villa Sofia/Cervello | Palermo | Sicily | 90146 | Italy |
| U.O. Di Ematologia-Azienda Policlinico Consorziale, Ospedaliero-Universitaria, Ospedale | Bari | 70124 | Italy |
| Fondazione Serena Onlus - Azienda Ospedaliera Niguarda Ca' Granda - Centro Clinico Nemo (Neuro Muscular Omnicentre) | Milan | 20162 | Italy |
| Azienda Ospedaliero Universitaria Pisana | Pisa | 56124 | Italy |
| Ospedale S Giovanni Calibita Fatebenefratelli Isola Tiberina | Roma | 00186 | Italy |
| University of Rome - Pediatric Gastroenterology and Liver Unit | Rome | 00161 | Italy |
| Iizuka Hospital | Iizuka | Fukuoka | 820-8505 | Japan |
| Ogaki Municipal Hospital | Ōgaki | Gifu | 503-8502 | Japan |
| Kure Kyosai Hospital | Kure | Hiroshima | 737-8505 | Japan |
| Hyogo Prefectural Harima-Himeji General Medical Center | Himeji | Hyōgo | 670-8560 | Japan |
| Kobe University Graduate School of Medicine | Kobe | Hyōgo | 650-0017 | Japan |
| Yokohama City University Hospital | Yokohama | Kanagawa | 236-0004 | Japan |
| Kawasaki Medical School Hospital | Kurashiki | Okayama-ken | 701-0192 | Japan |
| Toranomon Hospital | Minato-ku | Tokyo | 105-8470 | Japan |
| Yamagata University Hospital | Yamagata | 990-9585 | Japan |
| ID | Term |
|---|---|
| C535952 | Eosinophilic enteropathy |
| D057765 | Eosinophilic Esophagitis |
| ID | Term |
|---|---|
| D004941 | Esophagitis |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D005759 | Gastroenteritis |
| D004802 | Eosinophilia |
| D007960 | Leukocyte Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C582203 | dupilumab |
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