Clinical trial NCT05831176: 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
Official title: A Phase 2, 2-Part, Open-Label, Single-Arm Study to Investigate the Efficacy and Safety of Dupilumab in Adult and Adolescent Patients With Eosinophilic Gastritis With or Without Eosinophilic Duodenitis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Eosinophilic Gastritis (EoG)
Eosinophilic Duodenitis (EoD)
Eosinophilic Gastrointestinal Disease (EGID)
Eosinophilic Gastroenteritis
Keywords: Eosinophilic Gastritis (EoG) with or without Eosinophilic Duodenitis (EoD)
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Sanofi
First posted: 2023-04-26
Enrollment: 22
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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)

Detailed description: 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: Key Inclusion Criteria:

1. Adolescent participants will only be enrolled at study sites in countries/regions as permitted by local regulatory authorities and ethic committees (ECs)
2. Documented endoscopic biopsy supporting a pathologic diagnosis of Eosinophilic gastritis (EoG) at least 3 months prior to screening
3. Screening endoscopic biopsies with a demonstration of eosinophilic infiltration for a diagnosis of EoG, as defined in the protocol
4. Completed at least 11 of 14 days of EoG/EoD-SQ eDiary data entry in the 2 weeks prior to the baseline visit
5. 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
6. 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.

Key Exclusion Criteria:

1. Body weight less than 40 kg at screening
2. Prior participation in a dupilumab clinical trial, or past or current treatment with dupilumab
3. Helicobacter pylori infection
4. Any esophageal stricture unable to be passed with a standard, diagnostic, upper endoscope or any critical esophageal stricture that requires dilation at screening
5. History of achalasia, Crohn's disease, eosinophilic colitis, ulcerative colitis, celiac disease, and prior gastric or duodenal surgery, as defined in the protocol
6. Other causes of gastric and, if applicable, duodenal eosinophilia or the following conditions: eosinophilic granulomatosis with polyangiitis (Churg-Strauss syndrome) or hyper-eosinophilic syndrome
7. 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
8. 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
9. Planned or anticipated use of any prohibited medications and procedures during the study
10. Planned or anticipated major surgical procedure during the study
11. Receiving tube feeding or parenteral nutritional at screening

NOTE: Other Protocol Defined Inclusion / Exclusion Criteria Apply

Primary outcomes:
measure: Percent change in peak gastric eosinophil count eosinophils/high power field (eos/hpf)
timeFrame: Baseline to Week 24
Secondary outcomes:
measure: Proportion of participants achieving a peak gastric eosinophil count of ≤20 eos/hpf
timeFrame: Up to 52 Weeks
measure: Proportion of participants achieving a peak gastric eosinophil count of ≤30 eos/hpf
timeFrame: Up to 52 Weeks
measure: Proportion of participants achieving both a peak gastric eosinophil count of ≤20 eos/hpf and a peak duodenal eosinophil count of ≤30 eos/hpf
timeFrame: Up to 52 Weeks
measure: Proportion of participants achieving a peak duodenal eosinophil count of ≤30 eos/hpf
timeFrame: Up to 52 Weeks
measure: Absolute change in the EoG/EoD-SQ Total Symptom Score (TSS)
timeFrame: Baseline up to 52 Weeks
measure: Percent change in the EoG/EoD-SQ TSS
timeFrame: Baseline up to 52 Weeks
measure: Percent change in peak duodenal tissue eosinophil count (eos/hpf)
timeFrame: Baseline up to 52 Weeks
measure: Absolute change in EoG scores from the EoG Histology Scoring System (EoGHSS)
timeFrame: Baseline up to 52 Weeks
measure: Change in frequency of diarrhea episodes
timeFrame: Baseline up to 52 Weeks
measure: Change in frequency of vomiting episodes
timeFrame: Baseline up to 52 Weeks
measure: Change in the Normalized Enrichment Scores (NES) for the type 2 inflammation transcriptome signature
timeFrame: Baseline up to 52 Weeks
measure: Change in the NES for the type 2 inflammation transcriptome signature
timeFrame: Baseline up to 52 Weeks
measure: Change in the NES for the EoG disease (EoG diagnostic panel (EGDP]) transcriptome signature
timeFrame: Baseline up to 52 Weeks
measure: Proportion of participants who receive rescue medications or procedures
timeFrame: Up to 52 Weeks
measure: Incidence of treatment-emergent adverse events (TEAEs)
timeFrame: Up to 52 Weeks
measure: Incidence of treatment-emergent serious adverse events (SAEs)
timeFrame: Up to 52 Weeks
measure: Incidence of treatment-emergent adverse events of special interest (AESIs)
timeFrame: Up to 52 Weeks
measure: Incidence of TEAEs leading to permanent discontinuation of study treatment
timeFrame: Up to 52 Weeks
measure: Incidence of anti-drug antibody (ADA)
timeFrame: Up to 52 Weeks
measure: Titer of ADA
timeFrame: Up to 52 Weeks
measure: Incidence of neutralizing antibody (NAb) to dupilumab
timeFrame: Up to 52 Weeks
measure: Concentrations of functional dupilumab in serum at each assessment time point
timeFrame: Baseline to 64 Weeks
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Phoenix Childrens Hospital
state: Arizona
city: Apple Valley
country: United States
facility: Om Research LLC
state: California
city: La Jolla
country: United States
facility: Scripps Memorial Hospital La Jolla
state: California
city: Lancaster
country: United States
facility: Om Research LLC
state: California
city: Los Alamitos
country: United States
facility: United Gastroenterologists
state: California
city: Los Angeles
country: United States
facility: USC, Keck School of Medicine
state: California
city: Los Angeles
country: United States
facility: GastroIntestinal BioSciences
state: California
city: Los Angeles
country: United States
facility: University of California - Los Angeles (UCLA)
state: California
city: Murrieta
country: United States
facility: United Medical Doctors
state: California
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
city: Bristol
country: United States
facility: Connecticut Clinical Research Institute
state: Connecticut
city: Farmington
country: United States
facility: Uconn Health
state: Connecticut
city: Jacksonville
country: United States
facility: Encore Borland-Groover Clinical Research
state: Florida
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Gurnee
country: United States
facility: Gi Alliance
state: Illinois
city: Iowa City
country: United States
facility: The University of Iowa Hospitals & Clinics
state: Iowa
city: Kansas City
country: United States
facility: University Of Kansas
state: Kansas
city: Hagerstown
country: United States
facility: Meritus Medical Center
state: Maryland
city: Boston
country: United States
facility: Boston Specialists
state: Massachusetts
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center (BIDMC) Harvard Medical School
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Plymouth
country: United States
facility: Minnesota Gastroenterology, P.A.
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic Hospital Rochester
state: Minnesota
city: Omaha
country: United States
facility: Children's Hospital and Medical Center
state: Nebraska
city: Reno
country: United States
facility: Advanced Research Institute
state: Nevada
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center
state: New Hampshire
city: Great Neck
country: United States
facility: Northwell Health
state: New York
city: Great Neck
country: United States
facility: Long Island Gastrointestinal Research Group
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai (ISMMS) - The Mount Sinai Hospital (MSH)
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
city: Charlotte
country: United States
facility: Charlotte Gastroenterology & Hepatology, PLLC
state: North Carolina
city: Durham
country: United States
facility: Duke University Health System
state: North Carolina
city: Kinston
country: United States
facility: ESI Medical Research, PLLC
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati Medical Center-Children's Hospital Medical Center
state: Ohio
city: Columbus
country: United States
facility: Ohio State University Medical Center
state: Ohio
city: Mentor
country: United States
facility: Great Lakes Gastroenterology Research, LLC
state: Ohio
city: Oklahoma City
country: United States
facility: Allergy, Asthma and Clinical Research Center
state: Oklahoma
city: Portland
country: United States
facility: The Oregon Clinic - Gastroenterology East
state: Oregon
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Hixson
country: United States
facility: Galen Medical Group
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center-Digestive Disease Center
state: Tennessee
city: Fort Worth
country: United States
facility: Cook Children's Medical Center
state: Texas
city: Garland
country: United States
facility: GI Alliance Research - Garland
state: Texas
city: Laredo
country: United States
facility: Envision Clinical Research Lcc
state: Texas
city: Mansfield
country: United States
facility: TDDC dba GI Alliance Research
state: Texas
city: Salt Lake City
country: United States
facility: The University of Utah Health Sciences Center
state: Utah
city: West Jordan
country: United States
facility: Velocity Clinical Research
state: Utah
city: Seattle
country: United States
facility: Seattle Children's Home Health Company
state: Washington
city: Seattle
country: United States
facility: Seattle Allergy and Asthma Research Institute
state: Washington
city: Milwaukee
country: United States
facility: Froedtert Hospital
state: Wisconsin
city: Kingswood
country: Australia
facility: Nepean Hospital
state: New South Wales
city: South Brisbane
country: Australia
facility: Mater Research Ltd
state: Queensland
city: Woolloongabba
country: Australia
facility: The University of Queensland - Princess Alexandra Hospital (PAH)
state: Queensland
city: Fitzroy
country: Australia
facility: St. Vincent's Hospital
city: Joondalup
country: Australia
facility: Joondalup Health Campus
city: North Mackay
country: Australia
facility: Coral Sea Clinical Research Institute
city: Edmonton
country: Canada
facility: Stollery Children's Hospital - University of Alberta
state: Alberta
city: Rozzano
country: Italy
facility: Humanitas Research Hospital
state: Milan
city: Palermo
country: Italy
facility: AOOR Villa Sofia/Cervello
state: Sicilia
city: Bari
country: Italy
facility: U.O. Di Ematologia-Azienda Policlinico Consorziale, Ospedaliero-Universitaria, Ospedale
city: Milano
country: Italy
facility: Fondazione Irccs Ca Granda Ospedale Maggiore Policlinico
city: Pisa
country: Italy
facility: Azienda Ospedaliero Universitaria Pisana
city: Roma
country: Italy
facility: Ospedale S Giovanni Calibita Fatebenefratelli Isola Tiberina
city: Rome
country: Italy
facility: University of Rome - Pediatric Gastroenterology and Liver Unit
city: Iizuka
country: Japan
facility: Iizuka Hospital
state: Fukuoka
city: Ogaki
country: Japan
facility: Ogaki Municipal Hospital
state: Gifu
city: Isesaki
country: Japan
facility: Isesaki Municipal Hospital
state: Gunma
city: Kure
country: Japan
facility: Kure Kyosai Hospital
state: Hiroshima
city: Himeji
country: Japan
facility: Hyogo Prefectural Harima-Himeji General Medical Center
state: Hyogo
city: Kobe-shi
country: Japan
facility: Kobe University Hospital
state: Hyogo
city: Yokohama-shi
country: Japan
facility: Yokohama City University Hospital
state: Kanagawa
city: Kurashiki
country: Japan
facility: Kawasaki Medical School Hospital
state: Okayama
city: Minato-ku
country: Japan
facility: Federation of National Public Service Personnel Mutual Aid Associations Toranomon Hospital
state: Tokyo
city: Yamagata
country: Japan
facility: Yamagata University Hospital
city: Warszawa
country: Poland
facility: Wip Warsaw Ibd Point Profesor Kierkus
state: Mazowieckie
city: Rzeszow
country: Poland
facility: Korczowski Bartosz - Gabinet Lekarski
state: Podkarpackie
city: Wroclaw
country: Poland
facility: Centrum Medyczne Melita Medical
Study officials:
affiliation: Regeneron Pharmaceuticals
name: Clinical Trial Management
role: STUDY_DIRECTOR
References: