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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05831176




Registration number
NCT05831176
Ethics application status
Date submitted
14/04/2023
Date registered
26/04/2023

Titles & IDs
Public title
A Trial to Learn if Dupilumab is Safe for and Helps Adult and Adolescent Participants With Eosinophilic Gastritis With or Without Eosinophilic Duodenitis
Scientific title
A Phase 2/3, Randomized, 3-Part Study to Investigate the Efficacy and Safety of Dupilumab in Adult and Adolescent Patients With Eosinophilic Gastritis With or Without Eosinophilic Duodenitis
Secondary ID [1] 0 0
2022-500795-62-00
Secondary ID [2] 0 0
R668-EGE-2213
Universal Trial Number (UTN)
Trial acronym
ENGAGE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Eosinophilic Gastritis 0 0
Eosinophilic Duodenitis 0 0
Eosinophilic Gastrointestinal Disease 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Inflammatory and Immune System 0 0 0 0
Allergies
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Blood 0 0 0 0
Other blood disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Dupilumab Dose 1
Treatment: Drugs - Dupilumab Dose 2
Treatment: Drugs - Matching Placebo

Experimental: Part A: Phase 2 - Randomized 1:1

Experimental: Part B: Phase 3 - Randomized 1:1:1

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.


Treatment: Drugs: Dupilumab Dose 1
Administered subcutaneously (SC) once weekly (QW)

Treatment: Drugs: Dupilumab Dose 2
Administered SC once every 2 weeks (Q2W)

Treatment: Drugs: Matching Placebo
Administered SC
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of participants achieving a peak gastric eosinophil count of =6 eosinophils/high power field (eos/hpf)
Timepoint [1] 0 0
At Week 24
Primary outcome [2] 0 0
Absolute change in the Eosinophilic Gastritis/Eosinophilic Duodenitis Symptom Questionnaire (EoG/EoD-SQ) Total Symptom Score (TSS)
Timepoint [2] 0 0
Baseline to Week 24
Secondary outcome [1] 0 0
Proportion of participants achieving both a peak gastric eosinophil count of =6 eos/hpf and a peak duodenal eosinophil count of =15 eos/hpf
Timepoint [1] 0 0
At Week 24 and At Week 52
Secondary outcome [2] 0 0
Proportion of participants achieving a peak duodenal eosinophil count of =15 eos/hpf
Timepoint [2] 0 0
At Week 24 and At Week 52
Secondary outcome [3] 0 0
Absolute change in the EoG/EoD-SQ TSS
Timepoint [3] 0 0
Baseline to Week 24 and Baseline to Week 52
Secondary outcome [4] 0 0
Percent change in the EoG/EoD-SQ TSS
Timepoint [4] 0 0
Baseline to Week 24 and Baseline to Week 52
Secondary outcome [5] 0 0
Percent change in peak gastric tissue eosinophil count (eos/hpf)
Timepoint [5] 0 0
Baseline to Week 24 and Baseline to Week 52
Secondary outcome [6] 0 0
Proportion of participants achieving a peak gastric tissue eosinophil count of <30 eos/hpf
Timepoint [6] 0 0
At Week 24 and At Week 52
Secondary outcome [7] 0 0
Percent change in peak duodenal tissue eosinophil count (eos/hpf)
Timepoint [7] 0 0
Baseline to Week 24 and Baseline to Week 52
Secondary outcome [8] 0 0
Proportion of participants achieving a peak duodenal tissue eosinophil count of <30 eos/hpf
Timepoint [8] 0 0
At Week 24 and At Week 52
Secondary outcome [9] 0 0
Absolute change in EoG scores from the EoG Histology Scoring System (EoGHSS)
Timepoint [9] 0 0
Baseline to Week 24 and Baseline to Week 52
Secondary outcome [10] 0 0
Change in frequency of diarrhea epispodes
Timepoint [10] 0 0
Baseline at Week 24 and Baseline at Week 52
Secondary outcome [11] 0 0
Change in frequency of vomiting episodes
Timepoint [11] 0 0
Baseline at Week 24 and Baseline at Week 52
Secondary outcome [12] 0 0
Change in the Normalized Enrichment Scores (NES) for the type 2 inflammation transcriptome signature
Timepoint [12] 0 0
Baseline to Week 24 and Baseline to Week 52
Secondary outcome [13] 0 0
Change in the NES for the type 2 inflammation transcriptome signature
Timepoint [13] 0 0
Baseline to Week 24 and Baseline to Week 52
Secondary outcome [14] 0 0
Change in the NES for the EoG disease (EoG diagnostic panel (EGDP]) transcriptome signature
Timepoint [14] 0 0
Baseline to Week 24 and Baseline to Week 52
Secondary outcome [15] 0 0
Proportion of participants who receive rescue medications or procedures
Timepoint [15] 0 0
At Week 24 and At Week 52
Secondary outcome [16] 0 0
Proportion of participants achieving a peak gastric eosinophil count of =6 eos/hpf
Timepoint [16] 0 0
At Week 52
Secondary outcome [17] 0 0
Incidence of treatment-emergent adverse events (TEAEs)
Timepoint [17] 0 0
Up to Week 52
Secondary outcome [18] 0 0
Incidence of treatment-emergent serious adverse events (SAEs)
Timepoint [18] 0 0
Up to Week 52
Secondary outcome [19] 0 0
Incidence of treatment-emergent adverse events of special interest (AESIs)
Timepoint [19] 0 0
Up to Week 52
Secondary outcome [20] 0 0
Incidence of TEAEs leading to permanent discontinuation of study treatment
Timepoint [20] 0 0
Up to Week 52
Secondary outcome [21] 0 0
Incidence of anti-drug antibody (ADA)
Timepoint [21] 0 0
Up to Week 52
Secondary outcome [22] 0 0
Titer of ADA
Timepoint [22] 0 0
Up to Week 52
Secondary outcome [23] 0 0
Incidence of neutralizing antibody (Nab) to dupilumab
Timepoint [23] 0 0
Up to Week 52
Secondary outcome [24] 0 0
Concentrations of functional dupilumab in serum at each assessment time point from baseline to end of study
Timepoint [24] 0 0
Baseline to Week 64

Eligibility
Key inclusion criteria
Key

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. Baseline 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 patient report) of at least 2 episodes of EoG (with or without EoD) symptoms per week in 8 weeks before screening
6. For the 2 weeks prior to baseline visit, an average total symptom score (TSS) of at least of 20 calculated using data from the EoG/EoD-SQ eDiary and an average severity score of at least 4 (on a scale of 0-10) per week for at least 2 of the 6 symptoms, as defined in the protocol.

Key
Minimum age
12 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Body weight less than 40 kg
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
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 (Part A and B).

NOTE: Other Protocol Defined Inclusion / Exclusion Criteria Apply

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
3/05/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
19/08/2027
Actual
Sample size
Target
279
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 0 0
Nepean Clinical School - Kingswood
Recruitment hospital [2] 0 0
Mater Research Ltd - South Brisbane
Recruitment hospital [3] 0 0
The University of Queensland - Princess Alexandra Hospital (PAH) - Woolloongabba
Recruitment hospital [4] 0 0
St. Vincent's Hospital - Fitzroy
Recruitment hospital [5] 0 0
Joondalup Health Campus - Joondalup
Recruitment hospital [6] 0 0
Coral Sea Clinical Research Institute - North Mackay
Recruitment postcode(s) [1] 0 0
2747 - Kingswood
Recruitment postcode(s) [2] 0 0
4101 - South Brisbane
Recruitment postcode(s) [3] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [4] 0 0
3065 - Fitzroy
Recruitment postcode(s) [5] 0 0
6027 - Joondalup
Recruitment postcode(s) [6] 0 0
4740 - North Mackay
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Iowa
Country [7] 0 0
United States of America
State/province [7] 0 0
Kansas
Country [8] 0 0
United States of America
State/province [8] 0 0
Maryland
Country [9] 0 0
United States of America
State/province [9] 0 0
Massachusetts
Country [10] 0 0
United States of America
State/province [10] 0 0
Michigan
Country [11] 0 0
United States of America
State/province [11] 0 0
Minnesota
Country [12] 0 0
United States of America
State/province [12] 0 0
Nebraska
Country [13] 0 0
United States of America
State/province [13] 0 0
Nevada
Country [14] 0 0
United States of America
State/province [14] 0 0
New Hampshire
Country [15] 0 0
United States of America
State/province [15] 0 0
New York
Country [16] 0 0
United States of America
State/province [16] 0 0
North Carolina
Country [17] 0 0
United States of America
State/province [17] 0 0
Ohio
Country [18] 0 0
United States of America
State/province [18] 0 0
Oklahoma
Country [19] 0 0
United States of America
State/province [19] 0 0
Oregon
Country [20] 0 0
United States of America
State/province [20] 0 0
Pennsylvania
Country [21] 0 0
United States of America
State/province [21] 0 0
Tennessee
Country [22] 0 0
United States of America
State/province [22] 0 0
Texas
Country [23] 0 0
United States of America
State/province [23] 0 0
Utah
Country [24] 0 0
United States of America
State/province [24] 0 0
Washington
Country [25] 0 0
Italy
State/province [25] 0 0
Bari
Country [26] 0 0
Italy
State/province [26] 0 0
Milano
Country [27] 0 0
Italy
State/province [27] 0 0
Palermo
Country [28] 0 0
Italy
State/province [28] 0 0
Pisa
Country [29] 0 0
Italy
State/province [29] 0 0
Roma
Country [30] 0 0
Italy
State/province [30] 0 0
Rome
Country [31] 0 0
Italy
State/province [31] 0 0
Rozzano
Country [32] 0 0
Japan
State/province [32] 0 0
Fukuoka
Country [33] 0 0
Japan
State/province [33] 0 0
Gifu
Country [34] 0 0
Japan
State/province [34] 0 0
Gunma
Country [35] 0 0
Japan
State/province [35] 0 0
Hiroshima
Country [36] 0 0
Japan
State/province [36] 0 0
Hyogo
Country [37] 0 0
Japan
State/province [37] 0 0
Kanagawa
Country [38] 0 0
Japan
State/province [38] 0 0
Okayama
Country [39] 0 0
Japan
State/province [39] 0 0
Tokyo
Country [40] 0 0
Japan
State/province [40] 0 0
Yamagata
Country [41] 0 0
Poland
State/province [41] 0 0
Rzeszow
Country [42] 0 0
Poland
State/province [42] 0 0
Warsaw
Country [43] 0 0
Poland
State/province [43] 0 0
Wroclaw

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Regeneron Pharmaceuticals
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Sanofi
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trial Management
Address 0 0
Regeneron Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Clinical Trials Administrator
Address 0 0
Country 0 0
Phone 0 0
844-734-6643
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR), Analytic code
When will data be available (start and end dates)?
When Regeneron has received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication, has made results publicly available (e.g., scientific publication, scientific conference, clinical trial registry), has the legal authority to share the data, and has ensured the ability to protect participant privacy.
Available to whom?
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
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org/


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05831176