Study to Determine the Efficacy and Safety of Dupilumab in Adult and Adolescent Patients With Eosinophilic Esophagitis (EoE)
NCT ID: NCT03633617
Last Updated: 2023-06-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
321 participants
INTERVENTIONAL
2018-09-24
2022-06-07
Brief Summary
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Part A:
To determine the treatment effect of dupilumab compared with placebo in adult and adolescent patients with EoE after 24 weeks of treatment as assessed by histological and clinical measures and to inform/confirm the final sample size determination for Part B.
Part B:
To demonstrate the efficacy of dupilumab treatment compared with placebo in adult and adolescent patients with EoE after 24 weeks of treatment as assessed by histological and clinical measures.
Part C:
To assess the safety and efficacy of dupilumab treatment in adult and adolescent patients with EoE after up to 52 weeks of treatment as assessed by histological and clinical measures.
The secondary objectives of the study are:
* To evaluate the safety, tolerability, and immunogenicity of dupilumab treatment for up to 52 weeks in adult and adolescent patients with EoE
* To explore the relationship between dupilumab concentration and responses in adult and adolescent patients with EoE, using descriptive analyses
* To evaluate the effects of dupilumab on transcriptomic signatures associated with EoE and type 2 inflammation
* To demonstrate the efficacy of dupilumab treatment compared to placebo after 24 weeks and 52 weeks of treatment in adult and adolescent patients with EoE who have previously received swallowed topical corticosteroids
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Part A: Dupilumab or Placebo
Part A consists of a 24-week double-blind treatment period. Participants will be randomized to receive dupilumab or placebo. At the end of the double-blind treatment visit (week 24), eligible participants may enter Part C. Participants who do not enter Part C will enter a 12-week follow-up period.
Dupilumab
Solution for injection administered subcutaneously
Placebo
Matching placebo
Part B: Dupilumab or Placebo
Part B consists of a 24-week double-blind treatment period. Participants will be randomized to receive dupilumab dosing regimen 1, dupilumab dosing regimen 2 or placebo. At the end of the double-blind treatment visit (week 24), eligible participants may enter Part C. Participants who do not enter Part C will enter a 12-week follow-up period.
Dupilumab
Solution for injection administered subcutaneously
Placebo
Matching placebo
Part C: Dupilumab
Part C is a 28-week extended active treatment period. Participants will receive dupilumab dosing regimen 1, dupilumab dosing regimen 2. At the end of the treatment period (week 52), participants will enter a 12-week follow-up period.
Dupilumab
Solution for injection administered subcutaneously
Interventions
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Dupilumab
Solution for injection administered subcutaneously
Placebo
Matching placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Baseline endoscopic biopsies with a demonstration on central reading of intraepithelial eosinophilic infiltration
* History (by patient report) of an average of at least 2 episodes of dysphagia (with intake of solids) per week in the 4 weeks prior to screening
Exclusion Criteria
* Prior participation in a dupilumab clinical trial, or past or current treatment with dupilumab
* Initiation or change of a food-elimination diet regimen or re-introduction of a previously eliminated food group in the 6 weeks prior to screening.
* Other causes of esophageal eosinophilia or the following conditions: hypereosinophilic syndrome and eosinophilic granulomatosis with polyangiitis (Churg-Strauss syndrome)
* Active Helicobacter pylori infection
* History of achalasia, Crohn's disease, ulcerative colitis, celiac disease, and prior esophageal surgery
* Any esophageal stricture unable to be passed with a standard, diagnostic, 9 to10 mm upper endoscope or any critical esophageal stricture that requires dilation at screening
* History of bleeding disorders or esophageal varices
* Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study
* Participants who, during Part A or Part B, developed a serious adverse event (SAE) and/or adverse event (AE) deemed related to study drug, which in the opinion of the investigator could indicate that continued treatment with study drug may present an unreasonable risk for the participant
* Participants who became pregnant during Part A or Part B
* Participants who are prematurely discontinued from study drug due to an AE (patients who are prematurely discontinued from study drug due to lack of efficacy are eligible to enter Part C)
* Patients who did not undergo endoscopy with biopsies prior to receiving rescue treatment
12 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Regeneron Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trial Management
Role: STUDY_DIRECTOR
Regeneron Pharmaceuticals
Locations
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Regeneron Study Site
Phoenix, Arizona, United States
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Scottsdale, Arizona, United States
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Little Rock, Arkansas, United States
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La Jolla, California, United States
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Los Angeles, California, United States
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Mountain View, California, United States
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Orange, California, United States
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Rolling Hills Estates, California, United States
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San Diego, California, United States
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Aurora, Colorado, United States
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Aurora, Colorado, United States
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Colorado Springs, Colorado, United States
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Lone Tree, Colorado, United States
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Bristol, Connecticut, United States
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Miami, Florida, United States
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St. Petersburg, Florida, United States
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Boise, Idaho, United States
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Idaho Falls, Idaho, United States
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Chicago, Illinois, United States
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Chicago, Illinois, United States
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Park Ridge, Illinois, United States
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Urbana, Illinois, United States
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Indianapolis, Indiana, United States
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Clive, Iowa, United States
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Iowa City, Iowa, United States
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Topeka, Kansas, United States
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Hagerstown, Maryland, United States
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Boston, Massachusetts, United States
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Worcester, Massachusetts, United States
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Ann Arbor, Michigan, United States
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Chesterfield, Michigan, United States
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Plymouth, Minnesota, United States
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Rochester, Minnesota, United States
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Lincoln, Nebraska, United States
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Omaha, Nebraska, United States
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Great Neck, New York, United States
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Great Neck, New York, United States
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New York, New York, United States
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New York, New York, United States
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New York, New York, United States
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The Bronx, New York, United States
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Chapel Hill, North Carolina, United States
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Cincinnati, Ohio, United States
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Dayton, Ohio, United States
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Dublin, Ohio, United States
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Mentor, Ohio, United States
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Hershey, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Charleston, South Carolina, United States
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Greenville, South Carolina, United States
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Johnson City, Tennessee, United States
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Memphis, Tennessee, United States
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Dallas, Texas, United States
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Fort Worth, Texas, United States
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Garland, Texas, United States
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Houston, Texas, United States
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San Antonio, Texas, United States
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Salt Lake City, Utah, United States
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Charlottesville, Virginia, United States
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Roanoke, Virginia, United States
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Seattle, Washington, United States
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Milwaukee, Wisconsin, United States
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Camperdown, New South Wales, Australia
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Woolloongabba, Queensland, Australia
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Elizabeth Vale, South Australia, Australia
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Melbourne, Victoria, Australia
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Bruges, , Belgium
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Edegem, , Belgium
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Leuven, , Belgium
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London, Ontario, Canada
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Ottawa, Ontario, Canada
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Montreal, Quebec, Canada
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Hamilton, , Canada
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Pessac, , France
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Toulouse, , France
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Hanover, , Germany
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Magdeburg, , Germany
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Munich, , Germany
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Genoa, , Italy
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Milan, , Italy
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Naples, , Italy
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Pisa, , Italy
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Rome, , Italy
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Rome, , Italy
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Rozzano, , Italy
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Amsterdam, , Netherlands
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Maastricht, , Netherlands
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Nijmegen, , Netherlands
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Tomelloso, Ciudad Real, Spain
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Barcelona, , Spain
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Madrid, , Spain
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Stockholm, , Sweden
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Zurich, , Switzerland
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London, Whitechapel, United Kingdom
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Barnsley, Yorkshire, United Kingdom
Countries
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References
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Bredenoord AJ, Dellon ES, Schlag C, Cianferoni A, Xia C, Pela T, Durrani S, Radwan A, Jacob-Nara JA. Dupilumab is efficacious for eosinophilic esophagitis irrespective of prior swallowed budesonide or fluticasone, or prior treatments used alongside swallowed topical corticosteroids: results from the phase 3, randomized, placebo-controlled, LIBERTY EoE TREET trial. Expert Rev Gastroenterol Hepatol. 2025 Jan-Feb;19(2):197-209. doi: 10.1080/17474124.2025.2461516. Epub 2025 Feb 5.
Spergel JM, Chehade M, Dellon ES, Bredenoord AJ, Sun X, Glotfelty L, Shabbir A, Tilton ST, McCann E. Dupilumab Improves Health-Related Quality of Life and a Range of Symptoms in Patients With Eosinophilic Esophagitis. Am J Gastroenterol. 2024 Dec 1;119(12):2398-2407. doi: 10.14309/ajg.0000000000002924. Epub 2024 Jun 28.
Bredenoord AJ, Dellon ES, Hirano I, Lucendo AJ, Schlag C, Sun X, Glotfelty L, Mannent L, Maloney J, Laws E, Mortensen E, Shabbir A. Dupilumab demonstrated efficacy and was well tolerated regardless of prior use of swallowed topical corticosteroids in adolescent and adult patients with eosinophilic oesophagitis: a subgroup analysis of the phase 3 LIBERTY EoE TREET study. Gut. 2024 Feb 23;73(3):398-406. doi: 10.1136/gutjnl-2023-330220.
McCann E, Chehade M, Spergel JM, Yaworsky A, Symonds T, Stokes J, Tilton ST, Sun X, Kamat S. Validation of the novel Eosinophilic Esophagitis Impact Questionnaire. J Patient Rep Outcomes. 2023 Nov 27;7(1):120. doi: 10.1186/s41687-023-00654-z.
Rothenberg ME, Dellon ES, Collins MH, Hirano I, Chehade M, Bredenoord AJ, Lucendo AJ, Spergel JM, Sun X, Hamilton JD, Mortensen E, Laws E, Maloney J, Mannent LP, McCann E, Liu X, Glotfelty L, Shabbir A. Efficacy and safety of dupilumab up to 52 weeks in adults and adolescents with eosinophilic oesophagitis (LIBERTY EoE TREET study): a multicentre, double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Gastroenterol Hepatol. 2023 Nov;8(11):990-1004. doi: 10.1016/S2468-1253(23)00204-2. Epub 2023 Aug 31.
Dellon ES, Rothenberg ME, Collins MH, Hirano I, Chehade M, Bredenoord AJ, Lucendo AJ, Spergel JM, Aceves S, Sun X, Kosloski MP, Kamal MA, Hamilton JD, Beazley B, McCann E, Patel K, Mannent LP, Laws E, Akinlade B, Amin N, Lim WK, Wipperman MF, Ruddy M, Patel N, Weinreich DR, Yancopoulos GD, Shumel B, Maloney J, Giannelou A, Shabbir A. Dupilumab in Adults and Adolescents with Eosinophilic Esophagitis. N Engl J Med. 2022 Dec 22;387(25):2317-2330. doi: 10.1056/NEJMoa2205982.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan: Part A/Part C
Document Type: Statistical Analysis Plan: Part B/Part C
Other Identifiers
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2018-000844-25
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
R668-EE-1774
Identifier Type: -
Identifier Source: org_study_id
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