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Eosinophilic EsophagitisPhase 3NCT03633617

Study to Determine the Efficacy and Safety of Dupilumab in Adult and Adolescent Patients With Eosinophilic Esophagitis (EoE)

A Phase 3 study testing Dupilumab in people with Eosinophilic Esophagitis, run by Regeneron Pharmaceuticals at 95 sites in 12 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The primary objectives of the study by study part are: 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… Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Eosinophilic Esophagitis
What is being tested?
Dupilumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
321 participants
Where
95 sitesin 12 countries
Study dates
24 Sep 2018to 7 Jun 2022
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • A documented diagnosis of EoE by endoscopic biopsy
  • 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

Who cannot join

  • Body weight ≤40 kg
  • 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
Show all 14Show fewer
  • 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
  • Note: Other inclusion/ exclusion criteria apply

Trial locations and contacts

95 sites in 12 countries.

95 sites in 12 countries

United States62 sites

  • Regeneron Study Site

    Ann Arbor, Michigan, 48109

  • Regeneron Study Site

    Aurora, Colorado, 80045

  • Regeneron Study Site

    Aurora, Colorado, 80220

  • Regeneron Study Site

    Boise, Idaho, 83706

  • Regeneron Study Site

    Boston, Massachusetts, 02111

  • Regeneron Study Site

    Bristol, Connecticut, 06010

  • Regeneron Study Site

    Chapel Hill, North Carolina, 27599

  • Regeneron Study Site

    Charleston, South Carolina, 29425

  • Regeneron Study Site

    Charlottesville, Virginia, 22903

  • Regeneron Study Site

    Chesterfield, Michigan, 48047

  • Regeneron Study Site #1

    Chicago, Illinois, 60611

  • Regeneron Study Site #2

    Chicago, Illinois, 60611

  • Regeneron Study Site

    Cincinnati, Ohio, 45229

  • Regeneron Study Site

    Clive, Iowa, 50325

  • Regeneron Study Site

    Colorado Springs, Colorado, 80907

  • Regeneron Study Site

    Dallas, Texas, 75207

  • Regeneron Study Site

    Dayton, Ohio, 45415

  • Regeneron Study Site

    Dublin, Ohio, 43016

  • Regeneron Study Site

    Fort Worth, Texas, 76104

  • Regeneron Study Site

    Garland, Texas, 75044

  • Regeneron Study Site

    Great Neck, New York, 11021

  • Regeneron Study Site

    Great Neck, New York, 11023

  • Regeneron Study Site

    Greenville, South Carolina, 29615

  • Regeneron Study Site

    Hagerstown, Maryland, 21742

  • Regeneron Study Site

    Hershey, Pennsylvania, 17033

  • Regeneron Study Site

    Houston, Texas, 77030

  • Regeneron Study Site

    Idaho Falls, Idaho, 83404

  • Regeneron Study Site

    Indianapolis, Indiana, 46202

  • Regeneron Study Site

    Iowa City, Iowa, 52242

  • Regeneron Study Site

    Johnson City, Tennessee, 37604

  • Regeneron Study Site

    La Jolla, California, 92037

  • Regeneron Study Site

    Lincoln, Nebraska, 68505

  • Regeneron Study Site

    Little Rock, Arkansas, 72202

  • Regeneron Study Site

    Lone Tree, Colorado, 80124

  • Regeneron Study Site

    Los Angeles, California, 90025

  • Regeneron Study Site

    Memphis, Tennessee, 38103

  • Regeneron Study Site

    Mentor, Ohio, 44060

  • Regeneron Study Site

    Miami, Florida, 33156

  • Regeneron Study Site

    Milwaukee, Wisconsin, 53226

  • Regeneron Study Site

    Mountain View, California, 94305

  • Regeneron Study Site

    New York, New York, 10016

  • Regeneron Study Site

    New York, New York, 10029

  • Regeneron Study Site

    New York, New York, 10032

  • Regeneron Study Site

    Omaha, Nebraska, 68130

  • Regeneron Study Site

    Orange, California, 92868

  • Regeneron Study Site

    Park Ridge, Illinois, 60068

  • Regeneron Study Site

    Philadelphia, Pennsylvania, 19104

  • Regeneron Study Site

    Phoenix, Arizona, 85016

  • Regeneron Study Site

    Plymouth, Minnesota, 55446

  • Regeneron Study Site

    Roanoke, Virginia, 24013

  • Regeneron Study Site

    Rochester, Minnesota, 55905

  • Regeneron Study Site

    Rolling Hills Estates, California, 90274

  • Regeneron Study Site

    Salt Lake City, Utah, 84132

  • Regeneron Study Site

    San Antonio, Texas, 78229

  • Regeneron Study Site

    San Diego, California, 92123

  • Regeneron Study Site

    Scottsdale, Arizona, 85259

  • Regeneron Study Site

    Seattle, Washington, 98115

  • Regeneron Study Site

    St. Petersburg, Florida, 33701

  • Regeneron Study Site

    The Bronx, New York, 10461

  • Regeneron Study Site

    Topeka, Kansas, 66606

  • Regeneron Study Site

    Urbana, Illinois, 61801

  • Regeneron Study Site

    Worcester, Massachusetts, 01655

Other trials in United States

Italy7 sites

  • Regeneron Study Site

    Genoa, 16132

  • Regeneron Study Site

    Milan, 20122

  • Regeneron Study Site

    Naples, 80100

  • Regeneron Study Site

    Pisa, 56124

  • Regeneron Study Site

    Rome, 00161

  • Regeneron Study Site

    Rome, 00165

  • Regeneron Study Site

    Rozzano, 20089

Other trials in Italy

Australia4 sites

  • Regeneron Study Site

    Camperdown, New South Wales, 2050

  • Regeneron Study Site

    Elizabeth Vale, South Australia, 5112

  • Regeneron Study Site

    Melbourne, Victoria, 3052

  • Regeneron Study Site

    Woolloongabba, Queensland, 4102

Other trials in Australia

Canada4 sites

  • Regeneron Study Site

    Hamilton, L8S 1G5

  • Regeneron Study Site

    London, Ontario, N6A5W9

  • Regeneron Study Site

    Montreal, Quebec, H3T1C5

  • Regeneron Study Site

    Ottawa, Ontario, K1G6S6

Other trials in Canada

Belgium3 sites

  • Regeneron Study Site

    Bruges, 8310

  • Regeneron Study Site

    Edegem, 2650

  • Regeneron Study Site

    Leuven, 03000

Other trials in Belgium

Germany3 sites

  • Regeneron Study Site

    Hanover, 30459

  • Regeneron Study Site

    Magdeburg, 39120

  • Regeneron Study Site

    Munich, 81675

Other trials in Germany

Netherlands3 sites

  • Regeneron Study Site

    Amsterdam, 1105 AZ

  • Regeneron Study Site

    Maastricht, 6229HX

  • Regeneron Study Site

    Nijmegen, 6525GA

Other trials in Netherlands

Spain3 sites

  • Regeneron Study Site

    Barcelona, 08036

  • Regeneron Study Site

    Madrid, 28006

  • Regeneron Study Site

    Tomelloso, Ciudad Real, 13700

Other trials in Spain

France2 sites

  • Regeneron Study Site

    Pessac, 33604 Cedex

  • Regeneron Study Site

    Toulouse, TSA 50032-31059

Other trials in France

United Kingdom2 sites

  • Regeneron Study Site

    Barnsley, Yorkshire, S752EP

  • Regeneron Study Site

    London, Whitechapel, E1 1BB

Other trials in United Kingdom

Sweden1 site

  • Regeneron Study Site

    Stockholm, 141 86

Other trials in Sweden

Switzerland1 site

  • Regeneron Study Site

    Zurich, CH-8091

Other trials in Switzerland

About this study

Official title: A Phase 3, Randomized, 3-Part Study to Investigate the Efficacy and Safety of Dupilumab in Adult and Adolescent Patients With Eosinophilic Esophagitis (EoE)

The primary objectives of the study by study part are:

Part A:

Read more

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
Being tested
Dupilumab, Placebo
Medical subject headings
Eosinophilic Esophagitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DupilumabDrug

    Also called DUPIXENT, REGN668, SAR231893

    Solution for injection administered subcutaneously

  • PlaceboDrug

    Matching placebo

Study groups in NCT03633617
Study groupRoleWhat they receive
Part A: Dupilumab or PlaceboExperimentalPart 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.
Receives: Drug: Dupilumab; Drug: Placebo
Part B: Dupilumab or PlaceboExperimentalPart 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.
Receives: Drug: Dupilumab; Drug: Placebo
Part C: DupilumabExperimentalPart 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.
Receives: Drug: Dupilumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants Achieving Peak Esophageal Intraepithelial Eosinophil Count of ≤6 Eosinophils Per High-power Field (Eos/Hpf) in All Three Regions at Week 24

    Esophageal intraepithelial eosinophil count obtained by esophageal endoscopy with biopsies (all 3 esophageal regions: proximal, mid, and distal).

    Measured: At week 24

  2. Absolute Change From Baseline in Dysphagia Symptom Questionnaire (DSQ) Total Score at Week 24

    The DSQ is used to measure the frequency and intensity of dysphagia. DSQ scores can range from 0 to 84, with a lower score indicating less-frequent or less-severe dysphagia.

    Measured: Baseline and week 24

Secondary outcomes (31)

  1. Percent Change From Baseline in Peak Esophageal Intraepithelial Eosinophil Count (Eos/Hpf) in All Three Regions at Week 24

    Esophageal intraepithelial eosinophil count obtained by esophageal endoscopy with biopsies (all 3 esophageal regions: proximal, mid, and distal). A greater esophageal intraepithelial eosinophil count from baseline indicates worsening disease.

    Measured: Baseline and week 24

  2. Percent Change From Baseline in DSQ Total Score at Week 24

    The DSQ is used to measure the frequency and intensity of dysphagia. DSQ scores can range from 0 to 84, with a lower score indicating less-frequent or less-severe dysphagia.

    Measured: Baseline and week 24

  3. Absolute Change From Baseline in Eosinophilic Esophagitis Histology Scoring System (EoEHSS) Mean Grade Score at Week 24

    Severity (grade) and extent (stage) of esophageal abnormalities were scored by blinded, central pathologists using a 4-point scale (0 normal; 3 maximum change) for eight features: eosinophil density, basal zone hyperplasia, eosinophil abscesses, eosinophil surface layering, dilated intercellular spaces, surface epithelial alteration, dyskeratotic epithelial cells and lamina propria fibrosis (absent/present). Higher score indicates greater severity and extent of histological abnormalities.

    Measured: Baseline and week 24

  4. Absolute Change From Baseline in EoEHSS Mean Stage Score at Week 24

    Severity (grade) and extent (stage) of esophageal abnormalities were scored by blinded, central pathologists using a 4-point scale (0 normal; 3 maximum change) for eight features: eosinophil density, basal zone hyperplasia, eosinophil abscesses, eosinophil surface layering, dilated intercellular spaces, surface epithelial alteration, dyskeratotic epithelial cells and lamina propria fibrosis (absent/present). Higher score indicates greater severity and extent of histological abnormalities.

    Measured: Baseline and week 24

  5. Absolute Change From Baseline in EoE Endoscopic Reference Total Score (EoE-EREFS) at Week 24

    EoE esophageal characteristics analyzed based on the EoE-EREFS, a scoring system for inflammatory and remodeling features of disease. The overall total score ranges from 0 to 18 with higher number indicating worse disease.

    Measured: Baseline and week 24

  6. Percentage of Participants Achieving Peak Esophageal Intraepithelial Eosinophil Count of <15 Eos/Hpf in All Three Regions at Week 24

    Esophageal intraepithelial eosinophil count obtained by esophageal endoscopy with biopsies (all 3 esophageal regions: proximal, mid, and distal).

    Measured: At week 24

  7. Normalized Enrichment Score (NES) for the Relative Change From Baseline in the EoE Diagnostic Panel (EDP) at Week 24

    NES reflects the degree to which the activity level of a set of disease 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. An NES of 0 indicates no change from baseline, a negative score reflects a reduction in the disease score (more like normal) and a positive score reflects worsening (more active disease).

    Measured: Baseline and week 24

  8. NES for the Relative Change From Baseline in the Type 2 Inflammation Signature (T2INF) at Week 24

    NES reflects the degree to which the activity level of a set of disease 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. An NES of 0 indicates no change from baseline, a negative score reflects a reduction in the disease score (more like normal) and a positive score reflects worsening (more active disease).

    Measured: Baseline and week 24

  9. Percentage of Participants Achieving Peak Esophageal Intraepithelial Eosinophil Count of ≤1 Eos/Hpf in All Three Regions at Week 24

    Esophageal intraepithelial eosinophil count obtained by esophageal endoscopy with biopsies (all 3 esophageal regions: proximal, mid, and distal).

    Measured: At week 24

  10. Absolute Change From Baseline in Health-related Quality of Life (QoL) Average Score as Measured by EoE Impact Questionnaire (EoE-IQ) at Week 24

    The EoE-IQ measures impact of EoE on emotional, social, work \& school, \& sleep aspects. Participants were asked to respond to 11 questions based on experience living with EoE during past 7 days. Response to each item is on a 5-point scale (1=Not at all [impacted] 2=A little, 3=Somewhat, 4=Quite a bit, 5=Extremely [impacted]). The average score is the sum of non-missing responses divided by the number of items with non-missing responses. The average score can range from 1 to 5; a higher score is indicative of a more negative impact.

    Measured: Baseline and week 24

  11. Absolute Change From Baseline in Severity of EoE Symptoms Other Than Dysphagia as Measured by EoE Symptom Questionnaire (EoE-SQ) at Week 24

    The EoE-SQ asks about symptoms that participants with EoE may have (chest pain, stomach pain, burning feeling in chest, food or liquid coming back up into throat, throwing up) during the past 7 days. Response to the severity of each symptom based on the worst experience in the past 7 days is on a scale of 0 to 10 (higher is worse). The EoE-SQ severity score is calculated as the sum of the severity scores from questions 1 to 3 (chest pain, stomach pain, burning feeling in chest), which could range from 0 to 30; a higher score is indicative of more severe symptoms.

    Measured: Baseline and week 24

  12. Absolute Change From Baseline in Frequency of EoE Symptoms Other Than Dysphagia as Measured by EoE-SQ at Week 24

    The EoE-SQ asks about symptoms that participants with EoE may have (chest pain, stomach pain, burning feeling in chest, food or liquid coming back up into throat, throwing up) during the past 7 days. Response to the frequency of each symptom is on a 5-point scale (1 = 'Never', 2 = 'One day', 3 = ' 2-6 days', 4 = 'Once a day', 5 = 'More than once a day'). The EoE-SQ frequency score is calculated as the sum of the frequency scores from the 5 items which could range from 5 to 25; a higher score is indicative of higher frequency of symptoms.

    Measured: Baseline and week 24

  13. Percentage of Participants Who Received Rescue Treatment During the Placebo-controlled, Double-blind Treatment Period at Week 24

    Measured: At week 24

  14. Absolute Change From Baseline in Esophageal Distensibility Plateau Measured by Functional Lumen Imaging, if Collected, at Week 24

    Measured: At week 24

  15. Percentage of Participants Achieving Peak Esophageal Intraepithelial Eosinophil Count of ≤6 Eosinophils Per High-power Field (Eos/Hpf) in All Three Regions at Week 52

    Esophageal intraepithelial eosinophil count obtained by esophageal endoscopy with biopsies (all 3 esophageal regions: proximal, mid, and distal).

    Measured: At week 52

  16. Absolute Change in Dysphagia Symptom Questionnaire (DSQ) Total Score at Week 52

    The DSQ is used to measure the frequency and intensity of dysphagia. DSQ scores can range from 0 to 84, with a lower score indicating less-frequent or less-severe dysphagia.

    Measured: Baseline (of previous study part) and week 52

  17. Percent Change in DSQ Total Score at Week 52

    The DSQ is used to measure the frequency and intensity of dysphagia. DSQ scores can range from 0 to 84, with a lower score indicating less-frequent or less-severe dysphagia.

    Measured: Baseline (of previous study part) and week 52

  18. Absolute Change in EoE Endoscopic Reference Total Score (EoE-EREFS) at Week 52

    EoE esophageal characteristics analyzed based on the EoE-EREFS, a scoring system for inflammatory and remodeling features of disease. The overall total score ranges from 0 to 18 with higher number indicating worse disease.

    Measured: Baseline (of previous study part) and week 52

  19. Percent Change in Peak Esophageal Intraepithelial Eosinophil Count (Eos/Hpf) in All Three Regions at Week 52

    Esophageal intraepithelial eosinophil count obtained by esophageal endoscopy with biopsies (all 3 esophageal regions: proximal, mid, and distal). A greater esophageal intraepithelial eosinophil count from baseline indicates worsening disease.

    Measured: Baseline (of previous study part) and week 52

  20. Absolute Change in EoE Histology Scoring System (EoEHSS) Mean Grade Score at Week 52

    Severity (grade) and extent (stage) of esophageal abnormalities were scored by blinded, central pathologists using a 4-point scale (0 normal; 3 maximum change) for eight features: eosinophil density, basal zone hyperplasia, eosinophil abscesses, eosinophil surface layering, dilated intercellular spaces, surface epithelial alteration, dyskeratotic epithelial cells and lamina propria fibrosis (absent/present). Higher score indicates greater severity and extent of histological abnormalities.

    Measured: Baseline (of previous study part) and week 52

  21. Absolute Change in EoEHSS Mean Stage Score at Week 52

    Severity (grade) and extent (stage) of esophageal abnormalities were scored by blinded, central pathologists using a 4-point scale (0 normal; 3 maximum change) for eight features: eosinophil density, basal zone hyperplasia, eosinophil abscesses, eosinophil surface layering, dilated intercellular spaces, surface epithelial alteration, dyskeratotic epithelial cells and lamina propria fibrosis (absent/present). Higher score indicates greater severity and extent of histological abnormalities.

    Measured: Baseline (of previous study part) and week 52

  22. Percentage of Participants Achieving Peak Esophageal Intraepithelial Eosinophil Count of <15 Eos/Hpf in All Three Regions at Week 52

    Esophageal intraepithelial eosinophil count obtained by esophageal endoscopy with biopsies (all 3 esophageal regions: proximal, mid, and distal).

    Measured: At week 52

  23. Percentage of Participants Achieving Peak Esophageal Intraepithelial Eosinophil Count of ≤1 Eos/Hpf in All Three Regions at Week 52

    Esophageal intraepithelial eosinophil count obtained by esophageal endoscopy with biopsies (all 3 esophageal regions: proximal, mid, and distal).

    Measured: At week 52

  24. Absolute Change in Health-related QOL as Measured by EoE-IQ at Week 52

    The EoE-IQ measures impact of EoE on emotional, social, work \& school, \& sleep aspects. Participants were asked to respond to 11 questions based on experience living with EoE during past 7 days. Response to each item is on a 5-point scale (1=Not at all [impacted] 2=A little, 3=Somewhat, 4=Quite a bit, 5=Extremely [impacted]). The average score is the sum of non-missing responses divided by the number of items with non-missing responses. The average score can range from 1 to 5; a higher score is indicative of a more negative impact.

    Measured: Baseline (of previous study part) and week 52

  25. Absolute Change From Baseline in Severity of EoE Symptoms Other Than Dysphagia as Measured by EoE-SQ at Week 52

    The EoE-SQ asks about symptoms that participants with EoE may have (chest pain, stomach pain, burning feeling in chest, food or liquid coming back up into throat, throwing up) during the past 7 days. Response to the severity of each symptom based on the worst experience in the past 7 days is on a scale of 0 to 10 (higher is worse). The EoE-SQ severity score is calculated as the sum of the severity scores from questions 1 to 3 (chest pain, stomach pain, burning feeling in chest), which could range from 0 to 30; a higher score is indicative of more severe symptoms.

    Measured: Baseline (of previous study part) and week 52

  26. Absolute Change From Baseline in Frequency of EoE Symptoms Other Than Dysphagia as Measured by EoE-SQ at Week 52

    The EoE-SQ asks about symptoms that participants with EoE may have (chest pain, stomach pain, burning feeling in chest, food or liquid coming back up into throat, throwing up) during the past 7 days. Response to the frequency of each symptom is on a 5-point scale (1 = 'Never', 2 = 'One day', 3 = ' 2-6 days', 4 = 'Once a day', 5 = 'More than once a day'). The EoE-SQ frequency score is calculated as the sum of the frequency scores from the 5 items which could range from 5 to 25; a higher score is indicative of higher frequency of symptoms.

    Measured: Baseline (of previous study part) and week 52

  27. Percentage of Participants Who Received Rescue Medication During the 28-week Extended Active Treatment Period

    Measured: Baseline (of Part C) to week 28

  28. NES for the Relative Change From Baseline in EoE Diagnostic Panel (EDP) at Week 52

    NES reflects the degree to which the activity level of a set of disease 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. An NES of 0 indicates no change from baseline, a negative score reflects a reduction in the disease score (more like normal) and a positive score reflects worsening (more active disease).

    Measured: Baseline (of previous study part) and week 52

  29. NES for the Relative Change in the Type 2 Inflammation Signature (T2INF) at Week 52

    NES reflects the degree to which the activity level of a set of disease 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. An NES of 0 indicates no change from baseline, a negative score reflects a reduction in the disease score (more like normal) and a positive score reflects worsening (more active disease).

    Measured: Baseline (of previous study part) and week 52

  30. Concentration of Functional Dupilumab in Serum at Week 52

    Measured: Baseline (of Part C) up to week 52

  31. Incidence of Treatment-emergent Anti-drug Antibody (ADA) Response

    Number of treatment-emergent ADA responses to dupilumab reported.

    Measured: Baseline (of previous study part) up to week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Aug 2018
  2. Study start24 Sep 2018
  3. Primary completion9 Sep 2021
  4. Study completion7 Jun 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
321 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03633617
Sponsor's protocol ID
R668-EE-1774
Other IDs
2018-000844-25, 2018
Status last verified
Jun 2023
First submitted
14 Aug 2018
Last updated
28 Jun 2023
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Dellon ES, Rothenberg ME, Spergel JM, Bredenoord AJ, Cianferoni A, Xia C, Louisias M, Radin A. Clinical Trial: Dupilumab Improves Eosinophilic Oesophagitis Outcomes Versus Placebo Regardless of Comorbidities or Treatment History in a Randomised Clinical Trial. Aliment Pharmacol Ther. 2026 Oct 6. doi: 10.1111/apt.71001. Online ahead of print.

    PubMed 42836357

  • Dellon ES, Collins MH, Peterson K, Sun X, Raphael BP, Louisias M, Radin A. Dupilumab Improves Endoscopic Features in Adult and Adolescent Patients With Eosinophilic Esophagitis: Post Hoc Analysis of LIBERTY EoE TREET Study. Clin Transl Gastroenterol. 2026 Aug 27. doi: 10.14309/ctg.0000000000001090. Online ahead of print.

    PubMed 42658181

  • Strobel MJ, Spergel JM, Chehade M, Dellon ES, Bredenoord AJ, Raphael BP, Almansa C, Tilton ST, Thomas RB. Dupilumab improves symptoms and quality of life in patients with eosinophilic esophagitis: a plain language summary. Immunotherapy. 2026 Mar;18(4):275-283. doi: 10.1080/1750743X.2026.2658371. Epub 2026 May 7.

    PubMed 42093592

  • Lim WK, Wipperman MF, Rothenberg ME, Collins MH, Hamon SC, Chehade M, Spergel JM, Gayvert KM, Ehmann PJ, Horowitz JE, Farrell AB, Dellon ES, Maloney J, Radin A, Louisias M, Wolfe K, Akinlade B, Ajithdoss DK, Herman G, Yancopoulos GD, Hamilton JD. Dupilumab normalizes the eosinophilic esophagitis disease transcriptome. J Allergy Clin Immunol. 2026 Aug;158(2):542-554. doi: 10.1016/j.jaci.2026.01.033. Epub 2026 Apr 22.

    PubMed 42031097

  • Nguyen JH, Chehade M, Dellon ES, Radin A, Chittenden J, Kamal MA, Louisias M, Xu C, Kosloski MP. Population Pharmacokinetics of Dupilumab in Adults, Adolescents, and Children With Eosinophilic Esophagitis. Clin Pharmacol Ther. 2026 Jun;119(6):1555-1564. doi: 10.1002/cpt.70233. Epub 2026 Feb 26.

    PubMed 41749054

  • 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.

    PubMed 39909733

  • 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.

    PubMed 38940435

  • 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.

    PubMed 38050037

  • 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.

    PubMed 38010430

  • 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.

    PubMed 37660704

  • 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.

    PubMed 36546624

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Dupilumab in people with Eosinophilic Esophagitis, run by Regeneron Pharmaceuticals at 95 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 95 sites in United States, Italy, Australia, Canada, Belgium and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Dec 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Achieving Peak Esophageal Intraepithelial Eosinophil Count of ≤6 Eosinophils Per High-power Field (Eos/Hpf) in All Three Regions at Week 24 (time frame: At week 24). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03633617, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2023.

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