Trial · NCT03633617
Study to Determine the Efficacy and Safety of Dupilumab in Adult and Adolescent Patients With Eosinophilic Esophagitis (EoE)
NCT03633617, Phase 3, Completed, Regeneron Pharmaceuticals; results first posted 2022-12-28
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study to Determine the Efficacy and Safety of Dupilumab in Adult and Adolescent Patients With Eosinophilic Esophagitis (EoE). Trials, record NCT03633617. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03633617
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Determine the Efficacy and Safety of Dupilumab in Adult and Adolescent Patients With Eosinophilic Esophagitis (EoE)
- NCT number
- NCT03633617
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 321 participants, actual
- Lead sponsor
- Regeneron Pharmaceuticals
- Conditions
- Eosinophilic Esophagitis
- Interventions
- Dupilumab, Placebo
- First posted
- 2018-08-16
- Last updated
- 2023-06-28
- Other registries' IDs
- eudract:2018-000844-25
- Results first posted
- 2022-12-28
Source ClinicalTrials.gov
Registered outcomes33
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | At week 24 | Esophageal intraepithelial eosinophil count obtained by esophageal endoscopy with biopsies (all 3 esophageal regions: proximal, mid, and distal). |
| Primary | Absolute Change From Baseline in Dysphagia Symptom Questionnaire (DSQ) Total Score at Week 24 | Baseline and 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. |
| Secondary | Percent Change From Baseline in Peak Esophageal Intraepithelial Eosinophil Count (Eos/Hpf) in All Three Regions at Week 24 | Baseline and 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. |
| Secondary | Percent Change From Baseline in DSQ Total Score at Week 24 | Baseline and 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. |
| Secondary | Absolute Change From Baseline in Eosinophilic Esophagitis Histology Scoring System (EoEHSS) Mean Grade Score at Week 24 | Baseline and 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. |
| Secondary | Absolute Change From Baseline in EoEHSS Mean Stage Score at Week 24 | Baseline and 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. |
| Secondary | Absolute Change From Baseline in EoE Endoscopic Reference Total Score (EoE-EREFS) at Week 24 | Baseline and 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. |
| Secondary | Percentage of Participants Achieving Peak Esophageal Intraepithelial Eosinophil Count of <15 Eos/Hpf in All Three Regions at Week 24 | At week 24 | Esophageal intraepithelial eosinophil count obtained by esophageal endoscopy with biopsies (all 3 esophageal regions: proximal, mid, and distal). |
| Secondary | Normalized Enrichment Score (NES) for the Relative Change From Baseline in the EoE Diagnostic Panel (EDP) at Week 24 | Baseline and 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). |
| Secondary | NES for the Relative Change From Baseline in the Type 2 Inflammation Signature (T2INF) at Week 24 | Baseline and 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). |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 registered outcomesOutcomes33
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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 | At week 24 | Part A Full Analysis Set (FAS): All participants randomized to Part A (Participants considered non-responder after rescue treatment use and multiple imputation (MI) method for missing due to COVID-19); Part B FAS: All participants randomized to Part B (Participants considered non-responder after rescue treatment use or missing not due to COVID-19 and MI method for missing or dosing interruption due to COVID-19) | Percentage of Participants | NUMBER |
| PRIMARY | Absolute Change From Baseline in Dysphagia Symptom Questionnaire (DSQ) Total Score at Week 24 | Baseline and week 24 | Part A Full Analysis Set (FAS): All participant randomized to Part A (MI method with data set to missing after rescue treatment use); Part B FAS: All participants randomized to Part B (MI method with data set to missing after rescue treatment use) | Score on a Scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Peak Esophageal Intraepithelial Eosinophil Count (Eos/Hpf) in All Three Regions at Week 24 | Baseline and week 24 | Part A FAS (Worst-observation carried forward \[WOCF\]-MI method with data set to missing after rescue treatment use); Part B FAS (WOCF-MI method with WOCF for rescue treatment use and missing not due to COVID-19 and MI method for missing or dosing interruption due to COVID-19) | Percentage of Change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in DSQ Total Score at Week 24 | Baseline and week 24 | Part A FAS (MI method with data set to missing after rescue treatment use); Part B FAS (MI method with data set to missing after rescue treatment use) | Percentage of Change | LEAST_SQUARES_MEAN |
| SECONDARY | Absolute Change From Baseline in Eosinophilic Esophagitis Histology Scoring System (EoEHSS) Mean Grade Score at Week 24 | Baseline and week 24 | Part A FAS (WOCF-MI method with data set to missing after rescue treatment use); Part B FAS (WOCF-MI method with WOCF for rescue treatment use and missing not due to COVID-19 and MI method for missing or dosing interruption due to COVID-19) | Score on a Scale | LEAST_SQUARES_MEAN |
| SECONDARY | Absolute Change From Baseline in EoEHSS Mean Stage Score at Week 24 | Baseline and week 24 | Part A FAS (WOCF-MI Method With Data Set to Missing After Rescue Treatment Use); Part B FAS (WOCF-MI Method with WOCF for Rescue Treatment Use and Missing Not Due to COVID-19 and MI Method for Missing or Dosing Interruption Due to COVID-19) | Score on a Scale | LEAST_SQUARES_MEAN |
| SECONDARY | Absolute Change From Baseline in EoE Endoscopic Reference Total Score (EoE-EREFS) at Week 24 | Baseline and week 24 | Part A FAS (WOCF-MI Method With Data Set to Missing After Rescue Treatment Use); Part B FAS (WOCF-MI Method with WOCF for Rescue Treatment Use and Missing Not Due to COVID-19 and MI Method for Missing or Dosing Interruption Due to COVID-19) | Score on a Scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants Achieving Peak Esophageal Intraepithelial Eosinophil Count of <15 Eos/Hpf in All Three Regions at Week 24 | At week 24 | Part A FAS (Participants considered non-responder after rescue treatment use and MI method for missing due to COVID-19); Part B FAS (Participants considered non-responder after rescue treatment use or missing not due to COVID-19 and MI method for missing or dosing interruption due to COVID-19). | Percentage of Participants | NUMBER |
| SECONDARY | Normalized Enrichment Score (NES) for the Relative Change From Baseline in the EoE Diagnostic Panel (EDP) at Week 24 | Baseline and week 24 | Part A FAS (Participants with NES Score in Part A; Last observation carried forward \[LOCF\] method with data set to missing after rescue treatment use); Part B FAS (Participants with NES Score in Part B; LOCF method with data set to missing after rescue treatment use) | Score on a Scale | NUMBER |
| SECONDARY | NES for the Relative Change From Baseline in the Type 2 Inflammation Signature (T2INF) at Week 24 | Baseline and week 24 | Part A FAS (Participants with NES Score in Part A; LOCF Method with data set to missing after rescue treatment use); Part B FAS (Participants with NES Score in Part B; LOCF method with data set to missing after rescue treatment use) | Score on a Scale | NUMBER |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 outcomesResults by group188
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 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 | Part A: Placebo | 5.1 | 95% Confidence Interval 0.63 to 17.32 | Percentage of Participants | |
| 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 | Part A: Dupilumab 300 mg SC QW | 59.5 | 95% Confidence Interval 43.28 to 74.37 | Percentage of Participants | |
| 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 | Part B: Placebo | 6.3 | 95% Confidence Interval 2.09 to 14.16 | Percentage of Participants | |
| 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 | Part B: Dupilumab 300 mg SC Q2W | 60.5 | 95% Confidence Interval 49.01 to 71.19 | Percentage of Participants | |
| 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 | Part B: Dupilumab 300 mg SC QW | 58.8 | 95% Confidence Interval 47.18 to 69.65 | Percentage of Participants | |
| Absolute Change From Baseline in Dysphagia Symptom Questionnaire (DSQ) Total Score at Week 24 | Part A: Placebo | -9.60 | 95% Confidence Interval -15.056 to -4.136 | Score on a Scale | |
| Absolute Change From Baseline in Dysphagia Symptom Questionnaire (DSQ) Total Score at Week 24 | Part A: Dupilumab 300 mg SC QW | -21.92 | 95% Confidence Interval -26.870 to -16.967 | Score on a Scale | |
| Absolute Change From Baseline in Dysphagia Symptom Questionnaire (DSQ) Total Score at Week 24 | Part B: Placebo | -13.86 | 95% Confidence Interval -17.605 to -10.120 | Score on a Scale | |
| Absolute Change From Baseline in Dysphagia Symptom Questionnaire (DSQ) Total Score at Week 24 | Part B: Dupilumab 300 mg SC Q2W | -14.37 | 95% Confidence Interval -18.018 to -10.723 | Score on a Scale | |
| Absolute Change From Baseline in Dysphagia Symptom Questionnaire (DSQ) Total Score at Week 24 | Part B: Dupilumab 300 mg SC QW | -23.78 | 95% Confidence Interval -27.427 to -20.131 | Score on a Scale |
1 to 10 of 188Source ClinicalTrials.gov
See all 188 results by groupParticipant flow110
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Part A | STARTED | Part A: Placebo | 39 | |
| Part A | STARTED | Part A: Dupilumab 300 mg SC QW | 42 | |
| Part A | STARTED | Part B: Placebo | 0 | |
| Part A | STARTED | Part B: Dupilumab 300 mg SC Q2W | 0 | |
| Part A | STARTED | Part B: Dupilumab 300 mg SC QW | 0 | |
| Part A | STARTED | Part A/C: Placebo / Dupilumab 300 mg QW | 0 | |
| Part A | STARTED | Part A/C: Dupilumab 300 mg QW / Dupilumab 300 mg QW | 0 | |
| Part A | STARTED | Part B/C: Placebo / Dupilumab 300 mg Q2W | 0 | |
| Part A | STARTED | Part B/C: Placebo / Dupilumab 300 mg QW | 0 | |
| Part A | STARTED | Part B/C: Dupilumab 300 mg Q2W / Dupilumab 300 mg Q2W | 0 |
1 to 10 of 110Source ClinicalTrials.gov
See all 110 participant flowAdverse events486
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Injection site erythema | General disorders | Part A: Placebo | 6 | 39 | 22 |
| other | Injection site erythema | General disorders | Part A: Dupilumab 300 mg QW | 4 | 42 | 12 |
| other | Injection site erythema | General disorders | Part B: Placebo | 9 | 78 | 42 |
| other | Injection site erythema | General disorders | Part B: Dupilumab 300 mg Q2W | 18 | 81 | 93 |
| other | Injection site erythema | General disorders | Part B: Dupilumab 300 mg QW | 8 | 80 | 25 |
| other | Injection site erythema | General disorders | Part C: Dupilumab 300 mg Q2W (Placebo in Part B) | 2 | 37 | 32 |
| other | Injection site erythema | General disorders | Part C: Dupilumab 300 mg QW (Placebo in Part A or B) | 6 | 74 | 13 |
| other | Injection site erythema | General disorders | Part C: Dupilumab 300 mg Q2W (Part B Regimen Continued) | 6 | 79 | 36 |
| other | Injection site erythema | General disorders | Part C: Dupilumab 300 mg QW (Part A or B Regimen Continued) | 10 | 114 | 21 |
| other | Injection site reaction | General disorders | Part A: Placebo | 5 | 39 | 19 |
1 to 10 of 486Source ClinicalTrials.gov
See all 486 adverse eventsAdverse event totals27
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Part A: Placebo | 0 | 39 |
| Total, all-cause mortality | Part A: Dupilumab 300 mg QW | 0 | 42 |
| Total, all-cause mortality | Part B: Placebo | 0 | 78 |
| Total, all-cause mortality | Part B: Dupilumab 300 mg Q2W | 0 | 81 |
| Total, all-cause mortality | Part B: Dupilumab 300 mg QW | 0 | 80 |
| Total, all-cause mortality | Part C: Dupilumab 300 mg Q2W (Placebo in Part B) | 0 | 37 |
| Total, all-cause mortality | Part C: Dupilumab 300 mg QW (Placebo in Part A or B) | 0 | 74 |
| Total, all-cause mortality | Part C: Dupilumab 300 mg Q2W (Part B Regimen Continued) | 0 | 79 |
| Total, all-cause mortality | Part C: Dupilumab 300 mg QW (Part A or B Regimen Continued) | 0 | 114 |
| Total, other adverse events | Part A: Placebo | 28 | 39 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 adverse event totalsPapers11
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03633617
GET https://conductscience.org/api/trials/v1/NCT03633617/registered?page=2