Trial · NCT04682639
A Study to Assess the Safety and Efficacy of Oral Etrasimod in Adult Participants With Eosinophilic Esophagitis
NCT04682639, Phase 2, Completed, Pfizer; results first posted 2023-10-26
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Assess the Safety and Efficacy of Oral Etrasimod in Adult Participants With Eosinophilic Esophagitis. Trials, record NCT04682639. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04682639
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Assess the Safety and Efficacy of Oral Etrasimod in Adult Participants With Eosinophilic Esophagitis
- NCT number
- NCT04682639
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 108 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Eosinophilic Esophagitis
- Interventions
- Etrasimod, Placebo, Etrasimod
- First posted
- 2020-12-24
- Last updated
- 2024-05-06
- Other registries' IDs
- eudract:2020-003226-23
- Results first posted
- 2023-10-26
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change From Baseline in Esophageal Peak Eosinophil Count (PEC) at Week 16 | Baseline, Week 16 | Eosinophils was counted in the areas of greatest eosinophil density. Counts were reported as the number of eosinophils/high power field (eos/hpf) and multiple hpfs analyzed until the PEC was clearly identified after taking into account all biopsies from all esophageal levels. |
| Secondary | Absolute Change From Baseline in Dysphagia Symptom Questionnaire (DSQ) Score at Week 16 | Baseline, Week 16 | The DSQ was used to measure the frequency and intensity of dysphagia to solid food. DSQ contained 4 questions, all participants used a diary, and responded to Questions 1 (did you eat solid food) and 2 (did food pass slowly or get stuck). If the participant's answer to Question 2 was 'No', the diary ended for that day. If a participant answered 'Yes', he/she advanced to Questions 3 (did you have to do anything to make the food go down or get relief) and 4 (extent to which the participant experienced pain while swallowing). DSQ score = (Sum of points from questions 2+3 in the daily DSQ)×14 days/(Number of diaries reported with non-missing data). DSQ scores can range from 0 to 84, with a higher score indicating worse dysphagia. |
| Secondary | Absolute Change From Baseline in Esophageal Peak Eosinophil Count (PEC) at Week 16 | Baseline, Week 16 | Eosinophils was counted in the areas of greatest eosinophil density. Counts were reported as the number of eosinophils/high power field (eos/hpf) and multiple hpfs analyzed until the PEC was clearly identified after taking into account all biopsies from all esophageal levels. |
| Secondary | Percentage Of Participants With Esophageal Peak Eosinophil Count (PEC) Less Than (<) 15 Eosinophils/High Power Field (Eos/Hpf) at Week 16 | Week 16 | |
| Secondary | Percentage of Participants With Esophageal Peak Eosinophil Count (PEC) Less Than or Equal to (<=) 6 Eosinophils/High Power Field (Eos/Hpf) at Week 16 | Week 16 | |
| Other | Number of Participants With Treatment Emergent Adverse Events (TEAEs) by Maximum Severity During 24 Week Double Blind Treatment Period | Baseline, up to Week 24 | An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent AE is defined as an AE that started or worsened in severity on or after the first dose of study treatment. Severity is classified as Grade 1: Mild, Grade 2: Moderate, Grade 3: Severe, Grade 4: Life-Threatening, Grade 5: Death Related to AE. |
| Other | Number of Participants With Serious TEAEs, TEAEs Leading to Study Treatment Discontinuation, TEAEs Leading to Death and TEAEs of Special Interest During 24 Week Double Blind Treatment Period | Baseline up to Week 24 | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of death); new or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 24 weeks after last dose that were absent before treatment or that worsened relative to pretreatment state. Relatedness to etrasimod was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Change From Baseline in Esophageal Peak Eosinophil Count (PEC) at Week 16 | Baseline, Week 16 | The Full Analysis Set (FAS) will consist of all randomized participants in the Double-Blind Treatment Period who received at least 1 dose of study treatment. Here, Number of participants analyzed signifies number of participants evaluable for this outcome measure. | Percent change | MEDIAN |
| SECONDARY | Absolute Change From Baseline in Dysphagia Symptom Questionnaire (DSQ) Score at Week 16 | Baseline, Week 16 | The FAS will consist of all randomized participants in the Double-Blind Treatment Period who received at least 1 dose of study treatment. Here, Number of participants analyzed signifies number of participants evaluable for this outcome measure. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Absolute Change From Baseline in Esophageal Peak Eosinophil Count (PEC) at Week 16 | Baseline, Week 16 | The FAS will consist of all randomized participants in the Double-Blind Treatment Period who received at least 1 dose of study treatment. Here, Number of participants analyzed signifies number of participants evaluable for this outcome measure. | eos/hpf | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage Of Participants With Esophageal Peak Eosinophil Count (PEC) Less Than (<) 15 Eosinophils/High Power Field (Eos/Hpf) at Week 16 | Week 16 | The FAS will consist of all randomized participants in the Double-Blind Treatment Period who received at least 1 dose of study treatment. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Esophageal Peak Eosinophil Count (PEC) Less Than or Equal to (<=) 6 Eosinophils/High Power Field (Eos/Hpf) at Week 16 | Week 16 | The FAS will consist of all randomized participants in the Double-Blind Treatment Period who received at least 1 dose of study treatment. | Percentage of participants | NUMBER |
| OTHER_PRE_SPECIFIED | Number of Participants With Treatment Emergent Adverse Events (TEAEs) by Maximum Severity During 24 Week Double Blind Treatment Period | Baseline, up to Week 24 | The safety population included all randomized participants who received at least 1 dose of study treatment during the specified treatment period. Here, Number of participants analyzed signifies number of participants evaluable for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Number of Participants With Serious TEAEs, TEAEs Leading to Study Treatment Discontinuation, TEAEs Leading to Death and TEAEs of Special Interest During 24 Week Double Blind Treatment Period | Baseline up to Week 24 | The safety population included all randomized participants who received at least 1 dose of study treatment during the specified treatment period. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group39
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent Change From Baseline in Esophageal Peak Eosinophil Count (PEC) at Week 16 | Experimental: Etrasimod 2 mg | -58.4 | Inter-Quartile Range -86.21 to -26.25 | Percent change | |
| Percent Change From Baseline in Esophageal Peak Eosinophil Count (PEC) at Week 16 | Experimental: Etrasimod 1 mg | -39.4 | Inter-Quartile Range -71.08 to 78.95 | Percent change | |
| Percent Change From Baseline in Esophageal Peak Eosinophil Count (PEC) at Week 16 | Placebo Then Etrasimod Any Dose | -21.5 | Inter-Quartile Range -57.20 to 55.42 | Percent change | |
| Absolute Change From Baseline in Dysphagia Symptom Questionnaire (DSQ) Score at Week 16 | Experimental: Etrasimod 2 mg | -17.11 | Standard Error 2.247 | Units on a scale | |
| Absolute Change From Baseline in Dysphagia Symptom Questionnaire (DSQ) Score at Week 16 | Experimental: Etrasimod 1 mg | -14.78 | Standard Error 2.166 | Units on a scale | |
| Absolute Change From Baseline in Dysphagia Symptom Questionnaire (DSQ) Score at Week 16 | Placebo Then Etrasimod Any Dose | -19.49 | Standard Error 2.602 | Units on a scale | |
| Absolute Change From Baseline in Esophageal Peak Eosinophil Count (PEC) at Week 16 | Experimental: Etrasimod 2 mg | -46.3 | Standard Error 17.46 | eos/hpf | |
| Absolute Change From Baseline in Esophageal Peak Eosinophil Count (PEC) at Week 16 | Experimental: Etrasimod 1 mg | -5.7 | Standard Error 16.99 | eos/hpf | |
| Absolute Change From Baseline in Esophageal Peak Eosinophil Count (PEC) at Week 16 | Placebo Then Etrasimod Any Dose | 8.3 | Standard Error 22.37 | eos/hpf | |
| Percentage Of Participants With Esophageal Peak Eosinophil Count (PEC) Less Than (<) 15 Eosinophils/High Power Field (Eos/Hpf) at Week 16 | Experimental: Etrasimod 2 mg | 22.0 | Percentage of participants |
1 to 10 of 39Source ClinicalTrials.gov
See all 39 results by groupParticipant flow30
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Double-Blind Treatment Period (24 Weeks) | STARTED | Experimental: Etrasimod 2 mg | 41 | |
| Double-Blind Treatment Period (24 Weeks) | STARTED | Experimental: Etrasimod 1 mg | 39 | |
| Double-Blind Treatment Period (24 Weeks) | STARTED | Placebo Then Etrasimod Any Dose | 28 | |
| Double-Blind Treatment Period (24 Weeks) | STARTED | OLE: Placebo Then Etrasimod 2 mg | 0 | |
| Double-Blind Treatment Period (24 Weeks) | STARTED | OLE: Placebo Then Etrasimod 1 mg | 0 | |
| Double-Blind Treatment Period (24 Weeks) | COMPLETED | Experimental: Etrasimod 2 mg | 30 | |
| Double-Blind Treatment Period (24 Weeks) | COMPLETED | Experimental: Etrasimod 1 mg | 31 | |
| Double-Blind Treatment Period (24 Weeks) | COMPLETED | Placebo Then Etrasimod Any Dose | 24 | |
| Double-Blind Treatment Period (24 Weeks) | COMPLETED | OLE: Placebo Then Etrasimod 2 mg | 0 | |
| Double-Blind Treatment Period (24 Weeks) | COMPLETED | OLE: Placebo Then Etrasimod 1 mg | 0 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 participant flowAdverse events1,155
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 | Nausea | Gastrointestinal disorders | Experimental: Etrasimod 2 mg | 6 | 41 | |
| other | Nausea | Gastrointestinal disorders | Experimental: Etrasimod 1 mg | 3 | 39 | |
| other | Nausea | Gastrointestinal disorders | Placebo Then Etrasimod Any Dose | 3 | 28 | |
| other | Nausea | Gastrointestinal disorders | OLE: Etrasimod 2 mg | 2 | 30 | |
| other | Nausea | Gastrointestinal disorders | OLE: Etrasimod 1 mg | 1 | 31 | |
| other | Nausea | Gastrointestinal disorders | OLE: Placebo Then Etrasimod 2 mg | 0 | 12 | |
| other | Nausea | Gastrointestinal disorders | OLE: Placebo Then Etrasimod 1 mg | 0 | 12 | |
| other | Abdominal pain | Gastrointestinal disorders | Experimental: Etrasimod 2 mg | 2 | 41 | |
| other | Abdominal pain | Gastrointestinal disorders | Experimental: Etrasimod 1 mg | 1 | 39 | |
| other | Abdominal pain | Gastrointestinal disorders | Placebo Then Etrasimod Any Dose | 1 | 28 |
1 to 10 of 1,155Source ClinicalTrials.gov
See all 1,155 adverse eventsAdverse event totals21
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Experimental: Etrasimod 2 mg | 0 | 41 |
| Total, all-cause mortality | Experimental: Etrasimod 1 mg | 0 | 39 |
| Total, all-cause mortality | Placebo Then Etrasimod Any Dose | 0 | 28 |
| Total, all-cause mortality | OLE: Etrasimod 2 mg | 0 | 30 |
| Total, all-cause mortality | OLE: Etrasimod 1 mg | 0 | 31 |
| Total, all-cause mortality | OLE: Placebo Then Etrasimod 2 mg | 0 | 12 |
| Total, all-cause mortality | OLE: Placebo Then Etrasimod 1 mg | 0 | 12 |
| Total, other adverse events | Experimental: Etrasimod 2 mg | 30 | 41 |
| Total, other adverse events | Experimental: Etrasimod 1 mg | 27 | 39 |
| Total, other adverse events | Placebo Then Etrasimod Any Dose | 23 | 28 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 adverse event totalsPapers2
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/NCT04682639
GET https://conductscience.org/api/trials/v1/NCT04682639/results?page=2