Trial · NCT04706793
Oral Etrasimod Versus Placebo for the Treatment of Moderately to Severely Active Ulcerative Colitis in Adult Japanese Participants (ELEVATE UC 40 JAPAN)
NCT04706793, Phase 3, Completed, Pfizer; results first posted 2023-10-16
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Oral Etrasimod Versus Placebo for the Treatment of Moderately to Severely Active Ulcerative Colitis in Adult Japanese Participants (ELEVATE UC 40 JAPAN). Trials, record NCT04706793. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04706793
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Oral Etrasimod Versus Placebo for the Treatment of Moderately to Severely Active Ulcerative Colitis in Adult Japanese Participants (ELEVATE UC 40 JAPAN)
- NCT number
- NCT04706793
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 42 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Ulcerative Colitis
- Interventions
- Etrasimod, Placebo
- First posted
- 2021-01-13
- Last updated
- 2023-10-16
- Results first posted
- 2023-10-16
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Achieving Clinical Remission at Week 40 of Study APD334-308 | Week 40 of APD334-308 | Clinical remission was based on the modified Mayo score (MMS). The MMS is a composite score of 3 assessments consisting of participant-reported symptoms using daily electronic (e)-diary and centrally read endoscopy: stool frequency (SF), rectal bleeding (RB) and endoscopic score (ES). Clinical remission was defined as SF sub-score = 0 (or = 1 with a greater than or equal to \[\>=\] 1-point decrease from Baseline), RB sub-score = 0, and ES less than or equal to (\<=) 1 (excluding friability). Each component sub-score ranged from 0 to 3 and total score range of the MMS was from 0 to 9, with higher scores indicating more severe disease. |
| Secondary | Percentage of Participants Achieving Endoscopic Improvement at Week 40 of Study APD334-308 | Week 40 of APD334-308 | Endoscopic improvement was defined as an ES \<=1 (excluding friability) at Week 40 of APD334-308 compared with Week 12 of APD334-302. The ES ranged from 0 to 3 (where 0 = normal/inactive disease and 3 = severe disease); higher score indicated more severe disease. |
| Secondary | Percentage of Participants Achieving Symptomatic Remission at Week 40 of Study APD334-308 | Week 40 of APD334-308 | Symptomatic remission was defined as an SF sub-score = 0 (or = 1 with a \>= 1 point decrease from Baseline) and RB sub-score = 0. The SF sub-score ranged from 0 to 3 (where 0 = normal number of stools and 3 = at least 5 stools more than normal) and RB sub-score ranged from 0 to 3 (where 0 = no blood and 3 = blood alone passes). Higher scores indicated more severe disease. |
| Secondary | Percentage of Participants With Mucosal Healing at Week 40 of Study APD334-308 | Week 40 of APD334-308 | Mucosal healing was defined as an ES \<= 1 (excluding friability) with histologic remission measured by a Geboes Index score less than \[\<\] 2.0). The ES ranged from 0 to 3 (where 0 = normal/inactive disease and 3 = severe disease). The Geboes score grading system, was a validated score for evaluating histologic disease activity in UC as follows: grade 0 = structural and architectural changes; grade 1 = chronic inflammatory infiltrate; grade 2 = lamina propria neutrophils and eosinophils; grade 3 = neutrophils in the epithelium; grade 4 = crypt destruction; grade 5 = erosions or ulceration. A higher Geboes score indicated more severe disease. |
| Secondary | Percentage of Participants, Who Had Not Been Receiving Corticosteroids for ≥ 12 Weeks, Achieving Clinical Remission at Week 40 of Study APD334-308 Among Participants Receiving Corticosteroids at C5041015 (APD334-302) Study Entry | Week 40 of APD334-308 | Clinical remission was based on the modified Mayo score (MMS). The MMS is a composite score of 3 assessments consisting of participant-reported symptoms using daily electronic (e)-diary and centrally read endoscopy: stool frequency (SF), rectal bleeding (RB) and endoscopic score (ES). Clinical remission was defined as SF sub-score = 0 (or = 1 with a greater than or equal to \[\>=\] 1-point decrease from Baseline), RB sub-score = 0, and ES less than or equal to (\<=) 1 (excluding friability). Each component sub-score ranged from 0 to 3 and total score range of the MMS was from 0 to 9, with higher scores indicating more severe disease. |
| Secondary | Percentage of Participants Achieving Sustained Clinical Remission | Week 40 of APD334-308 | Clinical remission was based on the modified Mayo score (MMS). The MMS is a composite score of 3 assessments consisting of participant-reported symptoms using daily electronic (e)-diary and centrally read endoscopy: stool frequency (SF), rectal bleeding (RB) and endoscopic score (ES). Clinical remission was defined as SF sub-score = 0 (or = 1 with a greater than or equal to \[\>=\] 1-point decrease from Baseline), RB sub-score = 0, and ES less than or equal to (\<=) 1 (excluding friability). Each component sub-score ranged from 0 to 3 and total score range of the MMS was from 0 to 9, with higher scores indicating more severe disease. A subject with sustained clinical remission is defined as someone who achieved clinical remission at both Week 12 of APD334-302 and Week 40 of APD334-308. |
Source ClinicalTrials.gov
Outcomes6
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 Clinical Remission at Week 40 of Study APD334-308 | Week 40 of APD334-308 | Full Analysis Set Population (All randomized participants who received at least 1 dose of study intervention). Only those participants with data available at the specified time points were analyzed. Overall number of participants analyzed signifies participants evaluable for this outcome measure. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving Endoscopic Improvement at Week 40 of Study APD334-308 | Week 40 of APD334-308 | Full Analysis Set Population. Only those participants with data available at the specified time points were analyzed. Overall number of participants analyzed signifies participants evaluable for this outcome measure. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving Symptomatic Remission at Week 40 of Study APD334-308 | Week 40 of APD334-308 | Full Analysis Set Population. Overall number of participants analyzed signifies participants evaluable for this outcome measure. Only those participants with data available at the specified time points were analyzed. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Mucosal Healing at Week 40 of Study APD334-308 | Week 40 of APD334-308 | Full Analysis Set Population. Overall number of participants analyzed signifies participants evaluable for this outcome measure. Only those participants with data available at the specified time points were analyzed. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants, Who Had Not Been Receiving Corticosteroids for ≥ 12 Weeks, Achieving Clinical Remission at Week 40 of Study APD334-308 Among Participants Receiving Corticosteroids at C5041015 (APD334-302) Study Entry | Week 40 of APD334-308 | Full Analysis Set Population. Overall number of participants analyzed signifies participants evaluable for this outcome measure. Only those participants with data available at the specified time points were analyzed. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving Sustained Clinical Remission | Week 40 of APD334-308 | Full Analysis Set Population. Overall number of participants analyzed signifies participants evaluable for this outcome measure. Only those participants with data available at the specified time points were analyzed. | Percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group12
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 Clinical Remission at Week 40 of Study APD334-308 | Placebo Comparator: Placebo | 7.1 | Percentage of participants | ||
| Percentage of Participants Achieving Clinical Remission at Week 40 of Study APD334-308 | Experimental: Etrasimod 2 mg | 25.0 | Percentage of participants | ||
| Percentage of Participants Achieving Endoscopic Improvement at Week 40 of Study APD334-308 | Placebo Comparator: Placebo | 7.1 | Percentage of participants | ||
| Percentage of Participants Achieving Endoscopic Improvement at Week 40 of Study APD334-308 | Experimental: Etrasimod 2 mg | 35.7 | Percentage of participants | ||
| Percentage of Participants Achieving Symptomatic Remission at Week 40 of Study APD334-308 | Placebo Comparator: Placebo | 7.1 | Percentage of participants | ||
| Percentage of Participants Achieving Symptomatic Remission at Week 40 of Study APD334-308 | Experimental: Etrasimod 2 mg | 39.3 | Percentage of participants | ||
| Percentage of Participants With Mucosal Healing at Week 40 of Study APD334-308 | Placebo Comparator: Placebo | 7.1 | Percentage of participants | ||
| Percentage of Participants With Mucosal Healing at Week 40 of Study APD334-308 | Experimental: Etrasimod 2 mg | 28.6 | Percentage of participants | ||
Percentage of Participants, Who Had Not Been Receiving Corticosteroids for ≥ 12 Weeks, Achieving Clinical Remission at Week 40 of Study APD334-308 Among Participants Receiving Corticosteroids at C5041015 (APD334-302) Study Entry | Placebo Comparator: Placebo | 7.1 | Percentage of participants | ||
Percentage of Participants, Who Had Not Been Receiving Corticosteroids for ≥ 12 Weeks, Achieving Clinical Remission at Week 40 of Study APD334-308 Among Participants Receiving Corticosteroids at C5041015 (APD334-302) Study Entry | Experimental: Etrasimod 2 mg | 25.0 | Percentage of participants |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Treatment | STARTED | Placebo Comparator: Placebo | 14 | |
| Treatment | STARTED | Experimental: Etrasimod 2 mg | 28 | |
| Treatment | COMPLETED | Placebo Comparator: Placebo | 4 | |
| Treatment | COMPLETED | Experimental: Etrasimod 2 mg | 18 | |
| Treatment | NOT COMPLETED | Placebo Comparator: Placebo | 10 | |
| Treatment | NOT COMPLETED | Experimental: Etrasimod 2 mg | 10 | |
| Follow-up | STARTED | Placebo Comparator: Placebo | 14 | |
| Follow-up | STARTED | Experimental: Etrasimod 2 mg | 28 | |
| Follow-up | COMPLETED | Placebo Comparator: Placebo | 4 | |
| Follow-up | COMPLETED | Experimental: Etrasimod 2 mg | 18 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events38
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 | Colitis ulcerative | Gastrointestinal disorders | Placebo Comparator: Placebo | 1 | 14 | 2 |
| other | Colitis ulcerative | Gastrointestinal disorders | Experimental: Etrasimod 2 mg | 2 | 28 | 2 |
| other | Stomatitis | Gastrointestinal disorders | Placebo Comparator: Placebo | 1 | 14 | 2 |
| other | Stomatitis | Gastrointestinal disorders | Experimental: Etrasimod 2 mg | 0 | 28 | 0 |
| other | Pyrexia | General disorders | Placebo Comparator: Placebo | 2 | 14 | 2 |
| other | Pyrexia | General disorders | Experimental: Etrasimod 2 mg | 3 | 28 | 3 |
| other | Malaise | General disorders | Placebo Comparator: Placebo | 0 | 14 | 0 |
| other | Malaise | General disorders | Experimental: Etrasimod 2 mg | 3 | 28 | 4 |
| other | Vaccination site pain | General disorders | Placebo Comparator: Placebo | 0 | 14 | 0 |
| other | Vaccination site pain | General disorders | Experimental: Etrasimod 2 mg | 2 | 28 | 3 |
1 to 10 of 38Source ClinicalTrials.gov
See all 38 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo Comparator: Placebo | 0 | 14 |
| Total, all-cause mortality | Experimental: Etrasimod 2 mg | 0 | 28 |
| Total, other adverse events | Placebo Comparator: Placebo | 8 | 14 |
| Total, other adverse events | Experimental: Etrasimod 2 mg | 16 | 28 |
| Total, serious adverse events | Placebo Comparator: Placebo | 1 | 14 |
| Total, serious adverse events | Experimental: Etrasimod 2 mg | 1 | 28 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 42248437 | DERIVED |
Source PubMed
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Experimental: Etrasimod 2 mg vs Placebo Comparator: Placebo: deaths from any cause | Trial comparisons |
| Experimental: Etrasimod 2 mg vs Placebo Comparator: Placebo: serious adverse events | Trial comparisons |
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/NCT04706793
GET https://conductscience.org/api/trials/v1/NCT04706793/events?page=2