Trial · NCT05061446
Etrasimod Dose-Ranging Versus Placebo as Induction Therapy Study in Adult Japanese Subjects With Moderately to Severely Active Ulcerative Colitis
NCT05061446, Phase 2, Completed, Pfizer; results first posted 2024-10-29
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Etrasimod Dose-Ranging Versus Placebo as Induction Therapy Study in Adult Japanese Subjects With Moderately to Severely Active Ulcerative Colitis. Trials, record NCT05061446. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05061446
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Etrasimod Dose-Ranging Versus Placebo as Induction Therapy Study in Adult Japanese Subjects With Moderately to Severely Active Ulcerative Colitis
- NCT number
- NCT05061446
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 54 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Ulcerative Colitis
- Interventions
- Etrasimod, Etrasimod, Placebo
- First posted
- 2021-09-29
- Last updated
- 2024-10-29
- Results first posted
- 2024-10-29
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Who Achieved Clinical Remission at Week 12 | Week 12 | Clinical remission:Participants with stool frequency (SF)subscore=0(or of 1 with greater than or equal to(\>=)1 point decrease from baseline,rectal bleeding(RB)subscore=0 and endoscopic score(ES)less than or equal to(\<)=1(excluding friability).SF subscore:number of stools in 24-hours relative to normal number of stools for that participant in same period,score ranged from 0(normal number of stools) to 3(5 or more stools than normal),higher scores=more severity.RB subscore:most severe amount of blood passed per rectum in 24-hours,score ranged from 0(no blood seen)to 3(blood alone passes),higher scores=more severity.ES:reported worst appearance of mucosa on flexible sigmoidoscopy or colonoscopy,score ranged from 0(normal or inactive disease) to 3(severe disease \[spontaneous bleeding,ulceration\]),higher scores=more severity.Modified Mayo score:measure disease activity for UC,score:0(normal) to 9(maximum severity),comprised subscores for SF,RB,ES.higher score=more severe disease activity. |
| Secondary | Percentage of Participants Who Achieved Endoscopic Improvement at Week 12 | Week 12 | Endoscopic improvement was defined as ES \<= 1 (excluding friability). ES reported worst appearance of mucosa on flexible sigmoidoscopy or colonoscopy, score ranged from 0 (normal or inactive disease) to 3 (severe disease \[spontaneous bleeding, ulceration\]), higher scores = more severity. Modified Mayo score (MMS): measure disease activity for UC, score: 0 (normal) to 9 (maximum severity),and comprised the subscores for SF, RB, ES. Higher score = more severe disease activity. |
| Secondary | Percentage of Participants Who Achieved Symptomatic Remission at Week 12 | Week 12 | Symptomatic remission was defined as SF sub score = 0 (or = 1 with a \>= 1 point decrease from baseline) and RB sub score = 0. SF subscore: reported number of stools in a 24-hour period relative to normal number of stools for that participant in the same period, score ranged from 0 (normal number of stools) to 3 (5 or more stools than normal), higher scores = more severity. RB subscore: reported the most severe amount of blood passed per rectum in a 24-hour period, score ranged from 0 (no blood seen) to 3 (blood alone passes), higher scores = more severity. MMS: measure disease activity for UC, score: 0 (normal) to 9 (maximum severity), and comprised the subscores for SF, RB, ES. Higher score = more severe disease activity. |
| Secondary | Percentage of Participants Who Achieved Mucosal Healing at Week 12 | Week 12 | Mucosal healing was defined as ES \<= 1 (excluding friability) with histologic remission defined as a Geboes index score \< 2.0). ES reported worst appearance of mucosa on flexible sigmoidoscopy or colonoscopy, score ranged from 0 (normal or inactive disease) to 3 (severe disease \[spontaneous bleeding, ulceration\]), higher scores = more severity. 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. Modified Mayo score (MMS): measure disease activity for UC, score: 0 (normal) to 9 (maximum severity), comprised subscores for SF, RB, ES. Higher score = more severe disease activity. |
| Secondary | Percentage of Participants Who Achieved Clinical Response at Week 12 | Week 12 | Clinical response was defined as a \>= 2-point and \>= 30 percentage (%) decrease from baseline in MMS, and a \>= 1-point decrease from baseline in RB subscore or an absolute RB subscore \<= 1. MMS: measure disease activity for UC, score: 0 (normal) to 9 (maximum severity), and comprised the subscores for SF, RB, ES. Higher score = more severe disease activity. RB subscore: reported the most severe amount of blood passed per rectum in a 24-hour period, score ranged from 0 (no blood seen) to 3 (blood alone passes), higher scores = more severity. |
| Secondary | Percentage of Participants Who Achieved Endoscopic Normalization at Week 12 | Week 12 | Endoscopic normalization was defined as ES= 0. ES reported worst appearance of mucosa on flexible sigmoidoscopy or colonoscopy, score ranged from 0 (normal or inactive disease) to 3 (severe disease \[spontaneous bleeding, ulceration\]), higher scores = more severity. MMS: measure disease activity for UC, score: 0 (normal) to 9 (maximum severity), and comprised the subscores for SF, RB, ES. Higher score = more severe disease activity. |
| Other | Number of Participants With Adverse Events According to Severity | Day 1 of first dose of study treatment up to 4 weeks after administration of the final dose of study treatment (maximum up to 16 weeks) | An adverse event was any untoward medical occurrence in a participant or clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. An adverse event was therefore any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Severity was classified using common terminology criteria for adverse events (CTCAE), version 5.0, such as Grade 1 for mild, Grade 2 for moderate, Grade 3 for severe, Grade 4 for life-threatening, Grade 5 for death related to adverse event. |
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 | Percentage of Participants Who Achieved Clinical Remission at Week 12 | Week 12 | FAS consisted of all randomized participants who received at least 1 dose of study treatment. Here, number of participants analyzed signifies only those participants who had a baseline MMS score between 5 and 9. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Achieved Endoscopic Improvement at Week 12 | Week 12 | FAS consisted of all randomized participants who received at least 1 dose of study treatment. Here, number of participants analyzed signifies only those participants who had a baseline MMS score between 5 and 9. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Achieved Symptomatic Remission at Week 12 | Week 12 | FAS consisted of all randomized participants who received at least 1 dose of study treatment. Here, number of participants analyzed signifies only those participants who had a baseline MMS score between 5 and 9. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Achieved Mucosal Healing at Week 12 | Week 12 | FAS consisted of all randomized participants who received at least 1 dose of study treatment. Here, number of participants analyzed signifies only those participants who had a baseline MMS score between 5 and 9. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Achieved Clinical Response at Week 12 | Week 12 | FAS consisted of all randomized participants who received at least 1 dose of study treatment. Here, number of participants analyzed signifies only those participants who had a baseline MMS score between 5 and 9. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Achieved Endoscopic Normalization at Week 12 | Week 12 | FAS consisted of all randomized participants who received at least 1 dose of study treatment. Here, number of participants analyzed signifies only those participants who had a baseline MMS score between 5 and 9. | Percentage of participants | NUMBER |
| OTHER_PRE_SPECIFIED | Number of Participants With Adverse Events According to Severity | Day 1 of first dose of study treatment up to 4 weeks after administration of the final dose of study treatment (maximum up to 16 weeks) | The safety set included all randomized participants who received at least 1 dose of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group33
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Who Achieved Clinical Remission at Week 12 | Placebo | 0 | Percentage of participants | ||
| Percentage of Participants Who Achieved Clinical Remission at Week 12 | Etrasimod 1 mg | 6.7 | Percentage of participants | ||
| Percentage of Participants Who Achieved Clinical Remission at Week 12 | Etrasimod 2 mg | 26.3 | Percentage of participants | ||
| Percentage of Participants Who Achieved Endoscopic Improvement at Week 12 | Placebo | 0 | Percentage of participants | ||
| Percentage of Participants Who Achieved Endoscopic Improvement at Week 12 | Etrasimod 1 mg | 6.7 | Percentage of participants | ||
| Percentage of Participants Who Achieved Endoscopic Improvement at Week 12 | Etrasimod 2 mg | 26.3 | Percentage of participants | ||
| Percentage of Participants Who Achieved Symptomatic Remission at Week 12 | Placebo | 0 | Percentage of participants | ||
| Percentage of Participants Who Achieved Symptomatic Remission at Week 12 | Etrasimod 1 mg | 20.0 | Percentage of participants | ||
| Percentage of Participants Who Achieved Symptomatic Remission at Week 12 | Etrasimod 2 mg | 31.6 | Percentage of participants | ||
| Percentage of Participants Who Achieved Mucosal Healing at Week 12 | Placebo | 0 | Percentage of participants |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 18 | |
| Overall Study | STARTED | Etrasimod 1 mg | 17 | |
| Overall Study | STARTED | Etrasimod 2 mg | 19 | |
| Overall Study | COMPLETED | Placebo | 16 | |
| Overall Study | COMPLETED | Etrasimod 1 mg | 16 | |
| Overall Study | COMPLETED | Etrasimod 2 mg | 19 | |
| Overall Study | NOT COMPLETED | Placebo | 2 | |
| Overall Study | NOT COMPLETED | Etrasimod 1 mg | 1 | |
| Overall Study | NOT COMPLETED | Etrasimod 2 mg | 0 |
Source ClinicalTrials.gov
Adverse events129
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 | Stomatitis | Gastrointestinal disorders | Placebo | 0 | 18 | |
| other | Stomatitis | Gastrointestinal disorders | Etrasimod 1 mg | 2 | 17 | |
| other | Stomatitis | Gastrointestinal disorders | Etrasimod 2 mg | 0 | 19 | |
| other | Chronic gastritis | Gastrointestinal disorders | Placebo | 0 | 18 | |
| other | Chronic gastritis | Gastrointestinal disorders | Etrasimod 1 mg | 1 | 17 | |
| other | Chronic gastritis | Gastrointestinal disorders | Etrasimod 2 mg | 0 | 19 | |
| other | Gastrooesophageal reflux disease | Gastrointestinal disorders | Placebo | 0 | 18 | |
| other | Gastrooesophageal reflux disease | Gastrointestinal disorders | Etrasimod 1 mg | 0 | 17 | |
| other | Gastrooesophageal reflux disease | Gastrointestinal disorders | Etrasimod 2 mg | 1 | 19 | |
| other | Nausea | Gastrointestinal disorders | Placebo | 1 | 18 |
1 to 10 of 129Source ClinicalTrials.gov
See all 129 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 18 |
| Total, all-cause mortality | Etrasimod 1 mg | 0 | 17 |
| Total, all-cause mortality | Etrasimod 2 mg | 0 | 19 |
| Total, other adverse events | Placebo | 10 | 18 |
| Total, other adverse events | Etrasimod 1 mg | 9 | 17 |
| Total, other adverse events | Etrasimod 2 mg | 13 | 19 |
| Total, serious adverse events | Placebo | 0 | 18 |
| Total, serious adverse events | Etrasimod 1 mg | 0 | 17 |
| Total, serious adverse events | Etrasimod 2 mg | 0 | 19 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 40275818 | 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 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/NCT05061446
GET https://conductscience.org/api/trials/v1/NCT05061446/results?page=2