Trial · NCT06398626
An Observational Study of Etrasimod in Adult Patients With Moderate to Severe Ulcerative Colitis
NCT06398626, Recruiting, Pfizer
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. An Observational Study of Etrasimod in Adult Patients With Moderate to Severe Ulcerative Colitis. Trials, record NCT06398626. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06398626
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Observational Study of Etrasimod in Adult Patients With Moderate to Severe Ulcerative Colitis
- NCT number
- NCT06398626
- Status
- Recruiting
- Enrollment
- 300 participants, estimated
- Lead sponsor
- Pfizer
- Conditions
- Colitis, Ulcerative
- Interventions
- Etrasimod
- First posted
- 2024-05-03
- Last updated
- 2026-10-26
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of patients with symptomatic remission | Week 12 | Symptomatic remission is defined as partial Modified Mayo Score (pMMS) stool frequency subscore (SFS) = 0 (or = 1 with a ≥ 1-point decrease from baseline) and (RBS) rectal bleeding subscore = 0 |
| Secondary | Proportion of patients with symptomatic remission | Weeks 24, 36, 52 | Symptomatic remission is defined as partial Modified Mayo Score (pMMS) stool frequency subscore (SFS) = 0 (or = 1 with a ≥ 1-point decrease from baseline) and (RBS) rectal bleeding subscore = 0 |
| Secondary | Proportion of patients with symptomatic response | Weeks 12, 24, 36, 52 | Symptomatic response defined as a decrease from baseline ≥ 30% in pMMS composite RBS and SFS |
| Secondary | Proportion of patients with symptomatic response | Weeks 12, 24, 36, 52 | Symptomatic response defined as a decrease from baseline ≥ 20% in pMMS composite RBS and SFS |
| Secondary | Proportion of patients with clinical remission | Weeks 12, 24, 36, 52 | Clinical remission is defined as a pMMS ≤ 2 points, with no individual subscores \> 1 point. |
| Secondary | Proportion of patients with steroid-free symptomatic remission (among all patients and among patients in symptomatic remission) | Weeks 24, 36, 52 | Steroid-free symptomatic remission is defined as patients in symptomatic remission who did not take any corticosteroid treatment for 8 weeks prior to the visit/timepoint |
| Secondary | Proportion of patients with steroid-free clinical remission (among all patients and among patients in clinical remission) | Weeks 24, 36, 52 | Steroid-free clinical remission is defined as patients in clinical remission (using a pMMS) who did not take any corticosteroid treatment for 8 weeks prior to the visit/timepoint |
| Secondary | Change from baseline in fatigue | Weeks 12, 24, 36, 52 | Change from baseline in the Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue score Normalization of fatigue is defined as a FACIT Fatigue score ≥ 40.1 |
| Secondary | Change from baseline of bowel urgency | Weeks 12, 24, 36, 52 | Change from baseline in bowel urgency on a 0 (no urgency) - 10 (worst possible urgency) numeric rating scale |
| Secondary | Proportion of patients with a clinically meaningful improvement in bowel urgency | Weeks 12, 24, 36, 52 | Clinically meaningful improvement in bowel urgency is defined as ≥ 3-point decrease from baseline among patients with baseline bowel urgency score ≥ 3 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT06398626
GET https://conductscience.org/api/trials/v1/NCT06398626/registered