Trial · NCT03139032
Efficacy and Safety of Etrasimod (APD334) in Inflammatory Bowel Disease Patients With Active Skin Extra-intestinal Manifestations
NCT03139032, Phase 2, Terminated, Arena Pharmaceuticals; results first posted 2020-12-31
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy and Safety of Etrasimod (APD334) in Inflammatory Bowel Disease Patients With Active Skin Extra-intestinal Manifestations. Trials, record NCT03139032. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03139032
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Etrasimod (APD334) in Inflammatory Bowel Disease Patients With Active Skin Extra-intestinal Manifestations
- NCT number
- NCT03139032
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 1 participants, actual
- Lead sponsor
- Arena Pharmaceuticals
- Conditions
- Inflammatory Bowel Diseases, Skin Extra-intestinal Manifestations
- Interventions
- APD334
- First posted
- 2017-05-03
- Last updated
- 2020-12-31
- Results first posted
- 2020-12-31
- Limitations and caveats
Due to limited enrollment (N=1), this clinical trial was terminated by the Sponsor and no efficacy analyses were conducted. To protect the single participant's privacy, demography and efficacy data are not reported.
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Exploratory Endpoint - Change From Baseline in Endoscopic Improvement/Histologic Healing Using Endoscopy or Flexible Proctosigmoidoscopy | Weeks 12 | Only if there are signs of inflammation at screening another evaluation was planned to be performed at week 12. |
| Primary | Exploratory Endpoint - Change From Baseline in Level of Fecal Calprotectin | Weeks 4, 8, and 12 | |
| Primary | Exploratory Endpoint - Change From Baseline in Physician Global Assessments for Active Skin Extra-intestinal Manifestations (EIM) (PG, EN and Psoriasis) | Weeks 1, 2, 4, 8, and 12 | |
| Primary | Exploratory Endpoint - Change From Baseline in Patient Global Assessments for Active Skin EIM | Weeks 1, 2, 4, 8, and 12 | |
| Primary | Exploratory Endpoint - Change From Baseline in the Dermatology Life Quality Index Score | Weeks 1, 2, 4, 8, and 12 | |
| Primary | Exploratory Endpoint - Change From Baseline in Inflammatory Bowel Disease Questionnaire Score | Weeks 2, 4, 8, and 12 | |
| Primary | Exploratory Endpoint - Change From Baseline in C-reactive Protein | Weeks 1, 2, 4, 8, 12 and the 2-week follow-up visit | |
| Primary | Exploratory Endpoint - Change From Baseline in Leucocyte Characterization | Weeks 8 and 12 | |
| Primary | Exploratory Endpoint - Change From Baseline in Stool Frequency at Ulcerative Colitis Endpoint | Weeks 1, 2, 4, 8, and 12 | |
| Primary | Exploratory Endpoint - Change From Baseline in Rectal Bleeding at Ulcerative Colitis Endpoint | Weeks 1, 2, 4, 8, and 12 |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Exploratory Endpoint - Change From Baseline in Endoscopic Improvement/Histologic Healing Using Endoscopy or Flexible Proctosigmoidoscopy | Weeks 12 | Efficacy analyses were not conducted due to low enrollment (N=1). In order to protect participant's privacy, the results from a single participant cannot be reported. | ||
| PRIMARY | Exploratory Endpoint - Change From Baseline in Level of Fecal Calprotectin | Weeks 4, 8, and 12 | Efficacy analyses were not conducted due to low enrollment (N=1). In order to protect participant's privacy, the results from a single participant cannot be reported. | ||
| PRIMARY | Exploratory Endpoint - Change From Baseline in Physician Global Assessments for Active Skin Extra-intestinal Manifestations (EIM) (PG, EN and Psoriasis) | Weeks 1, 2, 4, 8, and 12 | Efficacy analyses were not conducted due to low enrollment (N=1). In order to protect participant's privacy, the results from a single participant cannot be reported. | ||
| PRIMARY | Exploratory Endpoint - Change From Baseline in Patient Global Assessments for Active Skin EIM | Weeks 1, 2, 4, 8, and 12 | Efficacy analyses were not conducted due to low enrollment (N=1). In order to protect participant's privacy, the results from a single participant cannot be reported. | ||
| PRIMARY | Exploratory Endpoint - Change From Baseline in the Dermatology Life Quality Index Score | Weeks 1, 2, 4, 8, and 12 | Efficacy analyses were not conducted due to low enrollment (N=1). In order to protect participant's privacy, the results from a single participant cannot be reported. | ||
| PRIMARY | Exploratory Endpoint - Change From Baseline in Inflammatory Bowel Disease Questionnaire Score | Weeks 2, 4, 8, and 12 | Efficacy analyses were not conducted due to low enrollment (N=1). In order to protect participant's privacy, the results from a single participant cannot be reported. | ||
| PRIMARY | Exploratory Endpoint - Change From Baseline in C-reactive Protein | Weeks 1, 2, 4, 8, 12 and the 2-week follow-up visit | Efficacy analyses were not conducted due to low enrollment (N=1). In order to protect participant's privacy, the results from a single participant cannot be reported. | ||
| PRIMARY | Exploratory Endpoint - Change From Baseline in Leucocyte Characterization | Weeks 8 and 12 | Efficacy analyses were not conducted due to low enrollment (N=1). In order to protect participant's privacy, the results from a single participant cannot be reported. | ||
| PRIMARY | Exploratory Endpoint - Change From Baseline in Stool Frequency at Ulcerative Colitis Endpoint | Weeks 1, 2, 4, 8, and 12 | Efficacy analyses were not conducted due to low enrollment (N=1). In order to protect participant's privacy, the results from a single participant cannot be reported. | ||
| PRIMARY | Exploratory Endpoint - Change From Baseline in Rectal Bleeding at Ulcerative Colitis Endpoint | Weeks 1, 2, 4, 8, and 12 | Efficacy analyses were not conducted due to low enrollment (N=1). In order to protect participant's privacy, the results from a single participant cannot be reported. |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 outcomesResults by group1
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Safety Measured by Number of Participants With Adverse Events and Serious Adverse Events | Etrasimod | 0 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Etrasimod | 1 | |
| Overall Study | COMPLETED | Etrasimod | 1 | |
| Overall Study | NOT COMPLETED | Etrasimod | 0 |
Source ClinicalTrials.gov
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 totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Etrasimod | 0 | 1 |
| Total, other adverse events | Etrasimod | 0 | 1 |
| Total, serious adverse events | Etrasimod | 0 | 1 |
Source ClinicalTrials.gov
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/NCT03139032
GET https://conductscience.org/api/trials/v1/NCT03139032/registered