Trial · NCT03137160
An Open-Label, Proof-of-Concept Study of Ixekizumab in the Treatment of Pyoderma Gangrenosum
NCT03137160, Phase 2, Completed, Ohio State University; results first posted 2022-06-06
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. An Open-Label, Proof-of-Concept Study of Ixekizumab in the Treatment of Pyoderma Gangrenosum. Trials, record NCT03137160. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03137160
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Open-Label, Proof-of-Concept Study of Ixekizumab in the Treatment of Pyoderma Gangrenosum
- NCT number
- NCT03137160
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 4 participants, actual
- Lead sponsor
- Ohio State University
- Conditions
- Pyoderma Gangrenosum
- Interventions
- Ixekizumab
- First posted
- 2017-05-02
- Last updated
- 2024-02-23
- Results first posted
- 2022-06-06
- Limitations and caveats
- Trial stopped early due to safety. Patients were all previously hospitalized as well. High risk of re-hospitalization was not necessarily unexpected.
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Proportion of Subjects Achieving 2-point Reduction in the 5-point Investigator Global Assessment (IGA) for the Target Ulcer at Week 12 | 12 Weeks | The primary outcome will be the proportion of subjects achieving a 2-point reduction in the 5-point investigator global assessment for the target ulcer at Week 12. The measure type and unit of measure are the proportion of participants. The IGA utilizes a 5 point Investigator Global Assessment measuring disease severity from 0- clear, 1-minimal, 2-mild, 3-moderate, 4- severe. 4 is the worst |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Proportion of Subjects Achieving 2-point Reduction in the 5-point Investigator Global Assessment (IGA) for the Target Ulcer at Week 12 | 12 Weeks | The proportion of subjects achieving a two point reduction in the five-point investigator global assessment (IGA) for the target ulcer from baseline to week 12. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group1
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Proportion of Subjects Achieving 2-point Reduction in the 5-point Investigator Global Assessment (IGA) for the Target Ulcer at Week 12 | Ixekizumab (Taltz) | 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 | Ixekizumab (Taltz) | 4 | |
| Overall Study | COMPLETED | Ixekizumab (Taltz) | 2 | |
| Overall Study | NOT COMPLETED | Ixekizumab (Taltz) | 2 |
Source ClinicalTrials.gov
Adverse events12
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 | hypotension | Cardiac disorders | Ixekizumab (Taltz) | 2 | 4 | 2 |
| other | fever | Immune system disorders | Ixekizumab (Taltz) | 2 | 4 | 3 |
| other | vomitting | Gastrointestinal disorders | Ixekizumab (Taltz) | 1 | 4 | 1 |
| other | diarrhea | Gastrointestinal disorders | Ixekizumab (Taltz) | 1 | 4 | 2 |
| other | infection of ulcer | Infections and infestations | Ixekizumab (Taltz) | 1 | 4 | 1 |
| other | pneumonia | Immune system disorders | Ixekizumab (Taltz) | 1 | 4 | 1 |
| other | h influenza | Immune system disorders | Ixekizumab (Taltz) | 1 | 4 | 1 |
| other | low WBC | Infections and infestations | Ixekizumab (Taltz) | 1 | 4 | 1 |
| other | low igG levels | Immune system disorders | Ixekizumab (Taltz) | 1 | 4 | 1 |
| serious | sepsis | Blood and lymphatic system disorders | Ixekizumab (Taltz) | 1 | 4 | 1 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ixekizumab (Taltz) | 0 | 4 |
| Total, other adverse events | Ixekizumab (Taltz) | 4 | 4 |
| Total, serious adverse events | Ixekizumab (Taltz) | 3 | 4 |
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/NCT03137160
GET https://conductscience.org/api/trials/v1/NCT03137160/registered