Trial · NCT03311464
A Study Assessing the Efficacy and Safety of Adalimumab in Active Ulcer(s) of Pyoderma Gangrenosum in Participants in Japan
NCT03311464, Phase 3, Completed, AbbVie
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study Assessing the Efficacy and Safety of Adalimumab in Active Ulcer(s) of Pyoderma Gangrenosum in Participants in Japan. Trials, record NCT03311464. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03311464
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study Assessing the Efficacy and Safety of Adalimumab in Active Ulcer(s) of Pyoderma Gangrenosum in Participants in Japan
- NCT number
- NCT03311464
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 22 participants, actual
- Lead sponsor
- AbbVie
- Conditions
- Pyoderma Gangrenosum
- Interventions
- adalimumab
- First posted
- 2017-10-17
- Last updated
- 2021-03-09
Source ClinicalTrials.gov
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of participants who have achieved target Pyoderma Gangrenosum Area Reduction (PGAR) | Week 26 | The participants will be assessed whether they meet target PGAR at Week 26 based on PGAR score. |
| Secondary | Proportion of participants achieving Physician's Global Assessment (PGA) 0 or 1 | Week 6 and Week 26 | The Investigator assesses the global improvement of all ulcers including the target ulcer according to the scales at the specified visits. |
| Secondary | Mean time to occurrence of new PG ulcers | Up to Week 26 | A new PG ulcer is defined as not present at Baseline and not caused by the epithelial bridging of an existing ulcer at Baseline. The time after Baseline when the new lesion was observed will be recorded. |
| Secondary | Change from Baseline in total number of active ulcers | Week 26 | The number of all active PG ulcers will be counted at the specified visits. |
| Secondary | Change from Baseline in Dermatology Life Quality Index (DLQI) | Week 6 and Week 26 | The DLQI will be used to assess the symptoms and the impact of skin problems on quality of life. |
| Secondary | Changes from Baseline in total ulcer area | Week 6 and Week 26 | The change in total ulcer area is assessed. |
| Secondary | Proportion of participants with inflammation reduction as assessed on an Investigator Inflammation Assessment (IIA) Score | Up to Week 26 | The Investigator assesses the inflammation status of the target ulcer at the specified visits according to the scales. |
| Secondary | Mean time to occurrence of a new PG ulcer(s) | Up to Week 52 | Mean time to occurrence of a new PG ulcer(s) is assessed. |
| Secondary | Mean time to healing of target ulcer | Up to Week 52 | The PG Area Reduction (PGAR) is calculated as the percentage area change in the target PG ulcer from Baseline. |
| Secondary | Proportion of participants achieving healing per PGAR for the target ulcer | Week 52 | The PG Area Reduction (PGAR) is calculated as the percentage area change in the target PG ulcer from Baseline. |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 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/NCT03311464
GET https://conductscience.org/api/trials/v1/NCT03311464/registered