Trial · NCT06563323
Guselkumab in the Treatment of Adults With Pyoderma Gangrenosum (PG)
NCT06563323, Phase 2, Active not recruiting, Oregon Health and Science University
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Guselkumab in the Treatment of Adults With Pyoderma Gangrenosum (PG). Trials, record NCT06563323. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06563323
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Guselkumab in the Treatment of Adults With Pyoderma Gangrenosum (PG)
- NCT number
- NCT06563323
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 17 participants, estimated
- Lead sponsor
- Oregon Health and Science University
- Conditions
- Pyoderma Gangrenosum, Skin Diseases, Wound Heal, Pyoderma, Skin Ulcer
- Interventions
- Guselkumab
- First posted
- 2024-08-20
- Last updated
- 2026-09-28
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Healing | Week 32 | Defined as the proportion of patients with complete re-epithelization, defined as a100% re-epithelialization without any drainage of the target ulcer at week 32. |
| Secondary | Physician Global Assessment (PGA) | Week 32 | Assessing the proportion of patients that show target ulcer healing in response to study treatment as measured by achieving PGA between 0 and 1 after treatment with guselkumab at week 32. This scale has been used in previous trials: 0 = total resolution of target ulcer with no signs of active PG 1= almost completely healed target ulcer with only minimal signs of active PG 2 = evidence of target ulcer healing which involves at least 50% of ulcer/ulcer margin 3 = evidence of target ulcer healing which involves less than 50% of ulcer/margin 4 = no evidence of target healing ulcer |
| Secondary | Decrease in ulcer area size long-term | Week 32 | The proportion of patients with decrease in ulcer area size of at least 50% after treatment at week 32 |
| Secondary | Decrease in ulcer area size short-term | Week 16 | The proportion of patients with decrease in ulcer area size of at least 50% after treatment at Week 16 |
| Secondary | Mean decrease in ulcer area size short-term | Week 16 | Mean decrease in ulcer area size from Week 0 to Week 16 |
| Secondary | Mean decrease in ulcer area size long-term | Week 32 | Mean decrease in ulcer area size from Week 0 to Week 32 |
| Secondary | Skindex Mini | Week 32 | The Skindex Mini is a 3-item questionnaire, assessing symptom, emotion, and function related to skin disease. We will measure the mean change in Skindex Mini score from Week 0 to Week-32 will be reported with two-sided 95% confidence interval. Change in Skindex Mini score will be analyzed using a paired t-test with 0.05 significance level. Generalized estimating equation (GEE) methods will be further used to characterize changes in Skindex Mini score (max = 5, min = 0) over time. Higher scores indicated worsened quality of life due to skin disease. |
| Secondary | Skin pain scale improvement over 7 days | Week 0 to 32 | The proportion of participants achieving a minimum of a 2 point decrease in the NRS at Week 0 and Week 32 The pain NRS is a subject-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing "no pain" and 10 representing "worst pain imaginable" in the last 7 days. |
| Secondary | Skin pain scale improvement over 24 hours | Week 0 to 32 | The proportion of participants achieving an improvement in reported peak pain Numeric Rating Scale (NRS) assessment at Week 0 and Week 32. The peak pain NRS assessment is a subject-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing "no pain" and 10 representing "worst pain imaginable" in the last 24 hours |
| Secondary | Change in physical function | Week 0 to 32 | The mean change in participant physical function from Week 0 to Week 32. Physical function is a subject-administered 5 category scale that assesses the impact of PG on participant physical function from "with no difficulty" to "can't do because of ulcer". |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 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.
Papers10
The papers the trial lists on ClinicalTrials.gov.
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/NCT06563323
GET https://conductscience.org/api/trials/v1/NCT06563323/registered