Trial · NCT06624670
A Study to Test Whether Spesolimab Helps People With a Skin Condition Called Pyoderma Gangrenosum
NCT06624670, Phase 3, Recruiting, LEO Pharma
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study to Test Whether Spesolimab Helps People With a Skin Condition Called Pyoderma Gangrenosum. Trials, record NCT06624670. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06624670
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Test Whether Spesolimab Helps People With a Skin Condition Called Pyoderma Gangrenosum
- NCT number
- NCT06624670
- Status
- Recruiting
- Phases
- Phase 3
- Enrollment
- 90 participants, estimated
- Lead sponsor
- LEO Pharma
- Conditions
- Pyoderma Gangrenosum
- Interventions
- Spesolimab, Placebo matching to spesolimab, Prednisone, Prednisolone
- First posted
- 2024-10-03
- Last updated
- 2026-11-09
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Achievement of complete closure (PGAR-100 (100% pyoderma gangrenosum area reduction)) of the target PG ulcer at any time up to Week 26 and confirmed at the next consecutive visit (at least 2 weeks later) | Up to Week 28. | PGAR-100 is defined as complete closure and re-epithelisation of a PG ulcer without drainage and requirements for dressing. |
| Secondary | Key secondary endpoint: Achievement of PGAR-100 of the target PG ulcer at Week 26 confirmed at the next consecutive visit (at least 2 weeks later) | Up to Week 28. | PGAR-100 is defined as complete closure and re-epithelisation of a PG ulcer without drainage and requirements for dressing. |
| Secondary | Achievement of 50% area reduction (PGAR-50) of the target PG ulcer at any time up to Week 26 | Up to Week 26. | Achievement of a PGAR-50 defines an area reduction of a PG ulcer from baseline by 50%. |
| Secondary | Achievement of ≥ 3 point reduction in NRS Pain score from baseline at Week 26 | At baseline and at Week 26. | Numeric Rating Scale for Pain (NRS Pain) is a unidimensional measure of pain intensity. It is a 11-point numeric scale, in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of their pain, with 0 representing "no pain" and 10 representing "worst pain imaginable". Trial participant is asked to report their pain intensity in the last 24 h. |
| Secondary | Achievement of a DLQI of ≤ 5 at Week 26 | At Week 26. | Dermatology Life Quality Index (DLQI) is a trial participant-administered, quality of life questionnaire consisting of 10 questions that cover 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, problems with treatment). Response categories include "not relevant" or "not at all" (score of 0), "a little" (score of 1), "a lot" (score of 2) and "very much" (score of 3). Question 7 is a "yes"/ "no" question where "yes" is scored as 3. DLQI total score is calculated by summing the scores of each question, resulting in a range of 0 to 30, with higher scores indicating more impairment of a trial participant's quality of life. |
| Secondary | Achievement of complete response | At Week 26. | Complete response (CR), defined as all ulcers completely closed and re- epithelised without drainage and requirements for dressing, as assessed by the investigator). |
| Secondary | Achievement of PGAR-100 of any measurable PG ulcer (≥5 cm^2 at baseline) at any time up to Week 26 and confirmed at the next consecutive visit (at least 2 weeks later) | Up to Week 28. | PGAR-100 is defined as complete closure and re-epithelisation of a PG ulcer without drainage and requirements for dressing. |
| Secondary | Achievement of PGAR-100 of all measurable PG ulcers (≥5 cm^2 at baseline) at any time up to Week 26 and confirmed at the next consecutive visit (at least 2 weeks later) | Up to Week 28. | PGAR-100 is defined as complete closure and re-epithelisation of a PG ulcer without drainage and requirements for dressing. |
| Secondary | Time to recurrence among trial participants who had achieved CR at Week 26 up to Week 52 | Up to Week 52. | Recurrence is defined as emergence of the disease (PG ulcer\[s\]) at the previous ulcer sites(s) or emergence of any new PG ulcer(s). |
Source ClinicalTrials.gov
Outcomes0
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/NCT06624670
GET https://conductscience.org/api/trials/v1/NCT06624670/registered