Trial · NCT06092216
Spesolimab in Pyoderma Gangrenosum
NCT06092216, Phase 2, Terminated, Icahn School of Medicine at Mount Sinai
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Spesolimab in Pyoderma Gangrenosum. Trials, record NCT06092216. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06092216
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Spesolimab in Pyoderma Gangrenosum
- NCT number
- NCT06092216
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 5 participants, actual
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Conditions
- Pyoderma Gangrenosum
- Interventions
- Spesolimab
- First posted
- 2023-10-23
- Last updated
- 2026-03-31
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Global Pyoderma Gangrenosum (GPG) Severity Score | Baseline and Week 16 | Change in GPG severity score at week 16 from baseline in target lesion 0\. Completely clear; evidence of cribriform scarring, re-epithelization and possible residual hyperpigmentation. 0% ulceration apparent, lesion is dry. 1. Almost clear; \<25% of active ulceration present; \> 90% granulation tissue present with mild pink, slightly elevated borders. Some evidence of re-epithelization. Minimal to no purulent drainage at presentation; 2. Mild; \<50% of active ulceration with perceptible border elevation with mild red border. Evidence of granulation tissue without any re-epithelization of skin. Few drops purulence appreciated upon examination. 3. Moderate; \<75% active ulceration with marked red, rolled borders and significant purulence. Some evidence of granulation tissue with multiple purulent drops and significant purulence on ulcer bed at presentation 4. Severe; 100% active ulcer with violaceous, raised rolled borders. Necrotic tissue may be present. |
| Secondary | Number of Lesions With Complete Re-epithelization of PG Lesions | Up to Week 28 | Number of lesions with Complete re-epithelization of PG lesions = GPG Score 0 GPG Score 0 - Completely clear; evidence of cribriform scarring, re-epithelization and possible residual hyperpigmentation. 0% ulceration apparent and lesion is dry |
| Secondary | Absolute Change in Patient-reported Pain Severity (Pain-VAS) Score | Baseline and at Week 28 | Absolute change at Week 28 from baseline in patient-reported pain severity (Pain-VAS). Patient Pain Visual Analogue Scale (VAS): Patients will be asked to report pain scores at each visit. Patients will report scores on a scale of 0 to 10. 0 signifies no pain and 10 signifies the worst pain imaginable. Higher scores indicate increased levels of pain. |
| Secondary | Absolute Change in Dermatology Life Quality Index (DLQI) | Baseline and at Week 28 | Absolute Change at week 28 from baseline in DLQI. The DLQI is a validated questionnaire consisting of 10 questions that has been used in many randomized controlled trials in dermatology. Scoring of each question is as follows: Very much - 3 A lot - 2 A little - 1 Not at all - 0 Not relevant - 0 Question unanswered - 0 The DLQI is calculated by summing the score of each question with total scale from 0-30. Higher score represents a quality of life that is more impaired. Definition of DLQI Scores 0-1 = no effect at all on patient's life 2-5 = small effect on patient's life 6-10 = moderate effect on patient's life 11-20 = very large effect on patient's life 21-30 = extremely large effect on patient's life A change in DLQI score of at least 4 points is considered clinically important. Such change suggests that there has actually been a meaningful change in that patient's quality of life since the previous measurement of his/her/their DLQI scores. |
| Secondary | Number of Recurrence of PG Lesions (GPG >0) After Achieving Complete Re-epithelialization (GPG Score 0) and Spesolimab Cessation | Last dose (Week 26 or 28) up to 16 week post-spesolimab last dose | GPG Severity Score Scale: 0\. Completely clear; evidence of cribriform scarring, re-epithelization and possible residual hyperpigmentation. 0% ulceration apparent, lesion is dry 1. Almost clear; \<25% of active ulceration present; \> 90% granulation tissue present with mild pink, slightly elevated borders. Some evidence of re-epithelization. Minimal to no purulent drainage at presentation 2. Mild; \<50% of active ulceration with perceptible border elevation with mild red border. Evidence of granulation tissue without any re-epithelization of skin. Few drops purulence appreciated upon exam. 3. Moderate; \<75% active ulceration with marked red, rolled borders and significant purulence. Some evidence of granulation tissue with multiple purulent drops and significant purulence on ulcer bed at presentation 4. Severe; 100% active ulcer with violaceous, raised rolled borders. Necrotic tissue may be present. No evidence of granulation tissue. Extensive purulent drops on ulcer bed |
| Secondary | Number of Lesions With Global Pyoderma Gangrenosum (GPG) Severity Score of 1 | Last dose (Week 26 or 28) up to 16 week post-spesolimab last dose | Lesions with GPG score of 1 Scale: 0\. Completely clear; evidence of cribriform scarring, re-epithelization and possible residual hyperpigmentation. 0% ulceration apparent and lesion is dry 1. Almost clear; \<25% of active ulceration present; more than 90% granulation tissue present with mild pink, slightly elevated borders. Some evidence of re-epithelization. Minimal to no purulent drainage at presentation 2. Mild; \<50% of active ulceration with perceptible border elevation with mild red border. Evidence of granulation tissue without any re-epithelization of skin. Few drops purulence appreciated upon examination. 3. Moderate; \<75% active ulceration with marked red, rolled borders and significant purulence. Some evidence of granulation tissue with multiple purulent drops and significant purulence on ulcer bed at presentation 4. Severe; 100% active ulcer with violaceous, raised rolled borders. Necrotic tissue may be present. No evidence of granulation tissue |
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/NCT06092216
GET https://conductscience.org/api/trials/v1/NCT06092216/registered