18 and older, any sex, with Pyoderma Gangrenosum. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change in Global Pyoderma Gangrenosum (GPG) Severity ScorePrimary· 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 ski
Group
Value
95% CI
Spesolimab
-3
± 2
Number of Lesions With Complete Re-epithelization of PG LesionsSecondary· 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
Group
Value
95% CI
Spesolimab
3
Absolute Change in Patient-reported Pain Severity (Pain-VAS) ScoreSecondary· 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.
Group
Value
95% CI
Spesolimab
-5.33
± 4.62
Absolute Change in Dermatology Life Quality Index (DLQI)Secondary· 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 e
Group
Value
95% CI
Spesolimab
-7
± 4.62
Number of Recurrence of PG Lesions (GPG >0) After Achieving Complete Re-epithelialization (GPG Score 0) and Spesolimab CessationSecondary· 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
Group
Value
95% CI
Spesolimab
2
Number of Lesions With Global Pyoderma Gangrenosum (GPG) Severity Score of 1Secondary· 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 appr
Group
Value
95% CI
Spesolimab
2
Adverse events — posted to ClinicalTrials.gov
Time frame: Last dose (Week 26 or 28), up to 1 weeks post-spesolimab last dose.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The purpose of this research study is to assess the feasibility of using spesolimab in participants with moderate to severe pyoderma gangrenosum. Pyoderma gangrenosum is a rare, inflammatory, autoimmune condition which results in ulceration of skin. The study will also investigate the body's immune response to the spesolimab (when the body detects and defends itself against substances that appear unknown and harmful).
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
NCT06624670 — A Study to Test Whether Spesolimab Helps People With a Skin Condition Called Pyoderma Gangrenosum
· Phase 3
· recruiting
NCT06520514 — A Study to Test How Well Healthy People Tolerate Spesolimab When Given in 2 Different Ways
· Phase 1
· completed
NCT06241573 — A Study to Test Long-term Treatment With Spesolimab in People With a Skin Condition Disease Called Hidradenitis Suppurat
· Phase 2, PHASE3
· terminated
NCT06013969 — A Study to Test Whether Spesolimab Helps People With Generalized Pustular Psoriasis (GPP) Who Need Treatment for Repeate
· Phase 4
· active not recruiting
NCT05670821 — PMS of Spesolimab I.V. in GPP Patients With Acute Symptoms
· completed
Other recruiting trials for Pyoderma Gangrenosum
Currently open trials in the same condition.
NCT06624670 — A Study to Test Whether Spesolimab Helps People With a Skin Condition Called Pyoderma Gangrenosum
· Phase 3
· recruiting
NCT06563323 — Guselkumab in the Treatment of Adults With Pyoderma Gangrenosum (PG)
· Phase 2
· recruiting
Other Icahn School of Medicine at Mount Sinai trials
Trials by the same sponsor.
NCT07094308 — The LIFT-ECHO Last Mile Project
· NA
· not yet recruiting
NCT07291427 — Chronic Subdural Hematoma Embolization With Detachable Coils
· not yet recruiting
NCT07194187 — High Intensity Focused Ultrasound (HIFU) Ablation for Treatment of Prostate Tissue in Bladder Outlet Obstruction
· NA
· not yet recruiting
NCT07260916 — Minimally Invasive Neuroendoscopic Ultra-Early Targeted ICH Evacuation
· NA
· not yet recruiting
NCT07487948 — Safety and Biomarker Responses of Delgocitinib (JAK1,2,3/TYK2 Inhibitor) in Central Centrifugal Cicatricial Alopecia and
· Phase 2
· not yet recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Icahn School of Medicine at Mount Sinai
Last refreshed: 31 March 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06092216.