Trial Outcomes & Findings for Spesolimab in Pyoderma Gangrenosum (NCT NCT06092216)

Spesolimab in Pyoderma Gangrenosum

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.

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

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.

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.

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

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