Clinical Trial: Spesolimab in Pyoderma Gangrenosum
Study Status: RECRUITING
Recruit Status: RECRUITING
Study Type: INTERVENTIONAL
Official Title: Characterizing Pyoderma Gangrenosum Lesion Regression and Remission by IL-36 Receptor Targeting With Spesolimab
Brief Summary: The purpose of this research study is to assess the feasibility of using spesolimab in participants with moderate to severe pyoderma ganrenosum.
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).
Detailed Summary:
To date, there is no gold standard for treatment of PG.
Patients with pyoderma gangrenosum suffer from severe pain and poor quality of life due to frequent dressing changes and disfiguring lesions.
More importantly, rapidly progressing ulcers present an important risk for infection, morbidity, and mortality for patients.
Spesolimab is humanized antagonistic monoclonal IgG1 antibody that blocks human IL36R signalling and subsequent downstream pro-inflammatory pathways.
The IL-36 receptor blocker was recently approved for generalized pustular psoriasis (GPP).
The research team hypothesize that targeting IL-36 in refractory, ulcerative postoperative PG may result in regression and resolution of a patient's lesions.
There are, at minimum, a total of 12 visits (1 screening visits, 6 spesolimab treatment visits, 1 endpoint visits, and 4 follow-up visits) which includes physical exams, blood testing and infectious disease testing, completing questionnaires, and photographs of skin affected by PG.
Spesolimab will be administered via a 90-minute infusion at Weeks 0, 3, 6, 9, 12 and 15.
Sponsor: Icahn School of Medicine at Mount Sinai
Current Primary Outcome:
Scale:
0. Completely clear; evidence of cribriform scarring, re-epithelization and possible residual hyperpigmentation.
0% ulceration apparent and lesion is dry.
- 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; - 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. - 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 - Severe; 100% active ulcer with violaceous, raised rolled borders.
Necrotic tissue may be present.
No evidence of granulation tissue.
Extensive purulent drops present on ulcer bed
Original Primary Outcome:
Scale:
0. Completely clear; evidence of cribriform scarring, re-epithelization and possible residual hyperpigmentation.
0% ulceration apparent and lesion is dry.
- 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; - 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. - 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 - Severe; 100% active ulcer with violaceous, raised rolled borders.
Necrotic tissue may be present.
No evidence of granulation tissue.
Extensive purulent drops present on ulcer bed
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Icahn School of Medicine at Mount Sinai
Dates:
Date Received: October 16, 2023
Date Started: September 26, 2023
Date Completion: September 26, 2023
Last Updated: November 10, 2023
Last Verified: November 01, 2023
