Spesolimab in Pyoderma Gangrenosum

Pyoderma Gangrenosum Clinical Trial

Official title: Characterizing Pyoderma Gangrenosum Lesion Regression and Remission by IL-36 Receptor Targeting With Spesolimab

Status Recruiting

Clinical Trial 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).

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Pyoderma
• Pyoderma Gangrenosum

• NCT number: NCT06092216
• Study type: Interventional
• Source: Icahn School of Medicine at Mount Sinai
• Contact: Saakshi Khattri, MD
• Phone: 212-241-3288
• Email: saakshi.khattri@mountsinai.org
• Status: Recruiting
• Phase: Phase 2
• Start date: September 26, 2023
• Completion date: September 2025