NCT06092216

Spesolimab in Pyoderma Gangrenosum

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Icahn School of Medicine at Mount Sinai · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed 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 14 or 15 visits which will include physical exams, blood testing and infectious disease testing, completing questionnaires, and photographs and assessment of skin affected by PG. Spesolimab will be administered via a 90-minute infusion every 3 or 4 weeks (depending on response at Visit 4) at 8 or 9 Visits during the study.

Conditions

• Pyoderma Gangrenosum

Interventions

Type	Name	Description
DRUG	Spesolimab	900 mg of spesolimab intravenously (IV) administered every 4 weeks at Visits 2, 3, 4, 5, 6, 7, 8, 9. If at visit 4 dosing schedule changes to every 3 weeks, Spesolimab will be administered at Visits 2, 3, 4, 5, 6, 8, 9, 10 and 11.

Timeline

• Start date: 2023-09-23
• Primary completion: 2025-01-14
• Completion: 2025-01-14
• First posted: 2023-10-23
• Last updated: 2026-03-31
• Results posted: 2026-03-31

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study