NCT06563323

Guselkumab in the Treatment of Adults With Pyoderma Gangrenosum (PG)

A Single-arm Open-label Study Assessing Short-term (Week 6, 16) and Long-term (Week 32) Efficacy of Guselkumab in Adult Participants With Pyoderma Gangrenosum

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 17 (estimated)
• Sponsor: Oregon Health and Science University · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

A single-arm open-label study assessing short-term (week 6, 16) and long-term (week 32) efficacy of guselkumab in adult participants with pyoderma gangrenosum (PG)

Detailed description

This is a Phase II study that will be open label and include a total of 17 patients who will receive the investigational product. PG will be defined by the investigator on the basis of results from clinical, histological and laboratory assessments. These patients will undergo 28 weeks of guselkumab dosed every 4 weeks and a stable dose of prednisone dosed daily with follow-up until week 40.

Conditions

• Pyoderma Gangrenosum
• Skin Diseases
• Wound Heal
• Pyoderma
• Skin Ulcer

Interventions

Type	Name	Description
DRUG	Guselkumab	Subjects with PG will be treated with 100 mg in a pre-filled syringe to be injected subcutaneously every 4 weeks for 28 weeks.

Timeline

• Start date: 2025-02-01
• Primary completion: 2027-08-13
• Completion: 2027-08-13
• First posted: 2024-08-20
• Last updated: 2026-03-06

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study