Trial intelligence / Profile preview

Guselkumab in Pyoderma Gangrenosum

NCT06563323Phase 2

Key facts

Status: Active, not recruiting
Start: Feb 2025
Primary completion: Aug 2027
Countries: 1
Sponsor: Oregon Health & Science University
Modality: Monoclonal Antibodies

Drugs: guselkumab
Conditions: pyoderma gangrenosum (PG)

Overview

Phase 2, open-label, single-arm trial of guselkumab in pyoderma gangrenosum (PG), sponsored by Oregon Health & Science University. Primary endpoint: Healing at Week 32. Started Feb 2025; status: active, not recruiting.

Design

1 arm

Study design: Non-randomizedOpen-labelSingle group

Guselkumab for PG
Subjects with PG treated with 100 mg every 4 weeks of guselkumab for 28 weeks in addition to prednisone.

Who it enrols

Adults with pyoderma gangrenosum on a stable dose of prednisone, without active infections, recent malignancies, or prior IL-23 targeted therapy.

Endpoints

Primary

HealingWeek 32

Secondary

Physician Global AssessmentWeek 32
Decrease in ulcer area sizeWeek 32
Skindex MiniWeek 32
Skin pain scale improvementWeek 0 to 32
Change in physical functionWeek 0 to 32
Mean change in global assessment scoreWeek 0 to 32
Target ulcer remains healedWeek 40
Time to recurrenceWeek 40

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