Guselkumab in the Treatment of Adults With Pyoderma Gangrenosum (PG)
NCT Number: NCT06563323
Acronym: GEORGE
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Pyoderma Gangrenosum|Skin Diseases|Wound Heal|Pyoderma|Skin Ulcer
Interventions: DRUG: Guselkumab
Sponsor: Oregon Health and Science University
Collaborators: Janssen Scientific Affairs, LLC|Ohio State University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 17
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2025-01-01
Completion Date: 2027-08-13
Locations: Oregon Health and Science University, Portland, Oregon, 97239, United States

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)

Primary Outcome Measures: Healing, Defined as the proportion of patients with complete re-epithelization, defined as a100% re-epithelialization without any drainage of the target ulcer at week 32., Week 32
Secondary Outcome Measures: Physician Global Assessment (PGA), Assessing the proportion of patients that show target ulcer healing in response to study treatment as measured by achieving PGA between 0 and 1 after treatment with guselkumab at week 32. This scale has been used in previous trials:

0 = total resolution of target ulcer with no signs of active PG

1= almost completely healed target ulcer with only minimal signs of active PG 2 = evidence of target ulcer healing which involves at least 50% of ulcer/ulcer margin 3 = evidence of target ulcer healing which involves less than 50% of ulcer/margin 4 = no evidence of target healing ulcer, Week 32|Decrease in ulcer area size long-term, The proportion of patients with decrease in ulcer area size of at least 50% after treatment at week 32, Week 32|Decrease in ulcer area size short-term, The proportion of patients with decrease in ulcer area size of at least 50% after treatment at Week 16, Week 16|Mean decrease in ulcer area size short-term, Mean decrease in ulcer area size from Week 0 to Week 16, Week 16|Mean decrease in ulcer area size long-term, Mean decrease in ulcer area size from Week 0 to Week 32, Week 32|Skindex Mini, The Skindex Mini is a 3-item questionnaire, assessing symptom, emotion, and function related to skin disease. We will measure the mean change in Skindex Mini score from Week 0 to Week-32 will be reported with two-sided 95% confidence interval. Change in Skindex Mini score will be analyzed using a paired t-test with 0.05 significance level. Generalized estimating equation (GEE) methods will be further used to characterize changes in Skindex Mini score (max = 5, min = 0) over time. Higher scores indicated worsened quality of life due to skin disease., Week 32|Skin pain scale improvement over 7 days, The proportion of participants achieving a minimum of a 2 point decrease in the NRS at Week 0 and Week 32 The pain NRS is a subject-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing "no pain" and 10 representing "worst pain imaginable" in the last 7 days., Week 0 to 32|Skin pain scale improvement over 24 hours, The proportion of participants achieving an improvement in reported peak pain Numeric Rating Scale (NRS) assessment at Week 0 and Week 32. The peak pain NRS assessment is a subject-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing "no pain" and 10 representing "worst pain imaginable" in the last 24 hours, Week 0 to 32|Change in physical function, The mean change in participant physical function from Week 0 to Week 32. Physical function is a subject-administered 5 category scale that assesses the impact of PG on participant physical function from "with no difficulty" to "can't do because of ulcer"., Week 0 to 32|Mean change in global assessment score, The mean change in participant global assessment from Week 0 to Week 32. The participant global assessment is a subject administered 5 category scale (ranging from "clear" to "severe" that measures participant perspective of the status of their skin disease., Week 0 to 32|Target ulcer remains healed, The proportion of participants with target ulcer that remains healed by Week 40, Week 40|Time to recurrence, Time to recurrence defined as the duration of time from documented target lesion healing and further episodes of PG at any site., Week 40|Treatment failure, The number of participants experiencing treatment failure., Week 32
Other Outcome Measures: Evaluation of cytokine gene expression, Cytokine gene expression before and after treatment in skin, wound fluid, saliva and blood samples measured by enzyme-linked immunosorbent assay (ELISA), Week 0 and Week 32