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

Part of paid clinical trials in Columbus, Ohio.

Sponsor
Oregon Health and Science University
Study ID
NCT06563323
Phase
PHASE2
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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)

Key Dates

Start date
Feb 1, 2025
Status verified
Mar 2026
Primary completion
Aug 13, 2027
Completion
Aug 13, 2027

Study Design

Enrollment
17 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Guselkumab for PG
    Subjects with PG will be treated with 100 mg every 4 weeks of guselkumab for 28 weeks in addition to starting stable dose (at least 2 weeks) of prednisone at 20 mg daily. Prednisone will be tapered based on a pre-established algorithm assessed by investigator.

Primary Outcome Measure

Healing [ Time Frame: Week 32 ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Ohio State DermatologyColumbusOhio43215
Alison Rocchi Clinical Research Coordinator
[email protected]
614-658-0251
Benjamin Kaffenberger, MD (PRINCIPAL_INVESTIGATOR)
Oregon Health and Science UniversityPortlandOregon97239
Alex Ortega, MD, MCR
[email protected]
503-418-3376
Mekaila Hudson, BS
[email protected]
503-418-9386

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By research site
Ohio State Dermatology· Columbus, OHOregon Health and Science University· Portland, OR

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