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

NCT06563323 | Recruiting Phase 2 FDA Drug

• 1 other identifier: Guselkumab for treatment of PG
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 2

Brief 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)

Conditions

Pyoderma Gangrenosum; Skin Diseases; Wound Heal; Pyoderma; Skin Ulcer

Keywords

Guselkumab; IL-23 Inhibitor

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• Physician Global Assessment (PGA)

  Week 32

• Decrease in ulcer area size long-term

  Week 32

• Decrease in ulcer area size short-term

  Week 16

• Mean decrease in ulcer area size short-term

  Week 16

• Mean decrease in ulcer area size long-term

  Week 32

Other Outcomes (1)

• Evaluation of cytokine gene expression

  Week 0 and Week 32

Study Arms (1)

Guselkumab for PG

EXPERIMENTAL

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.

Drug: Guselkumab

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.

Also known as: Tremfya

Guselkumab for PG

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willingness to comply with study procedures/requirements
• Capable of giving informed consent
• Diagnosis of at least one PG ulcer by clinical, histological and laboratory assessments with a minimum wound size of 4 cm2.
• Undergoing at least once a week standard of care wound care at home or at a wound care facility
• Are candidate for systemic therapy. Must be on a stable dose of prednisone of 20 mg/day for at least two weeks prior to first drug administration.
• Males ages 18-99 who agree to not father a child or donate sperm while on study and at least 12 weeks following last dose of the study drug. If subject is sexually active male and could cause pregnancy, subject much be sure that female partner(s) are using birth control that works well or not have sex.
• Females ages 18-99; either of non-childbearing potential or of childbearing potential who test negative for pregnancy and agree to use at least two reliable methods of birth control or remain abstinent during the study for at least 12 weeks following the last dose of guselkumab.
• Willingness to travel to study site for all study visits or living \>30 miles from study site and willing/able to participate in remote videoconferencing visits with access to a computer with internet and webcam capabilities.
• Be willing to undergo perilesional and non-lesional skin biopsy at week 0 and week 32 resulting in 4 biopsies during the course of the study. Participants can choose if they are willing to provide 2 additional biopsies at week 16. Refusal to give consent for any of the optional research samples does not exclude participant from participation in the study.

You may not qualify if:

• Has previously received at any time any therapeutic agent directly targeted to IL-23 including, but not limited to, guselkumab, risankizumab, tildrakuzumab, or mirikizumab
• Any drug treatment specifically for PG including but not limited to biologics (or biosimilar of), experimental antibodies, small molecules and oral immunosuppressives used within washout periods specified below, prior to first dose of study drug:
• weeks for ustekinumab, ixekizumab, secukinumab, brodalumab;
• weeks for infliximab;
• weeks for adalimumab;
• weeks for cyclosporine A, etanercept, inhibitors of the JAK/TYK pathway and PD4 inhibitors;
• weeks for Calcineurin inhibitor topicals (including but not limited to pimecrolimus and tacrolimus) and other advanced topicals (including but not limited to roflumilast and tapinarof).
• If not specified specifically, a time of 4 weeks or 5 half-lives of the drug (whichever is longer) prior to first drug administration.
• Intralesional corticosteroids within 4 weeks of screening.
• Active clinically infected ulcers. Individuals will be eligible for enrollment following completed treatment and resolution of infection. Antibiotics for wound superinfection are allowed.
• Immunomodulating medications for managing underlying comorbidities associated with PG, but not PG itself (e.g., for irritable bowel disease (IBD) or rheumatoid arthritis), are allowed as combination therapy except for Methotrexate (MTX) and Leflunomide which are allowed individually but not in combination.
• Concurrent skin disease that is deemed to interfere with assessment of ulcer.
• Have signs or symptoms suggestive of possible lymphoproliferative disease, including lymphadenopathy or splenomegaly or a history of lymphoproliferative disease within 5 years before screening; or currently has a known malignancy or has a history of malignancy within 5 years before screening, with the exception of a nonmelanoma skin cancer that has been adequately treated with no evidence of recurrence for at least 3 months before the first study drug administration or cervical carcinoma in situ that has been treated with no evidence of recurrence for at least 3 months before the first study drug administration.
• Recent (within past 6 months) cerebrovascular accident, myocardial infarction, coronary stenting. Uncontrolled hypertension - confirmed systolic blood pressure \>160 mmHg or diastolic blood pressure \>100 mm Hg.
• Clinically significant (per investigator's judgement) drug or alcohol abuse within the last 6 months preceding the Baseline Visit.

Sponsors & Collaborators

• Oregon Health and Science University: lead
• Janssen Scientific Affairs, LLC: collaborator
• Ohio State University: collaborator

Study Sites (2)

Ohio State Dermatology

Columbus, Ohio, 43215, United States

RECRUITING

Oregon Health and Science University

Portland, Oregon, 97239, United States

NOT YET RECRUITING

Related Publications (10)

• Ormerod AD, Thomas KS, Craig FE, Mitchell E, Greenlaw N, Norrie J, Mason JM, Walton S, Johnston GA, Williams HC; UK Dermatology Clinical Trials Network's STOP GAP Team. Comparison of the two most commonly used treatments for pyoderma gangrenosum: results of the STOP GAP randomised controlled trial. BMJ. 2015 Jun 12;350:h2958. doi: 10.1136/bmj.h2958.

  PMID: 26071094 BACKGROUND

• Guillo L, D'Amico F, Danese S, Peyrin-Biroulet L. Ustekinumab for Extra-intestinal Manifestations of Inflammatory Bowel Disease: A Systematic Literature Review. J Crohns Colitis. 2021 Jul 5;15(7):1236-1243. doi: 10.1093/ecco-jcc/jjaa260.

  PMID: 33367674 BACKGROUND

• Baier C, Barak O. Guselkumab as a treatment option for recalcitrant pyoderma gangrenosum. JAAD Case Rep. 2020 Dec 14;8:43-46. doi: 10.1016/j.jdcr.2020.12.005. eCollection 2021 Feb. No abstract available.

  PMID: 33490346 BACKGROUND

• Burgdorf B, Schlott S, Ivanov IH, Dissemond J. Successful treatment of a refractory pyoderma gangrenosum with risankizumab. Int Wound J. 2020 Aug;17(4):1086-1088. doi: 10.1111/iwj.13359. Epub 2020 Apr 7. No abstract available.

  PMID: 32266771 BACKGROUND

• Reese AM, Erickson K, Reed KB, Ortega-Loayza AG. Modified dose of guselkumab for treatment of pyoderma gangrenosum. JAAD Case Rep. 2022 Jan 6;21:38-42. doi: 10.1016/j.jdcr.2021.11.030. eCollection 2022 Mar. No abstract available.

  PMID: 35146098 BACKGROUND

• Guenova E, Teske A, Fehrenbacher B, Hoerber S, Adamczyk A, Schaller M, Hoetzenecker W, Biedermann T. Interleukin 23 expression in pyoderma gangrenosum and targeted therapy with ustekinumab. Arch Dermatol. 2011 Oct;147(10):1203-5. doi: 10.1001/archdermatol.2011.168. Epub 2011 Jun 16.

  PMID: 21680759 BACKGROUND

• Langrish CL, Chen Y, Blumenschein WM, Mattson J, Basham B, Sedgwick JD, McClanahan T, Kastelein RA, Cua DJ. IL-23 drives a pathogenic T cell population that induces autoimmune inflammation. J Exp Med. 2005 Jan 17;201(2):233-40. doi: 10.1084/jem.20041257.

  PMID: 15657292 BACKGROUND

• Ortega-Loayza AG, Nugent WH, Lucero OM, Washington SL, Nunley JR, Walsh SW. Dysregulation of inflammatory gene expression in lesional and nonlesional skin of patients with pyoderma gangrenosum. Br J Dermatol. 2018 Jan;178(1):e35-e36. doi: 10.1111/bjd.15837. Epub 2017 Dec 5. No abstract available.

  PMID: 28734003 BACKGROUND

• Abdo AIK, Tye GJ. Interleukin 23 and autoimmune diseases: current and possible future therapies. Inflamm Res. 2020 May;69(5):463-480. doi: 10.1007/s00011-020-01339-9. Epub 2020 Mar 25.

  PMID: 32215665 BACKGROUND

• Cepeda MS, Africano JM, Polo R, Alcala R, Carr DB. What decline in pain intensity is meaningful to patients with acute pain? Pain. 2003 Sep;105(1-2):151-7. doi: 10.1016/s0304-3959(03)00176-3.

  PMID: 14499431 BACKGROUND

Related Links

• A Study of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease
• A Study of Guselkumab Subcutaneous Therapy in Participants With Moderately to Severely Active Crohn's Disease
• A Study of the Efficacy and Safety of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease
• Guselkumab in the Treatment of Pityriasis Rubra Pilaris

MeSH Terms

Conditions

Pyoderma Gangrenosum; Skin Diseases; Pyoderma; Skin Ulcer

Interventions

guselkumab

Condition Hierarchy (Ancestors)

Skin and Connective Tissue Diseases; Skin Diseases, Vascular

Study Officials

• Alex G Ortega-Loayza, MD, MCR

  Oregon Health and Science University, Department of Dermatology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alex G Ortega-Loayza, MD, MCR

CONTACT

503-418-3376; ortegalo@ohsu.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: August 7, 2024
• First Posted: August 20, 2024
• Study Start: February 1, 2025
• Primary Completion (Estimated): August 13, 2027
• Study Completion (Estimated): August 13, 2027
• Last Updated: March 6, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)