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

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)

Timeline

Start

2025-02-01

Primary completion

2027-08-13

Completion

2027-08-13

Publications

• Background 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Drugs

Indications