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

Oregon Health and Science University2 个研究点分布在 1 个国家目标入组 17 人2025年2月1日

适应症Pyoderma Gangrenosum Skin Diseases Wound Heal Pyoderma Skin Ulcer

干预措施Guselkumab

概览

阶段: 2 期
干预措施: Guselkumab
疾病 / 适应症: Pyoderma Gangrenosum
发起方: Oregon Health and Science University
入组人数: 17
试验地点: 2
主要终点: Healing
状态: 招募中
最后更新: 上个月

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验

概览

简要总结

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)

详细描述

This is a Phase II study that will be open label and include a total of 17 patients who will receive the investigational product. PG will be defined by the investigator on the basis of results from clinical, histological and laboratory assessments. These patients will undergo 28 weeks of guselkumab dosed every 4 weeks and a stable dose of prednisone dosed daily with follow-up until week 40.

注册库

clinicaltrials.gov

开始日期

2025年2月1日

结束日期

2027年8月13日

最后更新

上个月

研究类型

Interventional

研究设计

Single Group

性别

All

研究者

发起方

Oregon Health and Science University

责任方

Principal Investigator

主要研究者

Alex Ortega Loayza

Doctor

Oregon Health and Science University

入排标准

入选标准

•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 cm
•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
•Refusal to give consent for any of the optional research samples does not exclude participant from participation in the study.

排除标准

•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:
•12 weeks for ustekinumab, ixekizumab, secukinumab, brodalumab;
•8 weeks for infliximab;
•6 weeks for adalimumab;
•4 weeks for cyclosporine A, etanercept, inhibitors of the JAK/TYK pathway and PD4 inhibitors;
•2 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.

研究组 & 干预措施

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.

干预措施: Guselkumab

结局指标

主要结局

Healing

时间窗: Week 32

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.