EADV 2025｜EVERLAST-A：ORKA-001治疗斑块状银屑病的 2a 期研究设计

我是 Andrew Blauvelt 博士，一名来自美国马里兰州安那波利斯市的皮肤科医生。我在学术界工作了 19 年，随后从事临床试验 13 年，现在我担任多家制药公司的顾问。今年我在欧洲皮肤病与性传播病大会（EADV）上做了一场报告，名为 “EVERLAST 研究及研究设计说明”。EVERLAST-A 是一项 2a 期试验，使用一种新型白细胞介素 - 23 抑制剂，称为 ORKA-001。在这场报告中，我讲述了 ORKA-001 的背景。它的设计类似于利生奇珠单抗，但经工程化设计，其拥有一个长的半衰期。因此 ORKA-001 的半衰期远长于利生奇珠单抗，长达 100 天。接下来我介绍了这款药物的背景，并探讨 Oruka 公司的策略为何是采用高于常规的剂量。我们称之为 EVERLAST-A 研究中 ORKA-001 的强效剂量。我会解释这种剂量方案背后的理由以及这项临床试验设计的新颖性。目前我们还没有 EVERLAST-A 研究的结果。所以，这次报告主要是向大家介绍这款药物的背景及其独特临床设计的原因。 

My name is Dr. Andrew Blauvelt. I'm a dermatologist from Annapolis, Maryland. I've spent 19 years in academics and then 13 years doing clinical trials, and I serve as a consultant now for a number of pharmaceutical companies. I'm giving two talks at the EADV this year. One is called The EVERLAST study and the description of study design. So, EVERLAST-A is a phase 2a study with a novel interleukin-23 inhibitor called ORKA-001. And in this talk that I will be giving, I'll be describing the background of ORKA-001. It was designed to be similar to Risankizumab, but it has been engineered to have a long half-life. So the half-life for ORKA-001 is much longer than Risankizumab, up to 100 days. And so I'll be describing the background of that drug, and then going into the strategy of why the company Oruka is going to do higher than normal doses. We call it knockout doses of ORKA-001 in the EVERLAST-A study. So I'll explain the reasoning behind the dosing and the novelty of this clinical trial design. So we don't have results yet from this EVERLAST-A study. So, the presentation is only giving you the background on the drug and the reasons behind the novel clinical design.