NCT06588738已完成3 期
A Multicenter, Randomized, Double-Blind, Placebo and Active Comparator Controlled Phase 3 Study in Patients With Moderate to Severe Plaque Psoriasis to Evaluate the Efficacy and Safety of ESK-001 (ONWARD2)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Alumis Inc
- 入组人数
- 862
- 试验地点
- 221
- 主要终点
- To determine whether ESK-001 reduces the severity of psoriasis by 75% (using the PASI) or by at least 2 points (using sPGA score) compared to placebo
研究概览
简要总结
The goal of this clinical trial is to learn if ESK-001 works to treat moderate to severe plaque psoriasis. The main questions it aims to answer are:
- Does ESK-001 reduce the severity of people's psoriasis?
- How safe is ESK-001 in people with moderate to severe plaque psoriasis?
The study includes 2 comparators: a placebo control (a 'dummy' tablet that does not contain the medicine ESK-001 but looks just like it) and an active control (apremilast, which is a medicine approved to treat psoriasis).
People taking part in this study must be men or women aged at least 18 years and have had plaque psoriasis for at least 6 months, currently moderate to severe.
Participants will:
- take drug every day for 24 weeks.
- visit the clinic for checkups and tests.
- fill out questionnaires about their psoriasis, itch severity, and change in quality of life.
- be assessed for health issues and side effects, physical examinations, vital signs, heart electrical activity measurements, and psychological health.
- provide blood and urine samples.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females, age ≥18 years
- •Diagnosis of plaque psoriasis for ≥6 months
- •Plaques covering ≥10% of BSA
- •Women of childbearing potential (WOCBP) and males who are sexually active with WOCBP must agree to adhere to highly effective methods of contraception
排除标准
- •Nonplaque psoriasis or other inflammatory skin conditions
- •Immune-mediated conditions commonly associated with psoriasis (eg inflammatory bowel disease). Patients with psoriatic arthritis may participate
- •Pregnant, lactating, or planning to get pregnant during the study
- •Use of drugs prior to Study Day 1 that treat or may affect psoriasis:
- •Topical within 2 weeks
- •Phototherapy or any systemic treatments within 4 weeks
- •Any biologic agent targeted to IL-12 or IL-23 within 6 months, oral IL-12 or IL-23 or TNFα inhibitor within 2 months, or IL-17 within 4 months
- •Systemic immunosuppressants or immunomodulatory drugs within 4 weeks
- •Modulators of B cells within 6 months, or T cells within 3 months
- •JAK inhibitors or TYK2 inhibitors within 4 weeks
- •PDE4 inhibitor within 2 months
- •Any investigational agent, within 30 days or 5 half-lives or is currently enrolled in an investigational study
- •Lack of clinical response to a TYK2, IL-12, or IL-23 targeted psoriasis treatment
- •Patients with QTcF >450 msec (males) or >470 msec (females) at Screening
- •Unstable cardiovascular disease, defined as a recent clinical deterioration or a cardiac hospitalization within the last 3 months
- •Evidence of recent or recurrent herpes zoster or herpes simplex viral infection
- •Evidence of active infection or positive test result for hepatitis B, hepatitis C, HIV or TB
- •History of serious bacterial, fungal, or viral infections that led to hospitalization, or any recent serious infection requiring antibiotic treatment
- •Any history of known or suspected congenital or acquired immunodeficiency state or condition that would compromise the patient's immune status
- •Lab abnormalities indicating significant renal, hepatic or bone marrow dysfunction
- •History of any immune-mediated or inflammatory medical condition for which patient requires current systemic corticosteroids
研究组 & 干预措施
Placebo
Placebo Comparator
Matching oral placebo
干预措施: Placebo (Drug)
ESK-001
Experimental
ESK-001 administered as an oral tablet
干预措施: Envudeucitinib (Drug)
Apremilast
Active Comparator
Apremilast administered as an oral capsule
干预措施: Apremilast (Drug)
结局指标
主要结局
To determine whether ESK-001 reduces the severity of psoriasis by 75% (using the PASI) or by at least 2 points (using sPGA score) compared to placebo
时间窗: 16 weeks
Proportion of patients achieving ≥75% reduction in PASI score. Proportion of patients achieving a score of 0 or 1 on sPGA.
次要结局
- To compare the Psoriasis Symptoms and Signs Diary (PSSD) between ESK-001 and placebo or apremilast(24 weeks)
- To compare the Psoriasis Area and Severity Index (PASI-90 and PASI-100) between ESK-001 and placebo or apremilast(24 weeks)
- To compare the Psoriasis Area and Severity Index (PASI-75) between ESK-001 and apremilast(24 weeks)
- To compare the Static Physician's Global Assessment (sPGA-0/1) between ESK-001 and apremilast(24 weeks)
- To compare the affected body surface area (%BSA) between ESK-001 and placebo or apremilast(24 weeks)
- To compare the scalp specific Physician's Global Assessment (ssPGA) between ESK-001 and placebo or apremilast(24 weeks)
- To compare the Dermatology Life Quality Index (DLQI) between ESK-001 and placebo or apremilast(24 weeks)
- To compare the Pruritus numeric rating scale (NRS) between ESK-001 and placebo(24 weeks)
- Proportion of patients with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)(24 weeks)
- To characterize the pharmacokinetics of ESK-001(24 weeks)
研究者
研究点 (221)
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