2023-507193-40-00招募中3 期
A Multicenter, Randomized, Double-Blind, Placebo and Active Comparator Controlled Phase 3 Study to Evaluate the Efficacy and Safety of ESK-001 in Patients with Moderate to Severe Plaque Psoriasis (ONWARD1)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- Alumis Inc.
- 入组人数
- 389
- 试验地点
- 64
- 主要终点
- The proportion of patients who achieve co-primary endpoint (PASI-75 & sPGA-0/1) at Week 16 compared with Placebo
研究概览
简要总结
To determine whether efficacy of ESK-001 is superior to placebo at Week 16
研究设计
- 分配方式
- Randomized
- 主要目的
- Maintenance Period
- 盲法
- Double (Subject, Monitor, Analyst, Carer, Investigator)
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 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 prior to the Screening Visit
- •Plaques covering ≥10% of BSA at Screening and Day 1
- •PASI ≥12 at Screening and Day 1
- •sPGA ≥3 at Screening and Day 1
- •Women of childbearing potential (WOCBP) and males who are sexually active with WOCBP must agree to adhere to highly effective methods of contraception for the entirety of the study
排除标准
- •Nonplaque psoriasis or other inflammatory skin conditions
- •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 * Stable doses of inhaled corticosteroids for treatment of asthma are allowed
- •Known current malignancy or current evaluation for a potential malignancy or history of malignancy within the past 5 years prior to screening, except for adequately treated basal cell or squamous cell skin carcinoma or carcinoma in situ of the cervix
- •Live vaccines within 4 weeks prior to Study Day 1
- •Patient has planned surgery during the study period * Minor surgical procedures may be allowed
- •Any acute or chronic illness/condition or evidence of an unstable clinical condition that, in the opinion of the Investigator, will substantially increase the risk to the patient if he or she participates in the study
- •History of mental illness within the last 5 years, unless receiving a fixed regimen of psychiatric medications for at least 6 months before screening or has not required or been prescribed any psychiatric medication within 12 months before screening
- •Evidence of severe depressive symptoms or active suicidal ideation or behavior based on screening questionaires
- •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 (eg, deucravacitinib), IL-12, or IL-23 (eg, ustekinumab, risankizumab) 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 * Patients requiring medications to treat underlying stable chronic cardiovascular disease should be on a stable dose for at least 4 weeks before Study Day 1
- •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
结局指标
主要结局
The proportion of patients who achieve co-primary endpoint (PASI-75 & sPGA-0/1) at Week 16 compared with Placebo
The proportion of patients who achieve co-primary endpoint (PASI-75 & sPGA-0/1) at Week 16 compared with Placebo
次要结局
- Week 16 Endpoints: *The proportion of patients who achieve PASI-90, PASI-100, sPGA-0 PASI-75 and sPGA-0/1 compared to apremilast ss-PGA-0/1 PROs: PSSD-0 and DLQI-0/1 *Change from baseline in %BSA Pruritis NRS score
- Week 24 Endpoints compared to apremilast: *The proportion of patients who achieve PASI-75, PASI-90, PASI-100 sPGA-0/1, sPGA-0 ss-PGA-0/1 PROs: PSSD-0 and DLQI-0/1 *Change from baseline %BSA Pruritis NRS score
研究者
Clinical Trial Information Desk
Scientific
Alumis Inc.
研究点 (64)
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