NCT05966480进行中（未招募）2 期
A Phase 2, Multicenter, Multinational, Randomized, Double-blind, Placebo-Controlled Study to Assess the Safety, Efficacy, and Pharmacokinetics of Multiple Dose Levels of ESK-001 in Adult Patients With Systemic Lupus Erythematosus
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- Alumis Inc
- 入组人数
- 408
- 试验地点
- 338
- 主要终点
- To compare the effect on disease activity measured by the proportion of patients achieving British Isles Lupus Assessment Group (BILAG)-based Composite Lupus Assessment (BICLA) response at Week 48 between doses of ESK-001 and placebo
研究概览
简要总结
The purpose of this study is to assess the clinical efficacy, safety, PK, and PD of multiple dose levels of ESK-001 compared with placebo in adult patients with SLE.
详细描述
This study will consist of a 5 week screening period, 48 week treatment period, and a 4 week follow up period for a total of 57 weeks. Each participant will be randomized to receive ESK-001 or placebo for 48 weeks. An open label extension study will be available for those patients who complete the study.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with 6 or more months of SLE according to the 2019 EULAR/ACR criteria, have positive autoantibodies or low complement at screening, and have active SLE as measured by SLEDAI-2K of 6 or more, or 4 or more if joint involvement is present.
- •Patients need to be on treatment which can be:
- •A stable dose of oral corticosteroid (≤40 mg/day prednisone or equivalent) for a minimum of 2 weeks prior to signing of the informed consent form (ICF) at the Screening Visit. The dose of oral corticosteroid the patient is taking should not increase between screening and Week 0 (Day 1).
- •And/or antimalarial treatment (e.g., hydroxychloroquine, chloroquine, quinacrine),
- •And/or no more than 1 of the following conventional DMARDS:
- •Azathioprine ≤200 mg/day
- •Mycophenolate mofetil ≤2 g/day or mycophenolic acid ≤1.44 g/day
- •Oral, subcutaneous, or intramuscular (IM) methotrexate ≤20 mg/week.
排除标准
- •Drug-induced SLE or other autoimmune diseases that, in the opinion of the Investigator, are likely to confound efficacy assessments
- •Active, proliferative lupus nephritis that in the Investigator's opinion may require treatment not allowed by the protocol
- •Current disease other than SLE that, in the opinion of the Investigator, is likely to interfere with SLE disease activity assessments. Examples include severe fibromyalgia, severe osteoarthritis and severe cardiorespiratory diseases.
- •Active severe or unstable neuropsychiatric SLE including, but not limited to the following: aseptic meningitis; cerebral vasculitis; myelopathy; demyelination syndromes (ascending or transverse myelitis, acute inflammatory demyelinating polyradiculopathy); acute confusional state; impaired level of consciousness; psychosis; acute stroke or stroke syndrome; cranial neuropathy; new seizures; cerebellar ataxia; and mononeuritis multiplex.
- •That would make the patient unable to fully understand the ICF, or
- •Where, in the opinion of the Principal Investigator, protocol-specified SOC is insufficient and utilization of a more aggressive therapeutic approach not permitted in the protocol, is indicated
- •Known history of a primary immunodeficiency or an underlying condition such as HIV infection or splenectomy that predisposes the patient to infection
- •Currently active, clinically significant infection of any kind
- •Clinically significant chronic infection (eg, osteomyelitis, bronchiectasis) within 8 weeks prior to signing the ICF (chronic fungal nail infections are allowed)
- •Any infection requiring hospitalization or treatment with IV anti-infectives not completed at least 4 weeks prior to signing the ICF
- •Any infection requiring oral anti-infectives (including antivirals) within 2 weeks prior to Day 1
- •Any severe herpes infection at any time prior to Week 0 (Day 1), including, but not limited to, disseminated herpes (ever), herpes encephalitis (ever), recurrent herpes zoster (defined as 2 episodes within 2 years), or ophthalmic herpes (ever)
- •Active herpes zoster infection within 12 weeks of prior to signing the ICF
- •Active herpes simplex virus within 4 weeks of Day 1
- •Other protocol-defined inclusion/exclusion criteria apply
研究组 & 干预措施
Placebo
Placebo Comparator
Placebo administered as an oral tablet
干预措施: Placebo (Drug)
结局指标
主要结局
To compare the effect on disease activity measured by the proportion of patients achieving British Isles Lupus Assessment Group (BILAG)-based Composite Lupus Assessment (BICLA) response at Week 48 between doses of ESK-001 and placebo
时间窗: Week 48
次要结局
- To compare the effect on disease activity measured by the proportion of patients achieving BICLA responses at Week 48 between doses of ESK-001 and placebo by stratification groups(Week 48)
- To use the SF-36 (Short Form-36 item QoL measure) to compare the effect on health-related quality of life (HRQOL) between doses of ESK-001 and placebo(Week 48)
- To compare corticosteroid use in patients at Week 48(Week 48)
- To compare the Lupus Low Disease Activity State (LLDAS) response between doses of ESK-001 and placebo at Week 48(Week 48)
- To use the SLE-specific Lupus Quality of Life (LQoL) questionnaire to compare the effect on health-related quality of life (HRQOL) between doses of ESK-001 and placebo(Week 48)
- To assess the safety and tolerability of multiple dose levels of ESK-001(Week 48)
- To compare the effect on disease activity measured by the proportion of patients achieving an SLE Responder Index of ≥4 (SRI[4]) response at Week 48(Week 48)
- To compare the effect on cutaneous disease activity measured by the proportion of patients with a CLASI activity score of ≥8 at baseline achieving ≥ 50% reduction in the CLASI activity score at Week 48 between doses of ESK-001 and placebo(Week 48)
- To compare the annualized flare rate through Week 48(Week 48)
- To compare Fatigue measured by FACIT-F between doses of ESK-001 and placebo(Week 48)
- To compare patient global assessment of disease activity (PtGA) between doses of ESK-001 and placebo(Week 48)
- To compare disease-specific QoL between doses of ESK-001 and placebo(Week 48)
研究者
研究点 (338)
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