CTIS2022-502105-15-00招募中1 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 - ESK-001-010
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- Alumis Inc.
- 入组人数
- 390
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •Able and willing to provide written informed consent (signed and dated) to participate in this study and comply with all requirements in the study protocol, Males or females, age 18 to 70 years, inclusive, at the time of informed consent, Body mass index 18 to 40 kg/m2 and total body weight >40 kg (88 lbs), Adequate peripheral venous access, Diagnosed with SLE =6 months prior to screening, fulfills the 2019 European League Against Rheumatism (EULAR)/ACR criteria at the time of screening, Clinical SLEDAI-2K score =4 points with skin involvement prior to first administration of study drug, Currently receives at least 1 of the following: • A stable dose of oral corticosteroid as defined in the protocol • And/or antimalarial treatment (e.g., hydroxychloroquine, chloroquine, quinacrine), • And/or no more than 1 of the conventional DMARDS as detailed in the protocol, Negative serum ß-human chorionic gonadotropin (ß-hCG) test at screening (women of childbearing potential [WOCBP] only) Please see the protocol for the full list of inclusion criteria.
排除标准
- •Pregnant, lactating, or planning to get pregnant during the study period and for 1 month after study completion or discontinuation, Receipt of B cell-depleting therapy <6 months prior to signing the ICF or, if therapy was administered >6 months prior to signing the ICF, absolute B cell within the limits as defined in the protocol, Has received any therapeutic agent targeted to IL-12, IL-17, or IL-23 within 6 months or any tumor necrosis factor alpha inhibitor(s) within 12 weeks of prior to signing the ICF, Has received JAK inhibitors (eg, baricitinib, tofacitinib) or TYK2 inhibitors within 12 weeks of prior to signing the ICF, Any of the following: • Currently active, clinically significant infection of any kind • Clinically significant chronic infection (eg, osteomyelitis, bronchiectasis) within 8 weeks prior to signing the ICF • Any infection requiring hospitalization or treatment with IV anti-infectives not completed at least 4 weeks prior to signing the ICF Please see the protocol for the full list of exclusion criteria., Patients with QTcF >450 msec on ECG at screening, 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., Active severe or unstable neuropsychiatric SLE as defined in the protocol, History of or current diagnosis of catastrophic antiphospholipid syndrome within 12 months prior to signing the ICF, History of any recurrent non-SLE disease that required treatment with oral or parenteral Corticosteroids as defined in the protocol, Receipt of any commercially available biologic agent within 5 half-lives prior to signing of the ICF
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