PER-035-23尚未招募2 期
A PHASE 2, MULTICENTER, MULTINATIONAL, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLEDSTUDY TO ASSESS THE SAFETY, EFFICACY, AND PHARMACOKINETICS OF MULTIPLE DOSE LEVELS OF ESK-001 IN ADULT PATIENTS WITH SYSTEMIC LUPUSERYTHEMATOSUS
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- Alumis Inc.
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
- 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)/American College of Rheumatology (ACR) criteria at the time of
- •screening, AND has at least one of the following:
- •Positive antinuclear antibody test at screening by immunofluorescent assay at the
- •central laboratory with titer =1:80;
- •Elevated anti-dsDNA antibodies as determined by the central laboratory;
- •Elevated anti-Smith antibody at screening as determined by the central laboratory; or
- •C3 or C4 below the lower limit of normal as determined by the central laboratory.
- •During screening and prior to first administration of study drug, Central Review Team’s
- •confirmation of the following:
- •SLEDAI-2K Criteria: At screening the SLEDAI-2K score of =6. Clinical”
- •SLEDAI-2K score of =4 points. The Clinical” SLEDAI-2K is the SLEDAI-2K
- •assessment score without the inclusion of points attributable to any urine or laboratory
- •results including immunologic measures:
- •o Includes points from the following clinical components: arthritis, myositis,
- •rash, alopecia, mucosal ulcers, pleurisy, pericarditis, and vasculitis
- •o Excludes points attributable to fever, an SLE headache, and organic brain
- •BILAG-2004 Index Level Criteria: At least 1 of the following:
- •o BILAG-2004 Index level A disease in at least 1 body/organ system
- •? Excludes scores from Lupus Headache
- •o BILAG-2004 Index level B disease in more than 1 body/organ system
- •? Excludes scores from Lupus Headache
- •PGA score of >1.0 on a 0 to 3 VAS at screening
- •Clinical SLEDAI-2K score =4 points with skin involvement prior to first administration of
- •Currently receives at least 1 of the following:
- •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).
- •o If corticosteroid is the only medication used for SLE activity, the daily dose
- •must have been =10 mg and =40 mg prednisone equivalent for a minimum of 8
- •weeks prior to screening, and stable =10 mg and =40 mg for at least 2 weeks
- •prior to screening.
- •And/or antimalarial treatment (e.g., hydroxychloroquine, chloroquine, quinacrine),
- •And/or no more than 1 of the following conventional DMARDS:
- •o Azathioprine =200 mg/day
- •o Mycophenolate mofetil =2 g/day or mycophenol
排除标准
- •1.Any acute or chronic illness/condition or evidence of an unstable clinical condition that, in the Investigator’s judgment, will substantially increase the risk to the patient if he or she participates in the study
- •Presence or history (within 1 year) of psychiatric disease that, in the Investigator's opinion, is
- •likely to interfere with patient’s ability to provide informed consent, comply with study
- •procedures, or place the patient at increased risk by participating in the study
- •Current or history within 1 year of screening of alcohol or drug abuse (excluding cannabis)
- •based on Investigator’s clinical judgment.
- •Pregnant, lactating, or planning to get pregnant during the study period and for 1 month after
- •study completion or discontinuation
- •Patients with QTcF >450 msec on ECG at screening
- •Unstable cardiovascular disease, defined as a recent clinical deterioration (eg, unstable angina,
- •rapid atrial fibrillation) or a cardiac hospitalization within the last 3 months
- •At screening, has any of the following laboratory abnormalities:
- •Absolute neutrophil count <1 × 109/L
- •Hemoglobin <8 g/dL
- •Platelet count <30,000/uL
- •Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =2 × upper limit of
- •normal (ULN), unless attributable to lupus hepatitis
- •Total bilirubin =2 × ULN (unless the patient has documented Gilbert syndrome)
- •Estimated glomerular filtration rate (eGFR by Modification of Diet in Renal Disease
- •[MDRD] formula) <30 ml/min/m2 indicative severe renal insufficiency
- •UPCR >3.5 g/g
- •Patient has planned major surgery during the study period
- •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,
- •severe cardiorespiratory diseases
- •Active severe or unstable neuropsychiatric SLE including, but not limited to the followi
研究者
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