CTRI/2023/12/060518尚未招募2 期
A PHASE 2, MULTICENTER, MULTINATIONAL,RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLEDSTUDY TO ASSESS THE SAFETY, EFFICACY, ANDPHARMACOKINETICS OF MULTIPLE DOSE LEVELS OFESK-001 IN ADULT PATIENTS WITH SYSTEMIC LUPUSERYTHEMATOSUS
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
入选标准
- •1. 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
- •2. Males or females, age 18 to 70 years, inclusive, at the time of informed consent
- •3. Body mass index 18 to 40 kg/m2 and total body weight >40 kg (88 lbs).
- •Adequate peripheral venous access
- •5. 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:
- •i) Positive antinuclear antibody test at screening by immunofluorescent assay at the
- •central laboratory with titer =1:80;
- •ii) Elevated anti-dsDNA antibodies as determined by the central laboratory;
- •iii) Elevated anti-Smith antibody at screening as determined by the central laboratory; or
- •IV) C3 or C4 below the lower limit of normal as determined by the central laborator
- •6. During screening and prior to first administration of study drug, Central Review Team’s confirmation of the following:
- •6.a 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:
- •1. Includes points from the following clinical components: arthritis, myositis, rash, alopecia, mucosal ulcers, pleurisy, pericarditis, and vasculitis
- •2. Excludes points attributable to fever, an SLE headache, and organic brain syndrome
- •6b BILAG-2004 Index Level Criteria: At least 1 of the following:
- •1. BILAG-2004 Index level A disease in at least 1 body/organ system
- •1.a Excludes scores from Lupus Headache
- •1.b BILAG-2004 Index level B disease in more than 1 body/organ system
- •2.a Excludes scores from Lupus Headache
- •2.b PGA score of >1.0 on a 0 to 3 VAS at screening
- •7. Clinical SLEDAI-2K score =4 points with skin involvement prior to first administration of study drug
- •8. Currently receives at least 1 of the following:
- •8.a 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).
- •i) 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.
- •8.b And/or antimalarial treatment (e.g., hydroxychloroquine, chloroquine, quinacrine),
- •8.c And/or no more than 1 of the following conventional DMARDS:
- •i) Azathioprine =200 mg/day
- •ii) Mycophenolate mofetil =2 g/day or mycophenolic acid =1.44 g/day
- •iii) Oral, subcutaneous, or intramuscular (IM) methotrexate =20 mg/week.
- •9. Negative serum ß-human chorionic gonadotropin (ß-hCG) test at screening (women of
- •childbearing potential [WOCBP] only)
- •9.a WOCBP must agree to adhere to highly effective methods of contraception for the
- •entirety of the study and for 30 days after the las
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.
- •2. Current or history within 1 year of screening of alcohol or drug abuse (excluding cannabis) based on Investigator’s clinical judgment.
- •3. Pregnant, lactating, or planning to get pregnant during the study period and for 1 month after
- •study completion or discontinuation
- •4. Patients with QTcF >450 msec on ECG at screening
- •5. Unstable cardiovascular disease, defined as a recent clinical deterioration (eg, unstable angina,rapid atrial fibrillation) or a cardiac hospitalization within the last 3 months.
研究者
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