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临床试验/PER-100-20
PER-100-20招募中未知

A PHASE 1B/2 STUDY OF KZR-616 IN PATIENTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS WITH AND WITHOUT NEPHRITIS

Kezar Life Sciences, INC.,0 个研究点目标入组 6 人开始时间: 2021年4月20日最近更新:
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适应症

试验速览

阶段
未知
状态
招募中
入组人数
6
研究概览入排标准研究者记录与标识符相似试验

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. Male or female patients aged 18 to 75 years (inclusive)
  • •2. BMI of ≥ 18 kg/m2
  • •3. Fulfills the 2012 SLICC classification criteria for SLE
  • •4. At least one of the following at Screening per central lab:
  • •a) Positive ANA test (1:80 or higher) or
  • •b) Anti-dsDNA antibodies elevated to above normal (i.e., positive results); or
  • •c) Anti-Smith antibody at screening elevated to above normal (i.e., positive results)
  • •5. Active nephritis with UPCR ≥ 1.0 measured in 24-hour urine collection
  • •6. Currently receiving one or more immunosuppressive agents (see Section 7.2 for allowed
  • •background medications and Section 14.5, Appendix E for excluded medications) that has been
  • •stable for dose and route of administration for ≥ 8 weeks prior to Baseline. If patient is also on
  • •corticosteroids then must be on a stable dose for ≥ 2 weeks prior to Baseline
  • •7. Renal biopsy within 2 years of the Screening visit with a histologic diagnosis of LN (ISN/RPS)
  • •Classes III, IV-S or IV-G, (A) or (A/C) +/- Class V; for biopsies > 1 year before the Screening
  • •visit, one of the following must also be present at screening: low C3, low C4, or anti-ds-DNA
  • •elevated to above normal range.
  • •8. Acceptable screening laboratory values:
  • •a) Adequate hematologic criteria:
  • • Absolute neutrophil count ≥ 1.5 × 109/L (≥ 1 × 109/L if neutropenia is attributable
  • •to lupus disease activity)
  • • White blood cells ≥ 2.0 × 109/L (≥ 1.5 × 109/L if leukopenia is attributable to
  • •lupus disease activity)
  • • Absolute lymphocyte count ≥ 0.5 × 109/L
  • • Hgb ≥ 9 g/dL (≥ 8 g/dL if anemia is attributable to lupus disease activity)
  • • Platelet count ≥ 100 × 109/L (≥ 25 × 109/L if thrombocytopenia is attributable to
  • •lupus disease activity)
  • •b) Adequate hepatic function:
  • • Total bilirubin ≤ 1.5 × ULN (3 × ULN for patients with known Gilbert’s
  • • AST ≤ 2.5 × ULN
  • • ALT ≤ 2.5 × ULN
  • •c) eGFR ≥ 30 mL/min/1.73 m2 estimated based on CKD-EPI formula
  • •d) IgG ≥ 500 mg/dL
  • •9. Female patients of childbearing potential must have a negative serum pregnancy test at Screening
  • •and a negative urine pregnancy test at Baseline and must agree to employ adequate birth control
  • •measures for the duration of the study. Women of childbearing potential (WOCBP) must use
  • •highly effective and medically acceptable methods of contraception to prevent pregnancy during
  • •Screening and must agree to continue to practice adequate contraception during the study and for
  • •4 weeks after administration of the last dose of the study drug.
  • •For the purposes of this study, WOCBP are defined as: all postpubescent female patients, unless
  • •the patient is postmenopausal (defined by amenorrhea for at least 2 years or amenorrhea for at
  • •least 1 year with confirmatory follicle stimulating hormone [FSH] level in the postmenopausal
  • •range as documented historically or measured by the central laboratory at Screening and if patient
  • •is not on supplementary hormonal therapy) or if the patient is surgically sterile (i.e., tubal
  • •ligation, hysterectomy, bilateral salpingoophorectomy).
  • •Highly effective contraception is defined as the use of an intrauterine device or hormonal
  • •contraceptives (e.g., implant or oral), or having a vasec

排除标准

  • •1. Any of the following:
  • •a) Dialysis within 12 months prior to Screening or expected need for renal replacement
  • •therapy (dialysis or renal transplant) within a 6-month period after enrollment
  • •b) Rapidly progressive glomerulonephritis (RPGN) and/or renal disease other than ISN/RPS
  • •Classes III, IV-S or IV-G, [A] or [A/C] with or without Class V LN)
  • •c) Chronic kidney disease not due to LN
  • •d) > 50% sclerosed glomeruli on most recent renal biopsy
  • •2. Presence of another rheumatic (overlap) disease that may confound clinical assessments in the
  • •study. Secondary sicca or Sjogren’s syndrome and antiphospholipid antibody syndrome are
  • •3. History of antiphospholipid syndrome with history of thromboembolic event within 12 months of
  • •4. Active central nervous system involvement by autoimmune disease (e.g., neuropsychiatric SLE
  • •including seizures, psychosis, acute confusional state or cerebrovascular accident) requiring specific therapeutic intervention within 60 days prior to first day of study treatment. Headache treated only with acetaminophen, NSAIDs, or approved doses of triptans is permitted with medical monitor approval.
  • •5. Active or chronic infection:
  • •a) Acute or chronic bacterial or fungal infections:
  • • Requiring systemic antibiotic or antifungal therapy within 14 days of Screening
  • • Receipt of more than a 14-day course of antimicrobial therapy within 12 weeks
  • •of Screening to treat sepsis, abscess, osteomyelitis, joint infection, or bacterial
  • •endocarditis.
  • •b) Acute viral illness:
  • • Signs and symptoms of acute viral illness must be resolved ≥ 4 weeks prior to
  • •Day 1 (Baseline). Patients with history of SARS-CoV-2 must have full resolution
  • •of symptoms and no evidence of associated renal injury
  • • Symptomatic herpes zoster or herpes simplex infection (HSV) (not including
  • •simple oral HSV lesions) within 12 weeks prior to Screening or during the
  • •Screening Period
  • • Acute hepatitis B or C infection
  • •c) Chronic viral infection:
  • • Patients with chronic herpesvirus infections such as HSV or CMV should be on
  • •suppressive therapy at Baseline and during the study.
  • • Chronic hepatitis C infection. Patients with prior chronic hepatitis C infection
  • •should have received a full treatment course and have documented absence of
  • •detectable HCV DNA at the completion of at least 12 weeks of treatment to be
  • • Chronic hepatitis B infection. Patients who are HBsAg negative and hepatitis B
  • •core antibody positive with no detectable DNA will be allowed into the study and
  • •will require regular monitoring of hepatitis B virus DNA. (see Section 8.2.6.6).
  • • Known seropositivity for or active infection with human immunodeficiency virus
  • •(HIV). Those with a positive screening test and negative confirmatory test are
  • •6. Patient has or had any of the following:
  • •a) Progressive multifocal leukoencephalopathy
  • •b) Active or untreated latent TB, per QuantiFERON-TB Gold at screening per
  • •Section 8.2.6.6
  • • Patients with a history of latent TB with documented completed treatment per
  • •Centers for Disease Control and Prevention guidelines are allowed
  • • A chest x-ray must be performed during screening if one has not been done
  • •within 12 weeks prior to the screening visit

研究者

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