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临床试验/EUCTR2022-001377-31-ES
EUCTR2022-001377-31-ES进行中（未招募）1 期

A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE 2 STUDY EVALUATING THE EFFICACY AND SAFETY OF DAXDILIMAB IN ADULT PARTICIPANTS WITH ACTIVE PROLIFERATIVE LUPUS NEPHRITIS

Horizon Therapeutics Ireland DAC0 个研究点目标入组 210 人开始时间: 2022年9月19日最近更新:
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适应症

试验速览

阶段
1 期
状态
进行中（未招募）
入组人数
210
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

性别
All

入选标准

  • •1. Written informed consent and any locally required authorization (eg, Health Insurance Portability and Accountability Act [HIPAA] in the United States) obtained from the participant prior to performing any protocol-related procedures, including screening evaluations.
  • •2. Willing and able to comply with the prescribed treatment protocol and evaluations for the duration of the trial.
  • •3. Adult men or women = 18 and = 80 years of age.
  • •4. Fulfill the 2019 European League Against Rheumatism/American College of Rheumatology Classification Criteria for systemic lupus erythematosus (SLE) (Aringer et al, 2019).
  • •5. Have at least one of the following at Screening per central lab:
  • •- Antinuclear antibodies (ANA) = 1:80.
  • •- Anti-double stranded deoxyribonucleic acid (anti-dsDNA) antibodies elevated to above normal range as established by the central laboratory (ie, positive results).
  • •- Anti-Smith antibodies elevated to above normal (ie, positive results).
  • •6. Diagnosis of proliferative LN based on a renal biopsy obtained within 6 months prior to signing the informed consent form (ICF) or during the Screening Period:
  • •- Class III (± class V) or class IV (± class V) LN according to the World Health Organization (WHO) or 2003 ISN/RPS classification (based on local evaluation of renal biopsy).
  • •Note: the local biopsy report will be used to confirm participant eligibility. The submission of the Screening biopsy sample (archived or fresh tissue block, slides or digital pathology images) for adjudication is required to participate in the study.
  • •7. Urine protein to creatinine ratio =1.5 mg/mg (113.17 mg/mmol), obtained via a 24-hour urine collection at both:
  • •- The start of Screening and
  • •- Within 14 days of expected date of Randomization. Without the results of the second sample, which will be used for stratification, participants cannot be randomized. The second sample may be collected after a minimum of 10 days after the Screening sample was obtained. The second sample may be repeated once, upon approval by the Medical Monitor (this will not be considered a re-screen). Typical turn-around time for results from central laboratory is up to 7 days. On rare occasion, an extension of the 28-day screening window is allowed if re-collection of the sample is necessary or the results needed for Randomization are delayed.
  • •8. Estimated glomerular filtration rate (as calculated by the Modification of Diet in Renal Disease [MDRD] formula, with screening laboratory results for serum creatinine value) = 35 mL/min/1.73 m2.
  • •9. Negative serum ß human chorionic gonadotropin (ß-hCG) test at Screening (females of childbearing potential only).
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1.2 Adults (18-64 years) yes
  • •F.1.2.1 Number of subjects for this age range 190
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range 20

排除标准

  • •1. Individuals involved in the conduct of the study, their employees, or immediate family members of such individuals.
  • •2. Any condition that, in the opinion of the Investigator or the Sponsor/Central Review Committee, would interfere with evaluation of the IP or interpretation of participant safety or study results.
  • •3. Weight > 160 kg (352 pounds) at Screening.
  • •4. History of allergy, hypersensitivity reaction, or anaphylaxis to any component of the IP or to a previous monoclonal antibody (mAb) or human immunoglobulin (Ig) therapy.
  • •5. Known intolerance to =1.0 gm/day of MMF or equivalent dose of MPA.
  • •6. Participation in another clinical study with an investigational drug within 4 weeks prior to Day 1 or within 5 published half-lives, whichever is longer.
  • •7. Breastfeeding or pregnant women or women who intend to become pregnant anytime from signing the ICF through 6 months after receiving the last dose of IP.
  • •8. History of drug or alcohol abuse that, in the opinion of the Investigator, might affect participant safety or compliance with visits, or interfere with other study assessments.
  • •9. Major surgery within 8 weeks prior to Screening or elective surgery planned from Screening through the end of the trial.
  • •10. Spontaneous or induced abortion, still or live birth, or pregnancy = 4 weeks prior to Screening through Randomization.
  • •11. A diagnosis of pure Class V membranous LN based on a renal biopsy obtained within 6 months prior to signing ICF or during the Screening Period.
  • •12. History of dialysis within 12 months prior to signing the ICF or expected need for renal replacement therapy (dialysis or renal transplant) within a 12-month period after enrollment.
  • •13. History of, or current renal diseases (other than LN) that in the opinion of the Investigator could interfere with the LN assessment and confound the disease activity assessment (eg, diabetic nephropathy).
  • •14. Known history of a primary immunodeficiency or an underlying condition such as known human immunodeficiency virus (HIV) infection, a positive result for HIV infection per central laboratory, splenectomy, or any underlying condition that in the opinion of the Investigator significantly predisposes the participant to infection.
  • •15. During Screening, any of the following per central laboratory (tests may be repeated once within the same Screening Period to confirm results prior to Randomization):
  • •- Aspartate aminotransferase > 2.5× upper limit of normal (ULN)
  • •- Alanine aminotransferase > 2.5× ULN
  • •- Total bilirubin > 1.5× ULN (unless due to Gilbert’s syndrome)
  • •- Serum IgG < 600 mg/dL (or < 6 g/L) or < 400 mg/dL (<4 g/L) if due to active SLE/LN
  • •- Neutrophil count < 1000/µL (or < 1.0×10 9/L) or < 500/µL (< 0.5×10 9/L) if due to active SLE
  • •- Platelet count < 50,000/µL (or < 50×10 9/L) or < 25,000/µL (< 25×10 9/L) if due to active SLE
  • •- Hemoglobin < 8 g/dL (or < 80 g/L) or < 7 g/dL (< 70 g/L) if due to active SLE
  • •- Glycosylated hemoglobin > 8% (or > 0.08)
  • •-Total lymphocyte count < 200 cells/mm3
  • •16. Confirmed positive test for hepatitis B serology defined as:
  • •- Hepatitis B surface antigen, or
  • •- Hepatitis B core antibody (HBcAb) and hepatitis B virus (HBV) DNA detected above the lower limit of quantitation (LLOQ) by reflex testing by the central laboratory at Screening.
  • •17. Positive test for hepatitis C virus antibody unless documented as having had successful treatment of active hepatitis C infection.
  • •18. Active tuberculosis (TB), or a positive IFN-gamma release as

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