EUCTR2021-002862-42-PL进行中（未招募）1 期
A Multicenter Randomized Double-Blind Placebo-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of Anifrolumab in Adult Patients with Active Proliferative Lupus Nephritis
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 360
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Age 18 through 70 years at the time of Screening.
- •2. Fulfills updated 2019 SLE criteria.
- •3. Positive ANA, anti-dsDNA, or anti-Sm test result in sample obtained during Screening.
- •4. Urine protein to creatinine ratio > 1 mg/mg (113.17 mg/mmol) (mean of 2 spot UPCR [FMV] samples obtained during Screening).
- •5. Active proliferative LN Class III or IV either with or without the presence of Class V (excluding pure Class III[C], IV-S[C], or IV-G[C]) according to the 2003 ISN/RPS classification based on a renal biopsy obtained within 6 months prior to signing the ICF or during Screening Period.
- •6. eGFR = 35 mL/min/1.73 m2 (as calculated by the Chronic Kidney Disease Epidemiology Collaboration formula).
- •7. Adequate peripheral venous access.
- •8. Chest radiograph (obtained during Screening or within 12 weeks prior to signing of the informed consent) or a CT scan of the chest (within 12 weeks of signing the informed consent) that meets all of the following criteria: No evidence of current active infection (eg, pneumonia, TB) or previous TB; No evidence of malignancy; No CS abnormalities (unless due to SLE).
- •9. Meets all of the following TB criteria: No signs or symptoms of active TB prior to or during any Screening visit; No medical history or past physical examinations suggestive of active TB; A chest radiograph during the Screening Period or within 12 weeks prior to signing the ICF with no evidence of active or signs of prior TB infection; No recent contact with a person with active TB OR if there has been such contact, referral to a physician specializing in TB to undergo additional evaluation prior to Week 0 (Day 1) (documented comprehensively in source) and, if warranted, receipt of appropriate treatment for latent TB at or before the first administration of study intervention; No history of latent TB prior to signing the ICF, with the exception of latent TB with documented completion of appropriate treatment.The participant must undergo an IGRA (eg, QFT-G test) test for TB obtained from the study central laboratory at Screening with results in line with protocol specified rules.
- •10. Negative SARS-Cov-2 RT-PCR test result at Screening and no known or suspected COVID-19 infection or exposure between signing the ICF and Week 0 (Day 1). There must be a minimum of 2 weeks between the 2 tests at Screening and Week 0 (Day 1).
- •11. Body weight = 40.0 kg.
- •12. Females with an intact cervix must have documentation of a Pap smear with no documented malignancy (eg, CIN III, carcinoma in situ, or adenocarcinoma in situ) within 2 years prior to Week 0 (Day 1)
- •13. Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies (as described in protocol).
- •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 300
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 60
排除标准
- •1.A diagnosis of pure Class V LN based on the renal biopsy obtained within 6 months prior to signing the ICF or during Screening
- •2.History of dialysis within 12 months prior to the ICF or expected need for renal replacement therapy (dialysis or renal transplant) within a 6-month period after enrollment
- •3.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)
- •4.History of recurrent infection requiring hospitalization and/or IV antibiotics (eg, 2 or more of the same type of infection over the previous 52 weeks).
- •5.Known history of a primary immunodeficiency, splenectomy, or any underlying condition that predisposes the participant to infection, or a positive result for HIV confirmed by the central lab at Screening - an HIV test must be performed during Screening, and the result should be available prior to Week 0 (Day 1)
- •6.At Screening, confirmed positive test for hepatitis B serology, as confirmed by central lab, for: HBsAg or HBcAb and HBV DNA detected above the LLOQ by reflex testing by the central lab at Screening. Participants who are HBcAb positive at Screening will be tested every 3 months for HBV DNA. To remain eligible for the study, the participant’s HBV DNA levels must remain below the LLOQ as per the central lab
- •7.Positive test for hepatitis C antibody as confirmed by the central lab
- •8.Any severe case, as defined by study guidelines, of HZ infection at any time prior to Week 0 (Day 1)
- •9.Any clinical CMV or EBV infection that has not completely resolved within 12 weeks prior to the ICF
- •10.Opportunistic infection (see Section 8.3.8.2 of protocol) requiring hospitalization or IV antimicrobial treatment within 3 years prior to the ICF
- •11.Clinically significant chronic infection within 8 weeks prior to signingnthe ICF (chronic nail infections are allowed) or any infection requiring hospitalization or treatment with IV anti-infectives not completed at least 4 weeks prior to the ICF
- •12.Any infection requiring oral anti-infectives (including antivirals) within 2 weeks prior to Week 0 (Day 1)
- •13.History of cancer, apart from: Squamous or basal cell carcinoma of the skin treated with documented success of curative therapy =3 months
- •prior to Week 0 (Day 1); Cervical cancer in situ treated with apparent success with curative therapy =1 year prior to Week 0 (Day 1)
- •14.Any history of severe COVID-19 infection or any prior COVID-19 infection with documented long COVID and/or clinically significant unresolved sequelae. Any mild/asymptomatic COVID-19 infection within the last 6 weeks prior to first dosing
- •15.Failure to comply with all required Screening procedures due to circumstances related to pandemic or public health emergency
- •16.Prior receipt of anifrolumab
- •17.Previous receipt of >2 investigational treatments for LN since time of diagnosis of LN and through signing the ICF
- •18.Known intolerance to =1.0 g/day of MMF
- •19.Receipt of any commercially available biologic agent within 5 halflives prior to signing of the ICF
- •20.Receipt of any of the following prior to signing the ICF: Receipt of B cell-depleting therapy =26 weeks prior to signing the ICF or if therapy was administered >26 weeks ago, if absolute B cell count is <50 cells/microliter
- •21.A known history of allergy or reaction to any component of the study intervention formulation or history of anaphylaxis to any human gamma
研究者
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