EUCTR2021-002862-42-BG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
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 or historical.
- •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, and in the opinion of the investigator, participant needs high dose corticosteroids and immunosuppressive therapy.
- •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 evidence of pulmonary nodules suspicious for lung cancer that have not been appropriately followed-up prior to enrolment, No clinically significant 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. Any negative PCR or antigen test result (central or local laboratory, as appropriate) as per local policies at Screening in addition to no known or suspected COVID-19 exposure within 2 weeks prior to Screening.
- •11. Body weight = 40.0 kg.
- •12. Females who have been or are sexually-active with an intact cervix must have documentation of a cervical cancer screening (Pap smear or HPV tests as per local guidelines) with a normal test result within 2 years prior to randomization.
- •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 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
- •3.History of, or current renal diseases (other than LN) that 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
- •6.Confirmed positive test for hepatitis B serology (HBsAB or HBcAB+HBV DNA above the LLOQ) To remain eligible for the study, the participant's HBV DNA levels must remain below the LLOQ as per the central lab
- •7.Active hepatitis C infection (defined as positive hepatitis C virus antibody and detectable HCV ribonucleotide (RNA) as confirmed by central lab
- •8.Any severe case 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 requiring hospitalization or IV antimicrobial treatment within 3 years prior to the ICF
- •11.Clinically significant chronic infection within 8 weeks prior to signing the 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 withinthe 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 globulin therapy, human proteins, or monoclonal antibodies
- •22.Receipt of any of the following:
- •-Any live or attenuated vaccine within 8 weeks prior to signing the ICF (killed vaccines are acceptable)
- •-Any prohibited medication listed in Appendix O not discontinued according to the prescribed timeframe prior to signing of ICF
- •-Blood transfusion or receipt of blood products
研究者
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