CTRI/2022/02/040015招募中3 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
AstraZeneca AB and AstraZeneca KK0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
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
- •Informed consent- 1. Capable of giving signed informed consent prior to performing any protocol-related procedures, including Screening evaluations
- •2. Completion of Screening procedures within 30 days after signing the ICF.
- •Age and Sex- Males and females aged 18 to 70 years of age.
- •Disease Characteristics- 1. Fulfills updated 2019 SLE criteria
- •2. Have positive ANA, anti-dsDNA, or anti-Sm test result in sample obtained during Screening
- •3. Urine protein to creatinine ratio > 1 mg/mg (113.17 mg/mmol)
- •4. Have active proliferative LN Class III or IV either with or without the presence of Class V
- •5.Adequate peripheral venous access
- •6. eGFR = 35 mL/min/1.73 m2 (as calculated by the Chronic Kidney Disease Epidemiology Collaboration formula)
- •Tuberculosis 1. Chest radiograph or a CT scan of the chest
- •that meets all of the following criteria:No evidence of current active infection (eg, pneumonia, TB) or previous TB; and No evidence of malignancy; and No CS abnormalities (unless due to SLE)
- •2. 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) 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.
- •COVID-19 - 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).
- •Weight Body weight = 40.0 kg
- •Pap Smear- 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)
- •Contraceptive Requirements Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
- •Male participants:
- •All males (sterilized or non-sterilized) who are sexually active must use condom (with spermicide, where commercially available for contraception) from Day 1 until at least 12 weeks after receipt of the final dose of study intervention and until at least 90 days after the last dose of Sponsor-provided MMF
- •Male participants must not donate sperm during the course of the study and for 12 weeks after the last dose of the study intervention and 90 days after the last dose of Sponsor-provided MMF
- •Female participants:
- •females of childbearing potential must have Negative serum ß-hCG test at Screening.
- •Women of childbearing potential must have a negative urine pregnancy test at Week 0 (Day 1), prior to administration of study intervention and prior to the first dose of Sponsor-provided MMF.
- •Females of childbearing potential must use 2 effective methods of avoiding pregnancy, only one of which is a barrier method,
排除标准
- •Medical Conditions- 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 signing the ICF or expected need for renal replacement therapy
- •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)
- •infection and malignancy risk factors-
- •1.History of recurrent infection requiring hospitalization and/or IV antibiotics
- •2. Known history of a primary immunodeficiency, splenectomy, or any underlying condition that predisposes the participant to infection, or a positive result for HIV infection confirmed by the central laboratory at Screening
- •3. At Screening, confirmed positive test for hepatitis B serology, as confirmed by central laboratory,
- •4. Positive test for hepatitis C antibody as confirmed by the central laboratory
- •5. Any clinical CMV or EBV infection that has not completely resolved within 12 weeks prior to signing the ICF
- •6. Opportunistic infection requiring hospitalization or IV antimicrobial treatment within 3 years prior to signing the ICF
- •7. Any severe case, of HZ infection at any time prior to Week 0
- •Systemic HZ such as herpes encephalitis, ophthalmic herpes involving the retina at any time prior to Week 0 (Day 1)
- •8. Clinically significant chronic infection (ie, osteomyelitis, bronchiectasis, etc
- •9. Any infection requiring oral anti-infectives
- •10. 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)
- •COVID-19: 1. Any history of severe COVID-19 infection, eg, requiring hospitalization, intensive care unit care, or assisted ventilation, or any prior COVID-19 infection with unresolved sequelae
- •2. Confirmed or probable COVID-19 infection
- •3. Failure to comply with all required Screening procedures due to circumstances related to pandemic or public health emergency.
- •Prior/Concomitant Therapy- 1. Prior receipt of anifrolumab
- •2. Previous receipt of >?2 investigation treatments (other than anifrolumab) for LN or SLE since time of diagnosis and through signing the ICF
- •3. Known intolerance to = 1.0 g/day of MMF
- •4. Receipt of any commercially available biologic agent within 5 half-lives prior to signing of the ICF
- •5. Receipt of any of the following prior to signing the ICF:
- •Receipt of B cell-depleting therapy (eg, rituximab or obinutuzumab):
- •6. 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
- •7. Receipt of any of the following:
- •Any live or attenuated vaccine within 8 weeks prior to signing the ICF
- •Any restricted medication
- •Blood transfusion within 4 weeks prior to signing the ICF
- •Any of the following for the current LN flare (ie, since the qualifying renal biopsy):
- •o IV cyclophosphamide > 2 pulses of high-dose (= 0.5 g/m2) or > 4 doses of low-dose (500 mg every 2 weeks) or
研究者
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