CTIS2023-506359-68-00招募中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 - IRIS, D3466C00001
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 336
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
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •Age 18 through 70 years at the time of Screening., 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., Body weight = 40.0 kg., 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., 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)., Fulfills updated 2019 SLE criteria., Positive ANA, anti-dsDNA, or anti-Sm test result in sample obtained during Screening or historical., Urine protein to creatinine ratio > 1 mg/mg (113.17 mg/mmol) (mean of 2 spot UPCR [FMV] samples obtained during Screening)., 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., eGFR = 35 mL/min/1.73 m2 (as calculated by the Chronic Kidney Disease Epidemiology Collaboration formula)., Adequate peripheral venous access., 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)., 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.
排除标准
- •A diagnosis of pure Class V LN based on renal biopsy obtained within 6 months prior to signing the ICF or during Screening, Opportunistic infection requiring hospitalization or IV antimicrobial treatment within 3 years prior to the ICF, 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, Any infection requiring oral anti-infectives (including antivirals) within 2 weeks prior to Week 0 (Day 1), 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), 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, Failure to comply with all required Screening procedures due to circumstances related to pandemic or public health emergency, Prior receipt of anifrolumab, Previous receipt of >2 investigational treatments for LN since time of diagnosis of LN and through signing the ICF, Known intolerance to =1.0 g/day of MMF, Receipt of any commercially available biologic agent within 5 half-lives prior to signing of the ICF, 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, 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, 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, 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, except human albumin, within 4 weeks prior to signing the ICF -Any of the following for current LN flare (ie, since the qualifying renal biopsy): IV cyclophosphamide >2 pulses of high-dose (=0.5 g/m2) or >4 doses of low dose (500 mg every 2 weeks) or Average MMF >2.5 g/day (or >1800 mg/day of enteric coated mycophenolate sodium) for > 8 weeks or Tacrolimus >4 mg/day for more than 8 weeks or 4 weeks prior to signing the ICF; Cyclosporine for more than 8 weeks or during last 8 weeks prior to signing the ICF; Voclosporin for more than 8 weeks or during last 8 weeks prior to signing the ICF; Belimumab for more than 12 weeks or during last 12 weeks prior to signing the ICF, Receipt of any commercially available Janus kinase (JAK) inhibitor =12 weeks or Bruton’s tyrosine kinase (BTK) inhibitor =24 weeks prior to the ICF, Any new medicinal cannabinoid should not be started during the course of the study., Participation in another clinical study with another intervention (besides anifrolumab) administered within 4 weeks prior to ICF signing or within 5 half-lives of the study
研究者
相似试验
进行中（未招募）
1 期
Phase 3 Study of Anifrolumab in Adult Patients with Active Proliferative Lupus NephritisEUCTR2021-002862-42-BGAstraZeneca AB360
进行中（未招募）
1 期
Phase 3 Study of Anifrolumab in Adult Patients with Active Proliferative Lupus NephritisActive Proliferative Lupus NephritisMedDRA version: 21.1Level: PTClassification code 10025140Term: Lupus nephritisSystem Organ Class: 10038359 - Renal and urinary disordersEUCTR2021-002862-42-PLAstraZeneca AB360
招募中
3 期
Study on patient with active proliferative Lupus nephritis on treatment with SOC with Mycophenolate Mofetil (MMF) and glucocorticoids with anifrolumab to compare the safety and efficacy.CTRI/2022/02/040015AstraZeneca AB and AstraZeneca KK
尚未招募
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 Nephritisinflammation kidney due to auto-immune disease1000381610038430NL-OMON51523Astra Zeneca8
未知
2 期
ONO-3849 Phase II StudyJPRN-jRCT2080221274ONO PHARMACEUTICAL CO.,LTD.200