NCT05138133进行中（未招募）3 期
A Multicentre 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
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- AstraZeneca
- 入组人数
- 363
- 试验地点
- 164
- 主要终点
- Difference in proportion of participants with CRR (Complete Renal Response) in anifrolumab group compared with placebo group
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of IV antifrolumab in adult patients with Active Proliferative Lupus Nephritis
详细描述
This Phase 3, multicenter, multinational, randomized, double-blind, placebo-controlled study with OLE is to evaluate the efficacy and safety of anifrolumab versus placebo as added to SOC (MMF and glucocorticoids) in adults with active proliferative Class III or Class IV LN (both with or without concomitant Class V). The total study duration may be up to approximately 142 weeks, including screening and follow-up. Double-blind period will be 76 weeks. Participants who complete double-blind treatment period may enter open-label extension to receive anifrolumab for up 52 weeks. Approximately 360 of the enrolled participants will be randomly assigned to study intervention (anifrolumab or placebo) at a ratio of 1:1 during double-blind treatment period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double Blind (Participant, Care Provider and Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Active proliferative LN Class III or IV either with or without the presence of Class V according to the 2003 ISN/RPS classification
- •Renal biopsy obtained within 6 months prior to signing the ICF or during Screening Period.
- •Urine protein to creatinine ratio > 1 mg/mg (113.17 mg/mmol)
- •eGFR ≥ 35 mL/min/1.73 m2 (as calculated by the Chronic Kidney Disease Epidemiology Collaboration formula).
- •Fulfills updated 2019 EULAR/ACR SLE classification criteria.
- •No signs of symptoms of active TB prior to or during screening or no treatment for latent TB
排除标准
- •A diagnosis of pure Class V LN based on the renal biopsy obtained within 6 months prior to signing the ICF or during Screening.
- •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).
- •Evidence of hepatitis C or active hepatitis B.
- •Any history of cancer except sucessfully cured skin squamos or basal skin carcinoma and cervical cancer in situ.
- •Receipt of the following for the 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 more than 8 weeks or Tacrolimus > 4 mg/day for more than 8 weeks; 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 the ICF.
- •Previous receipt of >◦2 investigation treatments (other than anifrolumab) for LN or SLE since time of diagnosis and through the ICF.
- •Known intolerance to ≤ 1.0 g/day of MMF.
- •Any history of severe COVID-19 infection.
研究组 & 干预措施
Placebo
Placebo Comparator
Solution for intravenous infusion
干预措施: Placebo (Drug)
Anifrolumab
Experimental
Solution for intravenous infusion
干预措施: Anifrolumab (Drug)
结局指标
主要结局
Difference in proportion of participants with CRR (Complete Renal Response) in anifrolumab group compared with placebo group
时间窗: Week 52
CRR is defined as: * UPCR ≤ 0.5 mg/mg * eGFR ≥ 60 mL/min/1.73 m2 or no decrease from baseline of ≥ 20%
次要结局
- Difference in proportion of participants achieving sustained OCS reduction in anifrolumab group compared with placebo group(from Week 24 through Week 52)
- HR of achieving sustained CRR in anifrolumab compared with placebo group(baseline through Week 52)
- Difference in the mean standardized AUC for UPCR between anifrolumab and placebo participants(baseline through Week 52)
- Difference in proportion of participants with CRR in anifrolumab group compared with placebo group(Week 24)
- HR to summarize the difference in the risk of hazard of renal-related event or death at any given time between anifrolumab and placebo participants(Through Week 76)
- Difference between anifrolumab and placebo in proportions of participants who achieve aCRR(Week 52)
- Difference between anifrolumab and placebo in proportions of participants who achieve CRR with sustained OCS reduction(Week 52)
- HR of achieving sustained CRR in anifrolumab compared to placebo group(Through week 76)
- HR of achieving 50% reduction in UPCR in anifrolumab compared to placebo group(Through Week 52)
- Difference in mean UPCR between the anifrolumab and placebo group(Week 52)
- Difference in proportion of participants achieving PRR (Partial Renal Response) in anifrolumab group compared with placebo group(Week 52)
- Difference in change from baseline in extra-renal SLEDAI-2K total score(Through Week 76)
- Difference in mean change from baseline in domains and component scores of Short Form-36 Version 2 (SF-36v2) and Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-fatigue) total score(Week 52)
- HR to summarize the difference in the risk of hazard of renal-related event or death at any given time between anifrolumab and placebo participants(Through Week 52)
- Difference in the mean standardized AUC for UPCR between anifrolumab and placebo participants(baseline through Week 52)
- Difference in proportion of participants with CRR in anifrolumab group compared with placebo group(Week 24)
- Difference in proportion of participants achieving sustained OCS reduction in anifrolumab group compared with placebo group(from Week 24 through Week 52)
- HR of achieving sustained CRR in anifrolumab compared with placebo group(baseline through Week 52)
- HR to summarize the difference in the risk of hazard of renal-related event or death at any given time between anifrolumab and placebo participants(Through Week 76)
- Difference between anifrolumab and placebo in proportions of participants who achieve aCRR(Week 52)
- Difference between anifrolumab and placebo in proportions of participants who achieve CRR with sustained OCS reduction(Week 52)
- HR of achieving sustained CRR in anifrolumab compared to placebo group(Through week 76)
- HR of achieving 50% reduction in UPCR in anifrolumab compared to placebo group(Through Week 52)
- Difference in mean UPCR between the anifrolumab and placebo group(Week 52)
- Difference in proportion of participants achieving PRR (Partial Renal Response) in anifrolumab group compared with placebo group(Week 52)
- Difference in change from baseline in extra-renal SLEDAI-2K total score(Through Week 76)
- Difference in mean change from baseline in domains and component scores of Short Form-36 Version 2 (SF-36v2) and Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-fatigue) total score(Week 52)
研究者
研究点 (164)
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