2023-504022-19-01招募中3 期
A Multicenter, Parallel-group, Double-blind, 2-Arm, Phase III Study to Investigate the Efficacy and Safety of Anifrolumab Administered as Subcutaneous Injection and Added to Standard of Care Compared with Placebo Added to Standard of Care in Adult Participants with Idiopathic Inflammatory Myopathies (Polymyositis and Dermatomyositis)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 84
- 试验地点
- 67
- 主要终点
- Participants who have at least moderate improvement in disease activity (TIS ≥ 40) and has not met “confirmed deterioration” criteria at 2 consecutive visits
研究概览
简要总结
To demonstrate the superiority of anifrolumab to placebo on moderate improvement in disease activity at Week 52
研究设计
- 分配方式
- Randomized
- 主要目的
- Open-label treatment period
- 盲法
- Double (Monitor, Subject, Investigator, Carer)
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •18 - 75 years old
- •Body weight 40 kg - ≤ 100 kg
- •Must have “probable” or “definite” diagnosis of PM or DM according to the 2017 ACR/EULAR classification criteria for adult myositis.
- •Moderate or severe disease activity per core set measurements.
- •Currently receiving oral prednisone or other polymyositis or dermatomyositis treatments at a stable dose.
- •No history of active tuberculosis or severe COVID-
- •Male and female participants must follow contraception guidelines.
排除标准
- •Participants with documented inclusion body myositis (IBM), immune mediation necrotizing myositis (IMNM), juvenile myositis (if diagnosed within 10 years prior to signing the ICF), drug-induced myositis, cancer associated myositis, amyopathic DM, and non inflammatory myopathies (eg, muscular dystrophies).
- •Recent or concurrent enrollment in another clinical study with an investigational product.
- •Lactating, breastfeeding, or pregnant females or females who intend to become pregnant or begin breastfeeding
- •PM and DM patients at a high risk of malignancy.
- •Participants with rapidly progressive interstitial lung disease.
- •Participants with severe muscle damage or permanent weakness due to non-PM or non-DM conditions (i.e. stroke) as per the investigator's opinion.
- •Any history of severe case of herpes zoster infection
- •History of cancer (except adequately treated basal cell carcinoma or cervical cancer in-situ), immunodeficiency, HIV, HBV, active HCV .
- •Any clinical cytomegalovirus or Epstein-Barr virus infection that has not completely resolved within 12 weeks prior to signing the ICF.
- •Opportunistic infection requiring hospitalization or IV antimicrobial treatment within 3 years prior to randomization.
- •Recent non-opportunistic infection requiring hospitalization or anti-infective treatment.
结局指标
主要结局
Participants who have at least moderate improvement in disease activity (TIS ≥ 40) and has not met “confirmed deterioration” criteria at 2 consecutive visits
Participants who have at least moderate improvement in disease activity (TIS ≥ 40) and has not met “confirmed deterioration” criteria at 2 consecutive visits
次要结局
- MMT-8 (CSM) change from baseline at week 52
- Participants who achieve oral corticosteroid dose ≤ 7.5 mg/day at week 52 (yes/no)
- PM Participants who have at least moderate improvement in disease activity (TIS ≥ 40) at week 52 and has not met “confirmed deterioration” criteria at 2 consecutive visits up to and including week 52
- DM Participants who have at least moderate improvement in disease activity (TIS ≥ 40) at week 52 and has not met “confirmed deterioration” criteria at 2 consecutive visits up to and including week 52
- CDASI-activity change from baseline (DM participants only) at week 8
- "MMT-8 (CSM) change from baseline at Week 52. Only PM participants will be included in the analysis."
- "MMT-8 (CSM) change from baseline at Week 52 Only DM participants will be included in the analysis."
- "Participants who achieve OCS dose ≤ 7.5 mg/day at Week 52 (yes/no). Only PM participants with baseline OCS dose > 7.5 mg/day at baseline will be included in the analysis."
- "Participants who achieve OCS dose ≤ 7.5 mg/day at Week 52 (yes/no). Only DM participants with baseline OCS dose > 7.5 mg/day at baseline will be included in the analysis."
研究者
AstraZeneca Clinical Study Information Center
Scientific
AstraZeneca AB
研究点 (67)
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