NCT06455449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)
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- AstraZeneca
- 入组人数
- 240
- 试验地点
- 237
- 主要终点
- Total Improvement Score (TIS) ≥ 40 response
研究概览
简要总结
The purpose of this multicenter, randomized, placebo-controlled and double-blind study is to evaluate the efficacy and safety of subcutaneous anifrolumab compared with placebo on the overall disease activity in participants with moderate to severe Idiopathic Inflammatory Myopathies (IIM) [polymyositis (PM) or dermatomyositis (DM)] while receiving standard of care (SoC) treatment.
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)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Capable of giving informed consent.
- •Inclusion Criteria:
- •18 - 75 years old
- •Body weight ≥40 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).
- •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.
- •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
研究组 & 干预措施
Anifrolumab (subcutaneous weekly injection)
Experimental
Anifrolumab subcutaneous injection once weekly
干预措施: Anifrolumab (blinded) (Combination Product)
Anifrolumab (subcutaneous weekly injection)
Experimental
Anifrolumab subcutaneous injection once weekly
干预措施: Anifrolumab (unblinded, open label) (Combination Product)
Placebo (subcutaneous weekly injection)
Placebo Comparator
Matched placebo control subcutaneous injection once weekly
干预措施: Placebo (Other)
结局指标
主要结局
Total Improvement Score (TIS) ≥ 40 response
时间窗: 52 week
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
- Manual Muscle Testing 8 (MMT-8) (CSM)(52 week)
- Oral corticosteroid dose ≤ 7.5 mg/day(52 week)
- Oral corticosteroid dose ≤ 7.5 mg/day in PM participants(52 week)
- Moderate improvement in disease activity in participants with polymyositis (PM)(52 week)
- Moderate improvement in disease activity in dermatomyositis (DM) participants.(52 week)
- Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI)(8 week)
- Manual Muscle Testing 8 (MMT-8) in PM participants(52 Week)
- Manual Muscle Testing 8 (MMT-8) in DM participants(52 Week)
- Core Set Measures (CSMs)(52 week)
- Oral corticosteroid dose ≤ 7.5 mg/day in DM participants(52 week)
- Cutaneous Dermatomyositis Activity Investigator Global Assessment (CDA-IGA)(8, 24, & 52 week)
- 5-D itch(8, 24, & 52 week)
- Total Improvement Score (TIS) ≥ 20 Response(8 week)
- Total Improvement Score ≥ 60 Response(52 week)
- Cumulative Corticosteroid Use(24, 52 week)
研究者
研究点 (237)
Loading locations...
相似试验
已完成
3 期
Efficacy and Safety Study of Benralizumab in Patients With Uncontrolled Asthma on Medium to High Dose Inhaled Corticosteroid Plus LABA (MIRACLE)AsthmaNCT03186209AstraZeneca695
终止
3 期
A Multicentre Study to Evaluate the Efficacy and Safety of ENIA11 in Patients With Ankylosing SpondylitisAnkylosing SpondylitisNCT02685904Mycenax Biotech Inc.10
已完成
3 期
Study to Evaluate the Potential Effect of Benralizumab on the Humoral Immune Response to the Seasonal Influenza Vaccination in Adolescent and Young Adult Patients With Severe AsthmaAsthmaNCT02814643AstraZeneca103
已完成
3 期
CSL312 (Garadacimab) in the Prevention of Hereditary Angioedema AttacksHereditary AngioedemaNCT04656418CSL Behring64
撤回
2 期
A Phase II Study to Assess the Efficacy and Safety of Olokizumab in Patients With Crohn's DiseaseCrohn's DiseaseNCT01635621UCB BIOSCIENCES GmbH