NCT05833711招募中2 期
A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Froniglutide (PF1801) in Patients With Idiopathic Inflammatory Myopathy (IIM)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- IMACS-TIS Moderate Improvement at Week 24
研究概览
简要总结
This is a Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Froniglutide in Patients With Idiopathic Inflammatory Myopathy ("FROniGlutide Study")
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
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of IIM (DM or polymyositis [PM]) as per Bohan and Peter classification criteria
- •MMT-8 ≤125 units and two out of the following CSM items, or MMT-8 >125 units and three out of the following CSM items, together with verifiable muscular weakness A. PGA VAS ≥2 cm B. SGA VAS ≥2 cm C. HAQ-DI ≥0.25 D. Extramuscular activity (MDAAT) ≥2 cm E. Increase in one or more muscle enzyme (CK, LDH, AST, ALT, aldolase) values (must be ≥1.3 × ULN)
- •On treatment with standard of care (immunosuppressants and/or corticosteroids) for >12 weeks and on stable therapy for at least 4 weeks
排除标准
- •Inclusion body myositis (IBM) or amyopathic DM
- •Severe muscle damage (myositis damage index [MDI] >7/10 cm). Permanent deterioration caused by reasons other than PM/DM, or myositis with cardiac involvement
- •Clinically significant renal/hepatic impairment
- •Severe interstitial lung disease requiring supportive oxygen therapy
研究组 & 干预措施
Froniglutide 50 mg
Experimental
Froniglutide (PF1801) 50 mg will be administered subcutaneously once a week.
干预措施: Froniglutide (Drug)
Froniglutide 70 mg
Experimental
Froniglutide (PF1801) 70 mg will be administered subcutaneously once a week.
干预措施: Froniglutide (Drug)
Placebo
Placebo Comparator
Matching placebo will be administered subcutaneously once a week.
干预措施: Placebo (Drug)
结局指标
主要结局
IMACS-TIS Moderate Improvement at Week 24
时间窗: Week 24
Proportion of subjects who achieve moderate improvement (≥40) from baseline in IMACS TIS at Week 24
次要结局
- IMACS-TIS Minimal Improvement at Week 4, 8, 12, 16, 24(Week 4, 8, 12, 16, 24)
研究者
研究点 (1)
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