A Phase 2a, Double-blind, Randomized, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety and Effectiveness of AA4500 in the Treatment of Dupuytren's Disease Nodules
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 76
- 试验地点
- 22
- 主要终点
- Percent Change From Baseline in Surface Area and Volume of the Treated Nodule at Day 57 Using Caliper Measurements
研究概览
简要总结
The objectives of this study are to assess the safety and effectiveness of AA4500 in treating palmar Dupuytren's disease nodules.
详细描述
Approximately 13 sites in the United States and Australia, approximately 90 study subjects.
After all pre-injection procedures are completed on day 1, eligible men and women will be randomized in a 1:1:1 ratio to dose group and then in a 4:1 ratio to treatment group. Study drug will be administered into a palmar nodule located on the selected hand.
AA4500 (collagenase clostridium histolyticum) 3 doses (low, medium, and high) after reconstitution with sterile diluent (0.3 mg/mL calcium chloride dihydrate in 0.9% sodium chloride). Each dose of study drug will be injected into the nodule. The injection will be administered in 3 different volumes according to randomization.
Placebo after reconstitution with sterile diluent (0.3 mg/mL calcium chloride dihydrate in 0.9% sodium chloride). Each dose of study drug will be injected into the nodule. The injection will be administered in 3 different volumes according to randomization.
Follow up visits for the evaluation of safety and efficacy will be required for all subjects on days 8, 29, and 57.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provide a signed and dated informed consent
- •Be a man or woman ≥ 18 years of age
- •Have a diagnosis of Dupuytren's disease AND have at least one palmar nodule on the selected hand that is:
- •Measures between 0.5 cm and 2.0 cm in length and between 0.5 cm and 2.0 cm in width using hand-held calipers n
- •Not directly associated with a Dupuytren's cord
- •Have a negative urine pregnancy test at screening and before injection of study drug and be using a highly effective (ie, < 1% failure rate) contraception method as judged by the investigator (eg, abstinence, intrauterine device [IUD], hormonal [estrogen/progestin] contraceptives, or barrier control) for at least one menstrual cycle prior to study enrollment and for the duration of the study or be surgically sterile (if female of childbearing potential); or be a postmenopausal female (no menses for at least 1 year or hysterectomy)
- •Be able to comply with the study visit schedule as specified in the protocol
排除标准
- •Received steroid injections (eg, tri-amcinolone acetonide) on the selected nodule within 3 months before administration of study drug
- •Has a chronic muscular, neurological, or neuromuscular disorder that affects the hands
- •Has a known systemic allergy to collagenase or any other excipient of AA4500
- •Has received any collagenase treatments (eg, Santyl® ointment and/or XIAFLEX®/XIAPEX®) within 30 days before injection of study drug in the hand selected for treatment
- •Is currently receiving or plans to receive anticoagulant medication or has received anticoagulant medication (except for ≤ 150 mg aspirin daily) within 7 days before injection of study drug
- •Has a known recent history of stroke, bleeding, or other medical condition, which in the investigator's opinion would make the subject unsuitable for enrollment in the study
- •Received an investigational drug within 30 days before injection of study drug
- •Is pregnant or intends on becoming pregnant during the study or is breastfeeding a child
- •Has any clinically significant medical history or condition(s), including conditions that affect the hands, that would, in the opinion of the investigator, substantially increase the risk associated with the subject's participation in the protocol or compromise the scientific objectives of the study
- •Had surgery on the selected hand within 3 months before the screening visit
- •Has jewelry on the hand to be treated that cannot be removed
结局指标
主要结局
Percent Change From Baseline in Surface Area and Volume of the Treated Nodule at Day 57 Using Caliper Measurements
时间窗: Baseline, Day 57
Percent change from baseline in surface area and volume of the treated nodule was determined from hand-held caliper measurements of the length and width of the nodule. Percent change = 100\*(Day 57 area \[or volume\] - baseline area \[or volume\])/baseline area \[or volume\]. A negative value represents the improvement from baseline (decreased size) while a positive value represents worsening.
次要结局
- Investigator Global Assessment of Improvement With Treatment(Day 57)
- Subject Satisfaction With Treatment(Day 57)
- Change From Baseline in Nodular Pain of the Treated Nodule at Day 57(Baseline, Day 57)
- Composite Responder Analysis(Day 57)
- Change From Baseline in Consistency of the Treated Nodules at Day 57(Baseline, Day 57)
- Percent Change From Baseline in Surface Area and Volume of the Treated Nodule at Day 57 Using Ultrasound(Baseline, Day 57)
- Percent Change From Baseline in Hardness of the Treated Nodule at Day 57(Baseline, Day 57)