A Phase 3 Randomized, Parallel Group, Double-Blind Study to Evaluate the Efficacy, Tolerability, and Safety of TR987® 0.1% Gel Versus Standard of Care in the Treatment of Chronic Venous Insufficiency Leg Ulcers (VLU)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 312
- 试验地点
- 12
- 主要终点
- Proportion of participants with Complete Closure of the target ulcer at or before the Week-16 end of treatment (EOT) visit.
研究概览
简要总结
The goal of this clinical trial is to learn if TR987 0.1% gel + Standard of Care works better than Standard of Care alone to treat Venous Leg Ulcers (VLUs). It will also provide additional information about the safety of drug TR987 0.1% gel.
详细描述
This is an outpatient, randomized, parallel- group, double-blind, multicenter, 16-week study with 2 treatment arms: TR987 0.1% gel + Standard of Care and Standard of Care alone in participants who have a non-healing Venous Leg Ulcer (VLU).
The primary objective is to assess the proportion of participants with Complete Closure of the target ulcer at or before the Week-16 end of treatment (EOT) visit.
Secondary endpoints include:
- Proportion of participants with Complete Closure of the target ulcer at or before the Week 16 visit AND for whom the ulcer remains closed at the 3-Month Follow-Up visit after such closure (a composite endpoint).
- Change from baseline in participant's perception of pain level at 12 weeks.
- Percent change from baseline in the target ulcer area at 12 and 16 weeks. In the event of Complete Closure before these time points, the target ulcer area will be deemed to be zero at those time points for purposes of calculation of this endpoint.
- Proportion of participants with Complete Closure of the target ulcer at or before the Week 12 treatment visit.
- Proportion of participants with any significant reduction in pain at or before 12 weeks.
There are also some supplementary and safety endpoints.
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
Particpants will be randomized to either TR987 1% gel + Standard of Care and Standard of Care alone. Sponsor, particpant, and Investigator/Outcomes Assessor will be masked throughout the treatment period.
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
- •Adults 18 years and older
- •Venous insufficiency has been clinically diagnosed clinically and medically confirmed.
- •Females who are neither pregnant nor breastfeeding and if of child-bearing potential are on an acceptable method of birth control.
- •The Venous Ulcer should be between 2 cm2 and 12 cm2 at randomization.
- •Target ulcer age must be ≥ 4 weeks at Screening.
- •Participants must have adequate arterial flow as confirmed by ABI/TBI, TB, SPP, TCPo2, or Duplex Doppler.
- •Body mass index (BMI) ≤ 50 kg/m
- •HbA1C ≤12%.
排除标准
- •Target ulcer has been treated with prohibited medications or therapies.
- •History of radiation at the target ulcer site.
- •Target ulcer decreases in area by 30% or more during screening period.
- •History of osteomyelitis at the target ulcer within 6 months of screening.
- •History of cancer in the preceding 5 years (except as noted in the protocol).
- •Participants considered nutritionally deficient.
研究组 & 干预措施
TR987 0.1% gel + Standard of Care
Participants will receive up to 16 weeks of TR987 0.1% gel topically + Standard of Care (wound cleansing/dressings and compression bandaging). Treatment will be twice weekly for the first four weeks then weekly for the remaining 12 weeks.
干预措施: TR987 0.1% gel + Standard of Care (Drug)
Standard of Care
Participants will receive Standard of Care (wound cleansing/dressings and compression bandaging). Treatment will be twice weekly for the first four weeks then weekly for the remaining 12 weeks.
干预措施: Standard of care (Other)
结局指标
主要结局
Proportion of participants with Complete Closure of the target ulcer at or before the Week-16 end of treatment (EOT) visit.
时间窗: 16 weeks
Patient count
次要结局
- Change from baseline in participant's perception of pain level at 12 weeks.(12 weeks)
- Proportion of participants with Complete Closure of the target ulcer at or before the Week 16 visit AND for whom the ulcer remains closed at the 3-Month Follow-Up visit after such closure (a composite endpoint).(16 weeks)
- Percent change from baseline in the target ulcer area at 12 and 16 weeks. In the event of Complete Closure before these time points, the target ulcer area will be deemed to be zero at those time points for purposes of calculation of this endpoint.(12 and 16 weeks)
- Proportion of participants with Complete Closure of the target ulcer at or before the Week 12 treatment visit.(12 weeks)
- Proportion of participants with any significant reduction in pain at or before 12 weeks.(12 weeks)