A Long-Term Extension Study Evaluating the Safety and Efficacy of Lorecivivint in Subjects With Osteoarthritis of the Knee
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 276
- 试验地点
- 42
- 主要终点
- Change From OA-11-study Baseline Medial Joint Space Width (mJSW) in the Target Knee
研究概览
简要总结
Study OA-07 was a randomized, double-blind, placebo-controlled, Phase 3, multicenter, 2-year clinical trial that enrolled subjects from the recently completed Study OA-11 (NCT03928184).
The first 48 weeks of OA-07 the trial was placebo-controlled with subjects receiving the same randomized treatment received in OA-11. Investigators, research staff and subjects remained blinded to treatment allocation.
At Week 48, all subjects were administered LOR in the open-label portion of the trial.
详细描述
At Visit 1E (on Day 1), upon completion of initial study procedures (e.g., informed consent, eligibility requirements, clinical evaluations including pregnancy testing [as applicable], baseline patient-reported outcome [PRO] assessments and safety data collection), subjects received a blinded IA injection of either LOR or PBO (as originally randomized in the parent [OA-11] study) into their target knee.
At Visit 3E (Week 48), upon completion of scheduled clinical, medical, safety and Patient-reported outcome (PRO) assessments, all subjects received an open-label injection of IA LOR into their target knee, such that previously PBO-treated subjects were effectively crossed over to the LOR treatment cohort.
Subjects were given the option to either receive a final injection of IA LOR into their target knee and complete both Visit 6E (Week 100) assessments and End-of-Study Visit assessments, or receive no injection and complete End-of-Study Visit assessments only. Subjects who had completed Visit 6E prior to the announcement of study closure were instructed to return to the clinic for End-of-Study Visit assessments.
Study OA-07's initial study design was to assess the safety and efficacy of additional treatment with LOR compared to PBO over one year and conclude at Visit 3E. The study was amended to become an open-label study at the Visit 3E that included an End-of-Study visit but without a specified time. The study was intended and described in the protocol to be run until such time as the Sponsor chose to close it. Study OA-07 was administratively closed at Visit 6E (Week 100), with no safety concerns, one year into the open-label study. For these reasons, Study OA-07 is considered a completed 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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
The first 48 weeks were research site personnel (investigator, coordinators, assessors) and subjects were blinded to the treatment assignment. After Week 48, the remainder of the study was open-label with all subjects receiving LOR study injections.
入排标准
- 年龄范围
- 41 Years 至 81 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Completion of the Study SM04690-OA-11 (NCT03928184)
- •Compliance with procedures in study SM04690-OA-11, in the opinion of the Investigator
- •Fully understanding study requirements and willingness to comply with study visits and assessments
- •Understanding and signing of the informed consent form (ICF) prior to any study-related procedures
排除标准
- •Any condition that, in the opinion of the Investigator, constitutes a risk or contraindication for participation in the study or that could interfere with the study objectives, conduct, or evaluation
- •Any contraindications for an intra-articular (IA) injection in the target knee in the opinion of the Investigator
- •Any known reason identified by the Investigator or Sponsor that the subject may not be compliant with study visits or may no longer be an appropriate candidate for the study (e.g. planned major surgery, knee replacement during the parent study, planning to move away from the research site, or initiation of a prohibited concomitant medication including, but not limited to, IA injection of glucocorticoids, hyaluronic acid derivatives, platelet-rich plasma, stem cell therapies, or other agents with therapeutic intent into the target knee)
- •Participation in a clinical research trial (other than the prior SM04690-OA-11 study) that included the receipt of an investigational product (IP) or any experimental therapeutic procedure within 12 weeks before any study injection, or planned participation in any such trial
- •Current or pending disability claim, workers' compensation, or litigation(s) that may compromise response to treatment
- •Pregnant women, breastfeeding women, and women who are not post-menopausal (defined as 12 months with no menses without an alternative medical cause) or permanently surgically sterile (includes hysterectomy, bilateral salpingectomy, and bilateral oophorectomy) who have a positive or indeterminate pregnancy test result at Visit 1E (Day 1)
- •Women who are not post-menopausal or permanently surgically sterile who are sexually active, and who are not willing to use birth control (as outlined in the protocol) during the study period
结局指标
主要结局
Change From OA-11-study Baseline Medial Joint Space Width (mJSW) in the Target Knee
时间窗: OA-11-study baseline; Visit 3E (Week 48)
Change from OA-11-study baseline in mJSW measured in millimeters as documented by radiograph (X-ray) of the target knee. JSW measurements were provided by a blinded, central imaging vendor using landmark-based, computer-assisted proprietary methodology.
Change From OA-07-study Baseline OA Pain in the Target Knee
时间窗: OA-07-study baseline; Visit 2E (Week 24)
Change from OA-07-study baseline OA pain the target knee as assessed by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Numeric Rating Scale (NRS 3.1) pain subscore (WOMAC Pain). The WOMAC is a widely-used, proprietary outcome measurement tool used by health professionals to evaluate the condition of subjects with OA of the knee and hip, including pain (5 questions), stiffness (2 questions), and physical functioning (17 questions) of the joints. Each question is measured on a scale from 0 (lowest pain/lowest stiffness/highest function) to 10 (highest pain/highest stiffness/lowest function). The WOMAC Pain subscore ranges from 0 \[no pain\] to 100 \[pain as bad as it can be\].
Change From OA-07-study Baseline OA Function in the Target Knee
时间窗: OA-07-study baseline; Visit 2E (Week 24)
Change from OA-07-study baseline OA function in the target knee as assessed by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Numeric Rating Scale (NRS 3.1) physical functioning subscore (WOMAC Function). The WOMAC is a widely-used, proprietary outcome measurement tool used by health professionals to evaluate the condition of subjects with OA of the knee and hip, including pain (5 questions), stiffness (2 questions), and physical functioning (17 questions) of the joints. Each question is measured on a scale from 0 (lowest pain/lowest stiffness/highest function) to 10 (highest pain/highest stiffness/lowest function). The WOMAC Function subscore ranges from 0 \[highest functional status\] to 100 \[most impaired functional status\].
次要结局
- Change From OA-07-study Baseline OA Pain in the Target Knee(OA-07-study baseline; Visit 3E (Week 48))
- Change From OA-07-study Baseline OA Function in the Target Knee(OA-07-study baseline; Visit 3E (Week 48))