A Prospective Phase 1/2 Study to Evaluate the Safety and Exploratory Efficacy of Three Intra-articular Injections of Ampion™ (4 mL) Administered Two Weeks Apart in Adults With Pain Due to Osteoarthritis of the Knee
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Change in Knee Pain (Phase 2)
研究概览
简要总结
Phase 1 will evaluate the safety of 3 intra-articular injections of Ampion™ administered 2 weeks apart to adults with osteoarthritis of the knee.
In the absence of serious drug-related Adverse Events (AEs) of unanticipated drug-related AEs, enrollment will be initiated in Phase 2 of the study.
Phase 2 will evaluate the efficacy of 3 intra-articular injections, given 2 weeks apart, of Ampion™ in Adults with pain due to osteoarthritis of the knee.
详细描述
Phase 1: An open-label study to evaluate the safety of 3 intra-articular injections of of Ampion™ 4 mL at Baseline (Day 0) and Weeks 2 and 4 to adults with osteoarthritis (OA) knee pain. Enrollment will be initiated in Phase 2 if no serious drug-related adverse events or unanticipated drug-related adverse events are observed.
Phase 2: A randomized, placebo-controlled, double-blind, study to evaluate the safety and efficacy of 3 intra-articular (IA) injections of Ampion™ 4 mL at Baseline (Day 0) and Weeks 2 and 4 in adults with OA knee pain.
Study Objectives
Phase 1:
To evaluate the safety of Ampion™ 4 mL administered as 3 intra-articular injections, two weeks apart, in subjects suffering from OA of the knee from Baseline to Week 20.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to provide written informed consent to participate in the study
- •Willing and able to comply with all study requirements and instructions of the site study staff
- •Male or female, 40 years to 85 years old (inclusive)
- •Index knee must have been symptomatic for greater than 6 months with a clinical diagnosis of OA and supported by radiological evidence (Kellgren Lawrence Grade II-IV) acquired at Screening
- •Moderate to moderately severe OA pain in the index knee (rating of at least 1.5 on the WOMAC Pain Subscale) assessed at Screening and confirmed at randomization
- •Moderate to moderately severe OA pain in the index knee (even if chronic doses of nonsteroidal anti-inflammatory drugs [NSAIDs], which have not changed in the 4 weeks prior to Screening, had been used)
- •No analgesia taken 24 hours before efficacy measure
排除标准
- •As a result of medical review and screening investigation, the Principal Investigator considered the subject unfit for the study
- •Previous Ampion injection
- •Known clinically significant liver abnormality (eg, cirrhosis, transplant, etc.)
- •History of allergic reactions to human albumin (reaction to non-human albumin such as egg albumin was not an exclusion criterion)
- •History of allergic reactions to excipients in 5% human albumin (N-acetyltryptophan, sodium caprylate)
- •Presence of tense effusions in the index knee
- •Inflammatory or crystal arthropathies, acute fractures, history of aseptic necrosis or joint replacement in the index knee, as assessed locally by the Principal Investigator
- •Isolated patella femoral syndrome, also known as chondromalacia in the index knee
- •Any other disease or condition interfering with the free use and evaluation of the index knee for the duration of the trial (eg, cancer, congenital defects, spine OA)
- •Major injury to the index knee within the 12 months prior to Screening
- •Severe hip OA ipsilateral to the index knee
- •Any pain that could interfere with the assessment of index knee pain (eg, pain in any other part of the lower extremities, pain radiating to the knee)
- •Any pharmacological or non-pharmacological treatment targeting OA started or changed during the 4 weeks prior to treatment or likely to be changed during the duration of the study
- •Use of any of the following medications:
- •IA-injected pain medications in the index knee during the study
- •Analgesics containing opioids (NSAIDs were allowed at the levels preceding the study and acetaminophen was available as rescue medication during the study from the provided supply)
- •Topical prescription treatment on the index knee during the study
- •Significant anticoagulant therapy (eg, heparin or enoxaparin) during the study (aspirin and clopidogrel were allowed)
- •Systemic treatments that could interfere with safety or efficacy assessments during the study
- •Immunosuppressants
- •Corticosteroids >10 mg prednisolone equivalent per day or corticosteroids at doses ≤10 mg prednisolone equivalent that had been changed during the study
- •Any human albumin treatment in the 3 months before randomization
研究组 & 干预措施
AMPION™ 4 mL dose
4 mL injection of Ampion
干预措施: 4 mL injection of Ampion (Biological)
Placebo 4 mL dose
4 mL injection of placebo
干预措施: 4 mL injection of Placebo (Drug)
结局指标
主要结局
Change in Knee Pain (Phase 2)
时间窗: Scored at Baseline and 20 Weeks
Mean Change in WOMAC A Pain (Western Ontario and McMaster Universities Arthritis Index) score from Baseline to 12 weeks. 5-point Likert scale (0=none to 4=extreme). A negative difference constitutes a decrease in pain with a greater negative value indicating a greater reduction in pain.
Incidence and Severity of Adverse Events and Serious Adverse Events (Phase 1)
时间窗: 24 Weeks
Incidence and severity of adverse events and serious adverse events evaluated at 24 weeks
次要结局
- Change in Knee Function (Phase 2)(Scored at Baseline and 20 Weeks)