NCT05100225Unknown2 期
A Multiple Arm, Multicenter, Prospective, Randomized, Double-Blind, Placebo-Controlled, Parallel-Arm, Phase 2 Study of Intra-Articular Administration of an Allogeneic Human Placental Tissue Particulate (PTP-001) for the Treatment of Knee Osteoarthritis
适应症
试验速览
- 阶段
- 2 期
- 入组人数
- 210
- 试验地点
- 27
- 主要终点
- Efficacy - Change from pretreatment baseline in the WOMAC pain subscale
研究概览
简要总结
Evaluation of safety, tolerability and efficacy of a single intra-articular (IA) injection of PTP-001, an allogeneic placental tissue particulate, in individuals with knee osteoarthritis (OA).
详细描述
This is a multiple arm, multicenter, prospective, randomized, double-blind, placebo-controlled, parallel-arm, phase 2 study of intra-articular administration of an allogeneic human placental tissue particulate (PTP-001) for the treatment of knee osteoarthritis. The study is planned to be conducted outside the United States. A total of approximately 210 participants are planned to be randomized to receive 1 of 2 doses of PTP-001 (100 mg or 200 mg) or saline vehicle control (placebo) injection. The purpose of the trial is to evaluate the efficacy, safety and tolerability of a single low dose and high dose of PTP-001 compared to placebo over a 26-week period.
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)
盲法说明
This is a double-blinded trial, in which neither participant nor investigator will know the content of the investigational product. Additionally, the study staff preparing the syringe. The unblinded personnel must not be involved in any other operational aspects of the trial.
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants are eligible to be included in the study only if all of the following criteria apply:
- •Male or female, aged 40 to 80 years
- •Symptomatic knee OA with Kellgren-Lawrence radiographic classification of 2 or 3 (mild or moderate) as assessed by the central reading facility
- •Target knee pain ≥ 20 and ≤ 40 out of 50 the WOMAC®NRS 3.1 pain questionnaire (sum of 5 questions) at screening and baseline
- •Onset of symptomatic OA of the target knee was at least 6 months prior to screening
- •Insufficient or failed response or intolerance to analgesics and/or non-steroidal anti-inflammatory drugs, as reported by the participant
- •IF FEMALE, must meet all of the following:
- •Not breast feeding
- •Not planning to become pregnant during the study
- •If of childbearing potential, must have a negative pregnancy test result within 72 hours prior to receiving the intra-articular injection, and must commit to the use of a highly effective form of birth control (See Appendix A) for at least 12 weeks after the injection
- •Willingness to remain on the same oral "rescue" (as needed) analgesic as the only pharmacologic treatment for knee pain during the study
- •Willingness to abstain from taking any illicit or unauthorized medications for treatment of OA or any other concurrent condition during the study
- •Written informed consent is obtained from the participant
排除标准
- •Participants are excluded from the study if any of the following criteria apply:
- •Participant is non-ambulatory (unable to walk >50 feet without assistance)
- •Clinically severe obesity as defined by the National Institutes of Health (body mass target ≥40 kg/m2)
- •Contralateral knee pain equal to or exceeding the pain in the target knee (on the WOMAC® NRS3.1 pain questionnaire) at screening and/or baseline
- •Clinically significant effusion of the target knee at either the screening or baseline visits determined by physical examination (e.g., ballotable patella or positive bulge sign). Note: Participants presenting with effusion may be enrolled in the study after undergoing knee aspiration to remove excess fluid in the target joint.
- •Severe (excessive) malalignment of the tibial-femoral axis, assessed radiographically
- •Presence of active infection of the target knee or systemic infection requiring treatment within the 3 months prior to screening
- •Clinical diagnosis of inflammatory arthritis (e.g., rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, systemic lupus erythematosus, etc.) established by clinical history, examination, or serology
- •Participant is receiving, has received, or plans to receive any of the following therapies
- •Prior administration of hyaluronic acid, extended release corticosteroid (e.g., Zilretta®), platelet-rich plasma (PRP), or stem cell therapies by intra-articular injection(s) of the target knee within 6 months prior to screening
- •Prior intra-articular corticosteroid within 3 months prior to screening or into any other joint within 30 days prior to screening
- •Current chronic systemic use of corticosteroids in doses exceeding 10 mg prednisolone-equivalents daily
- •Treatment with any investigational therapy (drug, device, or biologic) within 3 months prior to screening or is planned for the duration of the study
- •Treatment with immunosuppressive medication or chemotherapy within the past 5 years
- •Chronic use of narcotics or alcohol abuse within the past 6 months prior to screening
- •Surgery to the target knee (including arthroscopy) within 6 months prior to receiving the intra-articular injection or planned surgery to the target knee within 6 months after the injection
- •Participant previously underwent arthroplasty of the target knee
- •Presence of joint instability or complaints of locking, intermittent limitation in range of motion, or loose body sensation, suggestive of internal derangement of the knee (either extremity)
- •Symptomatic OA of the non-target knee that is not responsive to paracetamol (acetaminophen) or oral nonsteroidal anti-inflammatory drugs (NSAIDs).
- •Diagnosis of lower extremity gout or pseudo-gout in the past 6 months
- •Osteonecrosis of either knee
- •Significant acute (within the past 3 months) injury to the target knee
- •History of receiving a solid organ or hematologic transplant
- •History of malignancy, radiotherapy, or chemotherapy for malignancy within the past 5 years, except for basal or squamous cell carcinoma of the skin
- •History of prior radiation therapy of the target knee
- •History of autoimmune disease affecting the musculoskeletal system
- •Known (documented) history of acquired immune deficiency syndrome or human immunodeficiency virus
- •Any condition causing pain in or around the target knee (e.g., radiating pain, pain in another region of the ipsilateral lower extremity) that may interfere with assessment(s) of the target knee
- •Other chronic pain anywhere in the body that requires the chronic use of analgesic medications, such as fibromyalgia, neuropathic pain, low back pain, etc.
- •Presence of contraindications for use of 3 g/day of orally administered paracetamol/acetaminophen due to known hypersensitivity or hepatic impairment.
- •Known presence of any concurrent medical condition (e.g., hematologic renal, hepatic, cardiac, or coagulation abnormalities) that in the investigator's judgment would interfere with the required study assessments and study participation
- •Participant is involved in litigation (e.g., worker's compensation) for a medical condition or injury at any anatomical site
结局指标
主要结局
Efficacy - Change from pretreatment baseline in the WOMAC pain subscale
时间窗: At 6 months
To evaluate the change from pretreatment baseline in the WOMAC pain sub-score in the target knee on an 11-box numerical rating scale, with categories from 0 (none) to 10 (extreme), normalized on scales of 0-100.
Safety - Incidence of local and systemic AEs
时间窗: Over 6 months
To assess the long-term (6 months) incidence of local and systemic AEs, and consists of physical examination, laboratory values, AEs, AESI, and immunogenicity testing.
次要结局
- Change from pretreatment baseline in participant self-reported quality of life measured by SF-36 overall score, PCS, and MCS.(At 3 months and 6 months.)
- Change from pretreatment baseline in the weekly average of daily pain assessed by patient self report (NRS).(At 2 weeks, 3 months, 4 months, 5 months, and 6 months.)
- Response to PTP-001 on the OMERACT-OARSI responder criteria.(At 2 weeks, 3 months, and 6 months.)
- Change from pretreatment baseline in pain intensity assessed by participant self report (WOMAC Pain subscale).(At 2 weeks, 3 months, 4 months, 5 months.)
- Change from pretreatment baseline in function assessed by participant self-report (WOMAC Function subscale).(At 2 weeks, 3 months, 4 months, 5 months, and 6 months.)
- Change from pretreatment baseline in patient global assessment of OA (PGA-OA) assessed by participant self report.(At 2 weeks, 3 months, 4 months, 5 months, and 6 months.)
研究者
研究点 (27)
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