临床试验/NCT05618782

NCT05618782已完成2 期

A Phase 2a, Randomized, Double-Blind, Placebo-Controlled Trial of the Efficacy and Safety of LEVI-04 in Patients With Osteoarthritis of the Knee

Levicept12 个研究点分布在 5 个国家目标入组 518 人开始时间: 2022年10月19日最近更新: 2025年11月20日

适应症

干预措施

试验速览

阶段: 2 期
状态: 已完成
发起方
入组人数: 518
试验地点: 12
主要终点: Least Squares Mean Change From Baseline in WOMAC Pain

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验相关资讯

研究概览

简要总结

This is a phase 2, randomized, double-blind, placebo-controlled trial of multiple doses and multiple administrations of LEVI-04 for the treatment of pain due to osteoarthritis of the knee.

详细描述

The study consists of a Screening Period (including a Diary Run- In/analgesic wash-out Period), Randomization, Post-Randomization Period, and a Follow-up Period. Up to 624 participants will be enrolled and randomized to one of four Treatment Arms at the ratio 1:1:1:1

The overall objective of this study is to evaluate the efficacy and safety of LEVI-04 compared to placebo in patients with knee OA.

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

Double- Blind

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

•Signed Informed Consent form (ICF).
•Male or female participants between ≥40 and ≤80 years of age.
•BMI ≤40 kg/m
•The ability to utilize the eDiary device provided by study sites.
•History of knee pain on most days for at least 3 months prior to Screening
•Confirmation of OA of the knee
•Radiographs of both knees with a Posterior-Anterior, Fixed-flexion view taken during the Screening Period.
•American College of Rheumatology (ACR) clinical and radiographic diagnostic criteria.
•Evidence of knee OA with a KL grade ≥2, determined through central reading.
•Target Knee must have a score of ≥20 out of 50 on the WOMAC pain subscale during Screening and at Randomization
•The Baseline (NRS) Pain score will be derived from the last seven days of the Diary Run-In Period and must meet following criteria:
•Completion of Average Daily (NRS) Pain score on at least 6 of the 7 days.
•Mean Average Daily (NRS) Pain score must be ≥4.0 and ≤9.0
•Mean Average Daily (NRS) Pain variability must be ≤1.5
•If female, not of childbearing potential defined as post-menopausal for at least 1 year, or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy), or practicing an agreed upon highly effective method of birth control throughout the study period.
•If male and sexually active with partner of childbearing potential, willing to agree to practice a highly effective method of contraception from Visit 2 and at least 3 months after Visit 11 (week 20).
•Willing to withdraw from any medication for Osteoarthritis including, but not limited to, Opioids, Non-Steroidal Anti-inflammatories (NSAIDs), COX-2 inhibitors, Topical medication, and Duloxetine.
•Participant agrees to take only the allowed Rescue Medications from the start of the Diary Run-In Period through study completion (maximum 4000 mg paracetamol per day).

排除标准

•Presence of OA of other major joints (including but not limited to nontarget knee) that could interfere with assessment of pain due to OA of the target knee, in the opinion of the investigator.
•Current comorbid condition, other than OA, known to be significantly associated with arthritis or joint pathology, including but not necessarily limited to autoimmune disease with significant joint involvement (e.g., Rheumatoid Arthritis or Paget's disease; Seronegative Spondyloarthropathies (e.g. Ankylosing Spondylitis, Psoriasis arthritis, Reactive arthritis); or other systemic disease involving the target knee (including endocrinopathies).
•The following conditions should be excluded: Known presence of rapidly Progressive Osteoarthritis (RPOA), primary osteonecrosis (including spontaneous osteonecrosis of the knee), subchondral insufficiency fractures (SIF), avascular necrosis, osteoporotic fractures, atrophic OA, excessive malalignment of the knee (anatomical axis angle greater than 10 degrees), pathological fractures, or stress fracture or reaction, vertical tear of the posterior meniscal root, or large or extensive subchondral cysts, or target knee anserine or patellar bursitis of clinical relevance
•Hip dislocation and congenital hip dysplasia with degenerative joint disease should be excluded.
•History of gout with recent (< 6 months) pain flares and uncontrolled uric acid levels. Participants with a history or diagnosis of pseudogout (calcium pyrophosphate dihydrate crystal deposition disease) can enroll if there has not been a flare within 6 months prior to screening and use of NSAIDs is not required for management of this condition.
•Presence of neuropathic pain deemed likely to interfere with trial endpoints, complex regional pain syndrome, or chronic widespread pain syndromes e.g., fibromyalgia.
•History of significant trauma (e.g., intra-articular fracture) or surgery (excluding injection therapies and arthroscopy) to a knee, hip, or shoulder within the previous 1 year
•Planned major surgery or other major invasive procedures while participating in the study.
•Surgery or stent placement for coronary artery disease in the six months prior to screening .
•Nondiagnostic arthroscopy performed on the target knee joint within 180 days prior to Screening; or diagnostic arthroscopy performed on the target knee joint within 90 days prior to Screening.
•Intraarticular injection therapies to the target knee joint within 12 weeks prior to Screening, or to any non-target joint within 6 weeks prior to Screening.
•Participants likely to be deemed unfit for joint replacement surgery due to concomitant illness, in the investigator opinion.
•Opioid use, including Tramadol, of 4 or more instances per week over the month prior to Screening.
•Known history of hypersensitivity to monoclonal antibodies.
•Presence of any medical condition or unstable health status that, in the judgment of the investigator, might adversely impact the safety of the participant.
•Signs and symptoms of significant cardiac disease, including but not limited to established ischemic heart disease, peripheral arterial disease and /or cerebrovascular disease (unstable angina, myocardial infarction, cardiovascular thrombotic events, transient ischemic attacks, and stroke in the six months prior to screening)
•Active malignancy or history of malignancy within the past 5 years, with exception of resected and cured basal cell carcinoma and squamous cell carcinoma of the skin.
•Clinically significant abnormal laboratory parameter(s) and/or ECG parameter(s) during Screening, that, in the judgment of the Investigator, would preclude the participant from participation in this study.
•Participation in other studies involving investigational drug(s) within 30 days (or 90 days for biologics) prior to screening.
•History of Carpal Tunnel Syndrome with symptoms within one year of Screening or a Boston Carpal Tunnel Questionnaire (Symptom Severity Scale) mean score ≥
•A total Symptom Impact score on the Survey of Autonomic Symptoms ≥
•Pregnant or breast feeding.
•Previously received any form of anti-NGF
•Requires walker or wheelchair for mobility (walking stick permitted).
•Active or historic substance abuse within one year of Screening in the opinion of the Investigator.
•Medical history within 5 years of Screening that involves suicidal ideation, suicide attempt, or increased risk of suicide as assessed by the Investigator.
•Presence of any contraindication to MRI

研究组 & 干预措施

0.3 mg/kg LEVI-04

Active Comparator

Intravenous infusion of 0.3 mg/kg LEVI-04

干预措施: LEVI-04 (Drug)

1.0 mg/kg LEVI-04

Active Comparator

Intravenous infusion of 1.0 mg/kg LEVI-04

干预措施: LEVI-04 (Drug)

2.0 mg/kg LEVI-04

Active Comparator

Intravenous infusion of 2.0 mg/kg LEVI-04

干预措施: LEVI-04 (Drug)

Placebo

Placebo Comparator

Intravenous infusion of saline vehicle as placebo

干预措施: Placebo (Other)

结局指标

主要结局

Least Squares Mean Change From Baseline in WOMAC Pain

时间窗: Week 17 Change from Baseline

The primary efficacy endpoint is the change from baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale score, measured on a 0-10 point scale (0=no pain; 10=worse pain; the result reported is mean change from baseline, therefore the greater the reduction in units the better the outcome)

次要结局

Least Squares Mean Change From Baseline in Post-Staircase Evoked Pain Procedure (StEPP) Pain Intensity(Week 17 Change from Baseline)
Least Squares Mean Change From Baseline in WOMAC Physical Function(Week 17 Change from Baseline)
Least Squares Mean Change From Baseline in WOMAC Joint Stiffness Subscale(Week 17 Change from Baseline)
Least Squares Mean Change From Baseline in Patient Global Assessment(Week 17 Change from Baseline)

研究者

发起方

Levicept

申办方类型

Industry

责任方

Sponsor

研究点 (12)

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