NCT05337540已完成不适用
A Double-Blind, Randomized, Controlled, Three Parallel Arm, Dose-Finding Study to Evaluate the Efficacy, Safety and Tolerability of One Single Intra-Articular Injection of EVI-01 in Patients With Symptomatic Osteoarthritis of the Knee
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Aptissen SA
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Changes to the questionnaire WOMAC A (Western Ontario and McMaster Universities) Numeric 3.1
研究概览
简要总结
Objective: Identifying the dose of EVI-01 with the best clinical response, balancing the efficacy, safety, and tolerability of the investigational product.
Study design: Interventional, dose-finding, three arms, randomized (1:1:1), parallel assignment, double-blind, controlled by an active comparator.
详细描述
Phase II, dose-finding, interventional, three-arm, randomized (1:1:1), double-blind, parallel, active-comparator-controlled clinical trial.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of both genders aged 18 years or older;
- •Body Mass Index (BMI) < 35 kg/m2;
- •Diagnosis of primary knee osteoarthritis, Kellgren-Lawrence Grade 2 to 4, according to American College of Rheumatology (ACR) criteria and confirmed radiologically within the previous 12 months, for which an intraarticular treatment is indicated;
- •Moderate to severe pain measured by VAS (0-100mm) and >40mm in the knee to be treated, partially responsive to chronic doses of nonsteroidal anti-inflammatory drugs (NSAIDs), analgesics, or weak opioids (codeine and tramadol);
- •Ability to understand and provide signed consent through the Informed Consent Form (ICF).
排除标准
- •History of hypersensitivity/allergy to hyaluronic acid (HA) or other excipients of the IP or product;
- •Pregnant or breastfeeding women;
- •Women at menace who do not agree to use acceptable contraceptive methods (oral contraceptive, injectable contraceptive, IUD, hormonal implant, barrier methods, sexual abstinence, hormone transdermal patch and tubal ligation); except those who are surgically sterile (bilateral oophorectomy or hysterectomy);
- •Emotional problems or any situation that, at the Investigator's discretion, places the safety of subjects at risk;
- •Application of visco-supplementation to the knee less than four months prior to randomization;
- •Corticosteroid IA injection less than 4 months prior to randomization and/or schedule during the course of the study;
- •Knee infection and/or inflammation (e.g., bursitis), skin infection at or around the IA injection;
- •Swelling, redness, warmth, or other clinically relevant inflammatory signs in the knee in the investigator's description
- •Knee injury or trauma;
- •Patients with bleeding diathesis or on anticoagulant therapy;
- •Major knee malformations or deformities that the investigator deems pertinent;
- •Active cancer at the Investigator's discretion;
- •Continuous or frequent use (use for more than 2 weeks in the last 2 months) of corticosteroids by any route of administration (oral, IM, IV)
- •Concomitant use of chondroprotective drugs such as glucosamine, chondroitin, or collagen. These medications should not be introduced during the study, but if the patient is already taking them may be included, but the medication will not change.
- •Need for the use of strong opioids (methadone, fentanyl, morphine, and oxycodone) for pain management;
- •Participation in a clinical trial within the last twelve months prior to enrollment (CNS Resolution 251, dated 07 August 1997, item III, item J), unless the investigator believes that there may be a benefit to the patient.
结局指标
主要结局
Changes to the questionnaire WOMAC A (Western Ontario and McMaster Universities) Numeric 3.1
时间窗: from baseline to 180 days after randomization
Questionnaire WOMAC A (Western Ontario and McMaster Universities) numeric scale, version 3.1, total knee pain score (pain, stiffness and physical function assessment)
Comparison of treatment-related Adverse Events in the three groups
时间窗: from baseline to 180 days after randomization
Incidence of treatment-emergent adverse events
次要结局
- Response rate, according to OMERACT-OARSI2 international criteria(from baseline to Days 28, 90 and 180 after randomization)
- Changes to the WOMAC (Western Ontario and McMaster Universities) A score(from Day 1 to Day 7 after randomization)
- Response to the Euro Quality of Life Questionnaire(from baseline to 180 days after randomization)
- Changes to the WOMAC (Western Ontario and McMaster Universities) Total Numeric 3.1 score(from baseline to 180 days after randomization)
研究者
研究点 (2)
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