A Phase 2, Randomized, Double-Blind, Vehicle-Controlled Study Evaluating the Safety, Efficacy and Pharmacokinetics of Single Dose EP-104IAR for 24 Weeks in Patients With Osteoarthritis of the Knee
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 318
- 试验地点
- 11
- 主要终点
- Difference in Change From Baseline Between EP-104IAR and Vehicle in WOMAC Pain Subscale
研究概览
简要总结
The purpose of this study is to evaluate the safety, efficacy and pharmacokinetics (PK) of EP-104IAR in patients with osteoarthritis (OA) of the knee
详细描述
This is a randomized, double-blind, placebo-controlled, single injection, 24-week study to evaluate the safety, efficacy and PK of EP-104IAR in subjects with osteoarthritis knee pain
Following screening and baseline assessments to determine eligibility, each participant will receive a single IA injection of either EP-104IAR or placebo (vehicle). Participants will be followed up for 24 weeks following the injection for safety, PK and efficacy assessments.
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)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females, aged ≥40 years
- •Body Mass Index (BMI) ≤ 40.0 kg/m2
- •Diagnosis of primary OA of the Index knee, with symptoms present for at least 6 months
- •OA severity Grade 2 or 3 (based on Kellgren Lawrence Grading Scale)
- •Unsatisfactory pain relief from at least 2 prior standard OA treatments
- •Qualifying pain in the Index knee during the baseline period
- •Ambulatory (without the need for a cane/other walking aide)
- •Female subjects willing to use highly effective birth control methods to prevent pregnancy
- •Willing and able to comply with study procedures and restrictions, including abstaining from use of restricted medications.
排除标准
- •OA of the Index knee due to acute injury or trauma, or unstable joint
- •X-ray evidence of chondrocalcinosis
- •Diagnosed or suspected ipsilateral hip OA
- •Knee pain that is not attributable to OA of the knee
- •Any other disorders that impact mobility, strength or sensation, or are a co-existent source of pain or inflammation that interfere with assessment of knee pain and function
- •History of infection in the Index knee
- •Skin breakdown on the Index knee where the injection will take place
- •Total Knee Replacement, or any other surgery (including arthroscopy) for the Index knee within prior 12 months, or planned surgery during the study
- •Total Knee Replacement Surgery of the non-Index knee within prior 6 months, or planned surgery (any location) during the study that would require a restricted medication
- •IA injection of corticosteroids in any joint within prior 3 months or IA injection of extended-release corticosteroids in any joint within prior 6 months
- •IA injection in the Index knee of platelet rich plasma, or other prolotherapy within prior 3 months, or hyaluronic acid within prior 6 months
- •Recent, current or planned use of corticosteroids for any indication (except for permitted uses)
- •Recent, current or planned use of prohibited medications (including analgesics, marijuana, investigational drugs and devices, immunosuppressive therapy), or unwilling or unable to stop using prohibited medications during the study.
- •Conditions including: sarcoidosis, amyloidosis, osteomyelitis, Cushing's Syndrome, hepatic or renal disease, Psychotic disorder, bipolar disorder, symptomatic depressive or anxiety disorders.
- •Current malignancy of any type, or history of a malignancy within prior 12 months
- •Active or quiescent systemic fungal, bacterial (including tuberculosis) viral (including HIV, Hepatitis B or C) or parasitic infections, or ocular herpes simplex, or any recent infection requiring IV or oral antibiotics
- •Laboratory results indicative of adrenal insufficiency, diabetes or renal or hepatic disease.
- •Positive urine drug screen for a substance of abuse
- •Females who are pregnant, lactating
- •Known or suspected hypersensitivity or contraindication to ingredients in the study drug
研究组 & 干预措施
EP-104IAR 25 mg
A single use intra-articular injection containing 25 mg of EP-104IAR
干预措施: EP-104IAR 25 mg (Drug)
Placebo (vehicle)
A single use intra-articular injection containing no active ingredients
干预措施: Vehicle (Drug)
结局指标
主要结局
Difference in Change From Baseline Between EP-104IAR and Vehicle in WOMAC Pain Subscale
时间窗: 12 weeks
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale (scores scaled 0-10, with 10 being the worst). Least squares mean from a mixed model for repeated measures (MMRM) for change from baseline with fixed effects for site, treatment, week, treatment-by-week interaction; random effect for subject; and covariate baseline WOMAC pain score.
次要结局
- Difference in Change From Baseline Between EP-104IAR and Vehicle in WOMAC Function Subscale(12 weeks)
- Difference Between EP-104IAR and Vehicle in the Area Under the Curve (AUC) of WOMAC Pain Subscale(12 weeks)
- Difference in Change From Baseline Between EP-104IAR and Vehicle in WOMAC Pain Subscale(24 weeks)
- Difference Between EP-104IAR and Vehicle in OMERACT-OARSI Strict Responders(12 weeks)