study to evaluate the efficacy and safety of ep-104iar in patients with osteoarthritis of the knee

Conditions: Osteoarthritis, Knee

Summary: 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

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.

Eligibility criteria:
key inclusion criteria: * 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. key exclusion criteria: * 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