Study to Evaluate the Efficacy and Safety of EP-104IAR in Patients With Osteoarthritis of the Knee

• Status: Recruiting
• Trial end date: 2022-10-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eupraxia Pharmaceuticals Inc.
• Collaborator: NBCD A/S

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, diabeties mellitus, 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