Safety Study of a Long-Acting Injectable Steroid to Treat Knee Osteoarthritis

Eupraxia Pharmaceuticals Inc.32 enrolled

Overview

The main purpose of this study is to understand the pharmacokinetics of EP-104IAR and to determine whether it is safe to use in patients with osteoarthritis (OA) of the knee. The study will also provide some preliminary insights into whether the experimental treatment reduces pain in the knee. Osteoarthritis is the most common joint disease, affecting over 20 million people in the US alone. Currently, pain treatments that are injected directly into the knee often work for only a short time and may also have side effects within the rest of the body. The experimental treatment is a steroid that is in the same family of drugs as the most common current injectable treatments for knee osteoarthritis. For this study, the drug is coated with a polymer intended to prolong the time it stays inside the knee and lessen potential side effects.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Osteoarthritis, Knee

Interventions

Eligibility

Sex: ALLMin age: 40 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * OA of Index Knee * Kellgren Lawrence Grade 2 or 3 * Patient-reported pain (PtPain) of Index Knee ≥4 but ≤9 * PtPain of non-Index Knee \<6 * BMI ≦ 40 kg/m2 Exclusion Criteria: * Intra-articular joint injection in the Index Knee within the past 8 weeks for glucocorticoids and 6 months for hyaluronic acid * Insulin-dependent diabetes * Active infection * Pregnant or breast feeding

Locations (3)

Rebalance MD

Victoria, British Columbia, Canada

Centre for Studies in Family Medicine

London, Ontario, Canada

Fowler Kennedy Sports Medicine Clinic

London, Ontario, Canada

Outcomes

Primary Outcomes

Peak Plasma Concentration (Cmax) of fluticasone propionate

Time frame: Up to 42 weeks

Fluticasone propionate concentrations in synovial fluid

Time frame: Up to 30 weeks

Area under the plasma concentration versus time curve (AUC) of fluticasone propionate

Time frame: 12 weeks

Incidence of treatment-emergent adverse events

Time frame: Up to 42 weeks

Change from baseline in clinical laboratory parameters: hematology, chemistry (including cortisol) and urinalysis

Time frame: Up to 42 weeks

Secondary Outcomes

Time to baseline pain in patient-reported Pain Numerical Rating Scale for Index knee

Time frame: Weekly up to 42 weeks

Change from baseline in patient-reported Pain Numerical Rating Scale for Index knee

Time frame: Weekly up to 42 weeks

Change from baseline in patient-reported Global Assessment of Arthritis

Time frame: Up to 42 weeks

Change from baseline in patient-reported Western Ontario and McMaster Universities Arthritis Index (WOMAC)

Time frame: Up to 42 weeks

Change from baseline in patient-reported Short Form - 36 quality of life scores

Time frame: Up to 42 weeks

Change from baseline in Physician's Global Assessment of Arthritis

Time frame: Up to 42 weeks