Conditions: Osteoarthritis, Knee
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 318
Healthy volunteers: no

Brief 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

Detailed description:
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.

Arms:
arm 1: A single use intra-articular injection containing 25 mg of EP-104IAR arm 2: A single use intra-articular injection containing no active ingredients

Interventions: intervention 1: EP-104IAR 25 mg intervention 2: Vehicle
Intervention descriptions: intervention 1: Single 5 mL intra-articular injection intervention 2: Single 5 mL intra-articular injection

Protocol document:
Prot_000.pdf: 
NCT04120402

































































































































































































































SAP_001.pdf: 
Statistical Analysis Plan
Sponsor:
Eupraxia Pharmaceuticals Inc.
Protocol No:
EP-104IAR-201
Protocol Title:
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
Document Date:
14-Jun-2023
Document Revision
Final 1.0
NCT04120402