NCT04120402

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 318 (actual)
• Sponsor: Eupraxia Pharmaceuticals Inc. · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Osteoarthritis, Knee

Interventions

Type	Name	Description
DRUG	EP-104IAR 25 mg	Single 5 mL intra-articular injection
DRUG	Vehicle	Single 5 mL intra-articular injection

Timeline

• Start date: 2021-09-10
• Primary completion: 2023-05-17
• Completion: 2023-06-01
• First posted: 2019-10-09
• Last updated: 2024-06-25
• Results posted: 2024-06-25

Locations

12 sites across 3 countries: Czechia, Denmark, Poland

Regulatory

• FDA-regulated drug study