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

2019-10-15 11:11:14 | BioPortfolio

Summary

The purpose of this study is to evaluate the safety, efficacy and pharmacokinetics (PK) of different doses of EP-104IAR in patients with osteoarthritis (OA) of the knee

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

The study has 2 parts:

Part A: A sequential dose-escalation phase to select a well-tolerated dose of EP-104IAR. Doses to be evaluated in this phase of the study include 25, 32, 40 and 50 mg.

Part B: A parallel group phase where the highest well-tolerated dose of EP-104IAR (chosen in Part A) will be compared to placebo (vehicle).

Participants in Parts A and B will complete the same assessments. 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.

Study Design

Conditions

Osteoarthritis, Knee

Intervention

EP-104IAR 25 mg, EP-104IAR 32 mg, EP-104IAR 40 mg, EP-104IAR 50 mg, Vehicle

Status

Not yet recruiting

Source

Eupraxia Pharmaceuticals Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-10-15T11:11:14-0400

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