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

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

Timeline

Start

2021-09-10

Primary completion

2023-05-17

Completion

2023-06-01

Outcome

Met primary endpoint

registry LEAST_SQUARES_MEAN EP-104IAR 25 mg: -2.89 (Standard Error 0.166) score on a scale NCT04120402 ↗

registry analysis (superiority test); EP-104IAR 25 mg vs Placebo (Vehicle); p = 0.004; ANCOVA NCT04120402 ↗

Publications

• Malone A, Kowalski MM, Helliwell J, Lynggaard Boll S, Rovsing H, Moriat K, Castillo Mondragon A, Li Y, Prener Miller C, Reinstrup Bihlet A, Dobek C, Peck V, Wilmink M, Simon LS, Conaghan PG. Efficacy and safety of a diffusion-based extended-release fluticasone propionate intra-articular injection (EP-104IAR) in knee osteoarthritis (SPRINGBOARD): a 24-week, multicentre, randomised, double-blind, vehicle-controlled, phase 2 trial. Lancet Rheumatol. 2024 Dec;6(12):e860-e870. doi: 10.1016/S2665-9913(24)00223-6. Epub 2024 Oct 11.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	EP-104IAR	Unknown	25 mg	Other

Indications