Study of Ampion for the Treatment of Pain and Function in Patients With Severe Osteoarthritis of the Knee.

Summary

The purpose of this study is to confirm the safety and efficacy of Ampion for the treatment of pain and function in patients with severe osteoarthritis of the knee.

Timeline

Start

2019-06-24

Primary completion

2021-07-13

Completion

2021-07-13

Outcome

Missed primary endpoint

Stopped: “The AP-013 study was prematurely terminated by the sponsor after Data Safety Monitoring Board (DSMB) guidance.”

registry analysis (superiority test); Ampion 4 mL Dose vs Placebo 4 mL Dose; p = 0.32; MMRM NCT03988023 ↗

registry analysis (superiority test); Ampion 4 mL Dose vs Placebo 4 mL Dose; p = 0.30; MMRM NCT03988023 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	ASPARTYL-ALANYL-DIKETOPIPERAZINE	Protein / enzyme biologic	4 ml	Other

Indications