A Study to Evaluate Safety of Three Intra-articular Injections of Ampion in the Knee of Adults With Osteoarthritis Pain

Summary

Phase 1 will evaluate the safety of 3 intra-articular injections of Ampion™ administered 2 weeks apart to adults with osteoarthritis of the knee. In the absence of serious drug-related Adverse Events (AEs) of unanticipated drug-related AEs, enrollment will be initiated in Phase 2 of the study. Phase 2 will evaluate the efficacy of 3 intra-articular injections, given 2 weeks apart, of Ampion™ in Adults with pain due to osteoarthritis of the knee.

Timeline

Start

2014-06

Primary completion

2015-10

Completion

2015-10

Outcome

Met primary endpoint

paper Those treated with LMWF-5A had a significant decrease in pain at 20 weeks compared with the saline group (-1.41 [SD, 0.81] vs -0.85 [SD, 0.64], P=.02), PMID 27684085 ↗

registry analysis (superiority test); Ampion 4 mL Injection vs Placebo 4 mL Injection; p = 0.02; t-test, 2 sided NCT02184156 ↗

Publications

• Results Schwappach J, Dryden SM, Salottolo KM. Preliminary Trial of Intra-articular LMWF-5A for Osteoarthritis of the Knee. Orthopedics. 2017 Jan 1;40(1):e49-e53. doi: 10.3928/01477447-20160926-02. Epub 2016 Sep 30.

Drugs

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

Indications