AP-003-C Study to Confirm the Efficacy of Ampion™ in Adults With Pain Due to Severe Osteoarthritis of the Knee

Phase 3 Completed 168 enrolled Ampio Pharmaceuticals. Inc.

RandomizedParallel-groupDouble-blindTreatment

Summary

This is a phase 3 randomized study to confirm the efficacy of an intra-articular injection of Ampion™ in adults with pain due to severe osteoarthritis of the knee.

Timeline

Start: 2017-06-19
Primary completion: 2017-12-07
Completion: 2017-12-07

Outcome

Met primary endpoint

registry analysis (superiority test); Ampion 4 mL Dose vs Saline 4 mL Dose; p <0.0001; Fisher Exact NCT03182686 ↗

paper Overall, 71% (95% CI: 63.4%-78.3%) of subjects treated with LMWF-5A met the OMERACT-OARSI responder criteria, exceeding the 30% threshold (p < 0.001). PMID 29910837 ↗

Publications

Results Salottolo K, Cole B, Bar-Or D. Intra-articular injection of the anti-inflammatory compound LMWF-5A in adults with severe osteoarthritis: a double-blind prospective randomized controlled multi-center safety and efficacy trial. Patient Saf Surg. 2018 Jun 18;12:11. doi: 10.1186/s13037-018-0158-0. eCollection 2018.

Drugs

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