Phase 1, Dose Escalation Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SM04690 in Moderate to Severe Knee Osteoarthritis (OA)

NCT02095548 ↗

Phase 1 Completed 61 enrolled Biosplice Therapeutics, Inc.

RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is to find the optimal dose of SM04690 that can be safely given by intra-articular injection into the target knee joint of subjects with moderate to severe osteoarthritis.

Timeline

Start: 2014-03
Primary completion: 2015-09
Completion: 2015-09

Publications

Yazici Y, McAlindon TE, Fleischmann R, Gibofsky A, Lane NE, Kivitz AJ, Skrepnik N, Armas E, Swearingen CJ, DiFrancesco A, Tambiah JRS, Hood J, Hochberg MC. A novel Wnt pathway inhibitor, SM04690, for the treatment of moderate to severe osteoarthritis of the knee: results of a 24-week, randomized, controlled, phase 1 study. Osteoarthritis Cartilage. 2017 Oct;25(10):1598-1606. doi: 10.1016/j.joca.2017.07.006. Epub 2017 Jul 13.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Lorecivivint	Small molecule	0.03 mg	Other
Subject	Lorecivivint	Small molecule	0.07 mg	Other
Subject	Lorecivivint	Small molecule	0.23 mg	Other

Indications

No indication recorded.