drugset / Trial / NCT04520607

A Long-Term Safety and Efficacy Study of Lorecivivint in Subjects With Osteoarthritis of the Knee

NCT04520607

Phase 3 Terminated 276 enrolled Biosplice Therapeutics, Inc.
RandomizedParallel-groupTriple-blindTreatment

Summary

Study OA-07 was a randomized, double-blind, placebo-controlled, Phase 3, multicenter, 2-year clinical trial that enrolled subjects from the recently completed Study OA-11 (NCT03928184). The first 48 weeks of OA-07 the trial was placebo-controlled with subjects receiving the same randomized treatment received in OA-11. Investigators, research staff and subjects remained blinded to treatment allocation. At Week 48, all subjects were administered LOR in the open-label portion of the trial.

Timeline

Start
2020-08-25
Primary completion
2023-06-30
Completion
2023-06-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Lorecivivint Small molecule 0.07 mg Other

Indications