A Long-Term Safety and Efficacy Study of Lorecivivint in Subjects With Osteoarthritis of the Knee
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
Outcome
Mixed primary results
Stopped: “Study OA-07 was designed to be conducted until the Sponsor closed it. Study OA-07 was administratively closed at Visit 6E (Week 100), with no safety concerns, one year into the open-label study as described in the protocol.”
registry analysis (superiority test); Placebo vs Lorecivivint; p = 0.233; Mean Difference (Final Values) 0.07 (95% CI -0.06 to 0.23); ANCOVA NCT04520607 ↗
registry analysis (superiority test); Placebo vs Lorecivivint; p = 0.044; Mean Difference (Final Values) -4.52 (95% CI -8.92 to -0.13); ANCOVA NCT04520607 ↗
registry analysis (superiority test); Placebo vs Lorecivivint; p = 0.096; Mean Difference (Final Values) -3.68 (95% CI -8.02 to 0.66); ANCOVA NCT04520607 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lorecivivint | Small molecule | 0.07 mg | Other |