NCT04520607

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

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 276 (actual)
• Sponsor: Biosplice Therapeutics, Inc. · Industry
• Sex: All
• Age: 41 Years – 81 Years
• Healthy volunteers: Not accepted

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.

Detailed description

At Visit 1E (on Day 1), upon completion of initial study procedures (e.g., informed consent, eligibility requirements, clinical evaluations including pregnancy testing \[as applicable\], baseline patient-reported outcome \[PRO\] assessments and safety data collection), subjects received a blinded IA injection of either LOR or PBO (as originally randomized in the parent \[OA-11\] study) into their target knee. At Visit 3E (Week 48), upon completion of scheduled clinical, medical, safety and Patient-reported outcome (PRO) assessments, all subjects received an open-label injection of IA LOR into their target knee, such that previously PBO-treated subjects were effectively crossed over to the LOR treatment cohort. Subjects were given the option to either receive a final injection of IA LOR into their target knee and complete both Visit 6E (Week 100) assessments and End-of-Study Visit assessments, or receive no injection and complete End-of-Study Visit assessments only. Subjects who had completed Visit 6E prior to the announcement of study closure were instructed to return to the clinic for End-of-Study Visit assessments. Study OA-07's initial study design was to assess the safety and efficacy of additional treatment with LOR compared to PBO over one year and conclude at Visit 3E. The study was amended to become an open-label study at the Visit 3E that included an End-of-Study visit but without a specified time. The study was intended and described in the protocol to be run until such time as the Sponsor chose to close it. Study OA-07 was administratively closed at Visit 6E (Week 100), with no safety concerns, one year into the open-label study. For these reasons, Study OA-07 is considered a completed study.

Conditions

• Osteoarthritis, Knee

Interventions

Type	Name	Description
DRUG	Placebo	Healthcare professional-administered intra-articular injection of vehicle.
DRUG	Lorecivivint	Healthcare professional-administered intra-articular injections of lorecivivint.

Timeline

• Start date: 2020-08-25
• Primary completion: 2023-06-30
• Completion: 2023-06-30
• First posted: 2020-08-20
• Last updated: 2026-03-24
• Results posted: 2026-03-24

Locations

42 sites across 1 country: United States

Regulatory

• FDA-regulated drug study