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NCT04520607 · ClinicalTrials.gov registry record · Phase 3
A Long-Term Safety and Efficacy Study of Lorecivivint in Subjects With Osteoarthritis of the Knee
A Phase 3 study, sponsored by Biosplice Therapeutics.
- Terminated
- Registry status
- Phase 3
- Development phase
- 276
- Enrollment target
NCT04520607: Clinical Trial Phase 3 study, sponsored by Biosplice Therapeutics.
NCT04520607 is a Phase 3 study that was terminated before completion, run by Biosplice Therapeutics. The registered enrollment target is 276 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (64% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04520607, a Phase 3 study, was terminated before completion, sponsored by Biosplice Therapeutics.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 276 participants
- Enrollment target
Study 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.
Primary Outcome
Change from OA-11-study baseline in mJSW measured in millimeters as documented by radiograph (X-ray) of the target knee. JSW measurements were provided by a blinded, central imaging vendor using landmark-based, computer-assisted proprietary methodology.
Interventions
- DRUG Placebo
- DRUG Lorecivivint
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 276 participants |
| Start Date | 2020-08-25 |
| Est. Completion | 2023-06-30 |
| Phase | Phase 3 |
Why NCT04520607 stopped before completion
NCT04520607 is an interventional study that assigns participants to a tested intervention. The registered 276 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (64% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04520607 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04520607 about?
NCT04520607 is a clinical study titled "A Long-Term Safety and Efficacy Study of Lorecivivint in Subjects With Osteoarthritis of the Knee". 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 treatmen...
What is the current status of trial NCT04520607?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 276 participants. The study started on 2020-08-25. Estimated completion is 2023-06-30.
What interventions are being tested in trial NCT04520607?
The interventions under investigation include: Placebo (DRUG), Lorecivivint (DRUG).
Who is sponsoring clinical trial NCT04520607?
This trial is sponsored by Biosplice Therapeutics, which has 20 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04520607's enrollment target sits among peer trials
276 1202nd of 2000 higher than 795 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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