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NCT04931667 · ClinicalTrials.gov registry record · Phase 3
3-year, Open-Label Study Evaluating Safety, Tolerability, and Efficacy of Lorecivivint in Knee Osteoarthritis
A Phase 3 study, sponsored by Biosplice Therapeutics.
- Terminated
- Registry status
- Phase 3
- Development phase
- 72
- Enrollment target
NCT04931667: Clinical Trial Phase 3 study, sponsored by Biosplice Therapeutics.
NCT04931667 is a Phase 3 study that was terminated before completion, run by Biosplice Therapeutics. The registered enrollment target is 72 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04931667, a Phase 3 study, was terminated before completion, sponsored by Biosplice Therapeutics.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 72 participants
- Enrollment target
Study Summary
This study is designed as a 3-year, multicenter, open-label study evaluating the safety, tolerability, and efficacy of intra-articular (IA) Lorecivivint (LOR) in subjects with osteoarthritis of the knee in a real-world setting.
Primary Outcome
Change from baseline in pain numeric rating scale (NRS) score for the left knee. The pain NRS is an 11-point scale \[0-10\] for subject self-reporting of average knee pain in the last 24 hours; 0 indicates no pain, and 10 represents the worst possible pain. Change was calculated as three-month visit minus baseline; a negative value indicates improvement while a positive value indicates worsening.
Interventions
- DRUG Lorecivivint
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2021-07-15 |
| Est. Completion | 2021-12-13 |
| Phase | Phase 3 |
Why NCT04931667 stopped before completion
NCT04931667 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 72 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 1 intervention - of which Lorecivivint is the first listed.
NCT04931667 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04931667 about?
NCT04931667 is a clinical study titled "3-year, Open-Label Study Evaluating Safety, Tolerability, and Efficacy of Lorecivivint in Knee Osteoarthritis". This study is designed as a 3-year, multicenter, open-label study evaluating the safety, tolerability, and efficacy of intra-articular (IA) Lorecivivint (LOR) in subjects with osteoarthritis of the knee in a real-world setting.
What is the current status of trial NCT04931667?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 72 participants. The study started on 2021-07-15. Estimated completion is 2021-12-13.
What interventions are being tested in trial NCT04931667?
The interventions under investigation include: Lorecivivint (DRUG).
Who is sponsoring clinical trial NCT04931667?
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 NCT04931667's enrollment target sits among peer trials
72 1780th of 2000 higher than 217 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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