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NCT03928184 · ClinicalTrials.gov registry record · Phase 3
Patient-Reported and Radiographic Outcomes in Evaluating Lorecivivint (SM04690) for the Treatment of Knee Osteoarthritis
A Phase 3 study, sponsored by Biosplice Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 501
- Enrollment target
NCT03928184: Completed Phase 3 study, sponsored by Biosplice Therapeutics.
NCT03928184 is a Phase 3 study that has completed, run by Biosplice Therapeutics. The registered enrollment target is 501 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (35% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03928184, a Phase 3 study, has completed, sponsored by Biosplice Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 501 participants
- Enrollment target
Study Summary
This phase 3 study is a multicenter, randomized, double-blind, placebo-controlled study of lorecivivint injected intra-articularly (IA) into the target knee (most painful) joint of moderately to severely symptomatic osteoarthritis (OA) subjects at a single dose of 0.07 mg lorecivivint per 2 mL injection. This study will utilize radiographs and patient reported outcomes (PROs) to evaluate the safety and efficacy of lorecivivint.
Primary Outcome
Evaluate change from baseline OA pain in the target knee as assessed by the weekly averages of daily pain numeric rating scale (NRS). 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.
Interventions
- DRUG Placebo
- DRUG Lorecivivint
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 501 participants |
| Start Date | 2019-05-17 |
| Est. Completion | 2021-08-20 |
| Phase | Phase 3 |
What the finished NCT03928184 record still lists
NCT03928184 is an interventional study that assigns participants to a tested intervention. The registered 501 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 (35% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03928184 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03928184 about?
NCT03928184 is a clinical study titled "Patient-Reported and Radiographic Outcomes in Evaluating Lorecivivint (SM04690) for the Treatment of Knee Osteoarthritis". This phase 3 study is a multicenter, randomized, double-blind, placebo-controlled study of lorecivivint injected intra-articularly (IA) into the target knee (most painful) joint of moderately to severely symptomatic osteoarthritis (OA) subjects at a single dose of 0.07 mg lorecivivint per 2 mL injec...
What is the current status of trial NCT03928184?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 501 participants. The study started on 2019-05-17. Estimated completion is 2021-08-20.
What interventions are being tested in trial NCT03928184?
The interventions under investigation include: Placebo (DRUG), Lorecivivint (DRUG).
Who is sponsoring clinical trial NCT03928184?
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 NCT03928184's enrollment target sits among peer trials
501 743rd of 2000 higher than 1,257 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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