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NCT03706521 · ClinicalTrials.gov registry record · Phase 2

MRI Study to Evaluate the Safety and Efficacy of SM04690 for Knee Osteoarthritis

A Phase 2 study, sponsored by Biosplice Therapeutics.

Terminated
Registry status
Phase 2
Development phase
13
Enrollment target

NCT03706521: Clinical Trial Phase 2 study, sponsored by Biosplice Therapeutics.

NCT03706521 is a Phase 2 study that was terminated before completion, run by Biosplice Therapeutics. The registered enrollment target is 13 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03706521, a Phase 2 study, was terminated before completion, sponsored by Biosplice Therapeutics.

TERMINATED
Registry status
Phase 2
Development phase
13 participants
Enrollment target

Study Summary

The purpose of this study was to evaluate the safety and efficacy of lorecivivint (LOR) injected in the target knee joint of moderately to severely symptomatic osteoarthritis (OA) subjects. Efficacy was primarily evaluated via magnetic resonance imaging (MRI).

Primary Outcome

The assessment of hyaline cartilage thickness present in the knee joint can be useful in evaluating cartilage health. Cartilage thickness decreases may indicate knee osteoarthritis progression. Cartilage thickness was measured using a semi-automated Local-Area Cartilage Segmentation (LACS) software for knee cartilage segmentation of knee MRI. The LACS coordinate system is based on anatomical bony landmarks and permits measurement within any subregion of the femorotibial joint consistently acros

Interventions

  • DRUG lorecivivint

Trial Details

FieldValue
Enrollment Target 13 participants
Start Date 2019-03-11
Est. Completion 2020-12-21
Phase Phase 2
Biosplice Therapeutics

20 total trials

Why NCT03706521 stopped before completion

NCT03706521 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (90% lower).

The record links to 0 conditions, and to 1 intervention - of which lorecivivint is the first listed.

NCT03706521 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03706521 about?

NCT03706521 is a clinical study titled "MRI Study to Evaluate the Safety and Efficacy of SM04690 for Knee Osteoarthritis". The purpose of this study was to evaluate the safety and efficacy of lorecivivint (LOR) injected in the target knee joint of moderately to severely symptomatic osteoarthritis (OA) subjects. Efficacy was primarily evaluated via magnetic resonance imaging (MRI).

What is the current status of trial NCT03706521?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 13 participants. The study started on 2019-03-11. Estimated completion is 2020-12-21.

What interventions are being tested in trial NCT03706521?

The interventions under investigation include: lorecivivint (DRUG).

Who is sponsoring clinical trial NCT03706521?

This trial is sponsored by Biosplice Therapeutics, which has 20 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03706521's enrollment target sits among peer trials

13 1947th of 2000 higher than 53 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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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Source: ClinicalTrials.gov NCT03706521, the US trial registry maintained by the National Library of Medicine. NCT03706521 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.