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Knee osteoarthritis drug trial ends early – what we know

NCT ID NCT04520607

Disease control Sponsor: Biosplice Therapeutics, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a drug called lorecivivint, given as a knee injection, to see if it could safely slow knee osteoarthritis and improve pain and function over two years. It enrolled 276 people who had already completed an earlier study. The trial was terminated early, so the full results are not available. The drug aims to control the disease rather than cure it.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
lorecivivint (a drug injected into the knee joint)
What this could lead to
If it works, this could point toward a treatment that slows knee osteoarthritis and eases pain and stiffness.
What could go wrong
This trial was terminated early, so results are limited. It is a Phase 3 study, but the drug may not work better than placebo, and injections carry risks like pain or infection.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

276 people

The number who actually took part.

Started

Aug 2020

Finished

Jun 2023

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

41 to 81 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Completion of the Study SM04690-OA-11 (NCT03928184) 2. Compliance with procedures in study SM04690-OA-11, in the opinion of the Investigator 3. Fully understanding study requirements and willingness to comply with study visits and assessments 4. Understanding and signing of the informed consent form (ICF) prior to any study-related procedures Exclusion Criteria: 1. Any condition that, in the opinion of the Investigator, constitutes a risk or contraindication for participation in the study or that could interfere with the study objectives, conduct, or evaluation 2. Any contraindications for an intra-articular (IA) injection in the target knee in the opinion of the Investigator 3. Any known reason identified by the Investigator or Sponsor that the subject may not be compliant with study visits or may no longer be an appropriate candidate for the study (e.g. planned major surgery, knee replacement during the parent study, planning to move away from the research site, or initiation of a prohibited concomitant medication including, but not limited to, IA injection of glucocorticoids, hyaluronic acid derivatives, platelet-rich plasma, stem cell therapies, or other agents with therapeutic intent into the target knee) 4. Participation in a clinical research trial (other than the prior SM04690-OA-11 study) that included the receipt of an investigational product (IP) or any experimental therapeutic procedure within 12 weeks before any study injection, or planned participation in any such trial 5. Current or pending disability claim, workers' compensation, or litigation(s) that may compromise response to treatment 6. Pregnant women, breastfeeding women, and women who are not post-menopausal (defined as 12 months with no menses without an alternative medical cause) or permanently surgically sterile (includes hysterectomy, bilateral salpingectomy, and bilateral oophorectomy) who have a positive or indeterminate pregnancy test result at Visit 1E (Day 1) 7. Women who are not post-menopausal or permanently surgically sterile who are sexually active, and who are not willing to use birth control (as outlined in the protocol) during the study period

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Conditions

The condition(s) this trial relates to.

osteoarthritis osteoarthritis, knee

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Osteoarthritis, knee

Contacts and locations

Locations

  • Research Site

    Tucson, Arizona, 85712, United States

  • Research Site

    Anaheim, California, 92805, United States

  • Research Site

    Pomona, California, 91767, United States

  • Research Site

    San Diego, California, 92103, United States

  • Research Site

    Thousand Oaks, California, 91360, United States

  • Research Site

    Denver, Colorado, 80209, United States

  • Research Site

    Hialeah, Florida, 33016, United States

  • Research Site

    Miami, Florida, 33173, United States

  • Research Site

    Miami Lakes, Florida, 33014, United States

  • Research Site

    Port Orange, Florida, 32127, United States

  • Research Site

    West Palm Beach, Florida, 33409, United States

  • Research Site

    Winter Haven, Florida, 33880, United States

  • Research Site

    Winter Park, Florida, 32789, United States

  • Research Site

    Newnan, Georgia, 30265, United States

  • Research Site

    Woodstock, Georgia, 30189, United States

  • Research Site

    Gurnee, Illinois, 60031, United States

  • Research Site

    Oak Brook, Illinois, 60523, United States

  • Research Site

    Valparaiso, Indiana, 46383, United States

  • Research Site

    New Orleans, Louisiana, 70124, United States

  • Research Site

    Bay City, Michigan, 48706, United States

  • Research Site

    Troy, Michigan, 48085, United States

  • Research Site

    Hazelwood, Missouri, 63042, United States

  • Research Site

    St Louis, Missouri, 63141, United States

  • Research Site

    Omaha, Nebraska, 68114, United States

  • Research Site

    Hartsdale, New York, 10530, United States

  • Research Site

    New York, New York, 10016, United States

  • Research Site

    Rochester, New York, 14609, United States

  • Research Site

    Charlotte, North Carolina, 28209, United States

  • Research Site

    Salisbury, North Carolina, 28144, United States

  • Research Site

    Winston-Salem, North Carolina, 27103, United States

  • Research Site

    Cincinnati, Ohio, 45242, United States

  • Research Site

    Columbus, Ohio, 43235, United States

  • Research Site

    Oklahoma City, Oklahoma, 73103, United States

  • Research Site

    Fort Mill, South Carolina, 29707, United States

  • Research Site

    Mt. Pleasant, South Carolina, 29464, United States

  • Research Site

    Rapid City, South Dakota, 57702, United States

  • Research Site

    Carrollton, Texas, 75007, United States

  • Research Site

    Plano, Texas, 75075, United States

  • Research Site

    San Antonio, Texas, 78229, United States

  • Research Site

    Draper, Utah, 84020, United States

  • Research Site

    Salt Lake City, Utah, 84107, United States

  • Research Site

    Charlottesville, Virginia, 22911, United States

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