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One shot to ease knee pain? new drug shows promise in large trial

NCT ID NCT04385303

Symptom relief 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 This study
The trial has finished. Results may not be published yet.
Stopped early
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This status has not been confirmed recently, so it may be out of date.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 single injection of a drug called lorecivivint in the knee joint of 496 people with moderate to severe knee osteoarthritis. The goal was to see if it reduces pain and improves function compared to a placebo (fake injection) over 28 weeks. Participants reported their pain levels weekly using a simple 0-10 scale.

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

496 people

The number who actually took part.

Started

May 2020

Finished

Sep 2021

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

40 to 80 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.

Key Inclusion Criteria: * Males and females between 40 and 80 years of age, inclusive, in general good health apart from their knee OA * Ambulatory (single assistive devices such as canes allowed if needed less than 50% of the time, subjects requiring a walker are excluded) * Diagnosis of femorotibial OA in the target knee by standard American College of Rheumatology (ACR) criteria at the Screening Visit (clinical AND radiographic criteria); OA of the knee is not to be secondary to any rheumatologic conditions (e.g., rheumatoid arthritis) * Radiographic disease Stage 2 or 3 in target knee within 24 weeks of the Screening Visit according to the Kellgren-Lawrence (KL) grading of knee OA as assessed by independent central readers * Qualifying mean score on the 24-h average pain score (0-10 numeric rating scale) * Pain compatible with OA of the knee(s) for at least 26 weeks prior to the Screening Visit * Primary source of pain throughout the body is due to OA in the target knee * Body mass index (BMI) ≤ 35 kg/m2 at the Screening Visit * Negative drug test for amphetamine, buprenorphine, cocaine, methadone, opiates, phencyclidine (PCP), propoxyphene, barbiturates, benzodiazepine, methaqualone, and tricyclic antidepressants, unless any of these drugs are allowed per protocol and prescribed by a physician to treat a specific condition Key Exclusion Criteria: * 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 the Screening Visit or Day 1 * Significant malalignment of anatomical axis (medial angle formed by the femur and tibia) of the target knee (varus \> 10°, valgus \> 10°) by radiograph within 24 weeks of the Screening Visit as assessed by independent central readers * Partial or complete joint replacement in either knee * Currently requires use of a lower extremity prosthesis, and/or a structural knee brace (i.e., a knee brace that contains hardware) * Any surgery (e.g., arthroscopy) in either knee within 26 weeks prior to Day 1 * Intra-articular (IA) injection into the target knee with a therapeutic aim including, but not limited to hyaluronic acid, platelet-rich plasma (PRP), and stem cell therapies within 26 weeks prior to Day 1; or IA glucocorticoids within 12 weeks prior to Day 1 allowed * Previous treatment with lorecivivint (SM04690) * Subjects who have previously failed screening on this protocol and fail to meet re-screening criteria * Participation in a clinical research trial that included the receipt of an investigational product or any experimental therapeutic procedure within 26 weeks prior to the Screening Visit, or planned participation in any such trial * Subjects requiring the use of opioids \> 1x per week within 12 weeks prior to Day 1 * History of malignancy within the last 5 years; not including subjects with prior history of adequately treated in situ cervical cancer or basal or squamous cell skin cancer * Clinically significant abnormal screening hematology values, blood chemistry values, or urinalysis values as determined by the Investigator * Any known active infections, including urinary tract infection, upper respiratory tract infection, sinusitis, suspicion of IA infection, hepatitis B or hepatitis C infection, and/or infections that may compromise the immune system such as human immunodeficiency virus (HIV) at Day 1

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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.

Knee osteoarthritis

Contacts and locations

Locations

  • Research Site

    Birmingham, Alabama, 35205, United States

  • Research Site

    Birmingham, Alabama, 35215, United States

  • Research Site

    Mobile, Alabama, 36608, United States

  • Research Site

    Phoenix, Arizona, 85018, United States

  • Research Site

    Phoenix, Arizona, 85053, United States

  • Research Site

    Tucson, Arizona, 85712, United States

  • Research Site

    Little Rock, Arkansas, 72205, United States

  • Research Site

    Anaheim, California, 92805, United States

  • Research Site

    Beverly Hills, California, 90211, United States

  • Research Site

    Canoga Park, California, 91303, United States

  • Research Site

    Garden Grove, California, 92840, United States

  • Research Site

    La Mesa, California, 91942, United States

  • Research Site

    Norco, California, 92860, United States

  • Research Site

    Pomona, California, 91767, United States

  • Research Site

    San Diego, California, 92103, United States

  • Research Site

    Santa Monica, California, 90404, United States

  • Research Site

    Thousand Oaks, California, 91360, United States

  • Research Site

    Westminster, California, 92683, United States

  • Research Site

    Boulder, Colorado, 80301, United States

  • Research Site

    Hamden, Connecticut, 06517, United States

  • Research Site

    Edgewater, Florida, 32132, United States

  • Research Site

    Gulf Breeze, Florida, 32561, United States

  • Research Site

    Miami, Florida, 33125, United States

  • Research Site

    Miami, Florida, 33173, United States

  • Research Site

    Miami Lakes, Florida, 33014, United States

  • Research Site

    Sunrise, Florida, 33351, United States

  • Research Site

    Sweetwater, Florida, 33172, United States

  • Research Site

    West Palm Beach, Florida, 33409, United States

  • Research Site

    Winter Haven, Florida, 33880, United States

  • Research Site

    Marietta, Georgia, 30060, United States

  • Research Site

    Newnan, Georgia, 30265, United States

  • Research Site

    Woodstock, Georgia, 30189, United States

  • Research Site

    Boise, Idaho, 83713, United States

  • Research Site

    Chicago, Illinois, 60607, United States

  • Research Site

    Gurnee, Illinois, 60031, United States

  • Research Site

    Oak Brook, Illinois, 60523, United States

  • Research Site

    Evansville, Indiana, 47714, United States

  • Research Site

    Greenwood, Indiana, 46143, United States

  • Research Site

    Valparaiso, Indiana, 46383, United States

  • Research Site

    New Orleans, Louisiana, 70124, United States

  • Research Site

    Wheaton, Maryland, 20902, United States

  • Research Site

    Boston, Massachusetts, 02111, United States

  • Research Site

    Troy, Michigan, 48085, United States

  • Research Site

    Hazelwood, Missouri, 63042, United States

  • Research Site

    Kansas City, Missouri, 64114, United States

  • Research Site

    Omaha, Nebraska, 68114, United States

  • Research Site

    Las Vegas, Nevada, 89119, United States

  • Research Site

    Reno, Nevada, 89519, United States

  • Research Site

    Freehold, New Jersey, 07728, United States

  • Research Site

    Albuquerque, New Mexico, 87102, United States

  • Research Site

    Hartsdale, New York, 10530, United States

  • Research Site

    Rochester, New York, 14642, United States

  • Research Site

    Greensboro, North Carolina, 27408, United States

  • Research Site

    Salisbury, North Carolina, 28144, United States

  • Research Site

    Winston-Salem, North Carolina, 27103, United States

  • Research Site

    Cincinnati, Ohio, 45224, United States

  • Research Site

    Edmond, Oklahoma, 73013, United States

  • Research Site

    Duncansville, Pennsylvania, 16635, United States

  • Research Site

    Charleston, South Carolina, 29406, 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

    Bellaire, Texas, 77401, United States

  • Research Site

    Carrollton, Texas, 75007, United States

  • Research Site

    Dallas, Texas, 75231, United States

  • Research Site

    Houston, Texas, 77029, United States

  • Research Site

    Plano, Texas, 75075, United States

  • Research Site

    Draper, Utah, 84020, United States

  • Research Site

    Ogden, Utah, 84405, United States

  • Research Site

    Salt Lake City, Utah, 84107, United States

  • Research Site

    Charlottesville, Virginia, 22911, United States

  • Research Site

    Richmond, Virginia, 23219, United States

  • Research Site 1

    Winter Park, Florida, 32789, United States

  • Research Site 1

    St Louis, Missouri, 63141, United States

  • Research Site 2

    St Louis, Missouri, 63141, United States

  • Reserach Site

    Clearwater, Florida, 33761, United States

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