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One shot for knee pain? trial tests a new injection for osteoarthritis

NCT ID NCT05603754

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 01, 2026 · Last updated Sep 02, 2026 · Updated 1 time

Summary

This trial tests whether a single injection of lorecivivint into the knee can reduce pain and improve function in people with moderate to severe knee osteoarthritis. About 499 adults aged 40 to 80 will receive either the drug or a placebo injection, and researchers will compare changes in pain and physical function after 12 weeks. The study is double-blind, meaning neither participants nor researchers know who gets the real drug.

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 given as a single injection into the knee joint
What this could lead to
If it works, a single injection could provide lasting pain relief and better knee function for millions with osteoarthritis, potentially reducing the need for frequent treatments or surgery.
What could go wrong
This is a phase 3 trial, but results are not yet known. The drug may not outperform placebo, and injections into the knee carry risks like pain, swelling, 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

499 people

The number who actually took part.

Started

Nov 2022

Finished

Feb 2024

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.

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 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 * 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) * 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 * Use of APAP or NSAIDs during washout period (between Screening Visit 2 and Day 1). Use of aspirin (up to 325 mg/day) for thrombosis prophylaxis is permitted.

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Conditions

The condition(s) this trial relates to.

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

  • Advance Medical Research Center

    Miami, Florida, 33135, United States

  • Albuquerque Clinical Trials

    Albuquerque, New Mexico, 87102, United States

  • AppleMed Research Group, LLC

    Miami, Florida, 33126, United States

  • Artemis Institute for Clinical Research

    San Diego, California, 92103, United States

  • BioMed Research and Medical Center

    Miami, Florida, 33156, United States

  • BioSolutions Clinical Research Center

    La Mesa, California, 91942, United States

  • Chicago Clinical Research Institute

    Chicago, Illinois, 60607, United States

  • Clinical Investigations of Texas

    Plano, Texas, 75075, United States

  • Clinical Trials of South Carolina

    Charleston, South Carolina, 29406, United States

  • Columbus Clinical Services, LLC

    Miami, Florida, 33125, United States

  • Conquest Research, LLC

    Winter Park, Florida, 32789, United States

  • Conrad Clinical Research

    Edmond, Oklahoma, 73013, United States

  • Core Healthcare Research

    Cerritos, California, 90703, United States

  • DelRicht Research

    New Orleans, Louisiana, 70124, United States

  • DelRicht Research - Mandeville

    Mandeville, Louisiana, 70471, United States

  • DelRicht Research - Prairieville

    Prairieville, Louisiana, 70817, United States

  • DelRicht Research - Rockville

    Rockville, Maryland, 20852, United States

  • DelRicht Research - Tulsa

    Tulsa, Oklahoma, 74133, United States

  • Diagnostic Research Group

    San Antonio, Texas, 78229, United States

  • Dream Team Clinical Research

    Pomona, California, 91767, United States

  • Eastern Research, Inc.

    Hialeah, Florida, 33013, United States

  • Encompass Clinical Research

    Spring Valley, California, 97978, United States

  • Health Concepts

    Rapid City, South Dakota, 57702, United States

  • Health and Life Research Institute, LLC

    Miami, Florida, 33155, United States

  • Healthcare Research Network

    Hazelwood, Missouri, 63042, United States

  • Hightop Medical Research Center

    Cincinnati, Ohio, 45224, United States

  • Infinity Clinical Research

    Norco, California, 92860, United States

  • MediSphere Medical Research Center, LLC

    Evansville, Indiana, 47714, United States

  • Millennium Clinical Trials, LLC

    Thousand Oaks, California, 91360, United States

  • Oakland Medical Research

    Troy, Michigan, 48085, United States

  • Piedmont Research Partners, LLC

    Fort Mill, South Carolina, 29707, United States

  • Pinnacle Trials, Inc.

    Stockbridge, Georgia, 30281, United States

  • Premier Medical Associates

    The Villages, Florida, 32159, United States

  • Skylight Health Research

    Burlington, Massachusetts, 01803, United States

  • South Florida Research Phase I-IV, Inc.

    Miami Springs, Florida, 33166, United States

  • Synergy Groups Medical, LLC

    Houston, Texas, 77036, United States

  • Synergy Groups Medical, LLC

    Houston, Texas, 77061, United States

  • Tampa Pain Relief Center

    Tampa, Florida, 33603, United States

  • TecTum Research

    Hollywood, Florida, 33024, United States

  • Tucson Orthopaedic Institute

    Tucson, Arizona, 85712, United States

  • Unique Clinical Trials

    Doral, Florida, 33172, United States

  • Wasatch Clinical Research, LLC

    Salt Lake City, Utah, 84107, United States

  • Well Pharma Medical Research, Corp

    Miami, Florida, 33173, United States

  • Zenos Clinical Research

    Dallas, Texas, 75230, United States

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