One-Shot knee treatment could ease arthritis pain for over a year

NCT ID NCT03928184

Symptom relief Sponsor: Biosplice Therapeutics, Inc. Source: ClinicalTrials.gov ↗

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

Summary

This study tested a single injection of lorecivivint into the knee joint of 501 people with moderate-to-severe knee osteoarthritis. The goal was to see if it reduces pain and improves function over 56 weeks compared to a placebo. Participants reported their pain levels weekly, and X-rays were used to track joint changes.

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 provide a new, long-lasting pain relief option for people with knee osteoarthritis, potentially reducing the need for frequent injections or surgery.
What could go wrong: This is a Phase 3 trial, but results are not yet published. The drug may not prove more effective than placebo, and there could be side effects like joint pain or swelling.

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

501 people

The number who actually took part.

Started

May 2019

Finished

Aug 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.

Inclusion Criteria: 1. Males and females between 40 and 80 years of age, inclusive, in general good health apart from their knee OA 2. Ambulatory (single assistive devices such as canes allowed if needed less than 50% of the time, subjects requiring a walker are excluded) 3. 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) 4. mJSW by radiograph between 1.5 and 4 mm, inclusive, in the target knee within 12 weeks of the Screening Visit as assessed by independent central readers 5. Radiographic disease Stage 2 or 3 in the target knee within 12 weeks of the Screening Visit according to the Kellgren-Lawrence (KL) grading of knee OA as assessed by independent central readers 6. Pain compatible with OA of the knee(s) for at least 26 weeks prior to the Screening Visit 7. Primary source of pain throughout the body is due to OA in the target knee 8. Body mass index (BMI) ≤ 40 kg/m2 at the Screening Visit 9. Widespread Pain Index (WPI) score of ≤ 4 and a Symptom Severity Question 2 (SSQ2) score of ≤ 2 at the Screening Visit and Day 1 10. Pain NRS scores recorded for the target knee on at least 4 out of the 7 days immediately preceding Day 1 11. Pain NRS scores recorded for the nontarget knee on at least 4 out of the 7 days immediately preceding Day 1 12. Daily OA knee pain diary average NRS intensity score ≥ 4 and ≤ 8 in the target knee on the 11-point (0-10) NRS scale for the 7 days immediately preceding Day 1 13. Daily OA knee pain diary average NRS intensity score \< 4 in the nontarget knee on the 11-point (0-10) NRS scale for the 7 days immediately preceding Day 1 14. WOMAC Pain of 20-40 (out of 50) for the target knee at baseline regardless of if the subject is on symptomatic oral treatment (baseline questionnaire completed during the screening period prior to randomization) 15. WOMAC Function of 68-136 (out of 170) for the target knee at baseline regardless of if the subject is on symptomatic oral treatment (baseline questionnaire completed during the screening period prior to randomization) 16. Willingness to use an electronic diary daily in the evening for the screening period and 56-week study duration 17. 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 18. Subjects with depression or anxiety must be clinically stable for at least 12 weeks prior to the Screening Visit and, if on treatment for depression or anxiety, be on at least 12 weeks of stable therapy 19. Full understanding of the requirements of the study and willingness to comply with all study visits and assessments 20. Subjects must have read and understood the informed consent form (ICF), and must have signed and dated it prior to any study-related procedure being performed Exclusion Criteria: 1. Pregnant women, breastfeeding woman, 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 2. Women who are not post-menopausal or permanently surgically sterile who are sexually active, and who are not willing to use birth control during the study period 3. Men who are sexually active and of reproductive potential, who have partners who are capable of becoming pregnant, and who are not willing to use birth control during the study period 4. Significant malalignment of anatomical axis (medial angle formed by the femur and tibia) of the target knee (varus \> 10°, valgus \> 10°) by radiograph within 12 weeks of the Screening Visit as assessed by independent central readers 5. Partial or complete joint replacement in either knee 6. Currently requires use of a lower extremity prosthesis, and/or a structural knee brace (i.e., a knee brace that contains hardware) 7. Any surgery (e.g., arthroscopy) in either knee within 26 weeks prior to Day 1 8. 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 9. Effusion of the target knee clinically requiring aspiration within 12 weeks prior to Day 1 10. Use of electrotherapy, acupuncture, physical therapy, therapeutic ultrasound, and/or chiropractic treatments for knee OA within 4 weeks prior to Day 1 11. Any bone fracture(s) within 26 weeks prior to the Screening Visit 12. Previous treatment with SM04690 13. Subjects who have previously failed screening on this protocol and fail to meet rescreening criteria 14. Participation in a clinical research trial that included the receipt of an investigational product (IP) or any experimental therapeutic procedure within 26 weeks prior to the Screening Visit, or planned participation in any such trial 15. Treatment with systemic (oral, intramuscular, or intravenous) glucocorticoids ≥10 mg prednisone or the equivalent per day within 4 weeks prior to Day 1, or subjects on \<10 mg prednisone or the equivalent per day who have not maintained a stable regimen for at least 2 weeks prior to Day 1 in the opinion of the Investigator 16. Use of centrally acting analgesics within 12 weeks prior to Day 1 17. Use of anticonvulsants within 12 weeks prior to Day 1 18. Subjects requiring the use of opioids \> 1x per week within 12 weeks prior to Day 1 19. Topical local anesthetic agents (gels, creams, or patches such as the Lidoderm patch) used for the treatment of knee OA within 7 days of Day 1 20. Planned surgery scheduled during the study period, not including non-surgical invasive procedures conducted for a diagnostic or therapeutic purpose scheduled during the study period 21. 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 22. Clinically significant abnormal screening hematology values, blood chemistry values, or urinalysis values as determined by the Investigator 23. 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 24. Other conditions that, in the opinion of the Investigator, could affect study endpoint assessments of either knee, including, but not limited to, peripheral neuropathy (e.g., diabetic neuropathy), symptomatic hip osteoarthritis, symptomatic degenerative disc disease, and patellofemoral syndrome 25. Comorbid conditions that could affect study endpoint assessments of the target knee, including, but not limited to, rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus, gout or pseudogout, and fibromyalgia 26. History of mania, bipolar disorder, psychotic disorder, schizophrenia, or schizoaffective disorder 27. 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 28. Any chronic condition that has not been well controlled or subjects with a chronic condition who have not maintained a stable therapeutic regimen of a prescription therapy in the opinion of the Investigator. 29. Hemoglobin A1c (HbA1c) \>9 at the Screening Visit 30. If using NSAIDs and/or acetaminophen, subjects who have not maintained a stable regimen in the opinion of the Investigator for at least 4 weeks prior to Day 1 31. Any contraindications for an IA injection in the target knee in the opinion of the Investigator 32. Subjects who have a current or pending disability claim, workers' compensation, or litigation(s) that may compromise response to treatment 33. Subjects who are immediate family members (spouse, parent, child, or sibling; biological or legally adopted) of personnel directly affiliated with the study at any investigative site, or are directly affiliated with the study at any investigative site 34. Subjects employed by Samumed, LLC, or any of its affiliates or development partners (that is, an employee, temporary contract worker, or designee) responsible for the conduct of the study, or who are immediate family members (spouse, parent, child, or sibling; biological or legally adopted) of said employees responsible for the conduct of the study

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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
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Birmingham, Alabama, 35216, United States
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Peoria, Arizona, 85381, United States
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Phoenix, Arizona, 85037, United States
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Tucson, Arizona, 85712, United States
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Little Rock, Arkansas, 72205, United States
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Anaheim, California, 92805, United States
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Garden Grove, California, 92840, United States
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Norco, California, 92860, United States
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Pomona, California, 91767, United States
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San Diego, California, 92103, United States
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San Marcos, California, 92078, United States
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Spring Valley, California, 91978, United States
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Westminster, California, 92683, United States
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Boulder, Colorado, 80301, United States
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Colorado Springs, Colorado, 80918, United States
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Denver, Colorado, 80209, United States
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Waterbury, Connecticut, 06708, United States
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Clearwater, Florida, 33761, United States
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Coral Gables, Florida, 33134, United States
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Hialeah, Florida, 33016, United States
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Miami, Florida, 33143, United States
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Miami Lakes, Florida, 33014, United States
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Orlando, Florida, 32806, United States
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Oviedo, Florida, 32765, United States
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Port Orange, Florida, 32127, United States
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Sunrise, Florida, 33351, United States
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West Palm Beach, Florida, 33409, United States
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Winter Haven, Florida, 33880, United States
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Marietta, Georgia, 30060, United States
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Newnan, Georgia, 30265, United States
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Stockbridge, Georgia, 30281, United States
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Woodstock, Georgia, 30189, United States
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Boise, Idaho, 83713, United States
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Meridian, Idaho, 83642, United States
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Bloomington, Illinois, 61704, United States
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Gurnee, Illinois, 60031, United States
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Oak Brook, Illinois, 60523, United States
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Rockford, Illinois, 61114, United States
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Anderson, Indiana, 46011, United States
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Evansville, Indiana, 47714, United States
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Valparaiso, Indiana, 46383, United States
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Kansas City, Kansas, 66160, United States
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Wichita, Kansas, 67205, United States
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Monroe, Louisiana, 71203, United States
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New Orleans, Louisiana, 70124, United States
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Wheaton, Maryland, 20902, United States
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Boston, Massachusetts, 02111, United States
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Bay City, Michigan, 48706, United States
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Troy, Michigan, 48085, United States
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Hazelwood, Missouri, 63042, United States
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St Louis, Missouri, 63141, United States
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La Vista, Nebraska, 68128, United States
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Lincoln, Nebraska, 68516, United States
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Omaha, Nebraska, 68114, United States
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Albuquerque, New Mexico, 87108, United States
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Great Neck, New York, 11021, United States
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Hartsdale, New York, 10530, United States
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New York, New York, 10016, United States
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Rochester, New York, 14609, United States
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Williamsville, New York, 14221, United States
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Charlotte, North Carolina, 28209, United States
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Leland, North Carolina, 28451, United States
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Salisbury, North Carolina, 28144, United States
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Winston-Salem, North Carolina, 27103, United States
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Fargo, North Dakota, 58104, United States
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Cincinnati, Ohio, 45219, United States
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Cincinnati, Ohio, 45224, United States
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Cincinnati, Ohio, 45242, United States
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Columbus, Ohio, 43235, United States
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Oklahoma City, Oklahoma, 73103, United States
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Oklahoma City, Oklahoma, 73112, United States
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Duncansville, Pennsylvania, 16635, United States
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Fort Mill, South Carolina, 29707, United States
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Greenville, South Carolina, 29607, United States
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Greer, South Carolina, 29651, United States
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Mt. Pleasant, South Carolina, 29464, United States
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Rapid City, South Dakota, 57702, United States
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Austin, Texas, 78745, United States
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Bedford, Texas, 76021, United States
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Carrollton, Texas, 75007, United States
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Dallas, Texas, 75231, United States
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Edinburg, Texas, 78539, United States
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Houston, Texas, 77029, United States
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Houston, Texas, 77055, United States
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Plano, Texas, 75075, United States
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San Antonio, Texas, 78215, United States
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San Antonio, Texas, 78229, United States
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San Antonio, Texas, 78258, United States
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Draper, Utah, 84020, United States
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Murray, Utah, 84123, United States
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Salt Lake City, Utah, 84107, United States
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Charlottesville, Virginia, 22911, United States
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Richmond, Virginia, 23219, United States
Research Site #1

Winter Park, Florida, 32789, United States
Research Site #2

Winter Park, Florida, 32789, United States
Research Site 1

New York, New York, 10021, United States
Research Site 2

New York, New York, 10021, United States

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