Knee OsteoarthritisPhase 3NCT05603754

Safety and Efficacy of Lorecivivint (SM04690) for the Treatment of Knee Osteoarthritis (STRIDES)

A Phase 3 study testing Lorecivivint in people with Knee Osteoarthritis, run by Biosplice Therapeutics, Inc. at 44 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This phase 3 study was a multicenter, randomized, double-blind, placebo-controlled study of lorecivivint injected intra-articularly (IA) into the target (most painful) knee joint of moderately to severely symptomatic osteoarthritis (OA) subjects at a single dose of 0.07 mg lorecivivint per 2 mL injection. Read more about this study

Who is it for?: Ages 40 to 80 years
Conditions the study is for: Knee Osteoarthritis
What is being tested?: Lorecivivint
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 499 participants
Where: 44 sitesUnited States
Study dates: 18 Nov 2022to 20 Feb 2024
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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)

Show all 12Show fewer

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.

Trial locations and contacts

44 sites in 1 country.

City, postcode or hospital

44 sites in 1 country

United States44 sites

Albuquerque Clinical Trials
Albuquerque, New Mexico, 87102
Skylight Health Research
Burlington, Massachusetts, 01803
Core Healthcare Research
Cerritos, California, 90703
Clinical Trials of South Carolina
Charleston, South Carolina, 29406
Chicago Clinical Research Institute
Chicago, Illinois, 60607
Hightop Medical Research Center
Cincinnati, Ohio, 45224
Zenos Clinical Research
Dallas, Texas, 75230
Unique Clinical Trials
Doral, Florida, 33172
Conrad Clinical Research
Edmond, Oklahoma, 73013
MediSphere Medical Research Center, LLC
Evansville, Indiana, 47714
Piedmont Research Partners, LLC
Fort Mill, South Carolina, 29707
Healthcare Research Network
Hazelwood, Missouri, 63042
Eastern Research, Inc.
Hialeah, Florida, 33013
TecTum Research
Hollywood, Florida, 33024
Synergy Groups Medical, LLC
Houston, Texas, 77036
Synergy Groups Medical, LLC
Houston, Texas, 77061
BioSolutions Clinical Research Center
La Mesa, California, 91942
DelRicht Research - Mandeville
Mandeville, Louisiana, 70471
Columbus Clinical Services, LLC
Miami, Florida, 33125
AppleMed Research Group, LLC
Miami, Florida, 33126
Advance Medical Research Center
Miami, Florida, 33135
Health and Life Research Institute, LLC
Miami, Florida, 33155
BioMed Research and Medical Center
Miami, Florida, 33156
Well Pharma Medical Research, Corp
Miami, Florida, 33173
South Florida Research Phase I-IV, Inc.
Miami Springs, Florida, 33166
DelRicht Research
New Orleans, Louisiana, 70124
Infinity Clinical Research
Norco, California, 92860
Clinical Investigations of Texas
Plano, Texas, 75075
Dream Team Clinical Research
Pomona, California, 91767
DelRicht Research - Prairieville
Prairieville, Louisiana, 70817
Health Concepts
Rapid City, South Dakota, 57702
DelRicht Research - Rockville
Rockville, Maryland, 20852
Wasatch Clinical Research, LLC
Salt Lake City, Utah, 84107
Diagnostic Research Group
San Antonio, Texas, 78229
Artemis Institute for Clinical Research
San Diego, California, 92103
Encompass Clinical Research
Spring Valley, California, 97978
Pinnacle Trials, Inc.
Stockbridge, Georgia, 30281
Tampa Pain Relief Center
Tampa, Florida, 33603
Premier Medical Associates
The Villages, Florida, 32159
Millennium Clinical Trials, LLC
Thousand Oaks, California, 91360
Oakland Medical Research
Troy, Michigan, 48085
Tucson Orthopaedic Institute
Tucson, Arizona, 85712
DelRicht Research - Tulsa
Tulsa, Oklahoma, 74133
Conquest Research, LLC
Winter Park, Florida, 32789

Other trials in United States

About this study

Official title: A Phase 3, Multicenter, Randomized, Double Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a Single Injection of Lorecivivint 0.07 mg in Subjects With Moderate to Severe Osteoarthritis Pain of the Knee

Read the detailed description

SM04690-OA-21 was a phase 3, 16-week multicenter, randomized, double-blind, placebo-controlled, parallel group study investigating the safety, tolerability and efficacy of LOR 0.07 mg (compared with PBO) injected into the target knee joint of moderately to severely symptomatic knee OA subjects.

Patient-reported outcomes included Pain Numeric Rating Scale (NRS) [0-10], Western Ontario and McMaster Universities Arthritis Index (WOMAC), and Patient Global Assessment (PGA) of knee osteoarthritis.

The primary efficacy endpoint was change from baseline in target knee Pain NRS at Week 12. Secondary endpoints included change at Week 12 in WOMAC Function and PGA.

Conditions: Knee Osteoarthritis
Being tested: Lorecivivint, Placebo
Medical subject headings: Osteoarthritis, Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LorecivivintDrug
Also called SM04690
One intra-articular injection of 0.07 mg lorecivivint in 2 mL vehicle
PlaceboDrug
Also called Vehicle
One intra-articular injection of 0 mg lorecivivint in 2 mL vehicle

Study groups in NCT05603754
Study group	Role	What they receive
Lorecivivint	Experimental	Healthcare professional-administered intra-articular injection; performed on Day 1. Receives: Drug: Lorecivivint
Vehicle	Placebo comparator	Healthcare professional-administered intra-articular injection; performed on Day 1. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline OA Pain in the Target Knee as Assessed by Weekly Average of Daily Pain Numeric Rating Scale (NRS) at Week 12
Evaluate change from baseline OA pain in the target knee as assessed by weekly average of daily pain NRS at Week 12.
The pain NRS is an 11-point scale [0-10] for subject self-reporting of average knee pain in the last 24 hours; 0 indicates no pain, and 10 indicates pain as bad as you can imagine.
Measured: Baseline to Week 12

Secondary outcomes (2)

Change From Baseline OA Function as Assessed by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscore (WOMAC Function) at Week 12
Evaluate change from baseline OA function as assessed by WOMAC Function at Week 12. The WOMAC is a widely-used, proprietary outcome measurement tool used to evaluate the condition of subjects with OA of the knee and hip, including pain (5 questions), stiffness (2 questions) and physical functioning (17 questions) of the joints. Each question is measured on an 11-point NRS scale [0-10], where 0 indicates no pain / no stiffness / no difficulty, and 10 indicates extreme pain / extreme stiffness / extreme difficulty.
For analysis, WOMAC Function scores were scaled to 0 to 100, where 0 represents "No Functional Difficulty" and 100 represents "Extreme Functional Difficulty".
Measured: Baseline and Week 12
Change From Baseline OA Disease Activity as Assessed by Patient Global Assessment at Week 12
Evaluate change from baseline OA disease activity as assessed by Patient Global Assessment at Week 12. The Patient Global Assessment is an 11-point NRS [0-10] for subject self-reporting of how they feel their target knee is impacting them. For analysis, PGA scores were scaled to 0 to 100, where 0 represents "Very Good" and 100 represents "Very Bad".
Measured: Baseline and Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Nov 202220 Feb 2024

First posted3 Nov 2022
Study start18 Nov 2022
Primary completion20 Feb 2024
Study completion20 Feb 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 499 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05603754
Sponsor's protocol ID: SM04690-OA-21
Status last verified: Aug 2026
First submitted: 27 Oct 2022
Last updated: 1 Sep 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Knee Osteoarthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3, Multicenter, Randomized, Double Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a Single Injection of Lorecivivint 0.07 mg in Subjects With Moderate to Severe Osteoarthritis Pain of the Knee
ClinicalTrials.gov ID: NCT05603754
Acronym / sponsor ID: SM04690-OA-21
Conditions: Knee Osteoarthritis
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 499 participants (actual)
Lead sponsor: Biosplice Therapeutics, Inc.Industry (pharma, biotech, devices)
Collaborators: NBCD A/S
Study start: 18 Nov 2022 (actual)
Primary completion: 20 Feb 2024 (actual)
Study completion: 20 Feb 2024 (actual)
First posted: 3 Nov 2022 (actual)
Results: Posted 1 Sep 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The primary efficacy endpoint was change from baseline in target knee Pain NRS at Week 12. Secondary endpoints included change at Week 12 in WOMAC Function and PGA.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Lorecivivint	Experimental	Drug: LorecivivintHealthcare professional-administered intra-articular injection; performed on Day 1.
Vehicle	Placebo comparator	Drug: PlaceboHealthcare professional-administered intra-articular injection; performed on Day 1.

Who may qualify

Ages: 40 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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)

Key exclusion criteria (12 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
LorecivivintAlso: SM04690One intra-articular injection of 0.07 mg lorecivivint in 2 mL vehicle	Drug	Lorecivivint
PlaceboAlso: VehicleOne intra-articular injection of 0 mg lorecivivint in 2 mL vehicle	Drug	Vehicle

Primary outcome

Change From Baseline OA Pain in the Target Knee as Assessed by Weekly Average of Daily Pain Numeric Rating Scale (NRS) at Week 12
Time frame: Baseline to Week 12
Evaluate change from baseline OA pain in the target knee as assessed by weekly average of daily pain NRS at Week 12. The pain NRS is an 11-point scale [0-10] for subject self-reporting of average knee pain in the last 24 hours; 0 indicates no pain, and 10 indicates pain as bad as you can imagine.

2 secondary outcomes

Change From Baseline OA Function as Assessed by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscore (WOMAC Function) at Week 12
Time frame: Baseline and Week 12
Change From Baseline OA Disease Activity as Assessed by Patient Global Assessment at Week 12
Time frame: Baseline and Week 12

Results and safety

Results posted to the registry on 1 Sep 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Lorecivivint	247	232
Vehicle	252	243

Primary outcome: Change From Baseline OA Pain in the Target Knee as Assessed by Weekly Average of Daily Pain Numeric Rating Scale (NRS) at Week 12

Time frame: Baseline to Week 12. Mean (Standard Deviation). Unit: score on a scale

Measure	Lorecivivint n = 215	Vehicle n = 227
Value	-3.64 (2.44)	-3.54 (2.45)

Lorecivivint vs Vehicle: Mean Difference (Final Values): -0.12 (95% CI -0.53 to 0.28), p = 0.543, Mixed Models Analysis

Population analysed: The Full Analysis Set (FAS) includes all subjects who were randomized and received a study injection. 2 subjects from Placebo and 3 from Lorecivivint were excluded from FAS due to duplicate enrollments in current or previous Lorecivivint clinical trials. FAS describes the analysis set which is as complete and as close as possible to the intent-to-treat ideal of including all randomized subjects. Subjects' observed data were analyzed as randomized for the FAS without imputation.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: AEs were assessed at each in-person study visit from the time of study medication injection on Day 1 through Week 16 (EOS) or Early Termination.. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Lorecivivint	2 of 242 (0.8%)	37 of 242 (15.3%)	0 of 242
Vehicle	3 of 249 (1.2%)	26 of 249 (10.4%)	0 of 249

Limitations and caveats (from the sponsor): Hispanic/Latino subjects constituted \~65% of the study population primarily enrolled by 10 sites in the Miami, FL region. This observed Hispanic/Latino proportion is significantly higher than the overall Hispanic population suffering from knee OA (estimated at approximately 14% \[Deshpande BR et al. Arthritis Care Res 2016;68(12):1743-1750\]). Given the unusually high percentage of Hispanic/Latino participants, post-hoc efficacy analysis was conducted for non-Hispanic/Latino subjects only.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Knee Osteoarthritis

Not yet recruiting
Holistic Healing for Knee Osteoarthritis
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Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
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Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
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Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Yusuf Yazici, MD study director

Biosplice Therapeutics, Inc.

44 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Lorecivivint in people with Knee Osteoarthritis, run by Biosplice Therapeutics, Inc. at 44 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 44 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline OA Pain in the Target Knee as Assessed by Weekly Average of Daily Pain Numeric Rating Scale (NRS) at Week 12 (time frame: Baseline to Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05603754.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.