Knee OsteoarthritisPhase 3STRIDES-1NCT04385303

Patient-Reported Outcomes in Evaluating Lorecivivint (SM04690) for Moderate to Severe Knee Osteoarthritis (STRIDES-1)

A Phase 3 study testing Lorecivivint in people with Knee Osteoarthritis, run by Biosplice Therapeutics, Inc. at 76 sites in United States.

Completed

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

Official record

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Trial summary

This phase 3 study is a multicenter, randomized, double-blind, placebo-controlled study of lorecivivint injected intraarticularly (IA) into the target knee (most painful) 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: 496 participants
Where: 76 sitesUnited States
Study dates: 26 May 2020to 8 Sep 2021
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

Show all 9Show fewer

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

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
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

Show all 13Show fewer

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

Trial locations and contacts

76 sites in 1 country.

City, postcode or hospital

76 sites in 1 country

United States76 sites

Research Site
Albuquerque, New Mexico, 87102
Research Site
Anaheim, California, 92805
Research Site
Bellaire, Texas, 77401
Research Site
Beverly Hills, California, 90211
Research Site
Birmingham, Alabama, 35205
Research Site
Birmingham, Alabama, 35215
Research Site
Boise, Idaho, 83713
Research Site
Boston, Massachusetts, 02111
Research Site
Boulder, Colorado, 80301
Research Site
Canoga Park, California, 91303
Research Site
Carrollton, Texas, 75007
Research Site
Charleston, South Carolina, 29406
Research Site
Charlottesville, Virginia, 22911
Research Site
Chicago, Illinois, 60607
Research Site
Cincinnati, Ohio, 45224
Reserach Site
Clearwater, Florida, 33761
Research Site
Dallas, Texas, 75231
Research Site
Draper, Utah, 84020
Research Site
Duncansville, Pennsylvania, 16635
Research Site
Edgewater, Florida, 32132
Research Site
Edmond, Oklahoma, 73013
Research Site
Evansville, Indiana, 47714
Research Site
Fort Mill, South Carolina, 29707
Research Site
Freehold, New Jersey, 07728
Research Site
Garden Grove, California, 92840
Research Site
Greensboro, North Carolina, 27408
Research Site
Greenwood, Indiana, 46143
Research Site
Gulf Breeze, Florida, 32561
Research Site
Gurnee, Illinois, 60031
Research Site
Hamden, Connecticut, 06517
Research Site
Hartsdale, New York, 10530
Research Site
Hazelwood, Missouri, 63042
Research Site
Houston, Texas, 77029
Research Site
Kansas City, Missouri, 64114
Research Site
La Mesa, California, 91942
Research Site
Las Vegas, Nevada, 89119
Research Site
Little Rock, Arkansas, 72205
Research Site
Marietta, Georgia, 30060
Research Site
Miami, Florida, 33125
Research Site
Miami, Florida, 33173
Research Site
Miami Lakes, Florida, 33014
Research Site
Mobile, Alabama, 36608
Research Site
Mt. Pleasant, South Carolina, 29464
Research Site
New Orleans, Louisiana, 70124
Research Site
Newnan, Georgia, 30265
Research Site
Norco, California, 92860
Research Site
Oak Brook, Illinois, 60523
Research Site
Ogden, Utah, 84405
Research Site
Omaha, Nebraska, 68114
Research Site
Phoenix, Arizona, 85018
Research Site
Phoenix, Arizona, 85053
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Plano, Texas, 75075
Research Site
Pomona, California, 91767
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Rapid City, South Dakota, 57702
Research Site
Reno, Nevada, 89519
Research Site
Richmond, Virginia, 23219
Research Site
Rochester, New York, 14642
Research Site
Salisbury, North Carolina, 28144
Research Site
Salt Lake City, Utah, 84107
Research Site
San Diego, California, 92103
Research Site
Santa Monica, California, 90404
Research Site 1
St Louis, Missouri, 63141
Research Site 2
St Louis, Missouri, 63141
Research Site
Sunrise, Florida, 33351
Research Site
Sweetwater, Florida, 33172
Research Site
Thousand Oaks, California, 91360
Research Site
Troy, Michigan, 48085
Research Site
Tucson, Arizona, 85712
Research Site
Valparaiso, Indiana, 46383
Research Site
West Palm Beach, Florida, 33409
Research Site
Westminster, California, 92683
Research Site
Wheaton, Maryland, 20902
Research Site
Winston-Salem, North Carolina, 27103
Research Site
Winter Haven, Florida, 33880
Research Site 1
Winter Park, Florida, 32789
Research Site
Woodstock, Georgia, 30189

Other trials in United States

About this study

Official title: A 28-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate a Single Injection of SM04690 Injected in the Target Knee Joint of Moderately to Severely Symptomatic Osteoarthritis Subjects

Read the detailed description

SM04690-OA-10 was a phase 3, 28-week multicenter, randomized, double-blind, placebo-controlled, parallel group study investigating the safety, tolerability and efficacy of lorecivivint 0.07 mg (compared with placebo) 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
Keywords: SM04690, Wnt pathway inhibitor, osteoarthritis, Samumed, lorecivivint
Medical subject headings: Osteoarthritis, Knee, Osteoarthritis

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 NCT04385303
Study group	Role	What they receive
Vehicle	Active comparator	Healthcare professional-administered intra-articular injection; performed on Day 1. Receives: Drug: Placebo
Lorecivivint	Experimental	Healthcare professional-administered intra-articular injection; performed on Day 1. Receives: Drug: Lorecivivint

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 the 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 the 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 represents the worst possible pain.
Measured: Baseline and Week 12

Secondary outcomes (5)

Change From Baseline OA Pain in the Target Knee as Assessed by the Weekly Average of Daily Pain Numeric Rating Scale (NRS) at Week 24
Evaluate change from baseline OA pain in the target knee as assessed by the weekly average of daily pain NRS at Week 24. 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 represents the worst possible pain.
Measured: Baseline and Week 24
Change From Baseline OA Function in the Target Knee 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 in the target knee as assessed by WOMAC Function subscore 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 numeric rating scale from 0 (lowest pain/lowest stiffness/highest function) to 10 (highest pain/highest stiffness/lowest function). The WOMAC Function raw subscore ranges from 0 to 170, and is scaled 0 (highest overall function) to 100 (lowest overall function) for analysis and reporting.
Measured: Baseline and Week 12
Change From Baseline OA Function in the Target Knee as Assessed by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscore (WOMAC Function) at Week 24
Evaluate change from baseline OA function in the target knee as assessed by WOMAC Function subscore at Week 24. 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 numeric rating scale from 0 (lowest pain/lowest stiffness/highest function) to 10 (highest pain/highest stiffness/lowest function). The WOMAC Function raw subscore ranges from 0 to 170, and is scaled 0 (highest overall function) to 100 (lowest overall function) for analysis and reporting.
Measured: Baseline and Week 24
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 [0-10] Numeric Rating Scale [NRS] on which the subjects will rate how they feel their target knee OA is doing, considering all the ways in which their target knee OA may affect them. The NRS is anchored by descriptors at each end ("Very Good" on the left and "Very Bad" on the right). For analysis, Patient Global Assessment scores were scaled to [0-100], where 0 represents "Very Good" and 100 represents "Very Bad".
Measured: Baseline and Week 12
Change From Baseline OA Disease Activity as Assessed by Patient Global Assessment at Week 24
Evaluate change from baseline OA disease activity as assessed by Patient Global Assessment at Week 24. The Patient Global Assessment is an 11-point [0-10] Numeric Rating Scale [NRS] on which the subjects will rate how they feel their target knee OA is doing, considering all the ways in which their target knee OA may affect them. The NRS is anchored by descriptors at each end ("Very Good" on the left and "Very Bad" on the right). For analysis, Patient Global Assessment scores were scaled to [0-100], where 0 represents "Very Good" and 100 represents "Very Bad".
Measured: Baseline and Week 24

Timeline

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

26 May 20208 Sep 2021

First posted12 May 2020
Study start26 May 2020
Primary completion8 Sep 2021
Study completion8 Sep 2021

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.
Publications (1)Papers the sponsor has linked to this study.
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: 496 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04385303
Sponsor's protocol ID: SM04690-OA-10
Acronym: STRIDES-1
Status last verified: Jan 2026
First submitted: 8 May 2020
Last updated: 4 Feb 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Tambiah J, Kennedy S, Swearingen C, McAlindon T, Yazici Y. Impact of structural severity on outcomes in knee osteoarthritis: an analysis of data from phase 2 and phase 3 lorecivivint clinical trials. Rheumatology (Oxford). 2025 May 1;64(5):2583-2590. doi: 10.1093/rheumatology/keae610.
PubMed 39495154

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 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A 28-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate a Single Injection of SM04690 Injected in the Target Knee Joint of Moderately to Severely Symptomatic Osteoarthritis Subjects
ClinicalTrials.gov ID: NCT04385303
Acronym / sponsor ID: STRIDES-1 / SM04690-OA-10
Conditions: Knee Osteoarthritis
Keywords: SM04690, Wnt pathway inhibitor, osteoarthritis, Samumed, lorecivivint
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 496 participants (actual)
Lead sponsor: Biosplice Therapeutics, Inc.Industry (pharma, biotech, devices)
Study start: 26 May 2020 (actual)
Primary completion: 8 Sep 2021 (actual)
Study completion: 8 Sep 2021 (actual)
First posted: 12 May 2020 (actual)
Results: Posted 4 Feb 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
Vehicle	Active comparator	Drug: PlaceboHealthcare professional-administered intra-articular injection; performed on Day 1.
Lorecivivint	Experimental	Drug: LorecivivintHealthcare 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 (9 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 (13 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
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

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 the Weekly Average of Daily Pain Numeric Rating Scale (NRS) at Week 12
Time frame: Baseline and Week 12
Evaluate change from baseline OA pain in the target knee as assessed by the 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 represents the worst possible pain.

5 secondary outcomes

Change From Baseline OA Pain in the Target Knee as Assessed by the Weekly Average of Daily Pain Numeric Rating Scale (NRS) at Week 24
Time frame: Baseline and Week 24
Change From Baseline OA Function in the Target Knee 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 Function in the Target Knee as Assessed by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscore (WOMAC Function) at Week 24
Time frame: Baseline and Week 24
Change From Baseline OA Disease Activity as Assessed by Patient Global Assessment at Week 12
Time frame: Baseline and Week 12
Change From Baseline OA Disease Activity as Assessed by Patient Global Assessment at Week 24
Time frame: Baseline and Week 24

Results and safety

Results posted to the registry on 4 Feb 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
Vehicle	253	233
Lorecivivint	243	221

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

Time frame: Baseline and Week 12. Least squares mean (Standard Error). Unit: units on a scale

Measure	Vehicle n = 213	Lorecivivint n = 211
Value	-2.15 (0.14)	-2.22 (0.14)

Vehicle vs Lorecivivint: Mean Difference (Final Values): -0.07 (95% CI -0.46 to 0.31), p = 0.703, Mixed Models Analysis

Population analysed: Full Analysis Set includes all subjects who were randomized and received a study injection. Subjects' observed data were analyzed as randomized without imputation.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: AEs were assessed at each clinic visit from the time of study medication injection on Day 1 through Week 28 (EOS) or Early Termination.. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Vehicle	1 of 251 (0.4%)	38 of 251 (15.1%)	1 of 251
Lorecivivint	4 of 241 (1.7%)	27 of 241 (11.2%)	0 of 241

Limitations and caveats (from the sponsor): This trial was conducted during COVID-19 and its confounding effects on clinical outcomes in knee OA patients based on observational data have been reported (Knee Surg Sports Traumatol Arthrosc, 2020;28(8):2435-43). Structural progression enrichment in the OA-11 trial, which enrolled concurrently, might have confounded short-term therapeutic pain detection; this hypothesis was evaluated in the post-hoc Kellgren-Lawrence Grade 2 only analysis.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 39495154Tambiah J, Kennedy S, Swearingen C, McAlindon T, Yazici Y. Impact of structural severity on outcomes in knee osteoarthritis: an analysis of data from phase 2 and phase 3 lorecivivint clinical trials. Rheumatology (Oxford). 2025 May 1;64(5):2583-2590. doi: 10.1093/rheumatology/keae610.

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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, M.D. study director

Biosplice Therapeutics, Inc.

76 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 76 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 9 inclusion and 13 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 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 76 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. 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 4 Feb 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 the Weekly Average of Daily Pain Numeric Rating Scale (NRS) at Week 12 (time frame: Baseline and 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 NCT04385303, which also lists 1 linked publication.

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 4 Feb 2026.