OsteoarthritisPhase 2NCT02536833

A Study Evaluating the Safety, Tolerability, and Efficacy of SM04690 Injected in the Target Knee Joint of Moderately to Severely Symptomatic Osteoarthritis Subjects

A Phase 2 study testing SM04690 in people with Osteoarthritis, run by Biosplice Therapeutics, Inc. at 36 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

The purpose of this study is to assess the efficacy, safety, and tolerability of three different strengths of SM04690 injected in the target knee joint of moderately to severely symptomatic osteoarthritis (OA) subjects. Read more about this study

Who is it for?: Ages 40 to 80 years
Conditions the study is for: Osteoarthritis
What is being tested?: SM04690
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 455 participants
Where: 36 sitesUnited States
Study dates: 9 Sep 2015to 20 Apr 2017
Phase: Phase 2
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
Ambulatory (single assistive devices such as canes allowed if needed less than 50% of the time, subjects requiring a walker are excluded)
Established diagnosis of primary femorotibial OA in the target knee by standard American College of Rheumatology (ACR) criteria for at least 6 months (clinical AND radiographic criteria); if bilateral knee OA is present, the target knee is defined as the knee with greater pain at screening based on the subject's evaluation and the Investigator's clinical judgment
Radiographic disease Stage 2 or 3 in the target knee according to the Kellgren-Lawrence grading of knee OA as assessed by independent central readers
Screening pain visual analog scale (VAS) score of 30-80 mm (on a scale of 0-100 mm) for the target knee while on symptomatic oral treatment at screening (if the subject requires oral treatment)
Total WOMAC score of 72-192 (out of 240) for the target knee while on symptomatic oral treatment at screening (if the subject requires oral treatment)

Show all 13Show fewer

Willingness to omit the following for 24 hours prior to all Study Visits, excluding the Screening Visit:
Pain medications
Medications or supplements for the treatment of OA
Participation in a formalized in-office and/or supervised OA disease program (e.g., a prescribed patient education program, physiotherapy, etc.)
Full understanding of the requirements of the study and willingness to comply with all study visits and assessments
Subjects must have read and understood the informed consent form, and must have signed it prior to any study-related procedure being performed
Subject's Day 1 visit must occur while enrollment into the study is open

Who cannot join

Women who are pregnant or lactating
Women of childbearing potential (i.e., who are not surgically sterile or postmenopausal as defined by no menstrual periods for 12 consecutive months and no other biological or physiological cause for amenorrhea can be identified); males who are sexually active and have a partner who is capable of becoming pregnant, neither of which have had surgery to become sterilized, who are not using an effective method of birth control (e.g., surgically-implanted hormonal therapy, intrauterine devices or oral birth control with barrier method)
Body mass index (BMI) >40
Partial or complete joint replacement in the target knee
Previous exposure to SM04690
Major surgery (e.g., interventional arthroscopy) in the target knee within 52 weeks prior to any study injection

Show all 32Show fewer

Any planned or elective surgery during the study period
Significant and clinically evident misalignment of the target knee that would impact subject function, as determined by the Investigator
History of malignancy within the last 5 years; however, subjects with prior history of in situ cancer or basal or squamous cell skin cancer are eligible. Subjects with other malignancies are eligible if they have been continuously disease free for at least 5 years prior to any study injection
Clinically significant abnormal Screening Visit hematology values, blood chemistry values, HbA1c, or urinalysis values as determined by the investigator
Any condition, including laboratory findings (not included in the Screening Visit laboratory tests) and findings in the medical history or in the pre-study assessments, 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
Comorbid conditions that could affect pain assessment of the target knee, including, but not limited to, inflammatory rheumatic conditions such as rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus, diabetic neuropathy, pseudogout, gout, and fibromyalgia
Other conditions that, in the opinion of the Investigator, could affect pain assessment of the target knee, including, but not limited to, symptomatic hip osteoarthritis and symptomatic degenerative disc disease
Any diagnosed psychiatric condition that includes, but is not limited to, a history of mania, bipolar disorder, psychotic disorder, schizophrenia, major depressive disorder, or generalized anxiety disorder
Participation in a clinical research trial that included the receipt of an investigational product or any experimental therapeutic procedure within 12 weeks prior to any study injection; the last date of participation in the trial, not the last date of receipt of investigational product, must be at least 12 weeks prior to Study Visit Day 1
Treatment of the target knee with systemic or intra-articular corticosteroids (e.g., methylprednisolone) within 8 weeks prior to Study Visit Day 1
Viscosupplementation (e.g., hyaluronic acid) in the target knee within 24 weeks prior to Study Visit Day 1
Effusion of the target knee clinically requiring aspiration within 12 weeks prior to Study Visit Day 1
Use of electrotherapy, acupuncture, and/or chiropractic treatments for knee OA within 4 weeks prior to Study Visit Day 1
Any known active infections, including suspicion of intra-articular infection, hepatitis B or hepatitis C infection, and/or infections that may compromise the immune system such as human immunodeficiency virus (HIV)
Subjects taking prescription medications for OA who have not maintained a stable therapeutic regimen for a minimum of 12 weeks prior to Study Visit Day 1
Subjects requiring the chronic use (i.e., regular and consistent use for ≥ 12 weeks) of the medications listed below within 12 weeks prior to Study Visit Day 1:
Opioids, both oral (e.g., tramadol) or transdermal (e.g., fentanyl patches) formulations
Centrally acting analgesics (e.g., duloxetine)
Glucocorticoids (e.g., methylprednisolone) administered by any route, with exception of inhaled, intranasal, and ophthalmic solutions
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 for a minimum of 12 weeks prior to Study Visit Day 1. In addition, the following subjects will be excluded:
Subjects with a baseline HbA1c >9
Subjects with uncontrolled hypertension in the opinion of the investigator
Subjects with symptomatic coronary artery disease in the opinion of the investigator
Subjects who have a current or pending disability claim, workers' compensation, or litigation(s) that may compromise response to treatment
Subjects who are immediate family members (spouse, parent, child, or sibling; biological or legally adopted) of personnel directly affiliated with the study at the investigative site, or are directly affiliated with the study at the investigative site
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

Trial locations and contacts

36 sites in 1 country.

City, postcode or hospital

36 sites in 1 country

United States36 sites

Research Site
Austin, Texas, 78745
Research Site
Boston, Massachusetts, 02111
Research Site
Charlottesville, Virginia, 22911
Research Site
Cincinnati, Ohio, 45246
Research Site
Clearwater, Florida, 33761
Research Site
Coral Gables, Florida, 33134
Research Site
Denver, Colorado, 80230
Research Site
Duncansville, Pennsylvania, 16635
Research Site
El Cajon, California, 92020
Research Site
Franklin, Wisconsin, 53132
Research Site
Frederick, Maryland, 21702
Research Site
Houston, Texas, 77074
Research Site
Jacksonville, Florida, 32216
Research Site
Knoxville, Tennessee, 37912
Research Site
Lexington, Kentucky, 40504
Research Site
Miami, Florida, 33173
Research Site
Mobile, Alabama, 36608
Research Site
Mt. Pleasant, South Carolina, 29464
Research Site
Newton, Kansas, 67114
Research Site
Orchard Park, New York, 14127
Research Site
Phoenix, Arizona, 85029
Research Site
Raleigh, North Carolina, 27612
Research Site
Rancho Mirage, California, 92270
Research Site
Rapid City, South Dakota, 57702
Research Site
Richmond, Virginia, 23225
Research Site
Rochester, New York, 14609
Research Site
Salisbury, North Carolina, 28144
Research Site
Spring Valley, California, 91978
Research Site 1
St Louis, Missouri, 63141
Research Site 2
St Louis, Missouri, 63141
Research Site
Tucson, Arizona, 85712
Research Site
West Layton, Utah, 84041
Research Site
West Palm Beach, Florida, 33409
Research Site
Wichita, Kansas, 67205
Research Site
Woodstock, Georgia, 30189
Research Site
Worcester, Massachusetts, 01605

Other trials in United States

About this study

Official title: A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, and Efficacy of SM04690 Injected in the Target Knee Joint of Moderately to Severely Symptomatic Osteoarthritis Subjects

Conditions: Osteoarthritis
Being tested: SM04690, Placebo
Keywords: Osteoarthritis, Samumed, SM04690
Medical subject headings: Osteoarthritis

What participants receive

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

SM04690Drug
PlaceboDrug

Study groups in NCT02536833
Study group	Role	What they receive
0.03 mg SM04690	Experimental	Single intra-articular injection of SM04690 0.03 mg in 2 mL injectable suspension Receives: Drug: SM04690
0.07 mg SM04690	Experimental	Single intra-articular injection of SM04690 0.07 mg in 2 mL injectable suspension Receives: Drug: SM04690
0.23 mg SM04690	Experimental	Single intra-articular injection of SM04690 0.23 mg in 2 mL injectable suspension Receives: Drug: SM04690
Placebo	Placebo comparator	Single intra-articular injection of SM04690 0 mg in 2 mL phosphate buffered saline Receives: Drug: Placebo

What is being measured

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

Change From Baseline Osteoarthritis (OA) Pain in the Target Knee
Change from baseline OA pain in the target knee as assessed by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Numeric Rating Scale (NRS 3.1) pain subscore (WOMAC Pain) at Week 13. The WOMAC is a widely-used, proprietary outcome measurement tool used by health professionals 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 a scale from 0 (lowest pain/lowest stiffness/highest function) to 10 (highest pain/highest stiffness/lowest function). The WOMAC Pain subscore is reported ranging from 0 to 100.
Measured: Baseline and Week 13

Secondary outcomes (6)

Change From Baseline OA Pain in the Target Knee
Change from baseline OA pain in the target knee as assessed by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Numeric Rating Scale (NRS 3.1) pain subscore (WOMAC Pain) at Week 26. The WOMAC is a widely-used, proprietary outcome measurement tool used by health professionals 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 a scale from 0 (lowest pain/lowest stiffness/highest function) to 10 (highest pain/highest stiffness/lowest function). The WOMAC Pain subscore is reported ranging from 0 to 100.
Measured: Baseline and Week 26
Change From Baseline OA Function in the Target Knee
Change from baseline OA function in the target knee as assessed by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Numeric Rating Scale (NRS 3.1) physical functioning subscore (WOMAC Function) at Week 13. The WOMAC is a widely-used, proprietary outcome measurement tool used by health professionals 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 a scale from 0 (lowest pain/lowest stiffness/highest function) to 10 (highest pain/highest stiffness/lowest function). The WOMAC Function subscore is reported ranging from 0 to 100.
Measured: Baseline and Week 13
Change From Baseline OA Function in the Target Knee
Change from baseline OA function in the target knee as assessed by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Numeric Rating Scale (NRS 3.1) physical functioning subscore (WOMAC Function) at Week 26. The WOMAC is a widely-used, proprietary outcome measurement tool used by health professionals 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 a scale from 0 (lowest pain/lowest stiffness/highest function) to 10 (highest pain/highest stiffness/lowest function). The WOMAC Function subscore is reported ranging from 0 to 100.
Measured: Baseline and Week 26
Change From Baseline OA Disease Activity as Assessed by the Patient
Change from baseline OA disease activity as assessed by the Patient Global Assessment at Week 13. The Patient Global Assessment was completed using a 100 mm visual analog scale (VAS) adapted from the Patient Assessment Form © 1999, American College of Rheumatology. The subject rated how well he/she was doing, considering all the ways in which illness and health conditions may affected him/her. The VAS scale was anchored by "Very Well" on the left (scored as 0) and "Very Poorly" on the right (scored as 100). Higher scores indicated poorer disease assessment by the subject.
Measured: Baseline and Week 13
Change From Baseline OA Disease Activity as Assessed by the Patient
Change from baseline OA disease activity as assessed by the Patient Global Assessment at Week 26. The Patient Global Assessment was completed using a 100 mm visual analog scale (VAS) adapted from the Patient Assessment Form © 1999, American College of Rheumatology. The subject rated how well he/she was doing, considering all the ways in which illness and health conditions may affected him/her. The VAS scale was anchored by "Very Well" on the left (scored as 0) and "Very Poorly" on the right (scored as 100). Higher scores indicated poorer disease assessment by the subject.
Measured: Baseline and Week 26
Change From Baseline in Medial Joint Space Width of Target Knee
Change from baseline in medial joint space width as documented by X-ray of the target knee at Week 26.
Measured: Baseline and Week 26

Timeline

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

9 Sep 201520 Apr 2017

First posted1 Sep 2015 (estimated)
Study start9 Sep 2015
Primary completion20 Apr 2017
Study completion20 Apr 2017

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 (2)Papers the sponsor has linked to this study.
Other trials for 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 455 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02536833
Sponsor's protocol ID: SM04690-OA-02
Status last verified: Mar 2021
First submitted: 28 Aug 2015
Last updated: 17 Mar 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Yazici Y, McAlindon TE, Gibofsky A, Lane NE, Clauw D, Jones M, Bergfeld J, Swearingen CJ, DiFrancesco A, Simsek I, Tambiah J, Hochberg MC. Lorecivivint, a Novel Intraarticular CDC-like Kinase 2 and Dual-Specificity Tyrosine Phosphorylation-Regulated Kinase 1A Inhibitor and Wnt Pathway Modulator for the Treatment of Knee Osteoarthritis: A Phase II Randomized Trial. Arthritis Rheumatol. 2020 Oct;72(10):1694-1706. doi: 10.1002/art.41315. Epub 2020 Sep 6.
PubMed 32432388
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 Osteoarthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, and Efficacy of SM04690 Injected in the Target Knee Joint of Moderately to Severely Symptomatic Osteoarthritis Subjects
ClinicalTrials.gov ID: NCT02536833
Acronym / sponsor ID: SM04690-OA-02
Conditions: Osteoarthritis
Keywords: Osteoarthritis, Samumed, SM04690
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 455 participants (actual)
Lead sponsor: Biosplice Therapeutics, Inc.Industry (pharma, biotech, devices)
Study start: 9 Sep 2015 (actual)
Primary completion: 20 Apr 2017 (actual)
Study completion: 20 Apr 2017 (actual)
First posted: 1 Sep 2015 (estimated)
Results: Posted 16 Sep 2020

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
0.03 mg SM04690	Experimental	Drug: SM04690Single intra-articular injection of SM04690 0.03 mg in 2 mL injectable suspension
0.07 mg SM04690	Experimental	Drug: SM04690Single intra-articular injection of SM04690 0.07 mg in 2 mL injectable suspension
0.23 mg SM04690	Experimental	Drug: SM04690Single intra-articular injection of SM04690 0.23 mg in 2 mL injectable suspension
Placebo	Placebo comparator	Drug: PlaceboSingle intra-articular injection of SM04690 0 mg in 2 mL phosphate buffered saline

Who may qualify

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

Key inclusion criteria (13 listed)

Males and females between 40 and 80 years of age, inclusive, in general good health
Ambulatory (single assistive devices such as canes allowed if needed less than 50% of the time, subjects requiring a walker are excluded)
Established diagnosis of primary femorotibial OA in the target knee by standard American College of Rheumatology (ACR) criteria for at least 6 months (clinical AND radiographic criteria); if bilateral knee OA is present, the target knee is defined as the knee with greater pain at screening based on the subject's evaluation and the Investigator's clinical judgment
Radiographic disease Stage 2 or 3 in the target knee according to the Kellgren-Lawrence grading of knee OA as assessed by independent central readers
Screening pain visual analog scale (VAS) score of 30-80 mm (on a scale of 0-100 mm) for the target knee while on symptomatic oral treatment at screening (if the subject requires oral treatment)

Key exclusion criteria (32 listed)

Women who are pregnant or lactating
Women of childbearing potential (i.e., who are not surgically sterile or postmenopausal as defined by no menstrual periods for 12 consecutive months and no other biological or physiological cause for amenorrhea can be identified); males who are sexually active and have a partner who is capable of becoming pregnant, neither of which have had surgery to become sterilized, who are not using an effective method of birth control (e.g., surgically-implanted hormonal therapy, intrauterine devices or oral birth control with barrier method)
Body mass index (BMI) >40
Partial or complete joint replacement in the target knee
Previous exposure to SM04690

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
SM04690	Drug	0.03 mg SM04690, 0.07 mg SM04690, 0.23 mg SM04690
Placebo	Drug	Placebo

Primary outcome

Change From Baseline Osteoarthritis (OA) Pain in the Target Knee
Time frame: Baseline and Week 13
Change from baseline OA pain in the target knee as assessed by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Numeric Rating Scale (NRS 3.1) pain subscore (WOMAC Pain) at Week 13. The WOMAC is a widely-used, proprietary outcome measurement tool used by health professionals 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 a scale from 0 (lowest pain/lowest stiffness/highest function) to 10 (highest pain/highest stiffness/lowest function). The WOMAC Pain subscore is reported ranging from 0 to 100.

6 secondary outcomes

Change From Baseline OA Pain in the Target Knee
Time frame: Baseline and Week 26
Change From Baseline OA Function in the Target Knee
Time frame: Baseline and Week 13
Change From Baseline OA Function in the Target Knee
Time frame: Baseline and Week 26
Change From Baseline OA Disease Activity as Assessed by the Patient
Time frame: Baseline and Week 13
Change From Baseline OA Disease Activity as Assessed by the Patient
Time frame: Baseline and Week 26
Change From Baseline in Medial Joint Space Width of Target Knee
Time frame: Baseline and Week 26

Results and safety

Results posted to the registry on 16 Sep 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
0.03 mg SM04690	112	103
0.07 mg SM04690	117	107
0.23 mg SM04690	110	95
Placebo	116	97

Primary outcome: Change From Baseline Osteoarthritis (OA) Pain in the Target Knee

Time frame: Baseline and Week 13. Least squares mean (Standard Error). Unit: score on a scale

Measure	0.03 mg SM04690 n = 112	0.07 mg SM04690 n = 117	0.23 mg SM04690 n = 110	Placebo n = 116
Value	-23.3 (2.2)	-23.5 (2.1)	-21.3 (2.2)	-22.1 (2.1)

0.07 mg SM04690 vs Placebo: Mean Difference (Final Values): -1.46 (95% CI -6.57 to 3.65), p = 0.575, ANCOVA
0.03 mg SM04690 vs Placebo: Mean Difference (Final Values): -1.27 (95% CI -6.63 to 4.09), p = 0.643, ANCOVA
0.23 mg SM04690 vs Placebo: Mean Difference (Final Values): 0.34 (95% CI -5.07 to 5.75), p = 0.901, ANCOVA

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
0.03 mg SM04690	5 of 111 (4.5%)	25 of 111 (22.5%)	0 of 111
0.07 mg SM04690	4 of 114 (3.5%)	23 of 114 (20.2%)	0 of 114
0.23 mg SM04690	4 of 104 (3.8%)	19 of 104 (18.3%)	0 of 104
Placebo	3 of 108 (2.8%)	18 of 108 (16.7%)	0 of 108
Other	1 of 15 (6.7%)	11 of 15 (73.3%)	0 of 15

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 32432388Yazici Y, McAlindon TE, Gibofsky A, Lane NE, Clauw D, Jones M, Bergfeld J, Swearingen CJ, DiFrancesco A, Simsek I, Tambiah J, Hochberg MC. Lorecivivint, a Novel Intraarticular CDC-like Kinase 2 and Dual-Specificity Tyrosine Phosphorylation-Regulated Kinase 1A Inhibitor and Wnt Pathway Modulator for the Treatment of Knee Osteoarthritis: A Phase II Randomized Trial. Arthritis Rheumatol. 2020 Oct;72(10):1694-1706. doi: 10.1002/art.41315. Epub 2020 Sep 6.
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.
Individual participant dataSharing planned: No

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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.

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SM04690 in people with Osteoarthritis, run by Biosplice Therapeutics, Inc. at 36 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 13 inclusion and 32 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 17 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 36 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 16 Sep 2020). 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 Osteoarthritis (OA) Pain in the Target Knee (time frame: Baseline and Week 13). 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 NCT02536833, which also lists 2 linked publications.

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 17 Mar 2021.