OsteoarthritisNCT02951026
An Observational Study Evaluating the Safety, Tolerability, and Efficacy of Treatment of SM04690 or Placebo Previously Injected in the Target Knee Joint of Subjects With Moderately to Severely Symptomatic Osteoarthritis
An observational study of Osteoarthritis, run by Biosplice Therapeutics, Inc. at 62 sites in United States.
Trial summary
This long-term extension study is designed to monitor the long-term safety, tolerability, and efficacy of treatment of SM04690 or placebo previously injected in the target knee joints of subjects with moderately to severely symptomatic osteoarthritis (OA) from a Samumed-sponsored SM04690-OA phase 2 or phase 3 study. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Not applicable (no therapy is administered as part of this study)
- Type of treatment
- Injection or infusion
- How many people
- 703 participants
- Where
- 62 sitesUnited States
- Study dates
- 19 Sep 2016to 31 Oct 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Subjects can only participate in this study upon completion of a Samumed SM04690-OA phase 2 or phase 3 study.
Who may be able to join
- Completion of scheduled end-of-study visit of Samumed-sponsored SM04690-OA phase 2 or phase 3 studies
- 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
Who cannot join
- Unable to undergo the radiograph procedures detailed within the protocol
- Partial or complete joint replacement in the target knee
- 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
62 sites in 1 country.
62 sites in 1 country
United States62 sites
Research Site
Albuquerque, New Mexico
Research Site
Arlington, Virginia
Research Site
Austin, Texas
Research Site
Bedford, Texas
Research Site
Birmingham, Alabama
Research Site
Boston, Massachusetts
Research Site
Boulder, Colorado
Research Site
Canoga Park, California
Research Site
Carmichael, California
Research Site
Cerritos, California
Research Site
Charleston, South Carolina
Research Site
Charlotte, North Carolina
Research Site
Charlottesville, Virginia
Research Site
Chicago, Illinois
Research Site
Cincinnati, Ohio
Research Site
City of Saint Peters, Missouri
Research Site
Clearwater, Florida
Research Site
Cleveland, Ohio
Research Site
Coral Gables, Florida
Research Site
DeLand, Florida
Research Site
Duncansville, Pennsylvania
Research Site
Edgewater, Florida
Research Site
El Cajon, California
Research Site
Frederick, Maryland
Research Site
Gold River, California
Research Site
High Point, North Carolina
Research Site
Houston, Texas
Research Site
Kansas City, Missouri
Research Site
Knoxville, Tennessee
Research Site
La Mesa, California
Research Site
Las Vegas, Nevada
Research Site
Lauderdale Lakes, Florida
Research Site
Layton, Utah
Research Site
Lexington, Kentucky
Research Site
Lincoln, Nebraska
Research Site
Marietta, Georgia
Research Site
Miami, Florida
Research Site
Mt. Pleasant, South Carolina
Research Site
Newton, Kansas
Research Site
Orchard Park, New York
Research Site
Oro Valley, Arizona
Research Site
Palm Springs, California
Research Site
Philadelphia, Pennsylvania
Research Site
Phoenix, Arizona
Research Site
Raleigh, North Carolina
Research Site
Rancho Mirage, California
Research Site
Rapid City, South Dakota
Research Site
Rochester, New York
Research Site
Sacramento, California
Research Site
Salisbury, North Carolina
Research Site
San Angelo, Texas
Research Site
San Diego, California
Research Site
San Marcos, California
Research Site
Spring Valley, California
Research Site
St Louis, Missouri
Research Site
Stamford, Connecticut
Research Site
Troy, Michigan
Research Site
Trumbull, Connecticut
Research Site
Tucson, Arizona
Research Site
Waterbury, Connecticut
Research Site
Wichita, Kansas
Research Site
Woodstock, Georgia
About this study
Official title: A Phase 3, Multicenter, Observational Long-term Study Evaluating the Safety, Tolerability, and Efficacy of Treatment of SM04690 or Placebo Previously Injected in the Target Knee Joint of Subjects With Moderately to Severely Symptomatic Osteoarthritis
This long-term extension study is designed to monitor the long-term safety, tolerability, and efficacy of treatment of SM04690 or placebo previously injected in the target knee joints of subjects with moderately to severely symptomatic osteoarthritis (OA) from a Samumed-sponsored SM04690-OA phase 2 or phase 3 study. No additional SM04690 or placebo therapy will be administered in this study.
- Conditions
- Osteoarthritis
- Being tested
- Not applicable (no therapy is administered as part of this study)
- Keywords
- knee, osteoarthritis, intra-articular injection, SM04690
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Not applicable (no therapy is administered as part of this study)Other
No experimental therapy or placebo is being administered in this study. All subjects in this observational study received a single intra-articular injection of SM04690 or placebo in a prior "parent" study.
| Study group | Role | What they receive |
|---|---|---|
| 0.03mg SM04690 (previously injected) | Subjects in this group received a single intra-articular injection of 0.03mg SM04690 into the target knee during the "parent" study prior to enrolling in this observational study. Receives: Other: Not applicable (no therapy is administered as part of this study) | |
| 0.07mg SM04690 (previously injected) | Subjects in this group received a single intra-articular injection of 0.07mg SM04690 into the target knee during the "parent" study prior to enrolling in this observational study. Receives: Other: Not applicable (no therapy is administered as part of this study) | |
| 0.23mg SM04690 (previously injected) | Subjects in this group received a single intra-articular injection of 0.23mg SM04690 into the target knee during the "parent" study prior to enrolling in this observational study. Receives: Other: Not applicable (no therapy is administered as part of this study) | |
| Placebo (previously injected) | Subjects in this group received a single intra-articular injection of placebo into the target knee during the "parent" study prior to enrolling in this observational study. Receives: Other: Not applicable (no therapy is administered as part of this study) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence rate of serious adverse events (SAEs)
Compare the incidence rate of SAEs occurring in the (previously injected) SM04690 treatment arms to the (previously injected) placebo treatment arm by Month 60
Measured: Month 60
Secondary outcomes (43)
Adverse events (AEs) of interest
Compare the number of subjects who experience an AE of interest occurring in the (previously injected) SM04690 treatment arms to the (previously injected) placebo treatment arm at Month 6. AEs of interest include those related to either knee and/or an AE that is a newly diagnosed chronic condition requiring treatment (e.g., hypertension, hyperlipidemia, diabetes).
Measured: Month 6
AEs of interest
Compare the number of subjects who experience an AE of interest occurring in the (previously injected) SM04690 treatment arms to the (previously injected) placebo treatment arm at Month 12.
Measured: Month 12
AEs of interest
Compare the number of subjects who experience an AE of interest occurring in the (previously injected) SM04690 treatment arms to the (previously injected) placebo treatment arm at Month 24.
Measured: Month 24
AEs of interest
Compare the number of subjects who experience an AE of interest occurring in the (previously injected) SM04690 treatment arms to the (previously injected) placebo treatment arm at Month 36.
Measured: Month 36
AEs of interest
Compare the number of subjects who experience an AE of interest occurring in the (previously injected) SM04690 treatment arms to the (previously injected) placebo treatment arm at Month 48.
Measured: Month 48
AEs of interest
Compare the number of subjects who experience an AE of interest occurring in the (previously injected) SM04690 treatment arms to the (previously injected) placebo treatment arm at Month 60.
Measured: Month 60
Incidence and incidence rate of total knee replacement (TKR)
Compare the incidence and incidence rate of TKR in the previously injected knee occurring in the (previously injected) SM04690 treatment arms to the (previously injected) placebo treatment arm by Month 60.
Measured: Month 60
Change in joint space width (JSW)
Change from baseline in JSW as documented by X-ray of the target knee in both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 6.
Measured: Baseline and Month 6
Change in joint space width (JSW)
Change from baseline in JSW as documented by X-ray of the target knee in both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 12.
Measured: Baseline and Month 12
Change in joint space width (JSW)
Change from baseline in JSW as documented by X-ray of the target knee in both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 24.
Measured: Baseline and Month 24
Change in joint space width (JSW)
Change from baseline in JSW as documented by X-ray of the target knee in both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 36.
Measured: Baseline and Month 36
Change in joint space width (JSW)
Change from baseline in JSW as documented by X-ray of the target knee in both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 48.
Measured: Baseline and Month 48
Change in joint space width (JSW)
Change from baseline in JSW as documented by X-ray of the target knee in both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 60.
Measured: Baseline and Month 60
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score
Change from baseline in WOMAC total score for the target knee for both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 6.
Measured: Baseline and Month 6
Change in WOMAC total score
Change from baseline in WOMAC total score for the target knee for both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 12.
Measured: Baseline and Month 12
Change in WOMAC total score
Change from baseline in WOMAC total score for the target knee for both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 24.
Measured: Baseline and Month 24
Change in WOMAC total score
Change from baseline in WOMAC total score for the target knee for both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 36.
Measured: Baseline and Month 36
Change in WOMAC total score
Change from baseline in WOMAC total score for the target knee for both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 48.
Measured: Baseline and Month 48
Change in WOMAC total score
Change from baseline in WOMAC total score for the target knee for both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 60.
Measured: Baseline and Month 60
Change in WOMAC pain subscore
Change from baseline in WOMAC pain subscore for the target knee for both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 6.
Measured: Baseline and Month 6
Change in WOMAC pain subscore
Change from baseline in WOMAC pain subscore for the target knee for both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 12.
Measured: Baseline and Month 12
Change in WOMAC pain subscore
Change from baseline in WOMAC pain subscore for the target knee for both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 24.
Measured: Baseline and Month 24
Change in WOMAC pain subscore
Change from baseline in WOMAC pain subscore for the target knee for both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 36.
Measured: Baseline and Month 36
Change in WOMAC pain subscore
Change from baseline in WOMAC pain subscore for the target knee for both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 48.
Measured: Baseline and Month 48
Change in WOMAC pain subscore
Change from baseline in WOMAC pain subscore for the target knee for both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 60.
Measured: Baseline and Month 60
Change in WOMAC function subscore
Change from baseline in WOMAC function subscore for the target knee for both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 6.
Measured: Baseline and Month 6
Change in WOMAC function subscore
Change from baseline in WOMAC function subscore for the target knee for both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 12.
Measured: Baseline and Month 12
Change in WOMAC function subscore
Change from baseline in WOMAC function subscore for the target knee for both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 24.
Measured: Baseline and Month 24
Change in WOMAC function subscore
Change from baseline in WOMAC function subscore for the target knee for both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 36.
Measured: Baseline and Month 36
Change in WOMAC function subscore
Change from baseline in WOMAC function subscore for the target knee for both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 48.
Measured: Baseline and Month 48
Change in WOMAC function subscore
Change from baseline in WOMAC function subscore for the target knee for both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 60.
Measured: Baseline and Month 60
Change in Physician Global Assessment
Change from baseline OA disease activity as assessed by Physician Global Assessment for both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 6.
Measured: Baseline and Month 6
Change in Physician Global Assessment
Change from baseline OA disease activity as assessed by Physician Global Assessment for both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 12.
Measured: Baseline and Month 12
Change in Physician Global Assessment
Change from baseline OA disease activity as assessed by Physician Global Assessment for both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 24.
Measured: Baseline and Month 24
Change in Physician Global Assessment
Change from baseline OA disease activity as assessed by Physician Global Assessment for both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 36.
Measured: Baseline and Month 36
Change in Physician Global Assessment
Change from baseline OA disease activity as assessed by Physician Global Assessment for both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 48.
Measured: Baseline and Month 48
Change in Physician Global Assessment
Change from baseline OA disease activity as assessed by Physician Global Assessment for both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 60.
Measured: Baseline and Month 60
Change in Patient Global Assessment
Change from baseline OA disease activity as assessed by Patient Global Assessment for both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 6.
Measured: Baseline and Month 6
Change in Patient Global Assessment
Change from baseline OA disease activity as assessed by Patient Global Assessment for both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 12.
Measured: Baseline and Month 12
Change in Patient Global Assessment
Change from baseline OA disease activity as assessed by Patient Global Assessment for both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 24.
Measured: Baseline and Month 24
Change in Patient Global Assessment
Change from baseline OA disease activity as assessed by Patient Global Assessment for both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 36.
Measured: Baseline and Month 36
Change in Patient Global Assessment
Change from baseline OA disease activity as assessed by Patient Global Assessment for both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 48.
Measured: Baseline and Month 48
Change in Patient Global Assessment
Change from baseline OA disease activity as assessed by Patient Global Assessment for both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 60.
Measured: Baseline and Month 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2016 (estimated)
- Study start19 Sep 2016
- Primary completion31 Oct 2019
- Study completion31 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 703 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biosplice Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yusuf Yazici, M.D., Study director, Biosplice Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02951026
- Sponsor's protocol ID
- SM04690-OA-05
- Status last verified
- Apr 2020
- First submitted
- 7 Oct 2016
- Last updated
- 17 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Swearingen CJ, Tambiah JRS, Simsek I, Ghandehari H, Kennedy S, Yazici Y. Evaluation of Safety and Efficacy of a Single Lorecivivint Injection in Patients with Knee Osteoarthritis: A Multicenter, Observational Extension Trial. Rheumatol Ther. 2025 Feb;12(1):157-171. doi: 10.1007/s40744-024-00731-9. Epub 2025 Jan 4.
PubMed 39755925
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Multicenter, Observational Long-term Study Evaluating the Safety, Tolerability, and Efficacy of Treatment of SM04690 or Placebo Previously Injected in the Target Knee Joint of Subjects With Moderately to Severely Symptomatic Osteoarthritis
- ClinicalTrials.gov ID
- NCT02951026
- Acronym / sponsor ID
- SM04690-OA-05
- Conditions
- Osteoarthritis
- Keywords
- knee, osteoarthritis, intra-articular injection, SM04690
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 703 participants (actual)
- Lead sponsor
- Biosplice Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 19 Sep 2016 (actual)
- Primary completion
- 31 Oct 2019 (actual)
- Study completion
- 31 Oct 2019 (actual)
- First posted
- 1 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This long-term extension study is designed to monitor the long-term safety, tolerability, and efficacy of treatment of SM04690 or placebo previously injected in the target knee joints of subjects with moderately to severely symptomatic osteoarthritis (OA) from a Samumed-sponsored SM04690-OA phase 2 or phase 3 study. No additional SM04690 or placebo therapy will be administered in this study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 0.03mg SM04690 (previously injected) | – | Other: Not applicable (no therapy is administered as part of this study)Subjects in this group received a single intra-articular injection of 0.03mg SM04690 into the target knee during the "parent" study prior to enrolling in this observational study. |
| 0.07mg SM04690 (previously injected) | – | Other: Not applicable (no therapy is administered as part of this study)Subjects in this group received a single intra-articular injection of 0.07mg SM04690 into the target knee during the "parent" study prior to enrolling in this observational study. |
| 0.23mg SM04690 (previously injected) | – | Other: Not applicable (no therapy is administered as part of this study)Subjects in this group received a single intra-articular injection of 0.23mg SM04690 into the target knee during the "parent" study prior to enrolling in this observational study. |
| Placebo (previously injected) | – | Other: Not applicable (no therapy is administered as part of this study)Subjects in this group received a single intra-articular injection of placebo into the target knee during the "parent" study prior to enrolling in this observational study. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects can only participate in this study upon completion of a Samumed SM04690-OA phase 2 or phase 3 study.
Key inclusion criteria (3 listed)
- Completion of scheduled end-of-study visit of Samumed-sponsored SM04690-OA phase 2 or phase 3 studies
- 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
Key exclusion criteria (4 listed)
- Unable to undergo the radiograph procedures detailed within the protocol
- Partial or complete joint replacement in the target knee
- 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
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 |
|---|---|---|
| Not applicable (no therapy is administered as part of this study)No experimental therapy or placebo is being administered in this study. All subjects in this observational study received a single intra-articular injection of SM04690 or placebo in a prior "parent" study. | Other | 0.03mg SM04690 (previously injected), 0.07mg SM04690 (previously injected), 0.23mg SM04690 (previously injected), Placebo (previously injected) |
Primary outcome
Incidence rate of serious adverse events (SAEs)
Time frame: Month 60
Compare the incidence rate of SAEs occurring in the (previously injected) SM04690 treatment arms to the (previously injected) placebo treatment arm by Month 60
43 secondary outcomes
Adverse events (AEs) of interest
Time frame: Month 6
AEs of interest
Time frame: Month 12
AEs of interest
Time frame: Month 24
AEs of interest
Time frame: Month 36
AEs of interest
Time frame: Month 48
AEs of interest
Time frame: Month 60
Incidence and incidence rate of total knee replacement (TKR)
Time frame: Month 60
Change in joint space width (JSW)
Time frame: Baseline and Month 6
Change in joint space width (JSW)
Time frame: Baseline and Month 12
Change in joint space width (JSW)
Time frame: Baseline and Month 24
Change in joint space width (JSW)
Time frame: Baseline and Month 36
Change in joint space width (JSW)
Time frame: Baseline and Month 48
Change in joint space width (JSW)
Time frame: Baseline and Month 60
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score
Time frame: Baseline and Month 6
Change in WOMAC total score
Time frame: Baseline and Month 12
Change in WOMAC total score
Time frame: Baseline and Month 24
Change in WOMAC total score
Time frame: Baseline and Month 36
Change in WOMAC total score
Time frame: Baseline and Month 48
Change in WOMAC total score
Time frame: Baseline and Month 60
Change in WOMAC pain subscore
Time frame: Baseline and Month 6
Change in WOMAC pain subscore
Time frame: Baseline and Month 12
Change in WOMAC pain subscore
Time frame: Baseline and Month 24
Change in WOMAC pain subscore
Time frame: Baseline and Month 36
Change in WOMAC pain subscore
Time frame: Baseline and Month 48
Change in WOMAC pain subscore
Time frame: Baseline and Month 60
Change in WOMAC function subscore
Time frame: Baseline and Month 6
Change in WOMAC function subscore
Time frame: Baseline and Month 12
Change in WOMAC function subscore
Time frame: Baseline and Month 24
Change in WOMAC function subscore
Time frame: Baseline and Month 36
Change in WOMAC function subscore
Time frame: Baseline and Month 48
Change in WOMAC function subscore
Time frame: Baseline and Month 60
Change in Physician Global Assessment
Time frame: Baseline and Month 6
Change in Physician Global Assessment
Time frame: Baseline and Month 12
Change in Physician Global Assessment
Time frame: Baseline and Month 24
Change in Physician Global Assessment
Time frame: Baseline and Month 36
Change in Physician Global Assessment
Time frame: Baseline and Month 48
Change in Physician Global Assessment
Time frame: Baseline and Month 60
Change in Patient Global Assessment
Time frame: Baseline and Month 6
Change in Patient Global Assessment
Time frame: Baseline and Month 12
Change in Patient Global Assessment
Time frame: Baseline and Month 24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2020.
- Derived from this study: PubMed 39755925Swearingen CJ, Tambiah JRS, Simsek I, Ghandehari H, Kennedy S, Yazici Y. Evaluation of Safety and Efficacy of a Single Lorecivivint Injection in Patients with Knee Osteoarthritis: A Multicenter, Observational Extension Trial. Rheumatol Ther. 2025 Feb;12(1):157-171. doi: 10.1007/s40744-024-00731-9. Epub 2025 Jan 4.
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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.
62 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis, run by Biosplice Therapeutics, Inc. at 62 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 3 inclusion and 4 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 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 62 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence rate of serious adverse events (SAEs) (time frame: Month 60). 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 NCT02951026, 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 17 Apr 2020.