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Study was terminated by Sponsor based on a business decision not due to safety. The study report was finalized without any statistical analysis.
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This study is designed as a 3-year, multicenter, open-label study evaluating the safety, tolerability, and efficacy of intra-articular (IA) Lorecivivint (LOR) in subjects with osteoarthritis of the knee in a real-world setting.
At Day 1, after a screening period of up to 14 days, subjects will receive an IA injection of 0.07 mg LOR into one or both knees, followed by a 36-month evaluation period.
Clinic visits will be scheduled at Day 1, and Months 3, 12, 24, and 36 [End of study (EOS)] or Early Termination (ET).
All Patient Reported Outcome (PRO) measurements, including Western Ontario and McMaster University Osteoarthritis Index (WOMAC), and Pain Numeric Rating Scale (NRS), as well as safety evaluations will be conducted at each clinic visit. An additional phone follow-up visit for safety will occur 4 weeks after the injection on Day 1.
Study was terminated by Sponsor based on a business decision not due to safety. The study report was finalized without any statistical analysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0.07 mg Lorecivivint | Experimental | One intra-articular injection of 0.07 mg Lorecivivint in 2 ml vehicle in one or both knees as clinically indicated. Bilateral injection of 0.07 mg LOR are allowed. Lorecivivint: Healthcare professional-administered intra-articular injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lorecivivint | Drug | Healthcare professional-administered intra-articular (IA) injection into one or both knees as clinically indicated. Bilateral injections of 0.07 mg of LOR are allowed. IA injection performed on Day 1. Additional IA injections of LOR to same knee (with at least a 6 month separation) between Day 1 and Month 33. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Pain Numeric Rating Scale (NRS) Score for the Left Knee | Change from baseline in pain numeric rating scale (NRS) score for the left knee. 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. Change was calculated as three-month visit minus baseline; a negative value indicates improvement while a positive value indicates worsening. | Three Months after Day 1 Injection |
| Change From Baseline in Pain Numeric Rating Scale (NRS) Score for the Right Knee | Change from baseline in pain numeric rating scale (NRS) score for the right knee. 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. Change was calculated as three-month visit minus baseline; a negative value indicates improvement while a positive value indicates worsening. | Three Months after Day 1 Injection |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscore (WOMAC Function) in Left Knee | Change from baseline OA function in the target knee as assessed by Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index NRS3.1 physical function subscore (WOMAC Function) in left knee. 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, stiffness, and physical functioning of a target joint. 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 ranges from 0 to 170 (raw) and will be scaled 0 to 100 for reporting. Change was calculated as three-month visit minus baseline; a negative value indicates improvement while a positive value indicates worsening. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yusuf Yazici, MD | Biosplice Therapeutics, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Tucson | Arizona | 85712 | United States | ||
| Research Site |
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| ID | Title | Description |
|---|---|---|
| FG000 | 0.07 mg Lorecivivint | One intra-articular injection of 0.07 mg Lorecivivint in 2 ml vehicle in one or both knees as clinically indicated. Bilateral injection of 0.07 mg LOR are allowed. Lorecivivint: Healthcare professional-administered intra-articular (IA) injection into one or both knees as clinically indicated. Bilateral injections of 0.07 mg of LOR are allowed. IA injection performed on Day 1. Additional IA injections of LOR to same knee (with at least a 6 month separation) between Day 1 and Month 33. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All subjects who received a study injection without previous exposure to Lorecivivint.
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| ID | Title | Description |
|---|---|---|
| BG000 | 0.07 mg Lorecivivint | One intra-articular injection of 0.07 mg Lorecivivint in 2 ml vehicle in one or both knees as clinically indicated. Bilateral injection of 0.07 mg LOR are allowed. Lorecivivint: Healthcare professional-administered intra-articular (IA) injection into one or both knees as clinically indicated. Bilateral injections of 0.07 mg of LOR are allowed. IA injection performed on Day 1. Additional IA injections of LOR to same knee (with at least a 6 month separation) between Day 1 and Month 33. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Pain Numeric Rating Scale (NRS) Score for the Left Knee | Change from baseline in pain numeric rating scale (NRS) score for the left knee. 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. Change was calculated as three-month visit minus baseline; a negative value indicates improvement while a positive value indicates worsening. | Efficacy analyses were not performed due to the early termination of the study (administrative reasons). Given the impact of early termination on data completeness, efficacy of LOR for the treatment of knee OA was not formally assessed. Data collected on those subjects completing Month 3 visit are summarized without any imputation for missing data. | Posted | Mean | Full Range | units on a scale | Three Months after Day 1 Injection |
|
Adverse events were assessed at each in-person and phone visit from the time of study injection(s) on Day 1 through the end of the study (Day 116 / four months duration).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 0.07 mg Lorecivivint | One intra-articular injection of 0.07 mg Lorecivivint in 2 ml vehicle in one or both knees as clinically indicated. Bilateral injection of 0.07 mg LOR are allowed. Lorecivivint: Healthcare professional-administered intra-articular (IA) injection into one or both knees as clinically indicated. Bilateral injections of 0.07 mg of LOR are allowed. IA injection performed on Day 1. Additional IA injections of LOR to same knee (with at least a 6 month separation) between Day 1 and Month 33. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Non-systematic Assessment | Right Knee Pain due to Possible Ligament / Tendon Related |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christopher Swearingen, PhD, VP of Biometrics | Biosplice Therapeutics, Inc. | 858.926.2900 | info@biosplice.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 16, 2021 | Dec 31, 2025 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 18, 2022 | Dec 31, 2025 | SAP_002.pdf |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| C000627701 | lorecivivint |
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|
|
| Three Months after Day 1 Injection |
| Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscore (WOMAC Function) in Right Knee | Change from baseline OA function in the target knee as assessed by Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index NRS3.1 physical function subscore (WOMAC Function) in right knee. 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, stiffness, and physical functioning of a target joint. 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 ranges from 0 to 170 (raw) and will be scaled 0 to 100 for reporting. Change was calculated as three-month visit minus baseline; a negative value indicates improvement while a positive value indicates worsening. | Three Months after Day 1 Injection |
| Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscore (WOMAC Pain) in Left Knee | Change from baseline OA pain in the target knee as assessed by Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index NRS3.1 pain subscore (WOMAC Pain) in left knee. 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, stiffness, and physical functioning of a target joint. 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 ranges from 0 to 50 (raw) and will be scaled 0 to 100 for reporting. Change was calculated as three-month visit minus baseline; a negative value indicates improvement while a positive value indicates worsening. | Three Months after Day 1 Injection |
| Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscore (WOMAC Pain) in Right Knee | Change from baseline OA pain in the target knee as assessed by Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index NRS3.1 pain subscore (WOMAC Pain) in right knee. 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, stiffness, and physical functioning of a target joint. 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 ranges from 0 to 50 (raw) and will be scaled 0 to 100 for reporting. Change was calculated as three-month visit minus baseline; a negative value indicates improvement while a positive value indicates worsening. | Three Months after Day 1 Injection |
| Winter Park |
| Florida |
| 32789 |
| United States |
| Research Site | Oak Brook | Illinois | 60523 | United States |
| Research Site | Dallas | Texas | 75231 | United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Symptomatic OA Laterality by Investigator Assessment | Count of Participants | Participants |
|
One intra-articular injection of 0.07 mg Lorecivivint in 2 ml vehicle in one or both knees as clinically indicated. Bilateral injection of 0.07 mg LOR are allowed. Lorecivivint: Healthcare professional-administered intra-articular (IA) injection into one or both knees as clinically indicated. Bilateral injections of 0.07 mg of LOR are allowed. IA injection performed on Day 1. Additional IA injections of LOR to same knee (with at least a 6 month separation) between Day 1 and Month 33. |
|
|
| Primary | Change From Baseline in Pain Numeric Rating Scale (NRS) Score for the Right Knee | Change from baseline in pain numeric rating scale (NRS) score for the right knee. 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. Change was calculated as three-month visit minus baseline; a negative value indicates improvement while a positive value indicates worsening. | Efficacy analyses were not performed due to the early termination of the study (administrative reasons). Given the impact of early termination on data completeness, efficacy of LOR for the treatment of knee OA was not formally assessed. Data collected on those subjects completing Month 3 visit are summarized without any imputation for missing data. | Posted | Mean | Full Range | units on a scale | Three Months after Day 1 Injection |
|
|
|
| Secondary | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscore (WOMAC Function) in Left Knee | Change from baseline OA function in the target knee as assessed by Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index NRS3.1 physical function subscore (WOMAC Function) in left knee. 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, stiffness, and physical functioning of a target joint. 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 ranges from 0 to 170 (raw) and will be scaled 0 to 100 for reporting. Change was calculated as three-month visit minus baseline; a negative value indicates improvement while a positive value indicates worsening. | Efficacy analyses were not performed due to the early termination of the study (administrative reasons). Given the impact of early termination on data completeness, efficacy of LOR for the treatment of knee OA was not formally assessed. Data collected on those subjects completing Month 3 visit are summarized. | Posted | Mean | Full Range | units on a scale | Three Months after Day 1 Injection |
|
|
|
| Secondary | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscore (WOMAC Function) in Right Knee | Change from baseline OA function in the target knee as assessed by Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index NRS3.1 physical function subscore (WOMAC Function) in right knee. 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, stiffness, and physical functioning of a target joint. 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 ranges from 0 to 170 (raw) and will be scaled 0 to 100 for reporting. Change was calculated as three-month visit minus baseline; a negative value indicates improvement while a positive value indicates worsening. | Efficacy analyses were not performed due to the early termination of the study (administrative reasons). Given the impact of early termination on data completeness, efficacy of LOR for the treatment of knee OA was not formally assessed. Data collected on those subjects completing Month 3 visit are summarized. | Posted | Mean | Full Range | units on a scale | Three Months after Day 1 Injection |
|
|
|
| Secondary | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscore (WOMAC Pain) in Left Knee | Change from baseline OA pain in the target knee as assessed by Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index NRS3.1 pain subscore (WOMAC Pain) in left knee. 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, stiffness, and physical functioning of a target joint. 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 ranges from 0 to 50 (raw) and will be scaled 0 to 100 for reporting. Change was calculated as three-month visit minus baseline; a negative value indicates improvement while a positive value indicates worsening. | Efficacy analyses were not performed due to the early termination of the study (administrative reasons). Given the impact of early termination on data completeness, efficacy of LOR for the treatment of knee OA was not formally assessed. Data collected on those subjects completing Month 3 visit are summarized. | Posted | Mean | Full Range | units on a scale | Three Months after Day 1 Injection |
|
|
|
| Secondary | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscore (WOMAC Pain) in Right Knee | Change from baseline OA pain in the target knee as assessed by Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index NRS3.1 pain subscore (WOMAC Pain) in right knee. 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, stiffness, and physical functioning of a target joint. 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 ranges from 0 to 50 (raw) and will be scaled 0 to 100 for reporting. Change was calculated as three-month visit minus baseline; a negative value indicates improvement while a positive value indicates worsening. | Efficacy analyses were not performed due to the early termination of the study (administrative reasons). Given the impact of early termination on data completeness, efficacy of LOR for the treatment of knee OA was not formally assessed. Data collected on those subjects completing Month 3 visit are summarized. | Posted | Mean | Full Range | units on a scale | Three Months after Day 1 Injection |
|
|
|
| 0 |
| 72 |
| 0 |
| 72 |
| 2 |
| 72 |
|
| Bacterial Vaginosis | Infections and infestations | MedDRA (24.0) | Non-systematic Assessment | Bacterial Vaginosis due to Routine PAP Smear |
|
There IS an agreement between the Principal Investigator and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.