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Study OA-07 was designed to be conducted until the Sponsor closed it. Study OA-07 was administratively closed at Visit 6E (Week 100), with no safety concerns, one year into the open-label study as described in the protocol.
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Study OA-07 was a randomized, double-blind, placebo-controlled, Phase 3, multicenter, 2-year clinical trial that enrolled subjects from the recently completed Study OA-11 (NCT03928184).
The first 48 weeks of OA-07 the trial was placebo-controlled with subjects receiving the same randomized treatment received in OA-11. Investigators, research staff and subjects remained blinded to treatment allocation.
At Week 48, all subjects were administered LOR in the open-label portion of the trial.
At Visit 1E (on Day 1), upon completion of initial study procedures (e.g., informed consent, eligibility requirements, clinical evaluations including pregnancy testing [as applicable], baseline patient-reported outcome [PRO] assessments and safety data collection), subjects received a blinded IA injection of either LOR or PBO (as originally randomized in the parent [OA-11] study) into their target knee.
At Visit 3E (Week 48), upon completion of scheduled clinical, medical, safety and Patient-reported outcome (PRO) assessments, all subjects received an open-label injection of IA LOR into their target knee, such that previously PBO-treated subjects were effectively crossed over to the LOR treatment cohort.
Subjects were given the option to either receive a final injection of IA LOR into their target knee and complete both Visit 6E (Week 100) assessments and End-of-Study Visit assessments, or receive no injection and complete End-of-Study Visit assessments only. Subjects who had completed Visit 6E prior to the announcement of study closure were instructed to return to the clinic for End-of-Study Visit assessments.
Study OA-07's initial study design was to assess the safety and efficacy of additional treatment with LOR compared to PBO over one year and conclude at Visit 3E. The study was amended to become an open-label study at the Visit 3E that included an End-of-Study visit but without a specified time. The study was intended and described in the protocol to be run until such time as the Sponsor chose to close it. Study OA-07 was administratively closed at Visit 6E (Week 100), with no safety concerns, one year into the open-label study. For these reasons, Study OA-07 is considered a completed study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lorecivivint | Experimental | Subjects assigned to this arm will receive one intra-articular injection of 0.07 mg lorecivivint in 2 ml vehicle (same treatment as in the parent-study) into their target knee (the same target knee injected in the parent study); performed on Day 1, at Week 48 and every 52 weeks thereafter. |
|
| Placebo | Placebo Comparator | Subjects assigned to this arm will receive one intra-articular injection of 0 mg lorecivivint in 2 ml vehicle (same treatment as in the parent-study) into their target knee (the same target knee injected in the parent study) on Day 1, followed by one intra-articular injection of 0.07 mg lorecivivint in 2 ml vehicle at Week 48 and every 52 weeks thereafter. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Healthcare professional-administered intra-articular injection of vehicle. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From OA-11-study Baseline Medial Joint Space Width (mJSW) in the Target Knee | Change from OA-11-study baseline in mJSW measured in millimeters as documented by radiograph (X-ray) of the target knee. JSW measurements were provided by a blinded, central imaging vendor using landmark-based, computer-assisted proprietary methodology. | OA-11-study baseline; Visit 3E (Week 48) |
| Change From OA-07-study Baseline OA Pain in the Target Knee | Change from OA-07-study baseline OA pain the target knee as assessed by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Numeric Rating Scale (NRS 3.1) pain subscore (WOMAC Pain). 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 ranges from 0 [no pain] to 100 [pain as bad as it can be]. | OA-07-study baseline; Visit 2E (Week 24) |
| Change From OA-07-study Baseline OA Function in the Target Knee | Change from OA-07-study 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). 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 ranges from 0 [highest functional status] to 100 [most impaired functional status]. | OA-07-study baseline; Visit 2E (Week 24) |
| Measure | Description | Time Frame |
|---|---|---|
| Change From OA-07-study Baseline OA Pain in the Target Knee | Change from OA-07-study baseline OA pain the target knee as assessed by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Numeric Rating Scale (NRS 3.1) pain subscore (WOMAC Pain). 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 ranges from 0 [no pain] to 100 [pain as bad as it can be]. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From OA-11-study Baseline Medial Joint Space Width (mJSW) in the Target Knee | Change from OA-11-study baseline in mJSW measured in millimeters as documented by radiograph (X-ray) of the target knee. JSW measurements were provided by a blinded, central imaging vendor using landmark-based, computer-assisted proprietary methodology. | OA-11-study baseline; Visit 6E (Week 100) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ismail Simsek, 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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Subjects who completed Study OA-11 were invited to participate in Study OA-07
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Subjects assigned to this arm will receive one intra-articular injection of 0 mg lorecivivint in 2 ml vehicle (same treatment as in the parent-study) into their target knee (the same target knee injected in the parent study) on Day 1, followed by one intra-articular injection of 0.07 mg lorecivivint in 2 ml vehicle at Week 48 and every 52 weeks thereafter. Placebo: Healthcare professional-administered intra-articular injection of vehicle. Lorecivivint: Healthcare professional-administered intra-articular injections of lorecivivint. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| 1st Injection-As Randomized |
|
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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 | May 4, 2021 | Dec 23, 2025 |
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The first 48 weeks were research site personnel (investigator, coordinators, assessors) and subjects were blinded to the treatment assignment. After Week 48, the remainder of the study was open-label with all subjects receiving LOR study injections.
| Lorecivivint | Drug | Healthcare professional-administered intra-articular injections of lorecivivint. |
|
|
| OA-07-study baseline; Visit 3E (Week 48) |
| Change From OA-07-study Baseline OA Function in the Target Knee | Change from OA-07-study 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). 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 ranges from 0 [highest functional status] to 100 [most impaired functional status]. | OA-07-study baseline; Visit 3E (Week 48) |
| Anaheim |
| California |
| 92805 |
| United States |
| Research Site | Pomona | California | 91767 | United States |
| Research Site | San Diego | California | 92103 | United States |
| Research Site | Thousand Oaks | California | 91360 | United States |
| Research Site | Denver | Colorado | 80209 | United States |
| Research Site | Hialeah | Florida | 33016 | United States |
| Research Site | Miami | Florida | 33173 | United States |
| Research Site | Miami Lakes | Florida | 33014 | United States |
| Research Site | Port Orange | Florida | 32127 | United States |
| Research Site | West Palm Beach | Florida | 33409 | United States |
| Research Site | Winter Haven | Florida | 33880 | United States |
| Research Site | Winter Park | Florida | 32789 | United States |
| Research Site | Newnan | Georgia | 30265 | United States |
| Research Site | Woodstock | Georgia | 30189 | United States |
| Research Site | Gurnee | Illinois | 60031 | United States |
| Research Site | Oak Brook | Illinois | 60523 | United States |
| Research Site | Valparaiso | Indiana | 46383 | United States |
| Research Site | New Orleans | Louisiana | 70124 | United States |
| Research Site | Bay City | Michigan | 48706 | United States |
| Research Site | Troy | Michigan | 48085 | United States |
| Research Site | Hazelwood | Missouri | 63042 | United States |
| Research Site | St Louis | Missouri | 63141 | United States |
| Research Site | Omaha | Nebraska | 68114 | United States |
| Research Site | Hartsdale | New York | 10530 | United States |
| Research Site | New York | New York | 10016 | United States |
| Research Site | Rochester | New York | 14609 | United States |
| Research Site | Charlotte | North Carolina | 28209 | United States |
| Research Site | Salisbury | North Carolina | 28144 | United States |
| Research Site | Winston-Salem | North Carolina | 27103 | United States |
| Research Site | Cincinnati | Ohio | 45242 | United States |
| Research Site | Columbus | Ohio | 43235 | United States |
| Research Site | Oklahoma City | Oklahoma | 73103 | United States |
| Research Site | Fort Mill | South Carolina | 29707 | United States |
| Research Site | Mt. Pleasant | South Carolina | 29464 | United States |
| Research Site | Rapid City | South Dakota | 57702 | United States |
| Research Site | Carrollton | Texas | 75007 | United States |
| Research Site | Plano | Texas | 75075 | United States |
| Research Site | San Antonio | Texas | 78229 | United States |
| Research Site | Draper | Utah | 84020 | United States |
| Research Site | Salt Lake City | Utah | 84107 | United States |
| Research Site | Charlottesville | Virginia | 22911 | United States |
| FG001 | Lorecivivint | Subjects assigned to this arm will receive one intra-articular injection of 0.07 mg lorecivivint in 2 ml vehicle (same treatment as in the parent-study) into their target knee (the same target knee injected in the parent study); performed on Day 1, at Week 48 and every 52 weeks thereafter. Lorecivivint: Healthcare professional-administered intra-articular injections of lorecivivint. |
| COMPLETED |
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| NOT COMPLETED |
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| 2nd Injection-Lorecivivint (Open Label) |
|
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| 3nd Injection-Lorecivivint (Open Label) |
|
|
Full Analysis Set
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Subjects assigned to this arm will receive one intra-articular injection of 0 mg lorecivivint in 2 ml vehicle (same treatment as in the parent-study) into their target knee (the same target knee injected in the parent study) on Day 1, followed by one intra-articular injection of 0.07 mg lorecivivint in 2 ml vehicle at Week 48 and every 52 weeks thereafter. Placebo: Healthcare professional-administered intra-articular injection of vehicle. Lorecivivint: Healthcare professional-administered intra-articular injections of lorecivivint. |
| BG001 | Lorecivivint | Subjects assigned to this arm will receive one intra-articular injection of 0.07 mg lorecivivint in 2 ml vehicle (same treatment as in the parent-study) into their target knee (the same target knee injected in the parent study); performed on Day 1, at Week 48 and every 52 weeks thereafter. Lorecivivint: Healthcare professional-administered intra-articular injections of lorecivivint. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Kellgren-Lawrence Grade | The Kellgren and Lawrence classification system is a common method used in research of classifying the severity of knee osteoarthritis (OA) by radiograph. Kellgren-Lawrence Grade has five categories, with OA deemed present at Grade 2+: 0: definite absence of OA
| Count of Participants | Participants |
| |||||||||||||||
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
|
| 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 OA-11-study Baseline Medial Joint Space Width (mJSW) in the Target Knee | Change from OA-11-study baseline in mJSW measured in millimeters as documented by radiograph (X-ray) of the target knee. JSW measurements were provided by a blinded, central imaging vendor using landmark-based, computer-assisted proprietary methodology. | The Full Analysis Set includes all subjects who received a study injection in the current study, analyzed as randomized in the parent study. Change in mJSW was calculated if both baseline and observation at timepoint were observed. No imputation methods were used for missing data. | Posted | Least Squares Mean | Standard Error | mm | OA-11-study baseline; Visit 3E (Week 48) |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Change From OA-07-study Baseline OA Pain in the Target Knee | Change from OA-07-study baseline OA pain the target knee as assessed by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Numeric Rating Scale (NRS 3.1) pain subscore (WOMAC Pain). 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 ranges from 0 [no pain] to 100 [pain as bad as it can be]. | The Full Analysis Set includes all subjects who received a study injection in the current study, analyzed as randomized in the parent study. Change in WOMAC Pain was calculated if both baseline and observation at timepoint were observed. No imputation methods were used for missing data. | Posted | Least Squares Mean | Standard Error | score on a scale | OA-07-study baseline; Visit 2E (Week 24) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Change From OA-07-study Baseline OA Function in the Target Knee | Change from OA-07-study 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). 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 ranges from 0 [highest functional status] to 100 [most impaired functional status]. | The Full Analysis Set includes all subjects who received a study injection in the current study, analyzed as randomized in the parent study. Change in WOMAC Function was calculated if both baseline and observation at timepoint were observed. No imputation methods were used for missing data. | Posted | Least Squares Mean | Standard Error | score on a scale | OA-07-study baseline; Visit 2E (Week 24) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From OA-07-study Baseline OA Pain in the Target Knee | Change from OA-07-study baseline OA pain the target knee as assessed by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Numeric Rating Scale (NRS 3.1) pain subscore (WOMAC Pain). 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 ranges from 0 [no pain] to 100 [pain as bad as it can be]. | The Full Analysis Set includes all subjects who received a study injection in the current study, analyzed as randomized in the parent study. Change in WOMAC Pain was calculated if both baseline and observation at timepoint were observed. No imputation methods were used for missing data. | Posted | Least Squares Mean | Standard Error | score on a scale | OA-07-study baseline; Visit 3E (Week 48) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From OA-07-study Baseline OA Function in the Target Knee | Change from OA-07-study 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). 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 ranges from 0 [highest functional status] to 100 [most impaired functional status]. | The Full Analysis Set includes all subjects who received a study injection in the current study, analyzed as randomized in the parent study. Change in WOMAC Function was calculated if both baseline and observation at timepoint were observed. No imputation methods were used for missing data. | Posted | Least Squares Mean | Standard Error | score on a scale | OA-07-study baseline; Visit 3E (Week 48) |
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| Other Pre-specified | Change From OA-11-study Baseline Medial Joint Space Width (mJSW) in the Target Knee | Change from OA-11-study baseline in mJSW measured in millimeters as documented by radiograph (X-ray) of the target knee. JSW measurements were provided by a blinded, central imaging vendor using landmark-based, computer-assisted proprietary methodology. | All subjects randomized to Lorecivivint are analyzed. Change in mJSW was calculated if both baseline and observation at Visit 6E (Week 100) were observed. No imputation methods were used for missing data. Open-label analysis without concurrent placebo comparison available. The baseline-adjusted ANCOVA estimate of change in mJSW at Visit 3E (Week 48) from the Placebo group was used to compare against the observed change in the Lorecivivint group at Visit 6E (Week 100). | Posted | Least Squares Mean | Standard Error | mm | OA-11-study baseline; Visit 6E (Week 100) |
|
|
Adverse events reported from the placebo-controlled, first year of OA-07 prior to open-label crossover to Lorecivivint from Baseline to Visit 3E (Week 48) by treatment group. If the subject participated in the open-label portion of the study, adverse events are reported from Visit 3E (Week 48) to Visit 6E (Week 100) by exposure group (i.e LOR-LOR vs PBO-LOR).
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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 | Placebo | Subjects assigned to this arm will receive one intra-articular injection of 0 mg lorecivivint in 2 ml vehicle (same treatment as in the parent-study) into their target knee (the same target knee injected in the parent study) on Day 1. Placebo: Healthcare professional-administered intra-articular injection of vehicle. Lorecivivint: Healthcare professional-administered intra-articular injections of lorecivivint. | 0 | 138 | 2 | 138 | 19 | 138 |
| EG001 | Lorecivivint | Subjects assigned to this arm will receive one intra-articular injection of 0.07 mg lorecivivint in 2 ml vehicle (same treatment as in the parent-study) into their target knee (the same target knee injected in the parent study); performed on Day 1. Lorecivivint: Healthcare professional-administered intra-articular injections of lorecivivint. | 0 | 138 | 1 | 138 | 23 | 138 |
| EG002 | Placebo-Lorecivivint | Subjects assigned to Placebo and continuing into the open-label portion of the study received one intra-articular injection of 0.7 mg lorecivivint in 2 ml vehicle into their target knee (the same target knee injected at Day 1) at Visit 3E (Week 48). Lorecivivint: Healthcare professional-administered intra-articular injections of lorecivivint. | 0 | 118 | 2 | 118 | 12 | 118 |
| EG003 | Lorecivivint-Lorecivivint | Subjects assigned to Lorecivivint and continuing into the open-label portion of the study received one intra-articular injection of 0.7 mg lorecivivint in 2 ml vehicle into their target knee (the same target knee injected at Day 1) at Visit 3E (Week 48). Lorecivivint: Healthcare professional-administered intra-articular injections of lorecivivint. | 1 | 110 | 4 | 110 | 19 | 110 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cholecystitis acute | Hepatobiliary disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| Gallbladder abscess | Infections and infestations | MedDRA (26.0) | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (26.0) | Non-systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| Invasive ductal breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (26.0) | Non-systematic Assessment |
| |
| Pancreatic Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (26.0) | Non-systematic Assessment |
| |
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA (26.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COVID-19 | Infections and infestations | MedDRA (26.0) | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (26.0) | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| Meniscus injury | Injury, poisoning and procedural complications | MedDRA (26.0) | Non-systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| Urine analysis abnormal | Investigations | MedDRA (26.0) | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (26.0) | Non-systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christopher Swearingen, VP Biometrics | Biosplice Therapeutics, Inc | 858-926-2900 | info@biosplice.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 3, 2023 | Dec 23, 2025 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000627701 | lorecivivint |
Not provided
Not provided
Not provided
| Lost to Follow-up |
|
| Physician Decision |
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| Withdrawal by Subject |
|
| Study Terminated by Sponsor |
|
| Not Otherwise Specified |
|
| Total or Partial Knee Replacement |
|
| Site Terminated by Sponsor |
|
| Male |
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| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Grade 3 |
|
| OG001 | Lorecivivint | Subjects assigned to this arm will receive one intra-articular injection of 0.07 mg lorecivivint in 2 ml vehicle (same treatment as in the parent-study) into their target knee (the same target knee injected in the parent study); performed on Day 1, at Week 48 and every 52 weeks thereafter. Lorecivivint: Healthcare professional-administered intra-articular injections of lorecivivint. |
|
|
|
| OG001 | Lorecivivint | Subjects assigned to this arm will receive one intra-articular injection of 0.07 mg lorecivivint in 2 ml vehicle (same treatment as in the parent-study) into their target knee (the same target knee injected in the parent study); performed on Day 1, at Week 48 and every 52 weeks thereafter. Lorecivivint: Healthcare professional-administered intra-articular injections of lorecivivint. |
|
|
|
| OG001 | Lorecivivint | Subjects assigned to this arm will receive one intra-articular injection of 0.07 mg lorecivivint in 2 ml vehicle (same treatment as in the parent-study) into their target knee (the same target knee injected in the parent study); performed on Day 1, at Week 48 and every 52 weeks thereafter. Lorecivivint: Healthcare professional-administered intra-articular injections of lorecivivint. |
|
|
|
| OG001 | Lorecivivint | Subjects assigned to this arm will receive one intra-articular injection of 0.07 mg lorecivivint in 2 ml vehicle (same treatment as in the parent-study) into their target knee (the same target knee injected in the parent study); performed on Day 1, at Week 48 and every 52 weeks thereafter. Lorecivivint: Healthcare professional-administered intra-articular injections of lorecivivint. |
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