| Primary | Change From Baseline OA Pain in the Target Knee as Assessed by the Weekly Average of Daily Pain Numeric Rating Scale (NRS) at Week 12 | Evaluate change from baseline OA pain in the target knee as assessed by the weekly average of daily pain NRS at Week 12. The pain NRS is an 11-point scale [0-10] for subject self-reporting of average knee pain in the last 24 hours; 0 indicates no pain, and 10 represents the worst possible pain. | Full Analysis Set includes all subjects who were randomized and received a study injection. Subjects' observed data were analyzed as randomized without imputation. | Posted | | Least Squares Mean | Standard Error | units on a scale | | Baseline and Week 12 | | | | ID | Title | Description |
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| OG000 | Vehicle | Healthcare professional-administered intra-articular injection; performed on Day 1. Placebo: One intra-articular injection of 0 mg lorecivivint in 2 mL vehicle | | OG001 | Lorecivivint | Healthcare professional-administered intra-articular injection; performed on Day 1. Lorecivivint: One intra-articular injection of 0.07 mg lorecivivint in 2 mL vehicle |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG000-2.15± 0.14
- OG001-2.22± 0.14
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| | Mixed Models Analysis | | 0.703 | | Mean Difference (Final Values) | -0.07 | Standard Error of the Mean | 0.20 | 2-Sided | 95 | -0.46 | 0.31 | | | | | Superiority | | |
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| Secondary | Change From Baseline OA Pain in the Target Knee as Assessed by the Weekly Average of Daily Pain Numeric Rating Scale (NRS) at Week 24 | Evaluate change from baseline OA pain in the target knee as assessed by the weekly average of daily pain NRS at Week 24. The pain NRS is an 11-point scale [0-10] for subject self-reporting of average knee pain in the last 24 hours; 0 indicates no pain, and 10 represents the worst possible pain. | Full Analysis Set includes all subjects who were randomized and received a study injection. Subjects' observed data were analyzed as randomized without imputation. | Posted | | Least Squares Mean | Standard Error | units on a scale | | Baseline and Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Vehicle | Healthcare professional-administered intra-articular injection; performed on Day 1. Placebo: One intra-articular injection of 0 mg lorecivivint in 2 mL vehicle | | OG001 | Lorecivivint | Healthcare professional-administered intra-articular injection; performed on Day 1. Lorecivivint: One intra-articular injection of 0.07 mg lorecivivint in 2 mL vehicle |
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| Secondary | Change From Baseline OA Function in the Target Knee as Assessed by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscore (WOMAC Function) at Week 12 | Evaluate change from baseline OA function in the target knee as assessed by WOMAC Function subscore at Week 12. The WOMAC is a widely-used, proprietary outcome measurement tool used to evaluate the condition of subjects with OA of the knee and hip, including pain (5 questions), stiffness (2 questions), and physical functioning (17 questions) of the joints. Each question is measured on an 11-point numeric rating scale from 0 (lowest pain/lowest stiffness/highest function) to 10 (highest pain/highest stiffness/lowest function). The WOMAC Function raw subscore ranges from 0 to 170, and is scaled 0 (highest overall function) to 100 (lowest overall function) for analysis and reporting. | Full Analysis Set includes all subjects who were randomized and received a study injection. Subjects' observed data were analyzed as randomized without imputation. | Posted | | Least Squares Mean | Standard Error | units on a scale | | Baseline and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Vehicle | Healthcare professional-administered intra-articular injection; performed on Day 1. Placebo: One intra-articular injection of 0 mg lorecivivint in 2 mL vehicle | | OG001 | Lorecivivint | Healthcare professional-administered intra-articular injection; performed on Day 1. Lorecivivint: One intra-articular injection of 0.07 mg lorecivivint in 2 mL vehicle |
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| Secondary | Change From Baseline OA Function in the Target Knee as Assessed by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscore (WOMAC Function) at Week 24 | Evaluate change from baseline OA function in the target knee as assessed by WOMAC Function subscore at Week 24. The WOMAC is a widely-used, proprietary outcome measurement tool used to evaluate the condition of subjects with OA of the knee and hip, including pain (5 questions), stiffness (2 questions), and physical functioning (17 questions) of the joints. Each question is measured on an 11-point numeric rating scale from 0 (lowest pain/lowest stiffness/highest function) to 10 (highest pain/highest stiffness/lowest function). The WOMAC Function raw subscore ranges from 0 to 170, and is scaled 0 (highest overall function) to 100 (lowest overall function) for analysis and reporting. | Full Analysis Set includes all subjects who were randomized and received a study injection. Subjects' observed data were analyzed as randomized without imputation. | Posted | | Least Squares Mean | Standard Error | units on a scale | | Baseline and Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Vehicle | Healthcare professional-administered intra-articular injection; performed on Day 1. Placebo: One intra-articular injection of 0 mg lorecivivint in 2 mL vehicle | | OG001 | Lorecivivint | Healthcare professional-administered intra-articular injection; performed on Day 1. Lorecivivint: One intra-articular injection of 0.07 mg lorecivivint in 2 mL vehicle |
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| Secondary | Change From Baseline OA Disease Activity as Assessed by Patient Global Assessment at Week 12 | Evaluate change from baseline OA disease activity as assessed by Patient Global Assessment at Week 12. The Patient Global Assessment is an 11-point [0-10] Numeric Rating Scale [NRS] on which the subjects will rate how they feel their target knee OA is doing, considering all the ways in which their target knee OA may affect them. The NRS is anchored by descriptors at each end ("Very Good" on the left and "Very Bad" on the right). For analysis, Patient Global Assessment scores were scaled to [0-100], where 0 represents "Very Good" and 100 represents "Very Bad". | Full Analysis Set includes all subjects who were randomized and received a study injection. Subjects' observed data were analyzed as randomized without imputation. | Posted | | Mean | Standard Error | units on a scale | | Baseline and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Vehicle | Healthcare professional-administered intra-articular injection; performed on Day 1. Placebo: One intra-articular injection of 0 mg lorecivivint in 2 mL vehicle | | OG001 | Lorecivivint | Healthcare professional-administered intra-articular injection; performed on Day 1. Lorecivivint: One intra-articular injection of 0.07 mg lorecivivint in 2 mL vehicle |
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| Secondary | Change From Baseline OA Disease Activity as Assessed by Patient Global Assessment at Week 24 | Evaluate change from baseline OA disease activity as assessed by Patient Global Assessment at Week 24. The Patient Global Assessment is an 11-point [0-10] Numeric Rating Scale [NRS] on which the subjects will rate how they feel their target knee OA is doing, considering all the ways in which their target knee OA may affect them. The NRS is anchored by descriptors at each end ("Very Good" on the left and "Very Bad" on the right). For analysis, Patient Global Assessment scores were scaled to [0-100], where 0 represents "Very Good" and 100 represents "Very Bad". | Full Analysis Set includes all subjects who were randomized and received a study injection. Subjects' observed data were analyzed as randomized without imputation. | Posted | | Least Squares Mean | Standard Error | units on a scale | | Baseline and Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Vehicle | Healthcare professional-administered intra-articular injection; performed on Day 1. Placebo: One intra-articular injection of 0 mg lorecivivint in 2 mL vehicle | | OG001 | Lorecivivint | Healthcare professional-administered intra-articular injection; performed on Day 1. Lorecivivint: One intra-articular injection of 0.07 mg lorecivivint in 2 mL vehicle |
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| Post-Hoc | Change From Baseline OA Pain in the Target Knee as Assessed by the Weekly Average of Daily Pain Numeric Rating Scale (NRS) at Week 12 in Subjects With Kellgren-Lawrence Grade 2 | Evaluate change from baseline OA pain in the target knee as assessed by the weekly average of daily pain NRS at Week 12 in those subjects with Kellgren-Lawrence Grade 2. 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. | The Per-Protocol Analysis Set (PPAS) includes FAS subjects who received the correct treatment, completed the study, and did not have any protocol deviations that might impact the evaluation of efficacy outcomes. Kellgren-Lawrence Grade 2 only subjects' observed data were analyzed as randomized without imputation. | Posted | | Least Squares Mean | Standard Error | units on a scale | | Baseline and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Vehicle | Healthcare professional-administered intra-articular injection; performed on Day 1. Placebo: One intra-articular injection of 0 mg lorecivivint in 2 mL vehicle | | OG001 | Lorecivivint | Healthcare professional-administered intra-articular injection; performed on Day 1. Lorecivivint: One intra-articular injection of 0.07 mg lorecivivint in 2 mL vehicle |
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| Post-Hoc | Change From Baseline OA Pain in the Target Knee as Assessed by the Weekly Average of Daily Pain Numeric Rating Scale (NRS) at Week 24 in Subjects With Kellgren-Lawrence Grade 2 | Evaluate change from baseline OA pain in the target knee as assessed by the weekly average of daily pain NRS at Week 24 in those subjects with Kellgren-Lawrence Grade 2. 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. | The Per-Protocol Analysis Set (PPAS) includes FAS subjects who received the correct treatment, completed the study, and did not have any protocol deviations that might impact the evaluation of efficacy outcomes. Kellgren-Lawrence Grade 2 only subjects' observed data were analyzed as randomized without imputation. | Posted | | Least Squares Mean | Standard Error | units on a scale | | Baseline and Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Vehicle | Healthcare professional-administered intra-articular injection; performed on Day 1. Placebo: One intra-articular injection of 0 mg lorecivivint in 2 mL vehicle | | OG001 | Lorecivivint | Healthcare professional-administered intra-articular injection; performed on Day 1. Lorecivivint: One intra-articular injection of 0.07 mg lorecivivint in 2 mL vehicle |
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| Post-Hoc | Change From Baseline OA Function in the Target Knee as Assessed by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscore (WOMAC Function) at Week 12 in Subjects With Kellgren-Lawrence Grade 2 | Evaluate change from baseline OA function in the target knee as assessed by WOMAC Function subscore at Week 12 in those subjects With Kellgren-Lawrence Grade 2. The WOMAC is a widely-used, proprietary outcome measurement tool used to evaluate the condition of subjects with OA of the knee and hip, including pain (5 questions), stiffness (2 questions), and physical functioning (17 questions) of the joints. Each question is measured on an 11-point numeric rating scale from 0 (lowest pain/lowest stiffness/highest function) to 10 (highest pain/highest stiffness/lowest function). The WOMAC Function raw subscore ranges from 0 to 170, and is scaled 0 (highest overall function) to 100 (lowest overall function) for analysis and reporting. | The Per-Protocol Analysis Set (PPAS) includes FAS subjects who received the correct treatment, completed the study, and did not have any protocol deviations that might impact the evaluation of efficacy outcomes. Kellgren-Lawrence Grade 2 only subjects' observed data were analyzed as randomized without imputation. | Posted | | Least Squares Mean | Standard Error | units on a scale | | Baseline and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Vehicle | Healthcare professional-administered intra-articular injection; performed on Day 1. Placebo: One intra-articular injection of 0 mg lorecivivint in 2 mL vehicle | | OG001 |
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| Post-Hoc | Change From Baseline OA Function in the Target Knee as Assessed by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscore (WOMAC Function) at Week 24 in Subjects With Kellgren-Lawrence Grade 2 | Evaluate change from baseline OA function in the target knee as assessed by WOMAC Function subscore at Week 24 in those subjects With Kellgren-Lawrence Grade 2. The WOMAC is a widely-used, proprietary outcome measurement tool used to evaluate the condition of subjects with OA of the knee and hip, including pain (5 questions), stiffness (2 questions), and physical functioning (17 questions) of the joints. Each question is measured on an 11-point numeric rating scale from 0 (lowest pain/lowest stiffness/highest function) to 10 (highest pain/highest stiffness/lowest function). The WOMAC Function raw subscore ranges from 0 to 170, and is scaled 0 (highest overall function) to 100 (lowest overall function) for analysis and reporting. | The Per-Protocol Analysis Set (PPAS) includes FAS subjects who received the correct treatment, completed the study, and did not have any protocol deviations that might impact the evaluation of efficacy outcomes. Kellgren-Lawrence Grade 2 only subjects' observed data were analyzed as randomized without imputation. | Posted | | Least Squares Mean | Standard Error | units on a scale | | Baseline and Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Vehicle | Healthcare professional-administered intra-articular injection; performed on Day 1. Placebo: One intra-articular injection of 0 mg lorecivivint in 2 mL vehicle | | OG001 |
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| Post-Hoc | Change From Baseline OA Disease Activity as Assessed by Patient Global Assessment at Week 12 in Subjects With Kellgren-Lawrence Grade 2 | Evaluate change from baseline OA disease activity as assessed by Patient Global Assessment at Week 12 in those subjects with Kellgren-Lawrence Grade 2. The Patient Global Assessment is an 11-point [0-10] Numeric Rating Scale [NRS] on which the subjects will rate how they feel their target knee OA is doing, considering all the ways in which their target knee OA may affect them. The NRS is anchored by descriptors at each end ("Very Good" on the left and "Very Bad" on the right). For analysis, Patient Global Assessment scores were scaled to [0-100], where 0 represents "Very Good" and 100 represents "Very Bad". | The Per-Protocol Analysis Set (PPAS) includes FAS subjects who received the correct treatment, completed the study, and did not have any protocol deviations that might impact the evaluation of efficacy outcomes. Kellgren-Lawrence Grade 2 only subjects' observed data were analyzed as randomized without imputation.) | Posted | | Mean | Standard Error | units on a scale | | Baseline and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Vehicle | Healthcare professional-administered intra-articular injection; performed on Day 1. Placebo: One intra-articular injection of 0 mg lorecivivint in 2 mL vehicle | | OG001 | Lorecivivint | Healthcare professional-administered intra-articular injection; performed on Day 1. Lorecivivint: One intra-articular injection of 0.07 mg lorecivivint in 2 mL vehicle |
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| Post-Hoc | Change From Baseline OA Disease Activity as Assessed by Patient Global Assessment at Week 24 in Subjects With Kellgren-Lawrence Grade 2 | Evaluate change from baseline OA disease activity as assessed by Patient Global Assessment at Week 24 in those subjects with Kellgren-Lawrence Grade 2. The Patient Global Assessment is an 11-point [0-10] Numeric Rating Scale [NRS] on which the subjects will rate how they feel their target knee OA is doing, considering all the ways in which their target knee OA may affect them. The NRS is anchored by descriptors at each end ("Very Good" on the left and "Very Bad" on the right). For analysis, Patient Global Assessment scores were scaled to [0-100], where 0 represents "Very Good" and 100 represents "Very Bad". | The Per-Protocol Analysis Set (PPAS) includes FAS subjects who received the correct treatment, completed the study, and did not have any protocol deviations that might impact the evaluation of efficacy outcomes. Kellgren-Lawrence Grade 2 only subjects' observed data were analyzed as randomized without imputation. | Posted | | Mean | Standard Error | units on a scale | | Baseline and Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Vehicle | Healthcare professional-administered intra-articular injection; performed on Day 1. Placebo: One intra-articular injection of 0 mg lorecivivint in 2 mL vehicle | | OG001 | Lorecivivint | Healthcare professional-administered intra-articular injection; performed on Day 1. Lorecivivint: One intra-articular injection of 0.07 mg lorecivivint in 2 mL vehicle |
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