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Phase 3 randomized, double-blind, placebo- and active comparator-controlled study of TLC599.
This is a Phase 3 randomized, double-blind, placebo- and active comparator-controlled pivotal study. Approximately 500 adult patients with moderate to severe pain due to OA of the knee will be enrolled and randomized. All patients will be followed for a total of 52 weeks. Efficacy and safety of 2 doses of TLC599 will be evaluated in comparison to Placebo and DSP through Week 52.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TLC599 | Experimental | TLC599 (1mL) IA injection |
|
| Dexamethasone sodium phosphate | Active Comparator | DSP 4mg (1mL) IA injection |
|
| Normal Saline | Placebo Comparator | Normal saline (1mL) IA injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TLC599 | Drug | TLC599 is a proprietary (Bioseizer) lipid formulation containing DSP (active ingredient) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in WOMAC Pain at Week 12 for TLC599 12 mg Versus Placebo | The WOMAC (Western Ontario & McMaster Universities Osteoarthritis Index, Version 3.1) consists of 24 questions rated on a 0-4 Likert scale, totaling a score from 0-96, reflecting the previous 24 hours. Sub-scale scores for Pain (5 items, a 0-20 scale), Stiffness (2 items, a 0-8 scale), and Physical Function (17 items, a 0-68 scale) are summed to calculate the WOMAC Composite score. Both composite and sub-scale scores are normalized to a 0-4 scale for analysis, with higher scores indicating greater severity. | Baseline, Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in WOMAC Pain at Week 16 for TLC599 12 mg Versus Placebo | The WOMAC (Western Ontario & McMaster Universities Osteoarthritis Index, Version 3.1) consists of 24 questions rated on a 0-4 Likert scale, totaling a score from 0-96, reflecting the previous 24 hours. Sub-scale scores for Pain (5 items, a 0-20 scale), Stiffness (2 items, a 0-8 scale), and Physical Function (17 items, a 0-68 scale) are summed to calculate the WOMAC Composite score. Both composite and sub-scale scores are normalized to a 0-4 scale for analysis, with higher scores indicating greater severity. |
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Inclusion Criteria:
Male or female ≥40 years of age. BMI ≤ 40 kg/m2. Radiographically documented OA with Kellgren-Lawrence severity Grade 2 or 3 and associated symptoms Patient-reported pain with NRS score ≥4 (on a 0-10 scale) Able to read, understand, and sign the informed consent form, communicate with the investigator, complete study diaries, and understand and comply with protocol requirements.
Exclusion Criteria:
Recent use of IA or systemic corticosteroids Patient who is not ambulatory Any surgery or arthroscopy in the index knee within 12 months Any condition that could possibly confound the patient's assessment of index knee pain Substance abuse disorder, or positive urine drug test for illegal drug substances History of acquired or congenital immunodeficiency diseases History of treated malignancy which is disease free for ≤5 years Known allergy or hypersensitivity to the study drugs or their components
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| Name | Affiliation | Role |
|---|---|---|
| Carl Brown, PhD | Taiwan Liposome Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cahaba Research, Inc | Birmingham | Alabama | 35242 | United States | ||
| Affinity Orthopedic Specialists Llc |
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Patients were screened for study eligibility at multiple study centers in the United States (US) and Australia.
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| ID | Title | Description |
|---|---|---|
| FG000 | TLC599 12 mg | TLC599: 1 mL IA injection TLC599 is a proprietary (Bioseizer) lipid formulation containing DSP (active ingredient) |
| FG001 | DSP 4 mg | DSP 4 mg: 1 mL IA injection Dexamethasone sodium phosphate (DSP) is a glucocorticoid widely used in the treatment of joint pain such as gout, osteoarthritis and rheumatoid arthritis via IA injection. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 9, 2022 |
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| DSP | Drug | Dexamethasone sodium phosphate (DSP) is a glucocorticoid widely used in the treatment of joint pain such as gout, osteoarthritis and rheumatoid arthritis via IA injection. |
|
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| Normal Saline | Other | 0.9% normal saline |
|
| Baseline, Week 16 |
| Change From Baseline in WOMAC Pain at Week 20 for TLC599 12 mg Versus Placebo | The WOMAC (Western Ontario & McMaster Universities Osteoarthritis Index, Version 3.1) consists of 24 questions rated on a 0-4 Likert scale, totaling a score from 0-96, reflecting the previous 24 hours. Sub-scale scores for Pain (5 items, a 0-20 scale), Stiffness (2 items, a 0-8 scale), and Physical Function (17 items, a 0-68 scale) are summed to calculate the WOMAC Composite score. Both composite and sub-scale scores are normalized to a 0-4 scale for analysis, with higher scores indicating greater severity. | Baseline, Week 20 |
| Change From Baseline in WOMAC Pain at Week 24 for TLC599 12mg Versus Placebo | The WOMAC (Western Ontario & McMaster Universities Osteoarthritis Index, Version 3.1) consists of 24 questions rated on a 0-4 Likert scale, totaling a score from 0-96, reflecting the previous 24 hours. Sub-scale scores for Pain (5 items, a 0-20 scale), Stiffness (2 items, a 0-8 scale), and Physical Function (17 items, a 0-68 scale) are summed to calculate the WOMAC Composite score. Both composite and sub-scale scores are normalized to a 0-4 scale for analysis, with higher scores indicating greater severity. | Baseline, Week 24 |
| Change From Baseline in WOMAC Pain at Week 36 for TLC599 12mg Versus Placebo | The WOMAC (Western Ontario & McMaster Universities Osteoarthritis Index, Version 3.1) consists of 24 questions rated on a 0-4 Likert scale, totaling a score from 0-96, reflecting the previous 24 hours. Sub-scale scores for Pain (5 items, a 0-20 scale), Stiffness (2 items, a 0-8 scale), and Physical Function (17 items, a 0-68 scale) are summed to calculate the WOMAC Composite score. Both composite and sub-scale scores are normalized to a 0-4 scale for analysis, with higher scores indicating greater severity. | Baseline, Week 36 |
| Change From Baseline in WOMAC Function at Week 12 for TLC599 12mg Versus Placebo | The WOMAC (Western Ontario & McMaster Universities Osteoarthritis Index, Version 3.1) consists of 24 questions rated on a 0-4 Likert scale, totaling a score from 0-96, reflecting the previous 24 hours. Sub-scale scores for Pain (5 items, a 0-20 scale), Stiffness (2 items, a 0-8 scale), and Physical Function (17 items, a 0-68 scale) are summed to calculate the WOMAC Composite score. Both composite and sub-scale scores are normalized to a 0-4 scale for analysis, with higher scores indicating greater severity. | Baseline, Week 12 |
| PGIC at Week 12 for TLC599 12mg Versus Placebo | Patient Global Impression of Change (PGIC) is a single-item question that measures change in patients' overall improvement rated on a 7-point scale including "1 = very much improved," "2 = much improved," "3 = minimally improved," "4 = no change," "5 = minimally worse," "6 = much worse," or "7 = very much worse". | Week 12 |
| Total Rescue Acetaminophen Consumption Through Week 12 for TLC599 12mg Versus Placebo | Rescue medication use of acetaminophen was provided and recorded in electronic patient diaries. Weekly Total Acetaminophen consumption was tabulated for analysis on a weekly basis, starting from the first date of study drug injection: (Day 1, 8), (Day 8, 15), and so on. Average daily use (e.g., Weekly Total Acetaminophen Consumption divided by 7) was computed to produce Weekly Average Daily Acetaminophen Consumption. | through Week 12 |
| Durable Responder With ≥30% Decrease in WOMAC Pain From Baseline for Weeks 4 Through 12 for TLC599 12mg Versus Placebo | Durable responder endpoints were derived based on the imputed WOMAC pain data. A subject which has ≥ 30% decrease in pain response from Baseline at each visit within a specified time period (x-y). This was derived for patients based on the Injection 1 Baseline for the following time period (x-y): (4-12). | Weeks 4 through 12 |
| Change From Baseline in WOMAC Function at Week 36 for TLC599 12mg Versus Placebo | The WOMAC (Western Ontario & McMaster Universities Osteoarthritis Index, Version 3.1) consists of 24 questions rated on a 0-4 Likert scale, totaling a score from 0-96, reflecting the previous 24 hours. Sub-scale scores for Pain (5 items, a 0-20 scale), Stiffness (2 items, a 0-8 scale), and Physical Function (17 items, a 0-68 scale) are summed to calculate the WOMAC Composite score. Both composite and sub-scale scores are normalized to a 0-4 scale for analysis, with higher scores indicating greater severity. | Baseline, Week 36 |
| PGIC at Week 36 for TLC599 12mg Versus Placebo | Patient Global Impression of Change (PGIC) is a single-item question that measures change in patients' overall improvement rated on a 7-point scale including "1 = very much improved," "2 = much improved," "3 = minimally improved," "4 = no change," "5 = minimally worse," "6 = much worse," or "7 = very much worse". | Week 36 |
| Change From Baseline in WOMAC Pain at Week 12 for TLC599 12mg Versus DSP 4 mg | The WOMAC (Western Ontario & McMaster Universities Osteoarthritis Index, Version 3.1) consists of 24 questions rated on a 0-4 Likert scale, totaling a score from 0-96, reflecting the previous 24 hours. Sub-scale scores for Pain (5 items, a 0-20 scale), Stiffness (2 items, a 0-8 scale), and Physical Function (17 items, a 0-68 scale) are summed to calculate the WOMAC Composite score. Both composite and sub-scale scores are normalized to a 0-4 scale for analysis, with higher scores indicating greater severity. | Baseline, Week 12 |
| Change From Baseline in WOMAC Pain at Week 52 for TLC599 12mg Versus Placebo | The WOMAC (Western Ontario & McMaster Universities Osteoarthritis Index, Version 3.1) consists of 24 questions rated on a 0-4 Likert scale, totaling a score from 0-96, reflecting the previous 24 hours. Sub-scale scores for Pain (5 items, a 0-20 scale), Stiffness (2 items, a 0-8 scale), and Physical Function (17 items, a 0-68 scale) are summed to calculate the WOMAC Composite score. Both composite and sub-scale scores are normalized to a 0-4 scale for analysis, with higher scores indicating greater severity. | Baseline, Week 52 |
| Birmingham |
| Alabama |
| 35243 |
| United States |
| Shoals Medical Trials Inc | Sheffield | Alabama | 35660 | United States |
| Gb Family Care | Phoenix | Arizona | 85037 | United States |
| Arizona Research Center | Phoenix | Arizona | 85053 | United States |
| Clinical Research Institute of Arizona Llc | Surprise | Arizona | 85374 | United States |
| Noble Clinical Research Llc | Tucson | Arizona | 85704 | United States |
| Biosolutions Clinical Research Center | La Mesa | California | 919142 | United States |
| Translational Reseach Group Inc Dba Providence Clinical Research | North Hollywood | California | 91606 | United States |
| Prospective Research Innovations Inc | Rancho Cucamonga | California | 91730 | United States |
| Encompass Clinical Research | Spring Valley | California | 91978 | United States |
| Chase Medical Research Llc | Waterbury | Connecticut | 06708 | United States |
| Tampa Bay Medical Research | Clearwater | Florida | 32789 | United States |
| University Clinical Research-Deland, Llc Dba Accel Clinical Research | DeLand | Florida | 32720 | United States |
| Jacksonville Center For Clinical Research | Jacksonville | Florida | 33216 | United States |
| Charter Research, Llc | Lady Lake | Florida | 32159 | United States |
| Well Pharma Medical Research Corp | Miami | Florida | 33143 | United States |
| Conquest Research, Llc | Orlando | Florida | 32822 | United States |
| Progressive Medical Research | Port Orange | Florida | 32127 | United States |
| Clinical Research of West Florida | Tampa | Florida | 33603 | United States |
| Conquest Research (Winter Park) | Winter Park | Florida | 32789 | United States |
| Drug Studies America | Marietta | Georgia | 30060 | United States |
| Georgia Institute For Clinical Research Llc | Marietta | Georgia | 30060 | United States |
| Better Health Clinical Research Inc | Newnan | Georgia | 30265 | United States |
| Chicago Clinical Research Institute, Inc. | Chicago | Illinois | 60607 | United States |
| Northwestern University | Chicago | Illinois | 60611 | United States |
| Healthcare Research Network Ii, Llc | Flossmoor | Illinois | 60422 | United States |
| Affinity Health | Oak Brook | Illinois | 60523 | United States |
| Medisphere Medical Research Center Llc | Evansville | Indiana | 47714 | United States |
| Professional Research Network of Kansas Llc | Wichita | Kansas | 67205 | United States |
| Delricht Research | New Orleans | Louisiana | 70115 | United States |
| Healthcare Research Network | Hazelwood | Missouri | 63042 | United States |
| Albuquerque Clinical Trials, Inc. | Albuquerque | New Mexico | 87102 | United States |
| Drug Trials America | Hartsdale | New York | 10530 | United States |
| Lillestol Research Llc | Fargo | North Dakota | 58104 | United States |
| Altoona Center For Clinical Research | Duncansville | Pennsylvania | 16635 | United States |
| Lowcountry Orthopedics C/O Coastal Carolina research center | North Charleston | South Carolina | 29406 | United States |
| Clinical Investigations of Texas | Plano | Texas | 75075 | United States |
| Quality Research Inc | San Antonio | Texas | 78209 | United States |
| Clinical Trials of Texas Inc (Ctt) | San Antonio | Texas | 78229 | United States |
| Charlottesville Medical Research Center Llc | Charlottesville | Virginia | 22911 | United States |
| Genesis Research Services | Broadmeadow | New South Wales | 2292 | Australia |
| Australian Clinical Research Network | Maroubra | New South Wales | 2035 | Australia |
| Northern Sydney Local Health District | Saint Leonards | New South Wales | 2065 | Australia |
| Austrials | Taringa | Queensland | 4068 | Australia |
| Colin Bayliss Research and Teaching Unit | Victoria Park | Western Australia | 6100 | Australia |
| FG002 | Placebo | Normal saline: 1 mL IA injection |
| COMPLETED |
|
| NOT COMPLETED |
|
|
The Full Analysis Set (FAS) includes all randomized patients who receive study drug at baseline.
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| ID | Title | Description |
|---|---|---|
| BG000 | TLC599 12 mg | TLC599:1 mL IA injection TLC599 is a proprietary (Bioseizer) lipid formulation containing DSP (active ingredient) |
| BG001 | DSP 4 mg | DSP 4mg:1 mL IA injection Dexamethasone sodium phosphate (DSP) is a glucocorticoid widely used in the treatment of joint pain such as gout, osteoarthritis and rheumatoid arthritis via IA injection. |
| BG002 | Placebo | Normal saline: 1 mL IA injection |
| BG003 | 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, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Mean body mass index | Body measurements - Mean body mass index (Kg/m^2) | Mean | Standard Deviation | kg/m^2 |
| ||||||||||||||
| Mean weight | Body measurements - Mean weight (kg) | Mean | Standard Deviation | Kg |
|
| 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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Change From Baseline in WOMAC Pain at Week 12 for TLC599 12 mg Versus Placebo | The WOMAC (Western Ontario & McMaster Universities Osteoarthritis Index, Version 3.1) consists of 24 questions rated on a 0-4 Likert scale, totaling a score from 0-96, reflecting the previous 24 hours. Sub-scale scores for Pain (5 items, a 0-20 scale), Stiffness (2 items, a 0-8 scale), and Physical Function (17 items, a 0-68 scale) are summed to calculate the WOMAC Composite score. Both composite and sub-scale scores are normalized to a 0-4 scale for analysis, with higher scores indicating greater severity. | The Full Analysis Set (FAS) includes all randomized patients who receive study drug at baseline. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Baseline, Week 12 |
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| Secondary | Change From Baseline in WOMAC Pain at Week 16 for TLC599 12 mg Versus Placebo | The WOMAC (Western Ontario & McMaster Universities Osteoarthritis Index, Version 3.1) consists of 24 questions rated on a 0-4 Likert scale, totaling a score from 0-96, reflecting the previous 24 hours. Sub-scale scores for Pain (5 items, a 0-20 scale), Stiffness (2 items, a 0-8 scale), and Physical Function (17 items, a 0-68 scale) are summed to calculate the WOMAC Composite score. Both composite and sub-scale scores are normalized to a 0-4 scale for analysis, with higher scores indicating greater severity. | The Full Analysis Set (FAS) includes all randomized patients who receive study drug at baseline. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Week 16 |
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| Secondary | Change From Baseline in WOMAC Pain at Week 20 for TLC599 12 mg Versus Placebo | The WOMAC (Western Ontario & McMaster Universities Osteoarthritis Index, Version 3.1) consists of 24 questions rated on a 0-4 Likert scale, totaling a score from 0-96, reflecting the previous 24 hours. Sub-scale scores for Pain (5 items, a 0-20 scale), Stiffness (2 items, a 0-8 scale), and Physical Function (17 items, a 0-68 scale) are summed to calculate the WOMAC Composite score. Both composite and sub-scale scores are normalized to a 0-4 scale for analysis, with higher scores indicating greater severity. | The Full Analysis Set (FAS) includes all randomized patients who receive study drug at baseline. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Week 20 |
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| Secondary | Change From Baseline in WOMAC Pain at Week 24 for TLC599 12mg Versus Placebo | The WOMAC (Western Ontario & McMaster Universities Osteoarthritis Index, Version 3.1) consists of 24 questions rated on a 0-4 Likert scale, totaling a score from 0-96, reflecting the previous 24 hours. Sub-scale scores for Pain (5 items, a 0-20 scale), Stiffness (2 items, a 0-8 scale), and Physical Function (17 items, a 0-68 scale) are summed to calculate the WOMAC Composite score. Both composite and sub-scale scores are normalized to a 0-4 scale for analysis, with higher scores indicating greater severity. | The Full Analysis Set (FAS) includes all randomized patients who receive study drug at baseline. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Week 24 |
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| Secondary | Change From Baseline in WOMAC Pain at Week 36 for TLC599 12mg Versus Placebo | The WOMAC (Western Ontario & McMaster Universities Osteoarthritis Index, Version 3.1) consists of 24 questions rated on a 0-4 Likert scale, totaling a score from 0-96, reflecting the previous 24 hours. Sub-scale scores for Pain (5 items, a 0-20 scale), Stiffness (2 items, a 0-8 scale), and Physical Function (17 items, a 0-68 scale) are summed to calculate the WOMAC Composite score. Both composite and sub-scale scores are normalized to a 0-4 scale for analysis, with higher scores indicating greater severity. | The Full Analysis Set (FAS) includes all randomized patients who receive study drug at baseline. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Week 36 |
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| Secondary | Change From Baseline in WOMAC Function at Week 12 for TLC599 12mg Versus Placebo | The WOMAC (Western Ontario & McMaster Universities Osteoarthritis Index, Version 3.1) consists of 24 questions rated on a 0-4 Likert scale, totaling a score from 0-96, reflecting the previous 24 hours. Sub-scale scores for Pain (5 items, a 0-20 scale), Stiffness (2 items, a 0-8 scale), and Physical Function (17 items, a 0-68 scale) are summed to calculate the WOMAC Composite score. Both composite and sub-scale scores are normalized to a 0-4 scale for analysis, with higher scores indicating greater severity. | The Full Analysis Set (FAS) includes all randomized patients who receive study drug at baseline. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Week 12 |
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| Secondary | PGIC at Week 12 for TLC599 12mg Versus Placebo | Patient Global Impression of Change (PGIC) is a single-item question that measures change in patients' overall improvement rated on a 7-point scale including "1 = very much improved," "2 = much improved," "3 = minimally improved," "4 = no change," "5 = minimally worse," "6 = much worse," or "7 = very much worse". | The Full Analysis Set (FAS) includes all randomized patients who receive study drug at baseline. | Posted | Least Squares Mean | Standard Error | score on a scale | Week 12 |
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| Secondary | Total Rescue Acetaminophen Consumption Through Week 12 for TLC599 12mg Versus Placebo | Rescue medication use of acetaminophen was provided and recorded in electronic patient diaries. Weekly Total Acetaminophen consumption was tabulated for analysis on a weekly basis, starting from the first date of study drug injection: (Day 1, 8), (Day 8, 15), and so on. Average daily use (e.g., Weekly Total Acetaminophen Consumption divided by 7) was computed to produce Weekly Average Daily Acetaminophen Consumption. | The Full Analysis Set (FAS) includes all randomized patients who receive study drug at baseline. | Posted | Least Squares Mean | Standard Error | tablets per week | through Week 12 |
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| Secondary | Durable Responder With ≥30% Decrease in WOMAC Pain From Baseline for Weeks 4 Through 12 for TLC599 12mg Versus Placebo | Durable responder endpoints were derived based on the imputed WOMAC pain data. A subject which has ≥ 30% decrease in pain response from Baseline at each visit within a specified time period (x-y). This was derived for patients based on the Injection 1 Baseline for the following time period (x-y): (4-12). | The Full Analysis Set (FAS) includes all randomized patients who receive study drug at baseline. | Posted | Number | percentage of responder | Weeks 4 through 12 |
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| Secondary | Change From Baseline in WOMAC Function at Week 36 for TLC599 12mg Versus Placebo | The WOMAC (Western Ontario & McMaster Universities Osteoarthritis Index, Version 3.1) consists of 24 questions rated on a 0-4 Likert scale, totaling a score from 0-96, reflecting the previous 24 hours. Sub-scale scores for Pain (5 items, a 0-20 scale), Stiffness (2 items, a 0-8 scale), and Physical Function (17 items, a 0-68 scale) are summed to calculate the WOMAC Composite score. Both composite and sub-scale scores are normalized to a 0-4 scale for analysis, with higher scores indicating greater severity. | The Full Analysis Set (FAS) includes all randomized patients who receive study drug at baseline. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Week 36 |
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| Secondary | PGIC at Week 36 for TLC599 12mg Versus Placebo | Patient Global Impression of Change (PGIC) is a single-item question that measures change in patients' overall improvement rated on a 7-point scale including "1 = very much improved," "2 = much improved," "3 = minimally improved," "4 = no change," "5 = minimally worse," "6 = much worse," or "7 = very much worse". | The Full Analysis Set (FAS) includes all randomized patients who receive study drug at baseline. | Posted | Least Squares Mean | Standard Error | score on a scale | Week 36 |
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| Secondary | Change From Baseline in WOMAC Pain at Week 12 for TLC599 12mg Versus DSP 4 mg | The WOMAC (Western Ontario & McMaster Universities Osteoarthritis Index, Version 3.1) consists of 24 questions rated on a 0-4 Likert scale, totaling a score from 0-96, reflecting the previous 24 hours. Sub-scale scores for Pain (5 items, a 0-20 scale), Stiffness (2 items, a 0-8 scale), and Physical Function (17 items, a 0-68 scale) are summed to calculate the WOMAC Composite score. Both composite and sub-scale scores are normalized to a 0-4 scale for analysis, with higher scores indicating greater severity. | The Full Analysis Set (FAS) includes all randomized patients who receive study drug at baseline. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Week 12 |
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| Secondary | Change From Baseline in WOMAC Pain at Week 52 for TLC599 12mg Versus Placebo | The WOMAC (Western Ontario & McMaster Universities Osteoarthritis Index, Version 3.1) consists of 24 questions rated on a 0-4 Likert scale, totaling a score from 0-96, reflecting the previous 24 hours. Sub-scale scores for Pain (5 items, a 0-20 scale), Stiffness (2 items, a 0-8 scale), and Physical Function (17 items, a 0-68 scale) are summed to calculate the WOMAC Composite score. Both composite and sub-scale scores are normalized to a 0-4 scale for analysis, with higher scores indicating greater severity. | The Full Analysis Set (FAS) includes all randomized patients who receive study drug at baseline. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Week 52 |
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Adverse events were collected from the time the subject signs the ICF through the end of the study. The AE collected duration will be up to 56 weeks, including a Screening period of up to 4 weeks before randomization, Injection 1 Period of 24 weeks and Injection 2 Period of 28 weeks.
All adverse events (AEs) were coded using the MedDRA v23.1 terminology to classify corresponding MedDRA System organ class (SOC) and preferred term (PT) for standardization and summary purposes.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | TLC599 12 mg | TLC599 :1 mL IA injection TLC599 is a proprietary (Bioseizer) lipid formulation containing DSP (active ingredient) | 1 | 252 | 16 | 252 | 73 | 252 |
| EG001 | DSP 4 mg | Dexamethasone sodium phosphate (DSP) is a glucocorticoid widely used in the treatment of joint pain such as gout, osteoarthritis and rheumatoid arthritis via IA injection. | 0 | 126 | 4 | 126 | 33 | 126 |
| EG002 | Placebo | Normal saline: 1 mL IA injection | 1 | 126 | 7 | 126 | 28 | 126 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COVID-19 | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Pyelonephritis acute | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Atrial thrombosis | Cardiac disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA (23.1) | Systematic Assessment |
| |
| colitis | Gastrointestinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Hiatus hemia | Gastrointestinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| extradural haematoma | Injury, poisoning and procedural complications | MedDRA (23.1) | Systematic Assessment |
| |
| Meniscus injury | Injury, poisoning and procedural complications | MedDRA (23.1) | Systematic Assessment |
| |
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA (23.1) | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (23.1) | Systematic Assessment |
| |
| Meningioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (23.1) | Systematic Assessment |
| |
| Rectal adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (23.1) | Systematic Assessment |
| |
| Cerebral venous sinus thrombosis | Nervous system disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA (23.1) | Systematic Assessment |
| |
| syncope | Nervous system disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| cholecystitis | Hepatobiliary disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Vertigo positional | Ear and labyrinth disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA (23.1) | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA (23.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (23.1) | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (23.1) | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Tien-Tzu Tai | Taiwan Liposome Company | +886 2 2655 7377 | 801 | tttai@tlcbio.com |
| Apr 18, 2024 |
| Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C004180 | dexamethasone 21-phosphate |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
Not provided
Not provided
| Between 18 and 65 years |
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| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
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| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Australia |
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| Participants |
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