Osteoarthritis of the KneePhase 3EXCELLENCENCT04123561
Extended and Controlled Release Liposomal Formulated Dexamethasone for Chronic Knee OA Pain
A Phase 3 study testing TLC599, DSP and Normal Saline in people with Osteoarthritis of the Knee, run by Taiwan Liposome Company at 46 sites in 2 countries.
Trial summary
Phase 3 randomized, double-blind, placebo- and active comparator-controlled study of TLC599. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Osteoarthritis of the Knee
- What is being tested?
- TLC599, DSP and Normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 504 participants
- Where
- 46 sitesin 2 countries
- Study dates
- 26 Nov 2019to 3 Feb 2022
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
46 sites in 2 countries.
46 sites in 2 countries
United States41 sites
Albuquerque Clinical Trials, Inc.
Albuquerque, New Mexico, 87102
Cahaba Research, Inc
Birmingham, Alabama, 35242
Affinity Orthopedic Specialists Llc
Birmingham, Alabama, 35243
Charlottesville Medical Research Center Llc
Charlottesville, Virginia, 22911
Chicago Clinical Research Institute, Inc.
Chicago, Illinois, 60607
Northwestern University
Chicago, Illinois, 60611
Tampa Bay Medical Research
Clearwater, Florida, 32789
University Clinical Research-Deland, Llc Dba Accel Clinical Research
DeLand, Florida, 32720
Altoona Center For Clinical Research
Duncansville, Pennsylvania, 16635
Medisphere Medical Research Center Llc
Evansville, Indiana, 47714
Lillestol Research Llc
Fargo, North Dakota, 58104
Healthcare Research Network Ii, Llc
Flossmoor, Illinois, 60422
Drug Trials America
Hartsdale, New York, 10530
Healthcare Research Network
Hazelwood, Missouri, 63042
Jacksonville Center For Clinical Research
Jacksonville, Florida, 33216
Biosolutions Clinical Research Center
La Mesa, California, 919142
Charter Research, Llc
Lady Lake, Florida, 32159
Drug Studies America
Marietta, Georgia, 30060
Georgia Institute For Clinical Research Llc
Marietta, Georgia, 30060
Well Pharma Medical Research Corp
Miami, Florida, 33143
Delricht Research
New Orleans, Louisiana, 70115
Better Health Clinical Research Inc
Newnan, Georgia, 30265
Lowcountry Orthopedics C/O Coastal Carolina research center
North Charleston, South Carolina, 29406
Translational Reseach Group Inc Dba Providence Clinical Research
North Hollywood, California, 91606
Affinity Health
Oak Brook, Illinois, 60523
Conquest Research, Llc
Orlando, Florida, 32822
Gb Family Care
Phoenix, Arizona, 85037
Arizona Research Center
Phoenix, Arizona, 85053
Clinical Investigations of Texas
Plano, Texas, 75075
Progressive Medical Research
Port Orange, Florida, 32127
Prospective Research Innovations Inc
Rancho Cucamonga, California, 91730
Quality Research Inc
San Antonio, Texas, 78209
Clinical Trials of Texas Inc (Ctt)
San Antonio, Texas, 78229
Shoals Medical Trials Inc
Sheffield, Alabama, 35660
Encompass Clinical Research
Spring Valley, California, 91978
Clinical Research Institute of Arizona Llc
Surprise, Arizona, 85374
Clinical Research of West Florida
Tampa, Florida, 33603
Noble Clinical Research Llc
Tucson, Arizona, 85704
Chase Medical Research Llc
Waterbury, Connecticut, 06708
Professional Research Network of Kansas Llc
Wichita, Kansas, 67205
Conquest Research (Winter Park)
Winter Park, Florida, 32789
Australia5 sites
Genesis Research Services
Broadmeadow, New South Wales, 2292
Australian Clinical Research Network
Maroubra, New South Wales, 2035
Northern Sydney Local Health District
Saint Leonards, New South Wales, 2065
Austrials
Taringa, Queensland, 4068
Colin Bayliss Research and Teaching Unit
Victoria Park, Western Australia, 6100
About this study
Official title: A Phase 3, Randomized, Double-blind, Placebo- and Active-controlled Study to Evaluate the Efficacy and Safety of TLC599 in Patients With Osteoarthritis of the Knee
Phase 3 randomized, double-blind, placebo- and active comparator-controlled study of TLC599.
Read the detailed description
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.
- Conditions
- Osteoarthritis of the Knee
- Being tested
- TLC599, DSP, Normal Saline
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TLC599Drug
Also called TLC599 Injection
TLC599 is a proprietary (Bioseizer) lipid formulation containing DSP (active ingredient)
DSPDrug
Also called Dexamethasone Sodium Phosphate
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.
Normal SalineOther
0.9% normal saline
| Study group | Role | What they receive |
|---|---|---|
| TLC599 | Experimental | TLC599 (1mL) IA injection Receives: Drug: TLC599 |
| Dexamethasone sodium phosphate | Active comparator | DSP 4mg (1mL) IA injection Receives: Drug: TLC599; Drug: DSP |
| Normal Saline | Placebo comparator | Normal saline (1mL) IA injection Receives: Other: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Week 12
Secondary outcomes (12)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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".
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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".
Measured: 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.
Measured: 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.
Measured: Baseline, Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2019
- Study start26 Nov 2019
- Primary completion3 Feb 2022
- Study completion3 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Osteoarthritis of the KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 504 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taiwan Liposome Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Carl Brown, PhD, Study director, Taiwan Liposome Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04123561
- Sponsor's protocol ID
- TLC599A3005
- Acronym
- EXCELLENCE
- Status last verified
- Sep 2024
- First submitted
- 9 Oct 2019
- Last updated
- 8 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Randomized, Double-blind, Placebo- and Active-controlled Study to Evaluate the Efficacy and Safety of TLC599 in Patients With Osteoarthritis of the Knee
- ClinicalTrials.gov ID
- NCT04123561
- Acronym / sponsor ID
- EXCELLENCE / TLC599A3005
- Conditions
- Osteoarthritis of the Knee
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 504 participants (actual)
- Lead sponsor
- Taiwan Liposome CompanyIndustry (pharma, biotech, devices)
- Study start
- 26 Nov 2019 (actual)
- Primary completion
- 3 Feb 2022 (actual)
- Study completion
- 3 Feb 2022 (actual)
- First posted
- 11 Oct 2019 (actual)
- Results
- Posted 8 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase 3 randomized, double-blind, placebo- and active comparator-controlled study of TLC599.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TLC599 | Experimental | Drug: TLC599TLC599 (1mL) IA injection |
| Dexamethasone sodium phosphate | Active comparator | Drug: TLC599, Drug: DSPDSP 4mg (1mL) IA injection |
| Normal Saline | Placebo comparator | Other: Normal SalineNormal saline (1mL) IA injection |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TLC599Also: TLC599 InjectionTLC599 is a proprietary (Bioseizer) lipid formulation containing DSP (active ingredient) | Drug | Dexamethasone sodium phosphate, TLC599 |
| DSPAlso: Dexamethasone Sodium PhosphateDexamethasone sodium phosphate (DSP) is a glucocorticoid widely used in the treatment of joint pain such as gout, osteoarthritis and rheumatoid arthritis via IA injection. | Drug | Dexamethasone sodium phosphate |
| Normal Saline0.9% normal saline | Other | Normal Saline |
Primary outcome
Change From Baseline in WOMAC Pain at Week 12 for TLC599 12 mg Versus Placebo
Time frame: Baseline, Week 12
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.
12 secondary outcomes
Change From Baseline in WOMAC Pain at Week 16 for TLC599 12 mg Versus Placebo
Time frame: Baseline, Week 16
Change From Baseline in WOMAC Pain at Week 20 for TLC599 12 mg Versus Placebo
Time frame: Baseline, Week 20
Change From Baseline in WOMAC Pain at Week 24 for TLC599 12mg Versus Placebo
Time frame: Baseline, Week 24
Change From Baseline in WOMAC Pain at Week 36 for TLC599 12mg Versus Placebo
Time frame: Baseline, Week 36
Change From Baseline in WOMAC Function at Week 12 for TLC599 12mg Versus Placebo
Time frame: Baseline, Week 12
PGIC at Week 12 for TLC599 12mg Versus Placebo
Time frame: Week 12
Total Rescue Acetaminophen Consumption Through Week 12 for TLC599 12mg Versus Placebo
Time frame: through Week 12
Durable Responder With ≥30% Decrease in WOMAC Pain From Baseline for Weeks 4 Through 12 for TLC599 12mg Versus Placebo
Time frame: Weeks 4 through 12
Change From Baseline in WOMAC Function at Week 36 for TLC599 12mg Versus Placebo
Time frame: Baseline, Week 36
PGIC at Week 36 for TLC599 12mg Versus Placebo
Time frame: Week 36
Change From Baseline in WOMAC Pain at Week 12 for TLC599 12mg Versus DSP 4 mg
Time frame: Baseline, Week 12
Change From Baseline in WOMAC Pain at Week 52 for TLC599 12mg Versus Placebo
Time frame: Baseline, Week 52
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carl Brown, PhD study director
Taiwan Liposome Company
46 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing TLC599, DSP and Normal Saline in people with Osteoarthritis of the Knee, run by Taiwan Liposome Company at 46 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 46 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in WOMAC Pain at Week 12 for TLC599 12 mg Versus Placebo (time frame: Baseline, Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2024.