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Completed

NCT Number: NCT04123561

Extended and Controlled Release Liposomal Formulated Dexamethasone for Chronic Knee OA Pain

Phase 3 randomized, double-blind, placebo- and active comparator-controlled study of TLC599.

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Key information

Conditions

Osteoarthritis of the Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Genesis Research Services, Broadmeadow, New South Wales, Australia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TLC599

Drug

TLC599 is a proprietary (Bioseizer) lipid formulation containing DSP (active ingredient)

Other names: TLC599 Injection

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.

Other names: Dexamethasone Sodium Phosphate

Normal Saline

Other

0.9% normal saline

Primary outcomes

  1. 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.

Secondary outcomes

  1. Change From Baseline in WOMAC Pain at Week 16 for TLC599 12 mg Versus Placebo

    Time frame: Baseline, Week 16

    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.

  2. Change From Baseline in WOMAC Pain at Week 20 for TLC599 12 mg Versus Placebo

    Time frame: Baseline, Week 20

    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.

  3. Change From Baseline in WOMAC Pain at Week 24 for TLC599 12mg Versus Placebo

    Time frame: Baseline, Week 24

    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.

  4. Change From Baseline in WOMAC Pain at Week 36 for TLC599 12mg Versus Placebo

    Time frame: Baseline, Week 36

    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.

  5. Change From Baseline in WOMAC Function at Week 12 for TLC599 12mg 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.

  6. PGIC at Week 12 for TLC599 12mg Versus Placebo

    Time frame: Week 12

    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".

  7. Total Rescue Acetaminophen Consumption Through Week 12 for TLC599 12mg Versus Placebo

    Time frame: through Week 12

    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.

  8. 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

    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).

  9. Change From Baseline in WOMAC Function at Week 36 for TLC599 12mg Versus Placebo

    Time frame: Baseline, Week 36

    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.

  10. PGIC at Week 36 for TLC599 12mg Versus Placebo

    Time frame: Week 36

    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".

  11. Change From Baseline in WOMAC Pain at Week 12 for TLC599 12mg Versus DSP 4 mg

    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. Change From Baseline in WOMAC Pain at Week 52 for TLC599 12mg Versus Placebo

    Time frame: Baseline, Week 52

    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.

Sponsors and collaborators

Lead sponsor

Taiwan Liposome Company

Industry

Registry information

Official study 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

Acronym: EXCELLENCE

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Oct 11, 2019
Registry last updated
Oct 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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