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

NCT04123561 | Completed Phase 3 Results FDA Drug

• 1 other identifier: TLC599A3005
• Study Type: interventional
• Target: 504
• Locations: 2 countries
• Sites: 46

Brief Summary

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

Conditions

Osteoarthritis of the Knee

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (12)

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

  Baseline, Week 16

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

  Baseline, Week 20

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

  Baseline, Week 24

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

  Baseline, Week 36

• Change From Baseline in WOMAC Function at Week 12 for TLC599 12mg Versus Placebo

  Baseline, Week 12

Study Arms (3)

TLC599

EXPERIMENTAL

TLC599 (1mL) IA injection

Drug: TLC599

Dexamethasone sodium phosphate

ACTIVE COMPARATOR

DSP 4mg (1mL) IA injection

Drug: TLC599; Drug: DSP

Normal Saline

PLACEBO COMPARATOR

Normal saline (1mL) IA injection

Other: Normal Saline

Interventions

TLC599 DRUG

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

Also known as: TLC599 Injection

Dexamethasone sodium phosphate; TLC599

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.

Also known as: Dexamethasone Sodium Phosphate

Dexamethasone sodium phosphate

Normal Saline OTHER

0.9% normal saline

Normal Saline

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Taiwan Liposome Company: lead

Study Sites (46)

Cahaba Research, Inc

Birmingham, Alabama, 35242, United States

Location

Affinity Orthopedic Specialists Llc

Birmingham, Alabama, 35243, United States

Location

Shoals Medical Trials Inc

Sheffield, Alabama, 35660, United States

Location

Gb Family Care

Phoenix, Arizona, 85037, United States

Location

Arizona Research Center

Phoenix, Arizona, 85053, United States

Location

Clinical Research Institute of Arizona Llc

Surprise, Arizona, 85374, United States

Location

Noble Clinical Research Llc

Tucson, Arizona, 85704, United States

Location

Biosolutions Clinical Research Center

La Mesa, California, 919142, United States

Location

Translational Reseach Group Inc Dba Providence Clinical Research

North Hollywood, California, 91606, United States

Location

Prospective Research Innovations Inc

Rancho Cucamonga, California, 91730, United States

Location

Encompass Clinical Research

Spring Valley, California, 91978, United States

Location

Chase Medical Research Llc

Waterbury, Connecticut, 06708, United States

Location

Tampa Bay Medical Research

Clearwater, Florida, 32789, United States

Location

University Clinical Research-Deland, Llc Dba Accel Clinical Research

DeLand, Florida, 32720, United States

Location

Jacksonville Center For Clinical Research

Jacksonville, Florida, 33216, United States

Location

Charter Research, Llc

Lady Lake, Florida, 32159, United States

Location

Well Pharma Medical Research Corp

Miami, Florida, 33143, United States

Location

Conquest Research, Llc

Orlando, Florida, 32822, United States

Location

Progressive Medical Research

Port Orange, Florida, 32127, United States

Location

Clinical Research of West Florida

Tampa, Florida, 33603, United States

Location

Conquest Research (Winter Park)

Winter Park, Florida, 32789, United States

Location

Drug Studies America

Marietta, Georgia, 30060, United States

Location

Georgia Institute For Clinical Research Llc

Marietta, Georgia, 30060, United States

Location

Better Health Clinical Research Inc

Newnan, Georgia, 30265, United States

Location

Chicago Clinical Research Institute, Inc.

Chicago, Illinois, 60607, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Healthcare Research Network Ii, Llc

Flossmoor, Illinois, 60422, United States

Location

Affinity Health

Oak Brook, Illinois, 60523, United States

Location

Medisphere Medical Research Center Llc

Evansville, Indiana, 47714, United States

Location

Professional Research Network of Kansas Llc

Wichita, Kansas, 67205, United States

Location

Delricht Research

New Orleans, Louisiana, 70115, United States

Location

Healthcare Research Network

Hazelwood, Missouri, 63042, United States

Location

Albuquerque Clinical Trials, Inc.

Albuquerque, New Mexico, 87102, United States

Location

Drug Trials America

Hartsdale, New York, 10530, United States

Location

Lillestol Research Llc

Fargo, North Dakota, 58104, United States

Location

Altoona Center For Clinical Research

Duncansville, Pennsylvania, 16635, United States

Location

Lowcountry Orthopedics C/O Coastal Carolina research center

North Charleston, South Carolina, 29406, United States

Location

Clinical Investigations of Texas

Plano, Texas, 75075, United States

Location

Quality Research Inc

San Antonio, Texas, 78209, United States

Location

Clinical Trials of Texas Inc (Ctt)

San Antonio, Texas, 78229, United States

Location

Charlottesville Medical Research Center Llc

Charlottesville, Virginia, 22911, United States

Location

Genesis Research Services

Broadmeadow, New South Wales, 2292, Australia

Location

Australian Clinical Research Network

Maroubra, New South Wales, 2035, Australia

Location

Northern Sydney Local Health District

Saint Leonards, New South Wales, 2065, Australia

Location

Austrials

Taringa, Queensland, 4068, Australia

Location

Colin Bayliss Research and Teaching Unit

Victoria Park, Western Australia, 6100, Australia

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

dexamethasone 21-phosphate; Saline Solution

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Dr. Tien-Tzu Tai
• Organization: Taiwan Liposome Company

tttai@tlcbio.com

+886 2 2655 7377

Study Officials

• Carl Brown, PhD

  Taiwan Liposome Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2019
• First Posted: October 11, 2019
• Study Start: November 26, 2019
• Primary Completion: February 3, 2022
• Study Completion: February 3, 2022
• Last Updated: October 8, 2024
• Results First Posted: October 8, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

AU (5); US (41)