Clinical trial NCT04123561: Extended and Controlled Release Liposomal Formulated Dexamethasone for Chronic Knee OA Pain
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoarthritis of the Knee
Lead sponsor: Taiwan Liposome Company
Sponsor class: INDUSTRY
First posted: 2019-10-11
Enrollment: 504
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline in WOMAC Pain at Week 12 for TLC599 12 mg Versus Placebo
timeFrame: Baseline, Week 12
Secondary outcomes:
measure: Change From Baseline in WOMAC Pain at Week 16 for TLC599 12 mg Versus Placebo
timeFrame: Baseline, Week 16
measure: Change From Baseline in WOMAC Pain at Week 20 for TLC599 12 mg Versus Placebo
timeFrame: Baseline, Week 20
measure: Change From Baseline in WOMAC Pain at Week 24 for TLC599 12mg Versus Placebo
timeFrame: Baseline, Week 24
measure: Change From Baseline in WOMAC Pain at Week 36 for TLC599 12mg Versus Placebo
timeFrame: Baseline, Week 36
measure: Change From Baseline in WOMAC Function at Week 12 for TLC599 12mg Versus Placebo
timeFrame: Baseline, Week 12
measure: PGIC at Week 12 for TLC599 12mg Versus Placebo
timeFrame: Week 12
measure: Total Rescue Acetaminophen Consumption Through Week 12 for TLC599 12mg Versus Placebo
timeFrame: through Week 12
measure: Durable Responder With ≥30% Decrease in WOMAC Pain From Baseline for Weeks 4 Through 12 for TLC599 12mg Versus Placebo
timeFrame: Weeks 4 through 12
measure: Change From Baseline in WOMAC Function at Week 36 for TLC599 12mg Versus Placebo
timeFrame: Baseline, Week 36
measure: PGIC at Week 36 for TLC599 12mg Versus Placebo
timeFrame: Week 36
measure: Change From Baseline in WOMAC Pain at Week 12 for TLC599 12mg Versus DSP 4 mg
timeFrame: Baseline, Week 12
measure: Change From Baseline in WOMAC Pain at Week 52 for TLC599 12mg Versus Placebo
timeFrame: Baseline, Week 52
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Cahaba Research, Inc
state: Alabama
city: Birmingham
country: United States
facility: Affinity Orthopedic Specialists Llc
state: Alabama
city: Sheffield
country: United States
facility: Shoals Medical Trials Inc
state: Alabama
city: Phoenix
country: United States
facility: Gb Family Care
state: Arizona
city: Phoenix
country: United States
facility: Arizona Research Center
state: Arizona
city: Surprise
country: United States
facility: Clinical Research Institute of Arizona Llc
state: Arizona
city: Tucson
country: United States
facility: Noble Clinical Research Llc
state: Arizona
city: La Mesa
country: United States
facility: Biosolutions Clinical Research Center
state: California
city: North Hollywood
country: United States
facility: Translational Reseach Group Inc Dba Providence Clinical Research
state: California
city: Rancho Cucamonga
country: United States
facility: Prospective Research Innovations Inc
state: California
city: Spring Valley
country: United States
facility: Encompass Clinical Research
state: California
city: Waterbury
country: United States
facility: Chase Medical Research Llc
state: Connecticut
city: Clearwater
country: United States
facility: Tampa Bay Medical Research
state: Florida
city: DeLand
country: United States
facility: University Clinical Research-Deland, Llc Dba Accel Clinical Research
state: Florida
city: Jacksonville
country: United States
facility: Jacksonville Center For Clinical Research
state: Florida
city: Lady Lake
country: United States
facility: Charter Research, Llc
state: Florida
city: Miami
country: United States
facility: Well Pharma Medical Research Corp
state: Florida
city: Orlando
country: United States
facility: Conquest Research, Llc
state: Florida
city: Port Orange
country: United States
facility: Progressive Medical Research
state: Florida
city: Tampa
country: United States
facility: Clinical Research of West Florida
state: Florida
city: Winter Park
country: United States
facility: Conquest Research (Winter Park)
state: Florida
city: Marietta
country: United States
facility: Drug Studies America
state: Georgia
city: Marietta
country: United States
facility: Georgia Institute For Clinical Research Llc
state: Georgia
city: Newnan
country: United States
facility: Better Health Clinical Research Inc
state: Georgia
city: Chicago
country: United States
facility: Chicago Clinical Research Institute, Inc.
state: Illinois
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Flossmoor
country: United States
facility: Healthcare Research Network Ii, Llc
state: Illinois
city: Oak Brook
country: United States
facility: Affinity Health
state: Illinois
city: Evansville
country: United States
facility: Medisphere Medical Research Center Llc
state: Indiana
city: Wichita
country: United States
facility: Professional Research Network of Kansas Llc
state: Kansas
city: New Orleans
country: United States
facility: Delricht Research
state: Louisiana
city: Hazelwood
country: United States
facility: Healthcare Research Network
state: Missouri
city: Albuquerque
country: United States
facility: Albuquerque Clinical Trials, Inc.
state: New Mexico
city: Hartsdale
country: United States
facility: Drug Trials America
state: New York
city: Fargo
country: United States
facility: Lillestol Research Llc
state: North Dakota
city: Duncansville
country: United States
facility: Altoona Center For Clinical Research
state: Pennsylvania
city: North Charleston
country: United States
facility: Lowcountry Orthopedics C/O Coastal Carolina research center
state: South Carolina
city: Plano
country: United States
facility: Clinical Investigations of Texas
state: Texas
city: San Antonio
country: United States
facility: Quality Research Inc
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas Inc (Ctt)
state: Texas
city: Charlottesville
country: United States
facility: Charlottesville Medical Research Center Llc
state: Virginia
city: Broadmeadow
country: Australia
facility: Genesis Research Services
state: New South Wales
city: Maroubra
country: Australia
facility: Australian Clinical Research Network
state: New South Wales
city: Saint Leonards
country: Australia
facility: Northern Sydney Local Health District
state: New South Wales
city: Taringa
country: Australia
facility: Austrials
state: Queensland
city: Victoria Park
country: Australia
facility: Colin Bayliss Research and Teaching Unit
state: Western Australia
Study officials:
affiliation: Taiwan Liposome Company
name: Carl Brown, PhD
role: STUDY_DIRECTOR
References: