Phase 3 N=504 Randomized Quadruple-blind Treatment

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

Osteoarthritis of the Knee

Bottom Line

View on ClinicalTrials.gov: NCT04123561 ↗

Enrolled (actual)

504

Serious AEs

5.4%

Results posted

Oct 2024

Primary outcome: Primary: Change From Baseline in WOMAC Pain at Week 12 for TLC599 12 mg Versus Placebo — -0.968; -0.798 score on a scale — p=0.0372

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: TLC599 (Drug); DSP (Drug); Normal Saline (Other)
Age: Adult, Older Adult · 40+ yrs
Sex: All
Sponsor: Taiwan Liposome Company
Primary completion: Feb 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in WOMAC Pain at Week 12 for TLC599 12 mg Versus Placebo	-0.968; -0.798	0.0372 sig
SECONDARY Change From Baseline in WOMAC Pain at Week 16 for TLC599 12 mg Versus Placebo	-0.929; -0.798	—
SECONDARY Change From Baseline in WOMAC Pain at Week 20 for TLC599 12 mg Versus Placebo	-0.873; -0.749	—
SECONDARY Change From Baseline in WOMAC Pain at Week 24 for TLC599 12mg Versus Placebo	-0.845; -0.688	—
SECONDARY Change From Baseline in WOMAC Pain at Week 36 for TLC599 12mg Versus Placebo	-0.964; -0.882	—
SECONDARY Change From Baseline in WOMAC Function at Week 12 for TLC599 12mg Versus Placebo	-0.903; -0.735	—
SECONDARY PGIC at Week 12 for TLC599 12mg Versus Placebo	2.554; 2.791	—
SECONDARY Total Rescue Acetaminophen Consumption Through Week 12 for TLC599 12mg Versus Placebo	15.568; 29.803	—
SECONDARY Durable Responder With ≥30% Decrease in WOMAC Pain From Baseline for Weeks 4 Through 12 for TLC599 12mg Versus Placebo	45.5; 39.0	—
SECONDARY Change From Baseline in WOMAC Function at Week 36 for TLC599 12mg Versus Placebo	-0.907; -0.787	—
SECONDARY PGIC at Week 36 for TLC599 12mg Versus Placebo	2.635; 2.738	—
SECONDARY Change From Baseline in WOMAC Pain at Week 12 for TLC599 12mg Versus DSP 4 mg	-0.968; -0.933	—
SECONDARY Change From Baseline in WOMAC Pain at Week 52 for TLC599 12mg Versus Placebo	-0.928; -0.934	—

Summary

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

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04123561). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.