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TLC599 for Knee Osteoarthritis

Phase 2
Waitlist Available
Research Sponsored by Taiwan Liposome Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up screening till 25 weeks post ip administration
Awards & highlights

Summary

This trial tests two treatments, TLC599 and DSP, for knee osteoarthritis. The treatments are given either directly into the knee or through an IV. The goal is to see how well they reduce pain and inflammation.

Eligible Conditions
  • Osteoarthritis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~screening till 25 weeks post ip administration
This trial's timeline: 3 weeks for screening, Varies for treatment, and screening till 25 weeks post ip administration for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Area under the Curve [AUC]
Cmax: maximum concentration
Tmax: time to peak concentration
Secondary study objectives
Hydrocortisone
Number of AEs, including SAE and treatment-emergent AE

Side effects data

From 2016 Phase 1 & 2 trial • 40 Patients • NCT02803307
5%
Upper respiratory tract infection
5%
Urinary tract infection
5%
Hyperlipidaemia
5%
Dizziness
5%
Rhinitis allergic
5%
Rhinorrhoea
5%
Dermatitis contact
5%
Pruritus
5%
Hypertension
5%
Arrhythmia
5%
Pyrexia
5%
Influenza
100%
80%
60%
40%
20%
0%
Study treatment Arm
6 mg TLC599
12 mg TLC599

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: TLC599 6 mgExperimental Treatment1 Intervention
6 mg DSP with 50 μmol phospholipid via IA injection.
Group II: TLC599 12 mgExperimental Treatment1 Intervention
12 mg DSP with 100 μmol phospholipid via IA injection;
Group III: DSP 10mgActive Control1 Intervention
Dexamethasone Sodium Phosphate (DSP): 4 mg/mL, 2.5 mL via IV injection.
Group IV: DSP 4mgActive Control1 Intervention
Dexamethasone Sodium Phosphate (DSP): 4 mg/mL, 1 mL via IA injection.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TLC599
2019
Completed Phase 3
~650

Find a Location

Who is running the clinical trial?

Taiwan Liposome CompanyLead Sponsor
18 Previous Clinical Trials
1,736 Total Patients Enrolled
3 Trials studying Osteoarthritis
622 Patients Enrolled for Osteoarthritis
Terry Tai, MDStudy DirectorTaiwan Liposome Company
Carl Brown, PhDStudy DirectorTaiwan Liposome Company
9 Previous Clinical Trials
1,323 Total Patients Enrolled
2 Trials studying Osteoarthritis
546 Patients Enrolled for Osteoarthritis
~15 spots leftby Sep 2025
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