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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
No Placebo-Only Group
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
- Knee Arthritis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ screening till 25 weeks post ip administration
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~screening till 25 weeks post ip administration
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 adverse events (AEs), including serious adverse event (SAE) and treatment-emergent AE
Side effects data
From 2022 Phase 3 trial • 504 Patients • NCT0412356112%
Arthralgia
5%
Back pain
5%
COVID-19
4%
Hypertension
4%
Urinary tract infection
1%
Asthma
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
TLC599 12 mg
DSP 4 mg
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: TLC599 6 mgExperimental Treatment1 Intervention
6 mg TLC590 (proprietary lipid formulation that consists of 6 mg DSP \[active ingredient\] with 50 μmol phospholipid) via IA injection in patients with OA of the knee. This 6 mg TLC599 treatment arm consists of two (2) cohorts (G7 and G8), each with different follow-up periods or visit schedules. However, the results will be pooled into a single treatment arm to allow for meaningful analysis across the various synovial fluid (SF) time points, as each subject only has one opportunity to collect an SF sample.
Group II: TLC599 12 mgExperimental Treatment1 Intervention
12 mg TLC590 (proprietary lipid formulation that consists of 12 mg DSP \[active ingredient\] with 100 μmol phospholipid) via IA injection in patients with OA of the knee. This 12 mg TLC599 treatment arm consists of six (6) cohorts (G1 to G6), each with different follow-up periods or visit schedules. However, the results will be pooled into a single treatment arm to allow for meaningful analysis across the various synovial fluid (SF) time points, as each subject only has one opportunity to collect an SF sample.
Group III: DSP 4 mgActive Control1 Intervention
Dexamethasone Sodium Phosphate (DSP) at a concentration of 4 mg/mL, 1 mL for a total of 4 mg DSP via IA injection in patients with OA of the knee (G9).
Group IV: DSP 10 mgActive Control1 Intervention
Dexamethasone Sodium Phosphate (DSP) at a concentration of 4 mg/mL, 2.5 mL for the total of 10 mg DSP via IV injection in healthy subjects (G10).
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
1,734 Total Patients Enrolled
Terry Tai, MDStudy DirectorTaiwan Liposome Company
Carl Brown, PhDStudy DirectorTaiwan Liposome Company
9 Previous Clinical Trials
1,321 Total Patients Enrolled