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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

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 adverse events (AEs), including serious adverse event (SAE) and treatment-emergent AE

Side effects data

From 2022 Phase 3 trial • 504 Patients • NCT04123561

12%

Arthralgia

Back pain

COVID-19

Hypertension

Urinary tract infection

Asthma

100%

80%

60%

40%

20%

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

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