Phase IIa, Randomized, Double Blinded, Placebo Controlled, Dose Finding Study for TLC599 in OA Patients

Phase 2

Completed

• Conditions: Osteoarthritis of the Knee
• Interventions: Drug: TLC599 LD group; Drug: TLC599 HD group; Drug: Normal Saline

• Registration Number: NCT03005873
• Lead Sponsor: Taiwan Liposome Company

Brief Summary

This trial is a Phase IIa, Randomized, Double blinded, Placebo controlled, Dose finding Study to investigate the safety and efficacy of TLC599 in subjects with osteoarthritis of the knee.

Detailed Description

Protocol No: TLC599A2003 Name of Finished Product: TLC599

Title of Study:

A Phase IIa, Randomized, Double blinded, Placebo controlled, Dose finding Study for Single dose Administration of TLC599 in Patients with Osteoarthritis (OA) of Knee.

Study duration:

The trial will last around 27 weeks including a 21-day screening period and a 24-week follow-up period.

Study Timeline

• Study First Submitted: 2016-12-12
• Study First Submitted QC: 2016-12-26
• Study First Posted: 2016-12-29
• Study Start: 2017-03-16
• Primary Completion: 2018-07-04
• Study Completion: 2018-07-04
• Results First Submitted: 2021-11-24
• Status Verified: 2024-04
• Results First Submitted QC: 2024-04-19
• Last Update Submitted: 2024-04-19
• Results First Posted: 2024-04-22
• Last Update Posted: 2024-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

Inclusion Criteria

1. Male or female patients, at least 50 years of age.
2. Documented diagnosis of OA of the knee for at least 6 months
3. The study knee has OA with Grade 2 to 3 severity based on the Kellgren Lawrence grades
4. Patients with patient related visual analogue scale (VAS) score of 5.0 to 9.0 at baseline.
5. Willing and able to comply with study procedures and provide written informed consent.

Main

Exclusion Criteria

1. Patients who received systemic corticosteroids within the last 30 days prior to dosing.

2. Patients who use prohibited medications within 7 days prior to study drug administration or any pain control medication including acetaminophen within 48 hours prior to study drug administration.

3. Patients who use prohibited medications other than acetaminophen and oral NSAIDs from screening visit to 7 days prior to study drug administration.

4. Documented history and confirmed autoimmune disease

5. History of post-traumatic knee arthritis, or evidence of intra articular bleeding of the study knee

6. History of infective arthritis

7. Unstable study knee joint

8. Use of IA corticosteroid, hyaluronic acid, or other IA injection in the study knee within 3 months prior to the screening visit.

9. A history of treated malignancy which is disease free for ≤ 5 years prior to the screening visit

10. Uncontrolled and unstable concurrent medical or psychiatric illness, that will jeopardize the safety of the patient

11. Use of any chemotherapeutic or systemic immunosuppressant agents for inflammatory diseases within 6 months prior to the screening visit.

12. Current use of anticoagulants, including warfarin, heparin, low molecular weight heparin, or dabigatran.

13. Abnormalities of laboratory parameters as described below will qualify for exclusion:

    • hemoglobin < 8 g/dL;
    • total white blood cell count < 4000/ µL;
    • serum bilirubin/ alanine aminotransferase/ aspartate aminotransferase > 2 times upper limit of normal (ULN) for the laboratory reference ranges;
    • serum creatinine > 2 times ULN for the laboratory reference range;
    • serum uric acid > ULN for the laboratory reference range;
    • prothrombin time/International Normalized Ratio > ULN for the laboratory reference range.

14. Contraindication to undergoing magnetic resonance imaging (MRI)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TLC599 LD group	TLC599 LD group	12 mg DSP with 100 µmol PL (1.0 mL)
TLC599 HD group	TLC599 HD group	18 mg DSP with 150 µmol PL (1.5 mL)
Placebo group	Normal Saline	1.5 mL normal saline

Primary Outcome Measures

Name	Time	Method
Change From Baseline in WOMAC Pain Subscale at Week 12	Baseline, Week 12	The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain subscale consist of five items, each ranging from 0 to 4, making the total Pain subscore 0 to 20. The total score of the pain subscale for each patient is normalized and expressed on a 0 to 4 scale.; Higher scores represent higher levels of pain (worse outcome), whereas lower scores represent lower levels of pain (better outcome).; Missing data were imputed.

Trial Locations

Locations (13)

Royal North Shore Hospital; 🇦🇺 Sydney, Australia

Linear Clinical Research Limited; 🇦🇺 Nedlands,, Australia

Shin Kong Wu Ho-Su Memorial Hospital; 🇨🇳 Taipei, Taiwan

Taichung Veterans General Hospital; 🇨🇳 Taichung, Taiwan

China Medical University Hospital; 🇨🇳 Taichung, Taiwan

Taipei Medical Universtiy Hospital; 🇨🇳 Taipei, Taiwan

Kaohsiung Medical University Hospital; 🇨🇳 Kaohsiung, Taiwan

Chung Shan Medical University Hosptial; 🇨🇳 Taichung, Taiwan

Genesis Research Services Pty Limited; 🇦🇺 Broadmeadow, Australia

Pendlebury Clinic Private Hospital; 🇦🇺 Cardiff, Australia

Footscray Hospital- Western Health; 🇦🇺 Footscray, Australia

Show Chwan Memorial Hospital; 🇨🇳 Changhua, Taiwan

Cheng Hsin General Hospital; 🇨🇳 Taipei, Taiwan