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

NCT ID: NCT03005873

Last Updated: 2024-04-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-16
• Study Completion Date: 2018-07-04

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.

Conditions

Osteoarthritis of the Knee

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

TLC599 LD group

12 mg DSP with 100 µmol PL (1.0 mL)

Group Type: EXPERIMENTAL

TLC599 LD group

Intervention Type: DRUG

Single dose via intra-articular injection

TLC599 HD group

18 mg DSP with 150 µmol PL (1.5 mL)

Group Type: EXPERIMENTAL

TLC599 HD group

Intervention Type: DRUG

Single dose via intra-articular injection

Placebo group

1.5 mL normal saline

Group Type: PLACEBO_COMPARATOR

Normal Saline

Intervention Type: DRUG

Single dose via intra-articular injection

Interventions

TLC599 LD group

Single dose via intra-articular injection

Intervention Type: DRUG

Normal Saline

Single dose via intra-articular injection

Intervention Type: DRUG

TLC599 HD group

Single dose via intra-articular injection

Intervention Type: DRUG

Other Intervention Names

12 mg DSP with 100 µmol PL (1.0 mL); Placebo; 18 mg DSP with 150 µmol PL (1.5 mL)

Eligibility Criteria

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.

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)

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Taiwan Liposome Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yvonne Shih, PhD

Role: STUDY_DIRECTOR

Taiwan Liposome Company

Locations

Genesis Research Services Pty Limited

Broadmeadow, , Australia

Pendlebury Clinic Private Hospital

Cardiff, , Australia

Footscray Hospital- Western Health

Footscray, , Australia

Linear Clinical Research Limited

Nedlands, , Australia

Royal North Shore Hospital

Sydney, , Australia

Show Chwan Memorial Hospital

Changhua, , Taiwan

Kaohsiung Medical University Hospital

Kaohsiung City, , Taiwan

Chung Shan Medical University Hosptial

Taichung, , Taiwan

China Medical University Hospital

Taichung, , Taiwan

Taichung Veterans General Hospital

Taichung, , Taiwan

Cheng Hsin General Hospital

Taipei, , Taiwan

Shin Kong Wu Ho-Su Memorial Hospital

Taipei, , Taiwan

Taipei Medical Universtiy Hospital

Taipei, , Taiwan

Countries

Australia; Taiwan

References

Hunter DJ, Chang CC, Wei JC, Lin HY, Brown C, Tai TT, Wu CF, Chuang WC, Shih SF. TLC599 in patients with osteoarthritis of the knee: a phase IIa, randomized, placebo-controlled, dose-finding study. Arthritis Res Ther. 2022 Feb 21;24(1):52. doi: 10.1186/s13075-022-02739-4.

Reference Type: DERIVED

PMID: 35189943 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

TLC599A2003

Identifier Type: -

Identifier Source: org_study_id