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

Taiwan Liposome Company (TLC)

Status and phase: Completed; Phase 2

Conditions: Osteoarthritis of the Knee

Treatments: Drug: TLC599 HD group; Drug: Normal Saline; Drug: TLC599 LD group

Study type: Interventional

Funder types: Industry

Identifiers

NCT03005873

TLC599A2003

Details and patient eligibility

About

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.

Full 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.

Enrollment: 76 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Main 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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76 participants in 3 patient groups, including a placebo group

TLC599 LD group

Experimental group

Description:

12 mg DSP with 100 µmol PL (1.0 mL)

Treatment:

Drug: TLC599 LD group

TLC599 HD group

Experimental group

Description:

18 mg DSP with 150 µmol PL (1.5 mL)

Treatment:

Drug: TLC599 HD group

Placebo group

Placebo Comparator group

Description:

1.5 mL normal saline

Treatment:

Drug: Normal Saline