Clinical trial NCT03005873: Phase IIa, Randomized, Double Blinded, Placebo Controlled, Dose Finding Study for TLC599 in OA Patients
Official title: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Osteoarthritis of the Knee
Keywords: osteoarthritis of the knee
TLC599
Dexamethasone
DSP
Lead sponsor: Taiwan Liposome Company
Sponsor class: INDUSTRY
First posted: 2016-12-29
Enrollment: 76
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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)

Primary outcomes:
measure: Change From Baseline in WOMAC Pain Subscale at Week 12
timeFrame: Baseline, Week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Broadmeadow
country: Australia
facility: Genesis Research Services Pty Limited
city: Cardiff
country: Australia
facility: Pendlebury Clinic Private Hospital
city: Footscray
country: Australia
facility: Footscray Hospital- Western Health
city: Nedlands,
country: Australia
facility: Linear Clinical Research Limited
city: Sydney
country: Australia
facility: Royal North Shore Hospital
city: Changhua
country: Taiwan
facility: Show Chwan Memorial Hospital
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Hospital
city: Taichung
country: Taiwan
facility: Chung Shan Medical University Hosptial
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Taipei
country: Taiwan
facility: Cheng Hsin General Hospital
city: Taipei
country: Taiwan
facility: Shin Kong Wu Ho-Su Memorial Hospital
city: Taipei
country: Taiwan
facility: Taipei Medical Universtiy Hospital
Study officials:
affiliation: Taiwan Liposome Company
name: Yvonne Shih, PhD
role: STUDY_DIRECTOR
References:
citation: 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.