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

Osteoarthritis of the Knee Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03005873
• Other study ID #: TLC599A2003
• Status: Completed
• Phase: Phase 2
• Start date: March 16, 2017
• Est. completion date: July 4, 2018

Study information

• Verified date: September 2018
• Source: Taiwan Liposome Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: July 4, 2018
• Est. primary completion date: July 4, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis of the Knee
• Osteoarthritis, Knee

Intervention

Drug:
• TLC599 LD group
Single dose via intra-articular injection
• Normal Saline
Single dose via intra-articular injection
• TLC599 HD group
Single dose via intra-articular injection

Locations

Country	Name	City	State
Australia	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
Taiwan	Show Chwan Memorial Hospital	Changhua
Taiwan	Kaohsiung Medical University Hospital	Kaohsiung
Taiwan	China Medical University Hospital	Taichung
Taiwan	Chung Shan Medical University Hosptial	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

Sponsors (1)

Lead Sponsor	Collaborator
Taiwan Liposome Company

Countries where clinical trial is conducted

Australia,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	WOMAC questionnaire pain sub-scale	The primary endpoint is to evaluate the change from baseline by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale through Week 12.	from dosing through Week 12
Secondary	WOMAC questionnaire pain sub-scale	Change from baseline to Weeks 1, 4, 8, 12, 16, 20, and 24 in pain / function subscales of WOMAC.	at Weeks 1, 4, 8, 12, 16, 20, and 24
Secondary	Pain score (VAS)	Change from baseline to Weeks 1, 4, 8, 12, 16, 20, and 24 in the patient rated visual analogue scale (VAS).	at Weeks 1, 4, 8, 12, 16, 20, and 24
Secondary	Pain score (VAS)	Change from baseline through Weeks 12, 16, 20, and 24 in the patient rated visual analogue scale (VAS).	from dosing through Week 12, 16, 20, 24
Secondary	WOMAC questionnaire pain sub-scale	Change from baseline through Weeks 12, 16, 20, and 24 in the patient rated visual analogue scale (VAS).	from dosing through Week 12, 16, 20, 24
Secondary	EuroQol-5 Dimension questionnaire	Change from baseline to Weeks 1, 4, 8, 12, 16, 20, and 24 in EuroQol-5 Dimension questionnaire.	at Weeks 1, 4, 8, 12, 16, 20, and 24
Secondary	Usage of acetaminophen	Total consumption of acetaminophen at Weeks 1, 4, 8, 12, 16, 20, and 24.	at Weeks 1, 4, 8, 12, 16, 20, and 24
Secondary	Incidence of Treatment-Emergent Adverse Events	To evaluate the safety and tolerability of TLC599 by incidence of Treatment-Emergent Adverse Events reported by Investigators	up to 24 weeks after dosing