Overview

This trial is active, not recruiting.

Condition osteoarthritis of the knee
Treatment tlc599
Phase phase 1/phase 2
Sponsor Taiwan Liposome Company
Start date June 2015
End date November 2016
Trial size 40 participants
Trial identifier NCT02803307, TLC599A1001

Summary

This trial is a multi-site, randomized, open-label, parallel, and single-dose administration study to investigate the safety and efficacy of TLC599 in subjects with osteoarthritis of the knee.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
6 mg DSP with 50 μmol PL
tlc599
Single dose via intra-articular injection
(Experimental)
12 mg DSP with 100 μmol PL
tlc599
Single dose via intra-articular injection

Primary Outcomes

Measure
Safety parameters
time frame: up to 12 weeks after dosing

Secondary Outcomes

Measure
Pain score (VAS)
time frame: Questionnaire will be collected at baseline, Week 1, Week 4, Week 8, Week 12.
WOMAC questionnaire
time frame: Questionnaire will be collected at baseline, Week 1, Week 4, Week 8, Week 12.
IGART questionnaire
time frame: Questionnaire will be collected at Week 1, Week 4, Week 8, Week 12.

Eligibility Criteria

Male or female participants at least 20 years old.

Inclusion Criteria: 1. Male or female subjects, at least 20 years of age 2. Documented diagnosis of OA of the knee for at least 6 months 3. At least a grade 2 severity based on the Kellgren and Lawrence Grading Scale 4. VAS score of ≥ 4 at baseline Exclusion Criteria: 1. Subjects who received systemic corticosteroids for the last 30 days prior to baseline 2. Subjects who received non-steroidal anti-inflammatory drug (NSAID), analgesics, or rehabilitations therapy within 7 days prior to baseline 3. History of rheumatoid arthritis or other autoimmune disease 4. Clinical signs and symptoms of acute infection or infection related inflammation in the other knee before dosing 5. History of infective arthritis, suspected or concurrent infection, or suspected or confirmed crystal diseases (gout or pseudogout) of the study knee 6. Concurrent systemic active or uncontrolled infectious disease 7. A history of treated malignancy which is disease free for ≤ 5 years. (The malignancy does not include non-basal-cell carcinoma of skin or carcinoma-insitu of the uterine cervix) 8. History of acquired or congenital immunodeficiency diseases 9. Platelet count < 80,000/μl, or blood coagulation disorders, including subjects with hemophilia, decompensated liver cirrhosis or uremia 10. Stroke or myocardial infarction within 3 months prior to the screening visit 11. Use of intra-articular corticosteroid, hyaluronic acid, or other intra-articular injection in the study knee joint within 3 months prior to the screening visit 12. Unstable study knee joint, including anterior cruciate ligament, any surgery to the study knee within the 12 months prior to the screening visit, and any prior arthroscopic or open surgery of the study knee or any planned/anticipated surgery during the study period 13. Any skin lesion/breakdown at the anticipated injection site or any condition that impairs penetration of the study knee joint space 14. Female subjects who are pregnant, nursing, planning pregnancy, or who are of childbearing potential and not using reliable means of contraception 15.Known allergy or hypersensitivity to the study drug or its components

Additional Information

Official title A Randomized, Open-label, Parallel, Phase I/II Single-Dose Administration Trial of TLC599 in Subjects With Osteoarthritis of the Knee
Description Protocol No: TLC599A1001 Name of Finished Product: TLC599 Title of Study: A Randomized, Open-label, Parallel, Phase I/II Single-Dose Administration trial of TLC599 in Subjects with Osteoarthritis (OA) of the Knee Methodology This trial is a multi-site, randomized, open-label, parallel, and single-dose administration study to investigate the safety and efficacy of TLC599 in subjects with osteoarthritis of the knee. Study duration: The trial will last 14 weeks including a 14-day screening period and a 12-week follow-up period.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Taiwan Liposome Company.