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

Launched by TAIWAN LIPOSOME COMPANY · Dec 26, 2016

Keywords

ClinConnect Summary

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.

Gender

ALL

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)