Osteoarthritis of the Knee
Conditions
Keywords
osteoarthritis of the knee, TLC599, Dexamethasone, DSP
Brief 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.
Detailed 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.
Interventions
DRUGTLC599
Single dose via intra-articular injection
Sponsors
Taiwan Liposome Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | up to 12 weeks after dosing | Number of participants with at least one TEAE |
Countries
Taiwan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 6 mg TLC599 6 mg DSP with 50 μmol PL
TLC599: Single dose via intra-articular injection | 20 |
| 12 mg TLC599 12 mg DSP with 100 μmol PL
TLC599: Single dose via intra-articular injection | 20 |
| Total | 40 |
Baseline characteristics
| Characteristic | 6 mg TLC599 | Total | 12 mg TLC599 |
|---|---|---|---|
| Age, Continuous | 66.70 years STANDARD_DEVIATION 10.04 | 67.40 years STANDARD_DEVIATION 9 | 68.10 years STANDARD_DEVIATION 8.03 |
| Kellgren-Lawrence grade Grade 0 | 0 Participants | 0 Participants | 0 Participants |
| Kellgren-Lawrence grade Grade 1 | 0 Participants | 0 Participants | 0 Participants |
| Kellgren-Lawrence grade Grade 2 | 7 Participants | 12 Participants | 5 Participants |
| Kellgren-Lawrence grade Grade 3 | 10 Participants | 20 Participants | 10 Participants |
| Kellgren-Lawrence grade Grade 4 | 3 Participants | 8 Participants | 5 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 20 Participants | 40 Participants | 20 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Taiwan | 20 participants | 40 participants | 20 participants |
| Sex: Female, Male Female | 18 Participants | 32 Participants | 14 Participants |
| Sex: Female, Male Male | 2 Participants | 8 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 9 / 20 | 9 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
Primary
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Number of participants with at least one TEAE
Time frame: up to 12 weeks after dosing
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 6 mg TLC599 | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | 9 Participants |
| 12 mg TLC599 | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | 9 Participants |