Moderate to Severe Osteoarthritis
Conditions
Brief summary
The purpose of this study is to find the optimal dose of SM04690 that can be safely given by intra-articular injection into the target knee joint of subjects with moderate to severe osteoarthritis.
Interventions
DRUGSM04690, 0.03mg/2mL
DRUGSM04690, 0.07mg/2mL
DRUGSM04690, 0.23mg/2mL
DRUGPlacebo
Sponsors
Biosplice Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
50 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosed with primary OA in target knee by American College of Rheumatology (ACR) criteria * Screening pain criteria sufficient as assessed by WOMAC and VAS scores * Ability to read and understand the informed consent
Exclusion criteria
* Women who are pregnant or lactating or child bearing potential, men must use a barrier method of contraception * Any condition, including laboratory findings, that in the opinion of the investigator constitutes a risk or contraindication for participation in the study or that could interfere with the study objectives, conduct or evaluation * Body mass index \>40 * Major knee surgery in the target knee within 12 months prior to study or planned surgery during the study period * History of malignancy within the last 5 years * Participation in a clinical research trial within 12 weeks prior * Treatment of the target knee with intra-articular steroids within 2 months or hyaluronic acid derivatives within 6 months * Effusion of the target knee requiring aspiration within 3 months * Use of electrotherapy or acupuncture for OA within 4 weeks * Significant and clinically evident misalignment of the target knee * Any known active infections * Any chronic condition that has not been well controlled for a minimum of 3 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety assessments for this study will include adverse events, dose limiting toxicity (DLT), physical exams, vital signs, ECGs, and clinical laboratory tests | during 24 weeks |
| Additional safety assessment of bone loss as measured by CT of the knee | during 24 weeks |
| The following PK parameters will be determined from the plasma of SM04690; Cmax, Tmax, AUC0-t, AUC0-∞, and t1/2 | during 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in joint space width as measured by X-ray | during 24 weeks |
| Change from baseline pain over the last 48 hours using a Visual Analog Scale (VAS) | during 24 weeks |
| Change from baseline of biomarkers of cartilage synthesis and cytokines | during 24 weeks |
| Change from baseline of cartilage volume and thickness as measure by MRI | during 24 weeks |
| Change from baseline per Western Ontario and McMaster Osteoarthritis (WOMAC) assessment of disease scale | During 24 weeks |
| Change from baseline per physician global assessment of disease scale | during 24 weeks |
Countries
United States
Outcome results
None listed