A Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Phase 3 Study to Determine the Efficacy and Safety of TG-C in Subjects With Kellgren and Lawrence Grade 2 or 3 Osteoarthritis of the Knee

TGC-15302

A randomized, double-blind, placebo-controlled, multi-center, phase 3 study to determine the efficacy and safety of TG-C in subjects with Kellgren and Lawrence Grade 2 or 3 Osteoarthritis of the Knee, Osteoarthritis Research Society International (OARSI) medial joint space narrowing (JSN) Grade 1 or 2 of the knee joint. TG-C is to be administered by a single intra-articular injection to the damaged joint area via ultrasound guidance. Patients will be followed for 24 months for safety and efficacy.

2021-12-09

2024-03-06

2026-03-06

Active (not recruiting)

Early phase I

511

Inclusion Criteria: * Aged 40 or older * BMI between 18.5 and 40 * KL Grade 2 or 3 knee OA * OARSI Grade 1 or 2 medial JSN * Pain \>= 40 on VAS scale * Written informed consent * Using birth control Exclusion Criteria: * Knee symptoms that result in difficulty or inability to walk * Knee effusion \>2+ * Has Grade 3 OARSI JSN * MRI exam indicates fracture or tumor * Has a positive result on RCR testing at screening * Has taken NSAIDS with 14 days of baseline * Has taken steroidal anti-inflammatory or biologic therapy medication within 2 months of baseline * Chronic (\>21 days) narcotic use * Recent history (within 1 year) of drug or alcohol abuse * Pregnant or lactating * Has received injection to target knee within 2 months prior to study entry * History of various disorders of the knee including but not limited to rheumatoid arthritis, psoriatic arthritis, autoimmune disorder, chondrocalcinosis, gout, hemochromatosis, villonodular synovitis, or synovial chondromatosis * Severe hip osteoarthritis ipsilateral to the target knee * Ongoing infectious disease including but not limited to HIV, HTLV-1, VSV-G, HBV, or HCV. * Clinically significant congestive heart failure, hepatic disease, kidney disease, adrenal insufficiency, acromegaly, uncontrolled hyper- or hypothyroidism, or non-specified uncontrolled endocrine disorder. * Uncontrolled diabetes based on a HbA1c \> 8% at screening. * Documented active malignancy within the last 5 years except for basal cell carcinoma, squamous cell carcinoma, and benign pigmented nevi.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'maskingDescription': 'Double-blind', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 511, 'type': 'ACTUAL'}}

2024-04-09