A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Determine the Efficacy, Safety, and Dosing of TG-C in Adult Subjects With Symptomatic Early Hip Osteoarthritis

TGC-OAH-201

A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Determine the Efficacy, Safety, and Dosing of TG-C in Adult Subjects with Symptomatic Early Hip Osteoarthritis. TG-C will be administered to the target hip by a single ultrasound (or fluoroscopy)-guided, intra-articular injection with image capture showing correct injection of study drug into the femoroacetabular joint. Patients will be followed for 12 months for safety and efficacy.

2024-10-01

2025-10-01

2025-10-01

Not yet recruiting

Early phase I

255

Inclusion Criteria: * Aged 18 to 80 years old * The subject has a diagnosis of Grade ≤2 primary OA of the target hip * Pain ≥ 40 on VAS scale * The subject has groin pain that is elicited by hip rotation on physical examination * No history of significant organ system disorders. * Body mass index (BMI) \<40 kg/m2 * Systolic blood pressure of 100 to 160 mmHg and diastolic blood pressure of 60 to 90 mmHg. * Using birth control * Written informed consent Exclusion Criteria: * The subject exhibits severe symptoms in the target hip that result in difficulty or an inability to walk. * The subject has severe hip OA ipsilateral to the target hip. * Previous cartilage transplantation procedure to the injured cartilage surface. * Major injury to the target hip within 12 months of screening. * Active dermal ulcer or infection in the proximity of the target hip within 1 month before screening. * The subject has had surgery on the target hip within the last 6 months. * Total hip replacement surgery or other surgery on the target hip in the next 12 months. * MRI indicates bone marrow infiltration, fracture, osteonecrosis/bone infarct, osteochondritis dissecans, tumor, moderate to severe dysplasia, avascular necrosis, post-traumatic arthritis, transient osteoporosis, slipped-cap femoral epiphysis, juvenile idiopathic arthritis, or axial juvenile spondyloarthritis. * Hip conditions including but not limited to any autoimmune or infectious cause for arthritis; metabolic joint disease; neuropathic disorders, groin pain from non-orthopedic sources, or tumors, congestive heart failure, or chronic kidney disease. * Uncontrolled diabetes based on a hemoglobin A1c (HbA1c) value \>8% at the screening Visit. * Increased risk for post-procedure bleeding or post-procedure infection. * Ongoing infectious disease, including, but not limited to, HIV, hepatitis C, or current or prior hepatitis B. * Cognitive impairment that would limit his/her ability to provide informed consent or to complete assessments and questionnaires. * 1 year history of drug or alcohol abuse. * Contraindication to or cannot undergo MRI. * Active malignancy within the last 5 years. * Pregnant or is lactating. * Taken steroidal or NSAIDs within 14 days before the Baseline Visit * Using topical analgesics on the target hip * Receiving chronic narcotic treatment at screening. * Received any injection to the target hip within the 3 months before the Baseline Visit. * Taking antiplatelet or anticoagulants. * Participated in an investigational study within 13 weeks before the Screening Visit or in the next 25 months. * Unable to comply with the requisite study follow-up and all of the follow-up office visits.

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2023-11-21