Clinical trial NCT05276011: A Study to Determine the Safety and Efficacy of TG-C in Subjects with Symptomatic Early Hip Osteoarthritis
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Degenerative Osteoarthritis
Keywords: hip
Lead sponsor: Kolon TissueGene, Inc.
Sponsor class: INDUSTRY
First posted: 2022-03-11
Enrollment: 255
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: This protocol is designed to assess the safety and efficacy of TG-C in treating symptoms of osteoarthritis of the hip and determining disease modifying effects of TG-C. TG-C will be compared to normal saline as a control. Safety will be evaluated by observation of the injection site for irritation or other effects, the incidence and severity of adverse events, and changes in physical examination findings, radiographic criteria, and laboratory tests. Patients will be followed for 12 months for both safety and efficacy.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Hip Pain as Assessed by VAS
timeFrame: Baseline to Month 12
Secondary outcomes:
measure: Hip Disability and Osteoarthritis Outcome Score (HOOS)
timeFrame: Baseline to Month 12
measure: Timed Up and Go Test (TUG)
timeFrame: Baseline to Months 1, 3, 6, 9, and 12
measure: UCLA Activity Score
timeFrame: Baseline to Months 1, 3, 6, 9, and 12
measure: Joint Space Width (JSW) on standing X-ray
timeFrame: Baseline to Month 12
measure: WOMAC® (Western Ontario and McMaster Universities Osteoarthritis Index) total score
timeFrame: Baseline to Month 12
Other outcomes:
measure: Physical Component Score (PCS) of the Short Form 12-Item Health Survey (SF-12 Questionnaire)
timeFrame: 12 months
measure: Clinician Global Impression of Change (CGI-C)
timeFrame: Week 1 and Months 1, 3, 6, 9, and 12
measure: Clinician Global Impression of Severity (CGI-S)
timeFrame: Baseline and at Months 1, 3, 6, 9, and 12
measure: Patient Global Impression of Severity (PGI-S)
timeFrame: Baseline and at Months 1, 3, 6, 9, and 12
measure: Patient Global Impression of Change (PGI-C)
timeFrame: Week 1 and Months 1, 3, 6, 9, and 12
Locations:
Study officials:
affiliation: Kolon TissueGene, Inc.
name: Moon Jong Noh, PhD
role: STUDY_CHAIR
References: