A Phase Ib/II Clinical Trial to Evaluate the Safety and Efficacy of LG00034053 in Patients With Knee OA

Study Overview
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Brief Summary
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This study is a multi-center, randomized, placebo-controlled, double-blind clinical study, consisting of Part 1 (Phase 1b) in a sequential, dose-escalating design and Part 2 (Phase 2) in a parallel design.

Official Title
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A Phase Ib/II, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of a Single Dose of LG00034053 Administered by Intra-articular Injection in Patients With Knee Osteoarthritis

Conditions
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Osteoarthritis, Knee

Intervention / Treatment
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* Drug: LG00034053


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients diagnosed with primary osteoarthritis of the knee according to the ACR clinical criteria, with Kellgren-Lawrence grade 2 to 3 in the corresponding knee as determined in the X-ray test Patients with pain in the index knee requiring NSAIDs or analgesics which sustained for at least 6 months Patients with a score of ≥ 4 and ≤ 9 in response to question 1 (walking pain) on the WOMAC pain subscale (11-point NRS) Patients with the subtotal score of ≥ 20 and ≤ 45 on the WOMAC pain subscale (11- point NRS) Patients with BMI at or below 40 kg/m2 Exclusion Criteria: Patients with chronic pain requiring continuous treatment Patients with rheumatoid arthritis or other inflammatory arthritis Patients with skin disorders at the administration site Patients with clinically significant renal or cardiovascular disease or those with suspected SARS-CoV-2 infection Patients in a medical condition which may affect the efficacy and/or safety assessment Patients with Kellgren-Lawrence grade 4 in the contralateral knee Patients with tense effusion Patients having administered an opioid analgesic/ other analgesic/health functional foods, single dose of IA injection within a certain period prior to drug administration Patients having undergone knee replacement

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LG00034053<br>White to slightly brown powder, dosage (6mg, 15mg, 45mg; dose escalation design), single dose administration | Drug: LG00034053<br>* a pan-caspase inhibitor, as a therapeutic agent of osteoarthritis<br>|
| Placebo Comparator: Placebo<br>Clear liquid, single dose administration | Drug: LG00034053<br>* a pan-caspase inhibitor, as a therapeutic agent of osteoarthritis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in WOMAC (Western Ontario and McMaster Universities Arthritis Index) (11-point NRS) pain score from baseline to time point | Change of WOMAC (11-point NRS) pain score from baseline to Week 12 - a total of 5 questions, each question's score is as below Mininum : 0 (no pain) Maximum : 10 (extreme pain) Higher score means worse outcome | week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in WOMAC score from baseline to time point | Change of WOMAC (11-point NRS) score WOMAC pain score (except week 12) WOMAC function, stiffness, total score function (17 questions, scores are 0 to 170) stiffness (2 questions, scores are 0 to 20) total score: pain + function + stiffness = 240 at maximum Higher score means worse outcome | week 1   week 24 | 
| Weekly mean of the average daily pain intensity score (11-point NRS) from baseline to time point | Change in weekly mean of average daily pain intensity score (11-point NRS) - 0 (no pain) to 10 (pain as bad as you can imagine) | week 1   week 24 |