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

• Status: Recruiting
• Trial end date: 2023-12-30
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: LG Chem

Criteria

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