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

LG Chem

Status and phase: Completed; Phase 2; Phase 1

Conditions: Osteoarthritis, Knee

Treatments: Drug: LG00034053

Study type: Interventional

Funder types: Industry

Identifiers

NCT05237752

LG-CSCL004

Details and patient eligibility

About

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.

Enrollment: 74 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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74 participants in 2 patient groups, including a placebo group

LG00034053

Experimental group

Description:

White to slightly brown powder, dosage (6mg, 15mg, 45mg; dose escalation design), single dose administration

Treatment:

Drug: LG00034053

Placebo

Placebo Comparator group

Description:

Clear liquid, single dose administration

Treatment:

Drug: LG00034053