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

NCT ID: NCT05237752

Last Updated: 2024-05-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-27
• Study Completion Date: 2024-03-11

Brief 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.

Conditions

Osteoarthritis, Knee

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

LG00034053

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

Group Type: EXPERIMENTAL

LG00034053

Intervention Type: DRUG

a pan-caspase inhibitor, as a therapeutic agent of osteoarthritis

Placebo

Clear liquid, single dose administration

Group Type: PLACEBO_COMPARATOR

LG00034053

Intervention Type: DRUG

a pan-caspase inhibitor, as a therapeutic agent of osteoarthritis

Interventions

LG00034053

a pan-caspase inhibitor, as a therapeutic agent of osteoarthritis

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

LG Chem

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Emeritus Research

Camberwell, , Australia

The Catholic Univ. of Korea Seoul St. Mary's Hospital

Seoul, , South Korea

Countries

Australia; South Korea

Other Identifiers

LG-CSCL004

Identifier Type: -

Identifier Source: org_study_id