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

NCT05237752 | Completed Phase 1

• 1 other identifier: LG-CSCL004
• Study Type: interventional
• Target: 74
• Locations: 2 countries
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change in WOMAC score from baseline to time point

  week 1 ~ week 24

• Weekly mean of the average daily pain intensity score (11-point NRS) from baseline to time point

  week 1 ~ week 24

Study Arms (2)

LG00034053

EXPERIMENTAL

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

Drug: LG00034053

Placebo

PLACEBO COMPARATOR

Clear liquid, single dose administration

Drug: LG00034053

Interventions

LG00034053 DRUG

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

LG00034053; Placebo

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• LG Chem: lead

Study Sites (2)

Emeritus Research

Camberwell, Australia

Location

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

Seoul, South Korea

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2021
• First Posted: February 14, 2022
• Study Start: April 27, 2022
• Primary Completion: December 19, 2023
• Study Completion: March 11, 2024
• Last Updated: May 3, 2024

Record last verified: 2024-05

Locations

AU (1); KR (1)