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

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

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.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis, Knee
• Intervention / Treatment: Drug: LG00034053

• Study Type: Interventional
• Enrollment (Actual): 74
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Australia
  • Camberwell, Australia
    • Emeritus Research
• Korea, Republic of
  • Seoul, Korea, Republic of
    • The Catholic Univ. of Korea Seoul St. Mary's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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 scorefunction (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

Collaborators and Investigators

• Sponsor: LG Chem
• Investigators: Principal Investigator: Chul-Won Ha, Samsung Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): April 27, 2022
• Primary Completion (Actual): December 19, 2023
• Study Completion (Actual): March 11, 2024

Study Registration Dates

• First Submitted: November 17, 2021
• First Submitted That Met QC Criteria: February 11, 2022
• First Posted (Actual): February 14, 2022

Study Record Updates

• Last Update Posted (Actual): May 3, 2024
• Last Update Submitted That Met QC Criteria: May 2, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: LG-CSCL004

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No