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

Osteoarthritis, Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05237752
• Other study ID #: LG-CSCL004
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: April 27, 2022
• Est. completion date: March 11, 2024

Study information

• Verified date: May 2024
• Source: LG Chem
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: March 11, 2024
• Est. primary completion date: December 19, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Drug:
• LG00034053
a pan-caspase inhibitor, as a therapeutic agent of osteoarthritis

Locations

Country	Name	City	State
Australia	Emeritus Research	Camberwell
Korea, Republic of	The Catholic Univ. of Korea Seoul St. Mary's Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
LG Chem

Countries where clinical trial is conducted

Australia,  Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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 score; function (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
Secondary	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