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

Phase 1

Completed

• Conditions: Osteoarthritis, Knee
• Interventions: Drug: LG00034053

• Registration Number: NCT05237752
• Lead Sponsor: LG Chem

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-11-17
• Study First Submitted QC: 2022-02-11
• Study First Posted: 2022-02-14
• Study Start: 2022-04-27
• Primary Completion: 2023-12-19
• Study Completion: 2024-03-11
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-02
• Last Update Posted: 2024-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LG00034053	LG00034053	White to slightly brown powder, dosage (6mg, 15mg, 45mg; dose escalation design), single dose administration
Placebo	LG00034053	Clear liquid, single dose administration

Primary Outcome Measures

Name	Time	Method
Changes in WOMAC (Western Ontario and McMaster Universities Arthritis Index) (11-point NRS) pain score from baseline to time point	week 12	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

Secondary Outcome Measures

Name	Time	Method
Change in WOMAC score from baseline to time point	week 1 ~ week 24	Change of WOMAC (11-point NRS) score; 1. WOMAC pain score (except week 12); 2. 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
Weekly mean of the average daily pain intensity score (11-point NRS) from baseline to time point	week 1 ~ week 24	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)

Trial Locations

Locations (2)

The Catholic Univ. of Korea Seoul St. Mary's Hospital; 🇰🇷 Seoul, Korea, Republic of

Emeritus Research; 🇦🇺 Camberwell, Australia