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Completed

NCT Number: NCT05237752

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

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.

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Key information

Conditions

Osteoarthritis, Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Emeritus Research, Camberwell, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LG00034053

Drug

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

Primary outcomes

  1. Changes in WOMAC (Western Ontario and McMaster Universities Arthritis Index) (11-point NRS) pain score from baseline to time point

    Time frame: 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 outcomes

  1. Change in WOMAC score from baseline to time point

    Time frame: week 1 ~ week 24

    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

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

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

LG Chem

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Feb 14, 2022
Registry last updated
May 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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