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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05237752




Registration number
NCT05237752
Ethics application status
Date submitted
17/11/2021
Date registered
14/02/2022
Date last updated
3/05/2024

Titles & IDs
Public title
A Phase Ib/II Clinical Trial to Evaluate the Safety and Efficacy of LG00034053 in Patients With Knee OA
Scientific 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
Secondary ID [1] 0 0
LG-CSCL004
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis, Knee 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - LG00034053

Experimental: LG00034053 - White to slightly brown powder, dosage (6mg, 15mg, 45mg; dose escalation design), single dose administration

Placebo Comparator: Placebo - Clear liquid, single dose administration


Treatment: Drugs: LG00034053
a pan-caspase inhibitor, as a therapeutic agent of osteoarthritis
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Changes in WOMAC (Western Ontario and McMaster Universities Arthritis Index) (11-point NRS) pain score from baseline to time point
Timepoint [1] 0 0
week 12
Secondary outcome [1] 0 0
Change in WOMAC score from baseline to time point
Timepoint [1] 0 0
week 1 ~ week 24
Secondary outcome [2] 0 0
Weekly mean of the average daily pain intensity score (11-point NRS) from baseline to time point
Timepoint [2] 0 0
week 1 ~ week 24

Eligibility
Key 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
Minimum age
40 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1/Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
27/04/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
11/03/2024
Sample size
Target
Accrual to date
Final
74
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Emeritus Research - Camberwell
Recruitment postcode(s) [1] 0 0
- Camberwell
Recruitment outside Australia
Country [1] 0 0
Korea, Republic of
State/province [1] 0 0
Seoul

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
LG Chem
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05237752
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries