Back to resultsA Phase Ib/II Clinical Trial to Evaluate the Safety and Efficacy of LG00034053 in Patients With Knee OA
Primary Purpose
Osteoarthritis, Knee
Status
Recruiting
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
LG00034053
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis, Knee
Eligibility Criteria
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
Sites / Locations
- Samsung Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
LG00034053
Placebo
Arm Description
White to slightly brown powder, dosage (6mg, 15mg, 45mg; dose escalation design), single dose administration
Clear liquid, single dose administration
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05237752
Brief Title
A Phase Ib/II Clinical Trial to Evaluate the Safety and Efficacy of LG00034053 in Patients With Knee OA
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 27, 2022 (Actual)
Primary Completion Date
March 31, 2024 (Anticipated)
Study Completion Date
November 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
LG Chem
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
135 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
LG00034053
Arm Type
Experimental
Arm Description
White to slightly brown powder, dosage (6mg, 15mg, 45mg; dose escalation design), single dose administration
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Clear liquid, single dose administration
Intervention Type
Drug
Intervention Name(s)
LG00034053
Intervention Description
a pan-caspase inhibitor, as a therapeutic agent of osteoarthritis
Primary Outcome Measure Information:
Title
Changes in WOMAC (Western Ontario and McMaster Universities Arthritis Index) (11-point NRS) pain score from baseline to time point
Description
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
Time Frame
week 12
Secondary Outcome Measure Information:
Title
Change in WOMAC score from baseline to time point
Description
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
Time Frame
week 1 ~ week 24
Title
Weekly mean of the average daily pain intensity score (11-point NRS) from baseline to time point
Description
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)
Time Frame
week 1 ~ week 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
SangHee Yun
Phone
82-2-6987-4112
Email
sanghee.yun@lgchem.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chul-Won Ha
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
12. IPD Sharing Statement
Learn more about this trial
A Phase Ib/II Clinical Trial to Evaluate the Safety and Efficacy of LG00034053 in Patients With Knee OA
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