Osteoarthritis, KneePhase 1/2NCT05237752
A Phase Ib/II Clinical Trial to Evaluate the Safety and Efficacy of LG00034053 in Patients With Knee OA
A Phase 1/2 study testing LG00034053 in people with Osteoarthritis, Knee, run by LG Chem at 2 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- LG00034053
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 27 Apr 2022to 11 Mar 2024
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
South Korea1 site
The Catholic Univ. of Korea Seoul St. Mary's Hospital
Seoul
About this study
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
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.
- Conditions
- Osteoarthritis, Knee
- Being tested
- LG00034053
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LG00034053Drug
a pan-caspase inhibitor, as a therapeutic agent of osteoarthritis
| Study group | Role | What they receive |
|---|---|---|
| LG00034053 | Experimental | White to slightly brown powder, dosage (6mg, 15mg, 45mg; dose escalation design), single dose administration Receives: Drug: LG00034053 |
| Placebo | Placebo comparator | Clear liquid, single dose administration Receives: Drug: LG00034053 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: week 12
Secondary outcomes (2)
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
Measured: week 1 ~ week 24
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)
Measured: week 1 ~ week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2022
- Study start27 Apr 2022
- Primary completion19 Dec 2023
- Study completion11 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- LG Chem
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05237752
- Sponsor's protocol ID
- LG-CSCL004
- Status last verified
- May 2024
- First submitted
- 17 Nov 2021
- Last updated
- 3 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05237752
- Acronym / sponsor ID
- LG-CSCL004
- Conditions
- Osteoarthritis, Knee
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- LG ChemIndustry (pharma, biotech, devices)
- Study start
- 27 Apr 2022 (actual)
- Primary completion
- 19 Dec 2023 (actual)
- Study completion
- 11 Mar 2024 (actual)
- First posted
- 14 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LG00034053 | Experimental | Drug: LG00034053White to slightly brown powder, dosage (6mg, 15mg, 45mg; dose escalation design), single dose administration |
| Placebo | Placebo comparator | Drug: LG00034053Clear liquid, single dose administration |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LG00034053a pan-caspase inhibitor, as a therapeutic agent of osteoarthritis | Drug | LG00034053, Placebo |
Primary outcome
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
2 secondary outcomes
Change in WOMAC score from baseline to time point
Time frame: week 1 ~ week 24
Weekly mean of the average daily pain intensity score (11-point NRS) from baseline to time point
Time frame: week 1 ~ week 24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing LG00034053 in people with Osteoarthritis, Knee, run by LG Chem at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia, South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in WOMAC (Western Ontario and McMaster Universities Arthritis Index) (11-point NRS) pain score from baseline to time point (time frame: week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2024.