Osteoarthritis of the KneePhase 2NCT03005873
Phase IIa, Randomized, Double Blinded, Placebo Controlled, Dose Finding Study for TLC599 in OA Patients
A Phase 2 study testing TLC599 LD group, Normal Saline and TLC599 HD group in people with Osteoarthritis of the Knee, run by Taiwan Liposome Company at 13 sites in 2 countries.
Trial summary
This trial is a Phase IIa, Randomized, Double blinded, Placebo controlled, Dose finding Study to investigate the safety and efficacy of TLC599 in subjects with osteoarthritis of the knee. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Osteoarthritis of the Knee
- What is being tested?
- TLC599 LD group, Normal Saline and TLC599 HD group
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 13 sitesin 2 countries
- Study dates
- 16 Mar 2017to 4 Jul 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Main Inclusion Criteria:
- Male or female patients, at least 50 years of age.
- Documented diagnosis of OA of the knee for at least 6 months
- The study knee has OA with Grade 2 to 3 severity based on the Kellgren Lawrence grades
- Patients with patient related visual analogue scale (VAS) score of 5.0 to 9.0 at baseline.
- Willing and able to comply with study procedures and provide written informed consent.
Main Exclusion Criteria:
- Patients who received systemic corticosteroids within the last 30 days prior to dosing.
- Patients who use prohibited medications within 7 days prior to study drug administration or any pain control medication including acetaminophen within 48 hours prior to study drug administration.
- Patients who use prohibited medications other than acetaminophen and oral NSAIDs from screening visit to 7 days prior to study drug administration.
- Documented history and confirmed autoimmune disease
- History of post-traumatic knee arthritis, or evidence of intra articular bleeding of the study knee
- History of infective arthritis
- Unstable study knee joint
- Use of IA corticosteroid, hyaluronic acid, or other IA injection in the study knee within 3 months prior to the screening visit.
- A history of treated malignancy which is disease free for ≤ 5 years prior to the screening visit
- Uncontrolled and unstable concurrent medical or psychiatric illness, that will jeopardize the safety of the patient
- Use of any chemotherapeutic or systemic immunosuppressant agents for inflammatory diseases within 6 months prior to the screening visit.
- Current use of anticoagulants, including warfarin, heparin, low molecular weight heparin, or dabigatran.
- Abnormalities of laboratory parameters as described below will qualify for exclusion:
- hemoglobin < 8 g/dL;
- total white blood cell count < 4000/ µL;
- serum bilirubin/ alanine aminotransferase/ aspartate aminotransferase > 2 times upper limit of normal (ULN) for the laboratory reference ranges;
- serum creatinine > 2 times ULN for the laboratory reference range;
- serum uric acid > ULN for the laboratory reference range;
- prothrombin time/International Normalized Ratio > ULN for the laboratory reference range.
- Contraindication to undergoing magnetic resonance imaging (MRI)
Trial locations and contacts
13 sites in 2 countries.
13 sites in 2 countries
Taiwan8 sites
Show Chwan Memorial Hospital
Changhua
Kaohsiung Medical University Hospital
Kaohsiung City
Chung Shan Medical University Hosptial
Taichung, 402
China Medical University Hospital
Taichung
Taichung Veterans General Hospital
Taichung
Cheng Hsin General Hospital
Taipei
Shin Kong Wu Ho-Su Memorial Hospital
Taipei
Taipei Medical Universtiy Hospital
Taipei
Australia5 sites
Genesis Research Services Pty Limited
Broadmeadow
Pendlebury Clinic Private Hospital
Cardiff, 2285
Footscray Hospital- Western Health
Footscray
Linear Clinical Research Limited
Nedlands
Royal North Shore Hospital
Sydney
About this study
Official title: A Phase IIa, Randomized, Double Blinded, Placebo Controlled, Dose Finding Study for Single Dose Administration of TLC599 in Patients With Osteoarthritis (OA) of Knee
This trial is a Phase IIa, Randomized, Double blinded, Placebo controlled, Dose finding Study to investigate the safety and efficacy of TLC599 in subjects with osteoarthritis of the knee.
Read the detailed description
Protocol No: TLC599A2003 Name of Finished Product: TLC599
Title of Study:
A Phase IIa, Randomized, Double blinded, Placebo controlled, Dose finding Study for Single dose Administration of TLC599 in Patients with Osteoarthritis (OA) of Knee.
Study duration:
The trial will last around 27 weeks including a 21-day screening period and a 24-week follow-up period.
- Conditions
- Osteoarthritis of the Knee
- Being tested
- TLC599 LD group, Normal Saline, TLC599 HD group
- Keywords
- osteoarthritis of the knee, TLC599, Dexamethasone, DSP
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TLC599 LD groupDrug
Also called 12 mg DSP with 100 µmol PL (1.0 mL)
Single dose via intra-articular injection
Normal SalineDrug
Also called Placebo
Single dose via intra-articular injection
TLC599 HD groupDrug
Also called 18 mg DSP with 150 µmol PL (1.5 mL)
Single dose via intra-articular injection
| Study group | Role | What they receive |
|---|---|---|
| TLC599 LD group | Experimental | 12 mg DSP with 100 µmol PL (1.0 mL) Receives: Drug: TLC599 LD group |
| TLC599 HD group | Experimental | 18 mg DSP with 150 µmol PL (1.5 mL) Receives: Drug: TLC599 HD group |
| Placebo group | Placebo comparator | 1.5 mL normal saline Receives: Drug: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in WOMAC Pain Subscale at Week 12
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain subscale consist of five items, each ranging from 0 to 4, making the total Pain subscore 0 to 20. The total score of the pain subscale for each patient is normalized and expressed on a 0 to 4 scale.
Higher scores represent higher levels of pain (worse outcome), whereas lower scores represent lower levels of pain (better outcome).
Missing data were imputed.
Measured: Baseline, Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2016 (estimated)
- Study start16 Mar 2017
- Primary completion4 Jul 2018
- Study completion4 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis of the 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taiwan Liposome Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yvonne Shih, PhD, Study director, Taiwan Liposome Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03005873
- Sponsor's protocol ID
- TLC599A2003
- Status last verified
- Apr 2024
- First submitted
- 12 Dec 2016
- Last updated
- 22 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hunter DJ, Chang CC, Wei JC, Lin HY, Brown C, Tai TT, Wu CF, Chuang WC, Shih SF. TLC599 in patients with osteoarthritis of the knee: a phase IIa, randomized, placebo-controlled, dose-finding study. Arthritis Res Ther. 2022 Feb 21;24(1):52. doi: 10.1186/s13075-022-02739-4.
PubMed 35189943
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIa, Randomized, Double Blinded, Placebo Controlled, Dose Finding Study for Single Dose Administration of TLC599 in Patients With Osteoarthritis (OA) of Knee
- ClinicalTrials.gov ID
- NCT03005873
- Acronym / sponsor ID
- TLC599A2003
- Conditions
- Osteoarthritis of the Knee
- Keywords
- osteoarthritis of the knee, TLC599, Dexamethasone, DSP
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Taiwan Liposome CompanyIndustry (pharma, biotech, devices)
- Study start
- 16 Mar 2017 (actual)
- Primary completion
- 4 Jul 2018 (actual)
- Study completion
- 4 Jul 2018 (actual)
- First posted
- 29 Dec 2016 (estimated)
- Results
- Posted 22 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial is a Phase IIa, Randomized, Double blinded, Placebo controlled, Dose finding Study to investigate the safety and efficacy of TLC599 in subjects with osteoarthritis of the knee.
Detailed description
Protocol No: TLC599A2003 Name of Finished Product: TLC599
Title of Study:
A Phase IIa, Randomized, Double blinded, Placebo controlled, Dose finding Study for Single dose Administration of TLC599 in Patients with Osteoarthritis (OA) of Knee.
Study duration:
The trial will last around 27 weeks including a 21-day screening period and a 24-week follow-up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TLC599 LD group | Experimental | Drug: TLC599 LD group12 mg DSP with 100 µmol PL (1.0 mL) |
| TLC599 HD group | Experimental | Drug: TLC599 HD group18 mg DSP with 150 µmol PL (1.5 mL) |
| Placebo group | Placebo comparator | Drug: Normal Saline1.5 mL normal saline |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| TLC599 LD groupAlso: 12 mg DSP with 100 µmol PL (1.0 mL)Single dose via intra-articular injection | Drug | TLC599 LD group |
| Normal SalineAlso: PlaceboSingle dose via intra-articular injection | Drug | Placebo group |
| TLC599 HD groupAlso: 18 mg DSP with 150 µmol PL (1.5 mL)Single dose via intra-articular injection | Drug | TLC599 HD group |
Primary outcome
Change From Baseline in WOMAC Pain Subscale at Week 12
Time frame: Baseline, Week 12
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain subscale consist of five items, each ranging from 0 to 4, making the total Pain subscore 0 to 20. The total score of the pain subscale for each patient is normalized and expressed on a 0 to 4 scale. Higher scores represent higher levels of pain (worse outcome), whereas lower scores represent lower levels of pain (better outcome). Missing data were imputed.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35189943Hunter DJ, Chang CC, Wei JC, Lin HY, Brown C, Tai TT, Wu CF, Chuang WC, Shih SF. TLC599 in patients with osteoarthritis of the knee: a phase IIa, randomized, placebo-controlled, dose-finding study. Arthritis Res Ther. 2022 Feb 21;24(1):52. doi: 10.1186/s13075-022-02739-4.
- Individual participant dataSharing planned: No
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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.
Yvonne Shih, PhD study director
Taiwan Liposome Company
13 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TLC599 LD group, Normal Saline and TLC599 HD group in people with Osteoarthritis of the Knee, run by Taiwan Liposome Company at 13 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?
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 22 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Taiwan, Australia. 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 phase mean?
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?
Yes. Results are posted in the registry (first posted 22 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change From Baseline in WOMAC Pain Subscale at Week 12 (time frame: Baseline, Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03005873, which also lists 1 linked publication.
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 22 Apr 2024.