Osteoarthritis, KneePhase 1/2NCT05807529
A Study to Evaluate the Safety and Efficacy of 2ccPA in Patients With Symptomatic Knee Osteoarthritis
A Phase 1/2 study testing 2ccPA in people with Osteoarthritis, Knee, run by Orient Europharma Co., Ltd. at 1 site in Taiwan.
Trial summary
This phase I/II study aims to evaluate the safety of single doses of 2ccPA 4,800 μg and 7,200 μg (Phase I), as well as the safety and efficacy of multiple doses of 2ccPA (Phase II) in patients with osteoarthritis (OA) of the knee. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- 2ccPA
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 136 participants
- Where
- 1 siteTaiwan
- Study dates
- 3 Nov 2022to Dec 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed written informed consent from any patient capable of giving consent.
- Male or female patients, 40 to 80 years of age.
- Documented clinical diagnosis of symptomatic OA affecting at least one knee of a minimum of 6 months prior to screening.
- The study knee has OA of Grade 2 to 3 severity based on the Kellgren Lawrence grading scale.
- A score > 6 and < 16 out of 20 on the WOMAC pain subscale for the study knee.
- Pain in the study knee for most of the 30 days (i.e., more than half of the days) prior to randomization.
- Women of childbearing potential must agree to practice a medically acceptable contraceptive regimen from screening visit until at least 1 month after the study treatment and must have a negative pregnancy test no earlier than 72 hours prior to study treatment. Male subjects must agree to practice a medically acceptable contraceptive regimen (i.e., sterilization surgery, barrier method, abstention) from screening visit until at least 1 month after the study treatment.
Who cannot join
- Patients with known or suspected hypersensitivity to 2ccPA or any of its excipients.
- Use of intra-articular corticosteroids, hyaluronic acid, or other IA injection in the study knee within 3 months prior to study entry (randomization).
- Use of chondroitin and/or glucosamine within 4 weeks prior to study entry (randomization).
- Administered or requiring systemic or topical treatment of the study knee joint including immunosuppressive agents, anti-inflammatory drugs, steroids, or opioids for knee OA within 1 week prior to randomization. Acetaminophen (oral daily dose ≤ 3000 mg or topical use at any dose) can be taken up to 24 hours prior to randomization. For long-acting steroids (i.e., dexamethasone, betamethasone), subjects who received systemic treatment within 2 weeks before randomization will be excluded.
- History of post-traumatic knee arthritis, or evidence of intra-articular bleeding of the study knee.
- History of reiter's syndrome, gouty arthritis, systemic lupus erythematosus (SLE), sicca syndrome, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, lymphoma, arthritis associated with inflammatory bowel disease, sarcoidosis, amyloidosis or any other immune disease that based on investigators' discretion.
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- Periarticular inflammation from any cause, including referred pain, bursitis, tendonitis, soft tissue tenderness or acute pain from injury.
- Subjects with clinical signs and symptoms of active knee infection or being treated for knee infection at screening.
- Arthroscopic or open surgery on the study knee within 6 months prior to study entry (randomization).
- Prior knee replacement on the study knee or planned knee replacement during the study period.
- Subjects with meniscus tears that require repairment surgery or known anterior cruciate ligament rupture.
- Subjects with known severe synovitis, synovium necrosis in the study knee joint.
- Subjects with known malignancy.
- Use of any chemotherapeutic or systemic immunosuppressant agents for inflammatory diseases within 6 months prior to study entry (randomization).
- Current use of anticoagulants, including warfarin, heparin, low molecular weight heparin, dabigatran, or factor Xa inhibitors (rivaroxaban, apixaban, edoxaban, and betrixaban). Subject requiring routine use of low-dose aspirin for preventing thrombosis (≤ 100 mg/day) will not be excluded.
- Abnormalities of laboratory parameters as described below will qualify for exclusion:
- hemoglobin < 8 g/dL
- total white blood cell count < lower limit of normal (LLN)
- serum bilirubin/ alanine aminotransferase (ALT)/ aspartate aminotransferase AST > 2.5 times upper limit of normal (ULN)
- serum creatinine > 2 times ULN
- Pregnancy or lactation.
- History of drug or alcohol dependence in the past 3 years.
- Having known infection with HIV-1, active hepatitis B, or active hepatitis C. Patients who are inactive carriers of HBV or HCV can be enrolled if the subjects have stable baseline condition during the screening period.
- Use of any investigational drug or participation in any drug study within 4 weeks prior to study entry (randomization).
- Subjects unwilling or unable to comply with study procedures.
- Any clinical condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk to participate in the study or confounds the ability to interpret data from the study as judged by the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I-II, Dose-escalation, Double-blinded, Placebo-controlled, and Dose-finding Study to Evaluate the Safety and Efficacy of 2ccPA in Patients With Osteoarthritis of the Knee
This phase I/II study aims to evaluate the safety of single doses of 2ccPA 4,800 μg and 7,200 μg (Phase I), as well as the safety and efficacy of multiple doses of 2ccPA (Phase II) in patients with osteoarthritis (OA) of the knee.
Read the detailed description
Osteoarthritis (OA) is a degenerative disease frequently associated with symptoms such as inflammation, stiffness, muscle weakness, joint swollen and joint pain. 2-carba-cyclic phosphatidic acid (2ccPA) is the derivative of natural occurring phospholipid mediator, cyclic phosphatidic acid (cPA). Previous studies suggested that 2ccPA inhibits inflammation and may relieve the pain caused by osteoarthritis. This phase I/II study aims to evaluate the safety of single doses of 2ccPA 4,800 μg and7,200 μg (Phase I), as well as the safety and efficacy of multiple doses of 2ccPA (Phase II) in patients with osteoarthritis (OA) of the knee.
- Conditions
- Osteoarthritis, Knee
- Being tested
- 2ccPA, Placebo
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2ccPADrug
Also called 2-carba-cyclic phosphatidic acid
2-carba-cyclic phosphatidic acid (2ccPA) is a first-in-class phospholipase autotaxin (ATX) inhibitor that may act as a disease-modifying drug and may relieve OA associated symptoms.
Phase I: 2 dose cohorts (4800μg, 7200μg) single dose at Day 1
Phase II: 3 dose cohorts (2400μg, 4800μg, 7200μg) multiple dose at Day 1, 15, 29
PlaceboDrug
Phase I: 2 dose cohorts (4800μg, 7200μg) single dose at Day 1
Phase II: 3 dose cohorts (2400μg, 4800μg, 7200μg) multiple dose at Day 1, 15, 29
| Study group | Role | What they receive |
|---|---|---|
| 2ccPA | Experimental | IP name: 2-carba-cyclic phosphatidic acid (2ccPA) Receives: Drug: 2ccPA |
| placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To define maximum tolerated dose (MTD) following the intra-articular (IA) administration of a single ascending dose (SAD) 2ccPA in patients with osteoarthritis of the knee.
Measured: 85 Days
To evaluate the safety of 2ccPA including incidence of adverse events (AEs) and serious adverse events (SAEs).
Measured: 85 Days
To evaluate the efficacy of multiple doses of 2ccPA vs placebo in terms of changes in the Western Ontario and McMaster Universities Arthritis Index (WOMAC) on Day 85
The Western Ontario and McMaster Universities Osteoarthritis (WOMAC) is a widely-used, proprietary outcome measurement tool used to evaluate the condition of subjects with Osteoarthritis (OA) of the knee and hip, including pain (5 questions), stiffness (2 questions) and physical functioning (17 questions) of the joints. Each question is scored on a scale of 0-4, which corresponds to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4).
Measured: 85 Days
Secondary outcomes (10)
To evaluate the efficacy of 2ccPA vs placebo in terms of changes in Western Ontario and McMaster Universities Osteoarthritis (WOMAC) on Day 15, 29, 57 and 168
WOMAC questionnaire consists of 24 items divided into 3 subscales: Pain (5 items), Stiffness (2 items), Physical Function (17 items). The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
Measured: 85 Days
To evaluate the efficacy of 2ccPA vs placebo in terms of proportion of subjects with a 20% (WOMAC20), 50% (WOMAC50), and 70% (WOMAC70) improvement in the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) on Days 15, 29, 57, 85 and 168
Measured: 168 Days
To evaluate the efficacy of 2ccPA vs placebo in terms of pain assessed by Numeric Rating Scale (NRS) on Days 15, 29, 57, 85 and 168.
NRS is an 11-point numeric scale ranges from '0' indicating "no pain" to '10' indicating "extreme pain".
Measured: 168 Days
To evaluate the efficacy of 2ccPA vs placebo in terms of changes in Joint Space Narrowing (JSN) measured by x-ray on Day 168
Measured: 168 Days
Maximum plasma concentration (Cmax) of 2ccPA
Pharmacokinetic profile of 2ccPA
Measured: 168 Days
Time to maximum plasma concentration (Tmax) of 2ccPA
Pharmacokinetic profile of 2ccPA
Measured: 168 Days
Area under plasma concentration-time curve (AUC0-infinity and AUC0-t) of 2ccPA
Pharmacokinetic profile of 2ccPA
Measured: 168 Days
Apparent total body clearance (CL/F) of 2ccPA
Pharmacokinetic profile of 2ccPA
Measured: 168 Days
Apparent volume of distribution (Vz/F) of 2ccPA
Pharmacokinetic profile of 2ccPA
Measured: 168 Days
Elimination half-life (t1/2) of 2ccPA
Pharmacokinetic profile of 2ccPA
Measured: 168 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2023
- Study start3 Nov 2022
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 136 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Orient Europharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hsiang-Cheng Chen, Principal investigator, Tri-Service General Hospital (TSGH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05807529
- Sponsor's protocol ID
- OEP-2PM102-201
- Status last verified
- Mar 2024
- First submitted
- 29 Dec 2022
- Last updated
- 21 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I-II, Dose-escalation, Double-blinded, Placebo-controlled, and Dose-finding Study to Evaluate the Safety and Efficacy of 2ccPA in Patients With Osteoarthritis of the Knee
- ClinicalTrials.gov ID
- NCT05807529
- Acronym / sponsor ID
- OEP-2PM102-201
- Conditions
- Osteoarthritis, Knee
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 136 participants (estimated)
- Lead sponsor
- Orient Europharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 3 Nov 2022 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 11 Apr 2023 (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 phase I/II study aims to evaluate the safety of single doses of 2ccPA 4,800 μg and 7,200 μg (Phase I), as well as the safety and efficacy of multiple doses of 2ccPA (Phase II) in patients with osteoarthritis (OA) of the knee.
Detailed description
Osteoarthritis (OA) is a degenerative disease frequently associated with symptoms such as inflammation, stiffness, muscle weakness, joint swollen and joint pain. 2-carba-cyclic phosphatidic acid (2ccPA) is the derivative of natural occurring phospholipid mediator, cyclic phosphatidic acid (cPA). Previous studies suggested that 2ccPA inhibits inflammation and may relieve the pain caused by osteoarthritis. This phase I/II study aims to evaluate the safety of single doses of 2ccPA 4,800 μg and7,200 μg (Phase I), as well as the safety and efficacy of multiple doses of 2ccPA (Phase II) in patients with osteoarthritis (OA) of the knee.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2ccPA | Experimental | Drug: 2ccPAIP name: 2-carba-cyclic phosphatidic acid (2ccPA) |
| placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Signed written informed consent from any patient capable of giving consent.
- Male or female patients, 40 to 80 years of age.
- Documented clinical diagnosis of symptomatic OA affecting at least one knee of a minimum of 6 months prior to screening.
- The study knee has OA of Grade 2 to 3 severity based on the Kellgren Lawrence grading scale.
- A score > 6 and < 16 out of 20 on the WOMAC pain subscale for the study knee.
Key exclusion criteria (26 listed)
- Patients with known or suspected hypersensitivity to 2ccPA or any of its excipients.
- Use of intra-articular corticosteroids, hyaluronic acid, or other IA injection in the study knee within 3 months prior to study entry (randomization).
- Use of chondroitin and/or glucosamine within 4 weeks prior to study entry (randomization).
- Administered or requiring systemic or topical treatment of the study knee joint including immunosuppressive agents, anti-inflammatory drugs, steroids, or opioids for knee OA within 1 week prior to randomization. Acetaminophen (oral daily dose ≤ 3000 mg or topical use at any dose) can be taken up to 24 hours prior to randomization. For long-acting steroids (i.e., dexamethasone, betamethasone), subjects who received systemic treatment within 2 weeks before randomization will be excluded.
- History of post-traumatic knee arthritis, or evidence of intra-articular bleeding of the study knee.
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 |
|---|---|---|
| 2ccPAAlso: 2-carba-cyclic phosphatidic acid2-carba-cyclic phosphatidic acid (2ccPA) is a first-in-class phospholipase autotaxin (ATX) inhibitor that may act as a disease-modifying drug and may relieve OA associated symptoms. Phase I: 2 dose cohorts (4800μg, 7200μg) single dose at Day 1 Phase II: 3 dose cohorts (2400μg, 4800μg, 7200μg) multiple dose at Day 1, 15, 29 | Drug | 2ccPA |
| PlaceboPhase I: 2 dose cohorts (4800μg, 7200μg) single dose at Day 1 Phase II: 3 dose cohorts (2400μg, 4800μg, 7200μg) multiple dose at Day 1, 15, 29 | Drug | placebo |
Primary outcome
To define maximum tolerated dose (MTD) following the intra-articular (IA) administration of a single ascending dose (SAD) 2ccPA in patients with osteoarthritis of the knee.
Time frame: 85 Days
To evaluate the safety of 2ccPA including incidence of adverse events (AEs) and serious adverse events (SAEs).
Time frame: 85 Days
To evaluate the efficacy of multiple doses of 2ccPA vs placebo in terms of changes in the Western Ontario and McMaster Universities Arthritis Index (WOMAC) on Day 85
Time frame: 85 Days
The Western Ontario and McMaster Universities Osteoarthritis (WOMAC) is a widely-used, proprietary outcome measurement tool used to evaluate the condition of subjects with Osteoarthritis (OA) of the knee and hip, including pain (5 questions), stiffness (2 questions) and physical functioning (17 questions) of the joints. Each question is scored on a scale of 0-4, which corresponds to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4).
10 secondary outcomes
To evaluate the efficacy of 2ccPA vs placebo in terms of changes in Western Ontario and McMaster Universities Osteoarthritis (WOMAC) on Day 15, 29, 57 and 168
Time frame: 85 Days
To evaluate the efficacy of 2ccPA vs placebo in terms of proportion of subjects with a 20% (WOMAC20), 50% (WOMAC50), and 70% (WOMAC70) improvement in the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) on Days 15, 29, 57, 85 and 168
Time frame: 168 Days
To evaluate the efficacy of 2ccPA vs placebo in terms of pain assessed by Numeric Rating Scale (NRS) on Days 15, 29, 57, 85 and 168.
Time frame: 168 Days
To evaluate the efficacy of 2ccPA vs placebo in terms of changes in Joint Space Narrowing (JSN) measured by x-ray on Day 168
Time frame: 168 Days
Maximum plasma concentration (Cmax) of 2ccPA
Time frame: 168 Days
Time to maximum plasma concentration (Tmax) of 2ccPA
Time frame: 168 Days
Area under plasma concentration-time curve (AUC0-infinity and AUC0-t) of 2ccPA
Time frame: 168 Days
Apparent total body clearance (CL/F) of 2ccPA
Time frame: 168 Days
Apparent volume of distribution (Vz/F) of 2ccPA
Time frame: 168 Days
Elimination half-life (t1/2) of 2ccPA
Time frame: 168 Days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 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.
Hsiang-Cheng Chen principal investigator
Tri-Service General Hospital (TSGH)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing 2ccPA in people with Osteoarthritis, Knee, run by Orient Europharma Co., Ltd. at 1 site in Taiwan.
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 7 inclusion and 26 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: status not confirmed, as of the sponsor's last update on 21 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. 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?
Results are not available in the source record.
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?
To define maximum tolerated dose (MTD) following the intra-articular (IA) administration of a single ascending dose (SAD) 2ccPA in patients with osteoarthritis of the knee. (time frame: 85 Days). The study lists 3 primary outcomes in all. 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 21 Mar 2024; AzTrials last refreshed its copy on 7 Nov 2026.