OsteoarthritisPhase 3NCT06399042
Pivotal Study to Evaluate Efficacy and Safety of SP5M002 Inj. as Compared to Synovian Inj. in Patients With Mild to Moderate Knee Osteoarthritis
A Phase 3 study testing SP5M002 inj and Synovian inj in people with Osteoarthritis, run by Shin Poong Pharmaceutical Co. Ltd. at 16 sites in South Korea.
Trial summary
This is a randomized, double-blind, multicenter, Active Controlled, pivotal clinical trial to assess the efficacy and safety of the novel hexamethylenediamine (HMDA) cross-linked hyaluronate intra-articular injection (SP5M002) compared with an active comparator, the 1,4-butanediol diglycidyl ether (BDDE) cross-linked… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- SP5M002 inj and Synovian inj
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 297 participants
- Where
- 16 sitesSouth Korea
- Study dates
- 14 Jun 2023to Sep 2024
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult males and females aged 40 years or older as of the date of written consent
- Subject with knee osteoarthritis whose X-ray test results within 6 months from the screening or at the screening visit correspond to grades I - III of the Kellgren \& Lawrence scale
- Subject diagnosed with unilateral or bilateral knee osteoarthritis according to the clinical diagnostic criteria of the American College of Rheumatology (ACR) at screening who have knee joint pain and meet three or more of the following conditions
- Over 50 years of age
- Less than 30 minutes of morning stiffness ③ Crepitus on active motion ④ Bony tenderness ⑤ Bony enlargement ⑥ No palpable warmth of synovium
- Weight bearing pain (WBP) of at least one of both knee joints on 100 mm-VAS ≥ 40 mm when measured at screening and baseline [However, if both sides have symptoms, the knee joint with the higher WBP becomes the joint for evaluation, and the selected joint cannot be changed during the study period.]
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- Walk without relying on a walking aid such as a walker or cane (patients who have been using a walking aid every day since 6 months prior to the screening visit can use the walking aid, and must use the walking aid in the same way throughout the study period.)
- Ability to fully understand and complete the safety and efficacy measurement questionnaire
- Voluntary decision for participation and provision of written consent to comply with the precautions after hearing and fully understanding the detailed explanation of the purpose, method, and effects of this study
Who cannot join
- Body mass index (BMI) ≥ 35 kg/m2 at screening
- Hip osteoarthritis or osteoarthritis of another joint that is severe enough to preclude evaluation of knee osteoarthritis at the time of screening
- Having the following diseases that may affect the efficacy and safety evaluation but not being limited to the following
- Septic arthritis, rheumatoid arthritis, gout, recurrent pseudogout arthritis, trauma that may damage joint cartilage, congenital abnormalities, calcium deposition disease, diabetes, ochronosis, hemochromatosis, acromegaly, Wilson's disease, primary osteochondrosis, genetic diseases (e.g., hyperkinesis), secondary osteoarthritis caused by collagen gene abnormalities, etc.
- Sudek's atrophy or severe painful diseases such as Paget's disease
- Infection or skin disease in the joint area that is unsuitable for injection at the time of screening
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- Active or suspected knee joint infection at the time of screening
- Complete loss of the Patello-femoral joint space
- Received the following treatments within 14 days of the screening visit (except those who have passed a 14-day wash-out) or scheduled to be administered during the study period
- Taking medicines containing ingredients such as glucosamine, chondroitin sulfate, and diacerhein
- Taking herbal medicines and herbal medicines for osteoarthritis
- Taking anti-inflammatory painkillers, non-steroidal anti-inflammatory drugs (NSAIDs, prescription/non-prescription drugs), etc. (administration of acetaminophen allowed if passing a 3 day wash-out)
- Taking oral steroids
- Hospital physical therapy or oriental medicine treatment (cupping, acupuncture, moxibustion, etc.)
- Intra-articular injection, such as intra-articular corticosteroid, at the injection site within 6 months from the time of screening
- Systemic use of steroids within 3 months from the time of screening (including inhalants, however, topical application is permitted only on the upper body)
- Surgical operations such as knee joint replacement, including arthroscopic surgery, at the administration site within 6 months from the time of screening; or expecting surgery within 6 months
- Moderate or severe joint effusion by Patella tap test at the screening visit
- History of hypersensitivity to ingredients of the IP or active control drug
- Antiplatelet agents (excluding aspirin of 300 mg/day or less), heparin, oral anticoagulants (coumarin anticoagulants, thrombin inhibitors, Factor Xa inhibitors, etc.), and thrombolytics must be used during the study
- Clinically significant abnormalities in liver function (3 times or more than the upper limit of normal for ALT/AST) or abnormalities in renal function (3 times or more than the upper limit of normal for serum creatinine), or severe liver or renal disease at the discretion of the investigator which is judged to have an impact on the effectiveness and safety evaluation of the study
- The following clinically significant diseases in the past or present
- Diagnosis of malignancy within 5 years prior to screening or currently
- Cardiac disorders (myocardial infarction, coronary artery bypass surgery, arrhythmia, and other serious Cardiac disorders, etc.)
- Uncontrolled hypertension (systolic blood pressure greater than 160 mmHg or diastolic blood pressure greater than 100 mmHg)
- Severe endocrine diseases (diabetes insipidus, Cushing's disease, etc.) which is judged to have an impact on the efficacy and safety evaluation of the study
- Currently pregnant or lactating; or planning to become pregnant/lactating during this study
- Women of childbearing age who have not undergone sterilization surgery, women less than 1 year after menopause, or men who do not agree to avoid pregnancy or use appropriate contraceptive methods during the study period
- Planned to participate in another study during the study period or having administered (applied) other investigational product (investigational device) within 3 months prior to the screening visit
- Difficult to conduct the study as judged by the investigator due to other reasons
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
South Korea16 sites
Kyungpook National University Hospital
Daegu
Yeungnam University Medical Center
Daegu
Chonnam National University Bitgoeul Hospital
Gwangju
Gachon University Gil Medical Center
Incheon
Jeonbuk National University Hospital
Jeonju
Gyeongsang National University Hospital
Jinju
Chungnam National University Hospital
Sejong
CHA University Bundang Medical Center
Seongnam
EWHA Womans University Mokdong Hospital
Seoul
Gangnam Severance Hospita
Seoul
Kyung Hee University Hospital at Gangdong
Seoul
Kyunghee University Hospital
Seoul
Samsung Medical Center
Seoul
Seoul National University Boramae Medical Center
Seoul
Seoul National University Hospital
Seoul
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul
About this study
Official title: A Multi-center, Randomized, Double-Blinded, Active Controlled, Phase III Study to Evaluate Efficacy and Safety of SP5M002 Injection Compared With Synovian Injection in Patients With Mild to Moderate Knee Osteoarthritis
This is a randomized, double-blind, multicenter, Active Controlled, pivotal clinical trial to assess the efficacy and safety of the novel hexamethylenediamine (HMDA) cross-linked hyaluronate intra-articular injection (SP5M002) compared with an active comparator, the 1,4-butanediol diglycidyl ether (BDDE) cross-linked hyaluronate (Synovian) in patients with knee osteoarthritis.
- Conditions
- Osteoarthritis
- Being tested
- SP5M002 inj, Synovian inj
- Keywords
- Knee osteoarthritis, Intra-articular injection, hexamethylenediamine(HMDA), Cross-linked hyaluronate
- Medical subject headings
- Osteoarthritis, Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SP5M002 injDevice
pre-filled syringe
Synovian injDevice
pre-filled syringe
| Study group | Role | What they receive |
|---|---|---|
| SP5M002 inj | Experimental | SP5M002 inj 3 ml pre-filled syringe into Knee joint cavity of osteoarthritis patients Receives: Device: SP5M002 inj |
| Synovian inj | Active comparator | Synovian inj 3 ml pre-filled syringe into Knee joint cavity of osteoarthritis patients Receives: Device: Synovian inj |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in [Weight-Bearing Pain (WBP)-100mm-visual analogue scale (VAS)] at Week 12 from baseline (visit 2)
- Weight Bearing Pain (WBP) - 100mm-visual analogue scale (VAS)
Measured: 12 weeks
Change in [Weight-Bearing Pain (WBP)-100mm-visual analogue scale (VAS)] at Week 6 from baseline (visit 2)
- Weight Bearing Pain (WBP) - 100mm-visual analogue scale (VAS)
Measured: 6 weeks
Secondary outcomes (12)
Changes in the following at each visit: Weight Bearing pain (WBP) (Weeks 2, 24, and 36) from baseline (Visit 2)
Outcome Measurement of Weight Bearing pain(WBP): 100mm-visual analogue scale (VAS)
Measured: week 2, 24, 36
Changes in the following at each visit: Rest pain (RP) (Weeks 2, 6, 12, 24, and 36) from baseline (Visit 2)
Outcome Measurement of Rest pain (RP): 100mm-visual analogue scale (VAS)
Measured: week 2,6,12, 24, 36
Changes in the following at each visit: Night pain (NP) (Weeks 2, 6, 12, 24, and 36) from baseline (Visit 2)
Outcome Measurement of Night pain (NP): 100mm-visual analogue scale (VAS)
Measured: week 2,6,12, 24, 36
Changes in the following at each visit: Motion pain (MP) (Weeks 2, 6, 12, 24, and 36) from baseline (Visit 2)
Outcome Measurement of Motion pain (MP): 100mm-visual analogue scale (VAS)
Measured: week 2,6,12, 24, 36
Changes in the following at each visit: Patient Global Assessment(PGA) (Weeks 2, 6, 12, 24, and 36) from baseline (Visit 2)
Outcome Measurement of Patient Global Assessment(PGA): 100mm-visual analogue scale (VAS)
Measured: week 2,6,12, 24, 36
Changes in the following at each visit: Investigator Global Assessment (IGA) (Weeks 2, 6, 12, 24, and 36) from baseline (Visit 2)
Outcome Measurement of Investigator Global Assessment (IGA) : 100mm-visual analogue scale (VAS)
Measured: week 2,6,12, 24, 36
Changes in the following at each visit: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score and individual score evaluation (Pain, function, stiffness) (Weeks 2, 6, 12, 24, and 36) from baseline (Visit 2)
Outcome Measurement of Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score and individual score evaluation (Pain, function, stiffness) : WOMAC-Likert Assessment (5-point Likert scale)
Measured: week 2,6,12, 24, 36
Physical assessments at each post-administration visit: Swelling (Weeks 2, 6, 12, 24, and 36)
Outcome Measurement of Swelling : 4-point scale
*4-point scale: 0(none)/1(mild)/2(moderate)/3(severe)
Measured: week 2,6,12, 24, 36
Physical assessments at each post-administration visit: joint-line tenderness on pressure (Weeks 2, 6, 12, 24, and 36)
Outcome Measurement of joint-line tenderness on pressure : 4-point scale
*4-point scale: 0(none)/1(mild)/2(moderate)/3(severe)
Measured: week 2,6,12, 24, 36
Physical assessments at each post-administration visit: range of motion (Weeks 2, 6, 12, 24, and 36)
The angle was recorded as is for the range of motion.
Measured: week 2,6,12, 24, 36
Proportion (%) of participants who took rescue medication at each post-administration visit and dose of rescue medication (Weeks 2, 6, 12, 24, and 36)
Measured: week 2,6,12, 24, 36
Post-administration response rate A. Proportion at which WBP decreases by at least 20 mm or improves by at least 40% from baseline at the time of evaluation (B section-Description)
*B. Response rate of OMERACT-OARSI (Outcome Measures in Rheumatology-Osteoarthritis Research Society International) I. At least 50% improvement in WOMAC pain or function at the time of evaluation; or at least a 20 point improvement from baseline; or II. meeting 2 of the 3 conditions below
At least 20% improvement in WOMAC pain, at least a 10 point improvement from each baseline At least 20% improvement in WOMAC function, at least a 10 point improvement from each baseline At least 20% improvement in patient's global assessment (100 mm-VAS) and at least a 10 point improvement from each baseline
Measured: week 2,6,12, 24, 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2024
- Study start14 Jun 2023
- Primary completionJun 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 297 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shin Poong Pharmaceutical Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06399042
- Sponsor's protocol ID
- SP-HA-003-1
- Status last verified
- Apr 2024
- First submitted
- 30 Apr 2024
- Last updated
- 3 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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 Multi-center, Randomized, Double-Blinded, Active Controlled, Phase III Study to Evaluate Efficacy and Safety of SP5M002 Injection Compared With Synovian Injection in Patients With Mild to Moderate Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT06399042
- Acronym / sponsor ID
- SP-HA-003-1
- Conditions
- Osteoarthritis
- Keywords
- Knee osteoarthritis, Intra-articular injection, hexamethylenediamine(HMDA), Cross-linked hyaluronate
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 297 participants (actual)
- Lead sponsor
- Shin Poong Pharmaceutical Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 14 Jun 2023 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 3 May 2024 (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 is a randomized, double-blind, multicenter, Active Controlled, pivotal clinical trial to assess the efficacy and safety of the novel hexamethylenediamine (HMDA) cross-linked hyaluronate intra-articular injection (SP5M002) compared with an active comparator, the 1,4-butanediol diglycidyl ether (BDDE) cross-linked hyaluronate (Synovian) in patients with knee osteoarthritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SP5M002 inj | Experimental | Device: SP5M002 injSP5M002 inj 3 ml pre-filled syringe into Knee joint cavity of osteoarthritis patients |
| Synovian inj | Active comparator | Device: Synovian injSynovian inj 3 ml pre-filled syringe into Knee joint cavity of osteoarthritis patients |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Adult males and females aged 40 years or older as of the date of written consent
- Subject with knee osteoarthritis whose X-ray test results within 6 months from the screening or at the screening visit correspond to grades I - III of the Kellgren \& Lawrence scale
- Subject diagnosed with unilateral or bilateral knee osteoarthritis according to the clinical diagnostic criteria of the American College of Rheumatology (ACR) at screening who have knee joint pain and meet three or more of the following conditions
- Weight bearing pain (WBP) of at least one of both knee joints on 100 mm-VAS ≥ 40 mm when measured at screening and baseline [However, if both sides have symptoms, the knee joint with the higher WBP becomes the joint for evaluation, and the selected joint cannot be changed during the study period.]
- Walk without relying on a walking aid such as a walker or cane (patients who have been using a walking aid every day since 6 months prior to the screening visit can use the walking aid, and must use the walking aid in the same way throughout the study period.)
Key exclusion criteria (30 listed)
- Body mass index (BMI) ≥ 35 kg/m2 at screening
- Hip osteoarthritis or osteoarthritis of another joint that is severe enough to preclude evaluation of knee osteoarthritis at the time of screening
- Having the following diseases that may affect the efficacy and safety evaluation but not being limited to the following
- Infection or skin disease in the joint area that is unsuitable for injection at the time of screening
- Active or suspected knee joint infection at the time of screening
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 |
|---|---|---|
| SP5M002 injpre-filled syringe | Device | SP5M002 inj |
| Synovian injpre-filled syringe | Device | Synovian inj |
Primary outcome
Change in [Weight-Bearing Pain (WBP)-100mm-visual analogue scale (VAS)] at Week 12 from baseline (visit 2)
Time frame: 12 weeks
* Weight Bearing Pain (WBP) - 100mm-visual analogue scale (VAS)
Change in [Weight-Bearing Pain (WBP)-100mm-visual analogue scale (VAS)] at Week 6 from baseline (visit 2)
Time frame: 6 weeks
* Weight Bearing Pain (WBP) - 100mm-visual analogue scale (VAS)
12 secondary outcomes
Changes in the following at each visit: Weight Bearing pain (WBP) (Weeks 2, 24, and 36) from baseline (Visit 2)
Time frame: week 2, 24, 36
Changes in the following at each visit: Rest pain (RP) (Weeks 2, 6, 12, 24, and 36) from baseline (Visit 2)
Time frame: week 2,6,12, 24, 36
Changes in the following at each visit: Night pain (NP) (Weeks 2, 6, 12, 24, and 36) from baseline (Visit 2)
Time frame: week 2,6,12, 24, 36
Changes in the following at each visit: Motion pain (MP) (Weeks 2, 6, 12, 24, and 36) from baseline (Visit 2)
Time frame: week 2,6,12, 24, 36
Changes in the following at each visit: Patient Global Assessment(PGA) (Weeks 2, 6, 12, 24, and 36) from baseline (Visit 2)
Time frame: week 2,6,12, 24, 36
Changes in the following at each visit: Investigator Global Assessment (IGA) (Weeks 2, 6, 12, 24, and 36) from baseline (Visit 2)
Time frame: week 2,6,12, 24, 36
Changes in the following at each visit: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score and individual score evaluation (Pain, function, stiffness) (Weeks 2, 6, 12, 24, and 36) from baseline (Visit 2)
Time frame: week 2,6,12, 24, 36
Physical assessments at each post-administration visit: Swelling (Weeks 2, 6, 12, 24, and 36)
Time frame: week 2,6,12, 24, 36
Physical assessments at each post-administration visit: joint-line tenderness on pressure (Weeks 2, 6, 12, 24, and 36)
Time frame: week 2,6,12, 24, 36
Physical assessments at each post-administration visit: range of motion (Weeks 2, 6, 12, 24, and 36)
Time frame: week 2,6,12, 24, 36
Proportion (%) of participants who took rescue medication at each post-administration visit and dose of rescue medication (Weeks 2, 6, 12, 24, and 36)
Time frame: week 2,6,12, 24, 36
Post-administration response rate A. Proportion at which WBP decreases by at least 20 mm or improves by at least 40% from baseline at the time of evaluation (B section-Description)
Time frame: week 2,6,12, 24, 36
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SP5M002 inj and Synovian inj in people with Osteoarthritis, run by Shin Poong Pharmaceutical Co. Ltd. at 16 sites in South Korea.
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 9 inclusion and 30 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 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 16 sites in 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Change in [Weight-Bearing Pain (WBP)-100mm-visual analogue scale (VAS)] at Week 12 from baseline (visit 2) (time frame: 12 weeks). The study lists 2 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 3 May 2024; AzTrials last refreshed its copy on 8 Nov 2026.