Osteoarthritis ThumbPhase 3NCT06307847
Pivotal Study to Evaluate Efficacy and Safety of SP5M001 Inj. as Compared to Synovian Inj. in Patients With Mild to Moderate Knee Osteoarthritis
A Phase 3 study testing SP5M001 inj and Synovian inj in people with Osteoarthritis Thumb, run by Shin Poong Pharmaceutical Co. Ltd. at 14 sites in South Korea.
Trial summary
This is a randomized, double-blind, multicenter, non-inferiority, pivotal clinical trial to assess the efficacy and safety of the novel hexamethylenediamine (HMDA) cross-linked hyaluronate intra-articular injection (SP5M001) 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 Thumb
- What is being tested?
- SP5M001 inj and Synovian inj
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 223 participants
- Where
- 14 sitesSouth Korea
- Study dates
- 14 Apr 2021to 25 Oct 2022
- 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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- 5) Active or suspected knee joint infection at the time of screening
- 6) Complete loss of the Patello-femoral joint space
- 7) 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.)
- 8) Intra-articular injection, such as intra-articular corticosteroid, at the injection site within 6 months from the time of screening 9) Systemic use of steroids within 3 months from the time of screening (including inhalants, however, topical application is permitted only on the upper body) 10) Hyaluronic acid intra-articular injection administered to the injection site within 6 months from the time of screening 11) 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 10 months 12) History of artificial joint surgery on the knee joint subject for evaluation 13) Knee joint subject for evaluation diagnosed as Kellgren Lawrence grade 4 within 6 months from the time of screening 14) Moderate or severe joint effusion by Patella tap test at the screening visit 15) History of hypersensitivity to ingredients of the IP or active control drug 16) 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 17) 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
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
South Korea14 sites
Yeungnam University Medical Center
Daegu
Cheonam National University Hwasun Hospital
Hwasun
Gachon University Gil Medical Center
Incheon
Jeonbuk National University Hospital
Jeonju
Chungnam National University Hospital
Sejong
Seoul National University Bundang Hospital
Seongnam-si
Asan Medical Center
Seoul
Chung-ang University Hospital
Seoul
Kyung Hee University Hospital at Gangdong
Seoul
Kyunghee University Hospital
Seoul
Samsung Medical Center
Seoul
Seoul National University Hospital
Seoul
Soon Chun Hyang University Hospital Seoul
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, Non-Inferiority, Phase III Clinical Trial to Evaluate Efficacy and Safety of SP5M001 Inj. as Compared to Synovian Inj. in Patients With Mild to Moderate Knee Osteoarthritis
This is a randomized, double-blind, multicenter, non-inferiority, pivotal clinical trial to assess the efficacy and safety of the novel hexamethylenediamine (HMDA) cross-linked hyaluronate intra-articular injection (SP5M001) compared with an active comparator, the 1,4-butanediol diglycidyl ether (BDDE) cross-linked hyaluronate (Synovian) in patients with knee osteoarthritis.
- Conditions
- Osteoarthritis Thumb
- Being tested
- SP5M001 inj, Synovian inj
- Keywords
- osteoarthritis, Knee, Intra-articular injection, hexamethylenediamine, Cross-linked hyaluronate
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SP5M001 injDrug
pre-filled syringe
Synovian injDrug
pre-filled syringe
| Study group | Role | What they receive |
|---|---|---|
| SP5M001 inj | Experimental | SP5M001 inj 5 ml pre-filled syringe into Knee joint cavity of osteoarthritis patients Receives: Drug: SP5M001 inj |
| Synovian inj | Active comparator | Synovian inj 3 ml pre-filled syringe into Knee joint cavity of osteoarthritis patients Receives: Drug: 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: week 12
Secondary outcomes (12)
Changes in the following at each visit : Weight Bearing pain(WBP) (Weeks 2, 6, 24, and 36) from baseline (Visit 2)
Outcome Measurement of Weight Bearing pain(WBP): 100mm-visual analogue scale (VAS)
Measured: week 2, 6, 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: 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 posted13 Mar 2024
- Study start14 Apr 2021
- Primary completion25 Oct 2022
- Study completion25 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis ThumbStudies 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
- 223 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
- NCT06307847
- Sponsor's protocol ID
- SP-HA-003
- Status last verified
- Feb 2024
- First submitted
- 13 Feb 2024
- Last updated
- 13 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kim KI, In Y, Choi HS, Lee JH, Sim JA, Lee HJ, Moon YW, Shon OJ, Seon JK, Kim YM, Song SJ, Chang CB, Han HS. A Multicentre, Double-Blind, Randomised, Non-Inferiority Trial of a Novel Single-Injection Intra-Articular HMDA-Cross-Linked Hyaluronate Gel for Knee Osteoarthritis. J Clin Med. 2025 Jun 19;14(12):4384. doi: 10.3390/jcm14124384.
PubMed 40566128
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Double-Blinded, Active Controlled, Non-Inferiority, Phase III Clinical Trial to Evaluate Efficacy and Safety of SP5M001 Inj. as Compared to Synovian Inj. in Patients With Mild to Moderate Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT06307847
- Acronym / sponsor ID
- SP-HA-003
- Conditions
- Osteoarthritis Thumb
- Keywords
- osteoarthritis, Knee, Intra-articular injection, hexamethylenediamine, Cross-linked hyaluronate
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 223 participants (actual)
- Lead sponsor
- Shin Poong Pharmaceutical Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 14 Apr 2021 (actual)
- Primary completion
- 25 Oct 2022 (actual)
- Study completion
- 25 Oct 2022 (actual)
- First posted
- 13 Mar 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, non-inferiority, pivotal clinical trial to assess the efficacy and safety of the novel hexamethylenediamine (HMDA) cross-linked hyaluronate intra-articular injection (SP5M001) 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 |
|---|---|---|
| SP5M001 inj | Experimental | Drug: SP5M001 injSP5M001 inj 5 ml pre-filled syringe into Knee joint cavity of osteoarthritis patients |
| Synovian inj | Active comparator | Drug: 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 (15 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
- 8) Intra-articular injection, such as intra-articular corticosteroid, at the injection site within 6 months from the time of screening 9) Systemic use of steroids within 3 months from the time of screening (including inhalants, however, topical application is permitted only on the upper body) 10) Hyaluronic acid intra-articular injection administered to the injection site within 6 months from the time of screening 11) 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 10 months 12) History of artificial joint surgery on the knee joint subject for evaluation 13) Knee joint subject for evaluation diagnosed as Kellgren Lawrence grade 4 within 6 months from the time of screening 14) Moderate or severe joint effusion by Patella tap test at the screening visit 15) History of hypersensitivity to ingredients of the IP or active control drug 16) 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 17) 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
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 |
|---|---|---|
| SP5M001 injpre-filled syringe | Drug | SP5M001 inj |
| Synovian injpre-filled syringe | Drug | Synovian inj |
Primary outcome
Change in [Weight-Bearing Pain (WBP)-100mm-visual analogue scale (VAS)] at Week 12 from baseline (visit 2)
Time frame: week 12
* 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, 6, 24, and 36) from baseline (Visit 2)
Time frame: week 2, 6, 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
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 13 Mar 2024.
- Derived from this study: PubMed 40566128Kim KI, In Y, Choi HS, Lee JH, Sim JA, Lee HJ, Moon YW, Shon OJ, Seon JK, Kim YM, Song SJ, Chang CB, Han HS. A Multicentre, Double-Blind, Randomised, Non-Inferiority Trial of a Novel Single-Injection Intra-Articular HMDA-Cross-Linked Hyaluronate Gel for Knee Osteoarthritis. J Clin Med. 2025 Jun 19;14(12):4384. doi: 10.3390/jcm14124384.
- 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.
14 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 SP5M001 inj and Synovian inj in people with Osteoarthritis Thumb, run by Shin Poong Pharmaceutical Co. Ltd. at 14 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 15 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 13 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 14 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?
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?
Change in [Weight-Bearing Pain (WBP)-100mm-visual analogue scale (VAS)] at Week 12 from baseline (visit 2) (time frame: 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 NCT06307847, 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 13 Mar 2024.