Knee OsteoarthritisPhase 3NCT07047196
Evaluating the Efficacy and Safety of Intra-articular Injection of HS-20116 in Patients With Knee Osteoarthritis
A Phase 3 study testing HS-20116 and Medical Chitosan (for intra-articular injection) in people with Knee Osteoarthritis, run by Jiangsu Hansoh Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
The purpose of this trial is to evaluate the efficacy and safety of HS-20116 for intra-articular use in patients with symptomatic knee osteoarthritis. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- HS-20116 and Medical Chitosan (for intra-articular injection)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 1 siteChina
- Study dates
- 13 Aug 2024to 27 Apr 2025
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females aged 40-85 years (inclusive);
- Body mass index (BMI) ≤ 35 kg/m2;
- Primary knee osteoarthritis in accordance with the clinical and radiological diagnostic criteria of the American College of Rheumatology (ACR), unilateral or bilateral femorotibial arthritis, with or without patellofemoral arthritis;
- A radiographic Kellgren and Lawrence (K\&L) grade of II to III in the treated knee within 6 months prior to randomization;
- Recurrent knee pain for at least 6 months at screening, with no or poor response to the first-line oral non-opioid analgesics and non-steroidal anti-inflammatory drugs (NSAIDS);
- After a washout period of 48 h for analgesics, the degree of pain before bilateral knee injection was assessed using the WOMAC pain score (5-grade Likert method) prior to randomization, which should meet the following criteria:
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- Treated knee: WOMAC pain score of 7-17, of which item A1 was at least 2;
- Non-treated knee: WOMAC pain score of no more than 6.
- Completely free to move;
- Willing to undergo a 48-h analgesic washout period prior to visit;
Who cannot join
- Concomitant synovial chondromatosis and villonodular synovitis of the knee;
- Patellofemoral osteoarthritis only, where symptoms including pain mostly originated from the patellofemoral joint (patellofemoral pain syndrome);
- Onset of clinically significant knee effusion, knee inflammation or associated symptoms, or abnormal gross examination or volume of synovial fluid at the time of joint aspiration on the day of injection;
- Obvious varus or valgus deformity of the treated knee after clinical evaluation or imaging evaluation as judged by the investigator;
- Concomitant autoimmune diseases, autoinflammatory diseases, or infectious arthritis, such as rheumatoid arthritis, psoriatic arthritis, articular chondrocalcinosis, gout, ankylosing spondylitis, and lupus erythematosus;
- Other concomitant pathological changes affecting joint treatment/evaluation, such as arthrodysplasia, ipsilateral hip osteoarthritis, aseptic bone necrosis, acromegaly, Paget's disease, hemophilia, hemochromatosis, lumbosacral radicular pain, femoral nerve or sciatic nerve radicular pain, venous or lymphatic obstruction, arteritis, tendon disorder, etc.;
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- Skin infection, skin lesions, or chronic dermatosis at the puncture site;
- Any knee injury, surgical history, or arthroscopy and treatment within 6 months prior to screening; or any surgery or other invasive operation expected to be performed during the trial;
- Prior injection with hyaluronic acid into the treated knee within 6 months prior to randomization.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Single-Blind, Active-controlled, Multicenter Clinical Study Evaluating the Efficacy and Safety of Intra-articular Injection of HS-20116 in Patients With Knee Osteoarthritis
The purpose of this trial is to evaluate the efficacy and safety of HS-20116 for intra-articular use in patients with symptomatic knee osteoarthritis.
Read the detailed description
This is a prospective, randomized, single-blind, active-controlled, multicenter clinical study to evaluate the efficacy and safety of intra-articular injection of HS-20116 in patients with knee osteoarthritis. Eligible subjects after screening will be randomized in a 1:1 ratio into the test group and the control group. Test group subjects will receive a single intra-articular injection of HS-20116 (3 mL) into the treated knee on Day 0. Control group subjects will receive 2-3 intra-articular injections of chitosan (2-3 mL each) on Day 0 and Day 14, with an optional injection on Day 28. The primary endpoint is the change from baseline in WOMAC pain score at Week 12 after the first injection. Each subject may choose to participate in an optional long-term follow-up visit between Weeks 22 and 28.
- Conditions
- Knee Osteoarthritis
- Being tested
- HS-20116, Medical Chitosan (for intra-articular injection)
- Keywords
- Knee osteoarthritis,Hansoh, Chitosan Solution for Intra-Articular Use
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HS-20116Device
Innovative chitosan-based biomaterial intended for intra-articular injection
Medical Chitosan (for intra-articular injection)Device
Medical chitosan for intra-articular injection
| Study group | Role | What they receive |
|---|---|---|
| HS-20116 | Experimental | HS-20116 administered as a single intra-articular injection (3 mL per dose) Receives: Device: HS-20116 |
| Medical Chitosan (for intra-articular injection) | Active comparator | Medical Chitosan administered as 2-3 intra-articular injections (2-3 mL per dose) in total. Receives: Device: Medical Chitosan (for intra-articular injection) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score
Change from baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score at Week 12 after the first injection.
Measured: 12 weeks after the first injection.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2025
- Study start13 Aug 2024
- Primary completion26 Feb 2025
- Study completion27 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Jiangsu Hansoh Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Liu Fan, Principal investigator, Affiliated Hospital of Nantong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07047196
- Sponsor's protocol ID
- HS-20116-301
- Status last verified
- Jul 2025
- First submitted
- 24 Jun 2025
- Last updated
- 9 Jul 2025
- Results posted
- No
- Data monitoring committee
- 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 9 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Single-Blind, Active-controlled, Multicenter Clinical Study Evaluating the Efficacy and Safety of Intra-articular Injection of HS-20116 in Patients With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT07047196
- Acronym / sponsor ID
- HS-20116-301
- Conditions
- Knee Osteoarthritis
- Keywords
- Knee osteoarthritis,Hansoh, Chitosan Solution for Intra-Articular Use
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 13 Aug 2024 (actual)
- Primary completion
- 26 Feb 2025 (actual)
- Study completion
- 27 Apr 2025 (actual)
- First posted
- 2 Jul 2025 (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.
The purpose of this trial is to evaluate the efficacy and safety of HS-20116 for intra-articular use in patients with symptomatic knee osteoarthritis.
Detailed description
This is a prospective, randomized, single-blind, active-controlled, multicenter clinical study to evaluate the efficacy and safety of intra-articular injection of HS-20116 in patients with knee osteoarthritis. Eligible subjects after screening will be randomized in a 1:1 ratio into the test group and the control group. Test group subjects will receive a single intra-articular injection of HS-20116 (3 mL) into the treated knee on Day 0. Control group subjects will receive 2-3 intra-articular injections of chitosan (2-3 mL each) on Day 0 and Day 14, with an optional injection on Day 28. The primary endpoint is the change from baseline in WOMAC pain score at Week 12 after the first injection. Each subject may choose to participate in an optional long-term follow-up visit between Weeks 22 and 28.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HS-20116 | Experimental | Device: HS-20116HS-20116 administered as a single intra-articular injection (3 mL per dose) |
| Medical Chitosan (for intra-articular injection) | Active comparator | Device: Medical Chitosan (for intra-articular injection)Medical Chitosan administered as 2-3 intra-articular injections (2-3 mL per dose) in total. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Males or females aged 40-85 years (inclusive);
- Body mass index (BMI) ≤ 35 kg/m2;
- Primary knee osteoarthritis in accordance with the clinical and radiological diagnostic criteria of the American College of Rheumatology (ACR), unilateral or bilateral femorotibial arthritis, with or without patellofemoral arthritis;
- A radiographic Kellgren and Lawrence (K\&L) grade of II to III in the treated knee within 6 months prior to randomization;
- Recurrent knee pain for at least 6 months at screening, with no or poor response to the first-line oral non-opioid analgesics and non-steroidal anti-inflammatory drugs (NSAIDS);
Key exclusion criteria (9 listed)
- Concomitant synovial chondromatosis and villonodular synovitis of the knee;
- Patellofemoral osteoarthritis only, where symptoms including pain mostly originated from the patellofemoral joint (patellofemoral pain syndrome);
- Onset of clinically significant knee effusion, knee inflammation or associated symptoms, or abnormal gross examination or volume of synovial fluid at the time of joint aspiration on the day of injection;
- Obvious varus or valgus deformity of the treated knee after clinical evaluation or imaging evaluation as judged by the investigator;
- Concomitant autoimmune diseases, autoinflammatory diseases, or infectious arthritis, such as rheumatoid arthritis, psoriatic arthritis, articular chondrocalcinosis, gout, ankylosing spondylitis, and lupus erythematosus;
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 |
|---|---|---|
| HS-20116Innovative chitosan-based biomaterial intended for intra-articular injection | Device | HS-20116 |
| Medical Chitosan (for intra-articular injection)Medical chitosan for intra-articular injection | Device | Medical Chitosan (for intra-articular injection) |
Primary outcome
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score
Time frame: 12 weeks after the first injection.
Change from baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score at Week 12 after the first injection.
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 9 Jul 2025.
- 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.
Liu Fan principal investigator
Affiliated Hospital of Nantong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing HS-20116 and Medical Chitosan (for intra-articular injection) in people with Knee Osteoarthritis, run by Jiangsu Hansoh Pharmaceutical Co., Ltd. at 1 site in China.
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 10 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 9 Jul 2025. 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 China. 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?
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score (time frame: 12 weeks after the first injection.). 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 9 Jul 2025.