Mild Knee OsteoarthritisNCT07746843
The Efficacy and Safety Study of 2107 Injection in Subjects With Mild to Moderate Knee Osteoarthritis
A study testing 2107 Injection and DUROLANE® in people with Mild Knee Osteoarthritis and Moderate Knee Osteoarthritis, run by BioRegen Biomedical (Changzhou) Co., Ltd at 3 sites in 3 countries.
Trial summary
This will be a 26-week, prospective, international, multi-center, randomized, active-controlled, double-blinded (to subject and Investigator) study in subjects with mild to moderate OA in the knees to assess safety and efficacy of 2107 Injection following a single intra-articular injection as compared to DUROLANE®… Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Mild Knee Osteoarthritis, Moderate Knee Osteoarthritis
- What is being tested?
- 2107 Injection and DUROLANE®
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 286 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 1 Sep 2026to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- 1)Male or female outpatients 40-80 (inclusive) years of age. 2) Documented diagnosis of knee OA confirmed according to the American College of Rheumatology (ACR) criteria7 with symptoms for at least six (6) months.
- 3) Diagnosed with mild to moderate OA based on radiographs (Kellgren-Lawrence scale Grade II-III) taken within 12 months prior to entering the study. The rating of the alternative knee (Kellgren-Lawrence scale) should be no higher than that of the target knee.
- 4) Subjects could have OA in both knees, but the target knee for treatment should have an average total pain score of 40-80 mm (of the five [5] pain questions) and the walking pain question score of 40 60 mm on WOMAC Pain sub-score using a 100-mm VAS. The pain scores of the alternative knee should not be higher than that of the target knee (a higher-pain-score side of knee is defined as the target knee even if it has a lower Kellgren-Lawrence scale Grade).
- 5) Constant (daily) pain symptoms despite conservative care (e.g., physical therapy, analgesics) > two (2) weeks.
- 6) Agree to discontinue all analgesic therapies for at least 72 hours or four (4) to five (5) half-lives of the analgesics, whichever is longer.
- 7) Subject voluntarily agrees to sign the informed consent form (ICF). 8) Subject is self-conscious and able to read and write.
Who cannot join
- Subjects who meet any of the following criteria are not eligible for this clinical investigation:
- Diagnosed with rheumatoid arthritis, another inflammatory metabolic arthritis (gout), or any other diseases that affects joints (e.g., rheumatoid arthritis, metastatic bone diseases, psoriatic arthritis, gouty arthritis, symptomatic cartilaginous calcification, osteonecrosis or active infections).
- History of hypersensitivity to HA.
- Infection in the target knee, or skin ulceration or infection of the injection site, or chronic skin diseases that may affect manipulation of injection and/or assessment of the injection site, or localized skin disease at the site to be injected.
- History of clinically apparent tense effusion of the target knee.
- Chronic pain anywhere requiring analgesic therapy that would confound the measurement of pain in the target knee.
Show all 41Show fewer
- Received a corticosteroid injection within 12 weeks or oral corticosteroids within six (6) weeks prior to screening.
- Any intra-articular injection(s) within 36 weeks prior to screening or glucosamine-chondroitin within the past three (3) months prior to baseline.
- Took any of the following medications within seven (7) days prior to screening. Unless noted, these medications are prohibited in oral, injectable and suppository forms, but they can be used in inhaled, nasal or ophthalmic formulations. Topical administration is permitted except for the lower extremity of the ipsilateral side of the target knee:
- NSAIDs
- Medicines for neuropathic pain (pregabalin, gabapentin)
- Topical capsaicins
- Duloxetine (serotonin-norepinephrin reuptake inhibitors)
- Local anesthesia to either knee (local anesthesia to target knee during injection procedure is permitted)
- Anticonvulsant drugs, any type of medicine with analgesic properties
- Opioids
- Anti-depressants, anti-anxiety, anti-psychotic, mood stabilizers and sleeping drugs
- Documented history of serious injuries to the target knee restricting ambulation.
- Therapeutic arthroscopy and/or other surgical procedures within 12 months prior to screening (diagnostic arthroscopy ≥60 days prior to screening is allowed).
- Had a knee replacement.
- History of chondrocalcinosis, depression, or a sleep disorder.
- Had a body mass index (BMI) ≥39 kg/m2.
- Any other condition that could affect the outcome assessment.
- Clinically apparent tense effusion of the target knee on examination determined by either a positive bulge sign or positive ballottement of the patella (patellar tap).
- Unable to walk (walking aid is allowed to continue to use during the trial period, if its usage began ≥12 weeks prior to the enrollment check-up).
- Coxitis.
- Metastatic malignant tumor or received treatments for a metastatic malignant tumor within five (5) years prior to the enrollment check up, except for skin cancers other than melanoma.
- Valgus/varus deformities, ligament laxities, or meniscus instabilities;
- Combined chronic pain diseases with VAS ≥40 mm, peripheral or central neural diseases that possibly alter sensations of the target knee areas, including but not limited to back pain, hip pain, disk herniation, neuralgia, diabetic neuropathy, post-stroke pain or fibromyalgia.
- Lung diseases such as asthma and chronic obstructive pulmonary disease (COPD) that require the usages of systematic or inhaled corticosteroids during the trial period.
- Venostasis or lymphostasis of the lower extremities.
- Lymph or peripheral vascular diseases.
- Currently receiving oral or parenteral anticoagulation treatments, or receiving aspirin antiplatelet aggregation treatments; a low dose treatment of acetylsalicylic acid (Aspirin) will be considered acceptable at the discretion of the Principal Investigator (PI).
- Severe diseases such as myocardial infarction, congestive heart failure, unstable angina, cerebrovascular diseases, and severe renal insufficiency.
- Severe hepatic disease or history of severe hepatic disease.
- Positive for human immunodeficiency virus (HIV), hepatitis B virus or hepatitis C virus. Patients with serologic evidence of hepatitis B vaccination (hepatitis B surface antibody without the presence of hepatitis B surface antigen) will be allowed to participate.
- Coagulation dysfunction, such as hemophilia, Von Willebrand disease, antiphospholipid syndrome (APS). Subjects under anticoagulant therapies will have to interrupt their treatment 48 hours before the injection, and start their usual anticoagulant treatment again only 48 hours after the injection.
- Positive pregnancy test, lactating, planning to get pregnant, unwilling or unable to use highly effective contraceptive measures during the study.
- Any other conditions that lead the Investigators to consider the subject as ineligible to enroll, such as alcohol intake, drug usage, psychiatric disorder, etc.
- Any acute or chronic illness/condition or evidence of an unstable clinical condition that in the Investigator's judgement will substantially increase the risk to the subject if they participate in the study.
- Subject has an intellectual disability.
Trial locations and contacts
3 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
3 sites in 3 countries
Poland1 site
CenterMed Krakow Sp. z o.o.
Krakow, Lesser Poland Voivodeship, 31-530
Marcin Mazurek, mamazurek@tlen.pl
Spain1 site
Corporació Sanitària Parc Taulí
Sabadell, Barcelona, 08208
Cristobal Orellana Garrido, orellana.parctauli@gmail.com
United Kingdom1 site
NHS Greater Glasgow and Clyde
Glasgow, Scotland, G51 4TF
Rob Sinnerton, Rob.sinnerton@glasgow.ac.uk
About this study
Official title: A Prospective, Multi-center, Randomized, Active-controlled, Double-blinded (to Subject and Investigator), Non-inferiority Study of Single Intra-articular Injection of 2107 Injection in Subjects With Mild to Moderate Knee Osteoarthritis
This will be a 26-week, prospective, international, multi-center, randomized, active-controlled, double-blinded (to subject and Investigator) study in subjects with mild to moderate OA in the knees to assess safety and efficacy of 2107 Injection following a single intra-articular injection as compared to DUROLANE® (the active comparator).
A total of 286 subjects from approximately 15 sites and at least three (3) countries will be enrolled and randomized at a 1:1 ratio into the 2107 Injection arm or DUROLANE® arm.
Read more
One (1) target knee of each subject (only one [1] knee to be treated) will receive a single intra-articular dose of 3 mL of 2107 Injection (16 mg/mL HA, i.e. 48 mg per dose) or 3 mL of DUROLANE® (20 mg/mL HA, i.e. 60 mg per dose).
Subjects will be followed for 26 weeks after the intra-articular injection for safety and efficacy assessments. The study will consist of six (6) visits (see Table 1. Schedule of Assessments). Subjects who withdraw from the study will have an early termination visit.
The primary efficacy endpoint will be the mean change in the Western Ontario and McMaster Universities (WOMAC) Pain sub-score on 100-mm Visual Analog Scale (VAS) from baseline to 13 weeks after intra-articular injection.
The secondary efficacy endpoints include the changes in WOMAC sub-score and total score, PGA/IGA, the percentage of subjects taking rescue medication, the level of swelling and tenderness of the target knee and the Outcome Measures in Rheumatology Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) responder rate.
The safety endpoint includes systemic and local safety profile.
- Being tested
- 2107 Injection, DUROLANE®
- Keywords
- knee osteoarthritis, intra-articular injection, non-inferiority trial, active-controlled, double-blind, randomized controlled trial, 2107 Injection
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2107 InjectionDevice
Single intra-articular injection of 2107 Injection for knee osteoarthritis.
DUROLANE®Device
Single intra-articular injection of DUROLANE for knee osteoarthritis.
| Study group | Role | What they receive |
|---|---|---|
| 2107 Injection | Experimental | Participants with mild to moderate knee osteoarthritis receive a single intra-articular injection of 2107 Injection into the target knee joint. Receives: Device: 2107 Injection |
| DUROLANE® | Active comparator | Participants diagnosed with mild to moderate knee osteoarthritis will be administered one single intra-articular injection of DUROLANE® in the affected knee. Receives: Device: DUROLANE® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in WOMAC Pain sub-score (100-mm VAS) from baseline to Week 13
The primary endpoint will be the mean change in the Western Ontario and McMaster Universities (WOMAC) Pain sub-score on 100-mm Visual Analog Scale (VAS) from baseline to 13 weeks after intra-articular injection.
Measured: Baseline to Week 13
Secondary outcomes (7)
Change in WOMAC total, Physical Function and Stiffness sub-scores (100-mm VAS)
Changes in the WOMAC total score, WOMAC Physical Function and WOMAC Stiffness sub-scores on 100-mm VAS from baseline to 13 and 26 weeks post-injection.
Measured: Baseline to Week 13 and Week 26 post injection
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale (100-mm Visual Analog Scale)
Changes from baseline to each study visit (through 26 weeks post single intra-articular injection) in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale scored using a 100-mm Visual Analog Scale (VAS). This scale ranges from a minimum value of 0 mm to a maximum value of 100 mm; higher scores indicate worse knee pain symptoms, and lower scores indicate less pain.
Measured: Baseline through 26 weeks post injection
Change in Patient's Global Assessment (PGA) Scale (100-mm Visual Analog Scale)
Changes from baseline to Week 13 and Week 26 post-injection in scores of the Patient's Global Assessment Scale measured via a 100-mm Visual Analog Scale (VAS). The scale ranges from a minimum value of 0 mm to a maximum value of 100 mm; higher scores represent worse overall knee osteoarthritis condition, while lower scores represent milder symptoms and better clinical status.
Measured: Baseline through Week 13 and Week 26 post injection
Percentage of subjects using rescue medication
The percentage of subjects taking rescue medication at each visit post-injection.
Measured: All post-injection study visits up to 26 weeks
Knee swelling and tenderness (4-point scale)
The level of swelling and tenderness of the target knee using a 4-point scale (0 = none, 1 = mild, 2 = moderate, 3 = severe) at each visit.
Measured: All post-injection study visits up to 26 weeks
Change in Investigator's Global Assessment (IGA) Scale (100-mm Visual Analog Scale)
Investigator's Global Assessment Scale scores measured using a 100-mm Visual Analog Scale (VAS), assessed from baseline to Week 13 and Week 26 post-injection. This scale has a minimum value of 0 mm and a maximum value of 100 mm; higher scores indicate a more severe overall knee osteoarthritis condition (worse outcome), and lower scores indicate milder disease symptoms (better outcome).
Measured: Baseline through Week 13 and Week 26 post injection
OMERACT-OARSI responder rate
The OMERACT-OARSI responder rate at 13 and 26 weeks post-injection. An OMERACT-OARSI positive response is defined as WOMAC Pain or Physical Function sub-score improvement of ≥50% and ≥20 points over baseline or ≥20% improvement.
Measured: Week 13 and Week 26 post injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion30 Jun 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Knee 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 286 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BioRegen Biomedical (Changzhou) Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07746843
- Sponsor's protocol ID
- RDP2107-C-2024-001
- Status last verified
- Jul 2026
- First submitted
- 27 Jul 2026
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) including de-identified raw study data, annotated case report forms, study protocol, statistical analysis plan, informed consent form, and clinical study report will be available to qualified researchers upon submission of a formal research proposal and data sharing agreement. Proposals will be reviewed by the study sponsor to assess scientific merit. Data requests may be submitted after study completion and primary study results publication.
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-center, Randomized, Active-controlled, Double-blinded (to Subject and Investigator), Non-inferiority Study of Single Intra-articular Injection of 2107 Injection in Subjects With Mild to Moderate Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT07746843
- Acronym / sponsor ID
- RDP2107-C-2024-001
- Keywords
- knee osteoarthritis, intra-articular injection, non-inferiority trial, active-controlled, double-blind, randomized controlled trial, 2107 Injection
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 286 participants (estimated)
- Lead sponsor
- BioRegen Biomedical (Changzhou) Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 5 Aug 2026 (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 will be a 26-week, prospective, international, multi-center, randomized, active-controlled, double-blinded (to subject and Investigator) study in subjects with mild to moderate OA in the knees to assess safety and efficacy of 2107 Injection following a single intra-articular injection as compared to DUROLANE® (the active comparator).
A total of 286 subjects from approximately 15 sites and at least three (3) countries will be enrolled and randomized at a 1:1 ratio into the 2107 Injection arm or DUROLANE® arm.
One (1) target knee of each subject (only one [1] knee to be treated) will receive a single intra-articular dose of 3 mL of 2107 Injection (16 mg/mL HA, i.e. 48 mg per dose) or 3 mL of DUROLANE® (20 mg/mL HA, i.e. 60 mg per dose).
Subjects will be followed for 26 weeks after the intra-articular injection for safety and efficacy assessments. The study will consist of six (6) visits (see Table 1. Schedule of Assessments). Subjects who withdraw from the study will have an early termination visit.
The primary efficacy endpoint will be the mean change in the Western Ontario and McMaster Universities (WOMAC) Pain sub-score on 100-mm Visual Analog Scale (VAS) from baseline to 13 weeks after intra-articular injection.
The secondary efficacy endpoints include the changes in WOMAC sub-score and total score, PGA/IGA, the percentage of subjects taking rescue medication, the level of swelling and tenderness of the target knee and the Outcome Measures in Rheumatology Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) responder rate.
The safety endpoint includes systemic and local safety profile.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2107 Injection | Experimental | Device: 2107 InjectionParticipants with mild to moderate knee osteoarthritis receive a single intra-articular injection of 2107 Injection into the target knee joint. |
| DUROLANE® | Active comparator | Device: DUROLANE®Participants diagnosed with mild to moderate knee osteoarthritis will be administered one single intra-articular injection of DUROLANE® in the affected knee. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 1)Male or female outpatients 40-80 (inclusive) years of age. 2) Documented diagnosis of knee OA confirmed according to the American College of Rheumatology (ACR) criteria7 with symptoms for at least six (6) months.
- 3) Diagnosed with mild to moderate OA based on radiographs (Kellgren-Lawrence scale Grade II-III) taken within 12 months prior to entering the study. The rating of the alternative knee (Kellgren-Lawrence scale) should be no higher than that of the target knee.
- 4) Subjects could have OA in both knees, but the target knee for treatment should have an average total pain score of 40-80 mm (of the five [5] pain questions) and the walking pain question score of 40 60 mm on WOMAC Pain sub-score using a 100-mm VAS. The pain scores of the alternative knee should not be higher than that of the target knee (a higher-pain-score side of knee is defined as the target knee even if it has a lower Kellgren-Lawrence scale Grade).
- 5) Constant (daily) pain symptoms despite conservative care (e.g., physical therapy, analgesics) > two (2) weeks.
- 6) Agree to discontinue all analgesic therapies for at least 72 hours or four (4) to five (5) half-lives of the analgesics, whichever is longer.
Key exclusion criteria (41 listed)
- Subjects who meet any of the following criteria are not eligible for this clinical investigation:
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 |
|---|---|---|
| 2107 InjectionSingle intra-articular injection of 2107 Injection for knee osteoarthritis. | Device | 2107 Injection |
| DUROLANE®Single intra-articular injection of DUROLANE for knee osteoarthritis. | Device | DUROLANE® |
Primary outcome
Mean change in WOMAC Pain sub-score (100-mm VAS) from baseline to Week 13
Time frame: Baseline to Week 13
The primary endpoint will be the mean change in the Western Ontario and McMaster Universities (WOMAC) Pain sub-score on 100-mm Visual Analog Scale (VAS) from baseline to 13 weeks after intra-articular injection.
7 secondary outcomes
Change in WOMAC total, Physical Function and Stiffness sub-scores (100-mm VAS)
Time frame: Baseline to Week 13 and Week 26 post injection
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale (100-mm Visual Analog Scale)
Time frame: Baseline through 26 weeks post injection
Change in Patient's Global Assessment (PGA) Scale (100-mm Visual Analog Scale)
Time frame: Baseline through Week 13 and Week 26 post injection
Percentage of subjects using rescue medication
Time frame: All post-injection study visits up to 26 weeks
Knee swelling and tenderness (4-point scale)
Time frame: All post-injection study visits up to 26 weeks
Change in Investigator's Global Assessment (IGA) Scale (100-mm Visual Analog Scale)
Time frame: Baseline through Week 13 and Week 26 post injection
OMERACT-OARSI responder rate
Time frame: Week 13 and Week 26 post injection
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) including de-identified raw study data, annotated case report forms, study protocol, statistical analysis plan, informed consent form, and clinical study report will be available to qualified researchers upon submission of a formal research proposal and data sharing agreement. Proposals will be reviewed by the study sponsor to assess scientific merit. Data requests may be submitted after study completion and primary study results publication.
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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.
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 2107 Injection and DUROLANE® in people with Mild Knee Osteoarthritis and Moderate Knee Osteoarthritis, run by BioRegen Biomedical (Changzhou) Co., Ltd at 3 sites in 3 countries.
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 6 inclusion and 41 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: opening soon, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Poland, Spain, United Kingdom. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lingyu Pan (+8617753474390, lypan@bioregenmed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change in WOMAC Pain sub-score (100-mm VAS) from baseline to Week 13 (time frame: Baseline to Week 13). 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 6 Aug 2026.