The Efficacy and Safety Study of 2107 Injection in Subjects With Mild to Moderate Knee Osteoarthr… (NCT07746843) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
The Efficacy and Safety Study of 2107 Injection in Subjects With Mild to Moderate Knee Osteoarthritis
Poland, Spain, United Kingdom286 participantsStarted 2026-09-01
Plain-language 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® (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.
Who can participate
Age range
40 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Exclusion criteria
. 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.
. Received a corticosteroid injection within 12 weeks or oral corticosteroids within six (6) weeks prior to screening.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is listed as 'not yet recruiting' — do you know when it's expected to open, and would it make sense for me to wait for it or start standard treatment for my knee osteoarthritis now?
2The trial is measuring pain improvement using the WOMAC Pain score at 13 weeks — based on what you know about my current pain levels and functional limitations, is 13 weeks a meaningful window to judge whether a treatment is working for my situation?
3Since this study is listed as Phase NA, what does that tell us about how much is already known about the safety of this '2107 Injection,' and what risks should I be prepared to discuss before considering enrollment?
4My diagnosis is mild to moderate knee osteoarthritis — are there established treatments like physical therapy, NSAIDs, or corticosteroid injections that you'd recommend I try first before considering an experimental injection study like this one?
5What would participating in this trial actually involve for me day-to-day, such as how many clinic visits, whether I'd need to stop other knee treatments, and whether there's a placebo group where I might not receive the active injection?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Mean change in WOMAC Pain sub-score (100-mm VAS) from baseline to Week 13
. 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: