The Efficacy and Safety Study of 2107 Injection in Subjects With Mild to Moderate Knee Osteoarthritis

NCT07746843 | Not Yet Recruiting DMC

• 1 other identifier: RDP2107-C-2024-001
• Study Type: interventional
• Target: 286
• Locations: 3 countries
• Sites: 3

Brief 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.

Conditions

Mild Knee Osteoarthritis; Moderate Knee Osteoarthritis

Keywords

knee osteoarthritis; intra-articular injection; non-inferiority trial; active-controlled; double-blind; randomized controlled trial; 2107 Injection

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline to Week 13

Secondary Outcomes (7)

• Change in WOMAC total, Physical Function and Stiffness sub-scores (100-mm VAS)

  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)

  Baseline through 26 weeks post injection

• Change in Patient's Global Assessment (PGA) Scale (100-mm Visual Analog Scale)

  Baseline through Week 13 and Week 26 post injection

• Percentage of subjects using rescue medication

  All post-injection study visits up to 26 weeks

• Knee swelling and tenderness (4-point scale)

  All post-injection study visits up to 26 weeks

Other Outcomes (2)

• Number of participants with systemic adverse events, abnormal vital signs and abnormal laboratory parameters from screening to Week 13 or early termination visit

  From screening visit up to Week 13 or early study termination visit

• Number of participants with local injection-site adverse reactions on the treated knee from screening to Week 13 or early termination visit

  From screening visit up to Week 13 or early study termination visit

Study Arms (2)

2107 Injection

EXPERIMENTAL

Participants with mild to moderate knee osteoarthritis receive a single intra-articular injection of 2107 Injection into the target knee joint.

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.

Device: DUROLANE®

Interventions

2107 Injection DEVICE

Single intra-articular injection of 2107 Injection for knee osteoarthritis.

2107 Injection

DUROLANE® DEVICE

Single intra-articular injection of DUROLANE for knee osteoarthritis.

DUROLANE®

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• )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.
• \) 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.
• \) 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).
• \) Constant (daily) pain symptoms despite conservative care (e.g., physical therapy, analgesics) \> two (2) weeks.
• \) 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.
• \) Subject voluntarily agrees to sign the informed consent form (ICF). 8) Subject is self-conscious and able to read and write.

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• BioRegen Biomedical (Changzhou) Co., Ltd: lead

Study Sites (3)

CenterMed Krakow Sp. z o.o.

Krakow, Lesser Poland Voivodeship, 31-530, Poland

Location

Corporació Sanitària Parc Taulí

Sabadell, Barcelona, 08208, Spain

Location

NHS Greater Glasgow and Clyde

Glasgow, Scotland, G51 4TF, United Kingdom

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Central Study Contacts

Lingyu Pan

CONTACT

+8617753474390; lypan@bioregenmed.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2026
• First Posted: August 5, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: August 6, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Beginning 6 months after publication of primary study results, and available for up to 5 years thereafter.
• Access Criteria: Qualified researchers conducting methodologically sound scientific research; requesters must sign a legally binding data sharing agreement prohibiting re-identification and further data redistribution.

Locations

GB (1); PL (1); ES (1)