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

NCT07746843 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 286

Last updated 2026-08-06

No results posted yet for this study

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

Interventions

DEVICE

2107 Injection

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

DEVICE

DUROLANE®

Single intra-articular injection of DUROLANE for knee osteoarthritis.

Sponsors & Collaborators

  • BioRegen Biomedical (Changzhou) Co., Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-01
Primary Completion
2028-06-30
Completion
2028-12-31

Countries

  • Poland
  • Spain
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07746843 on ClinicalTrials.gov