Clinical Trial to Evaluate the Efficacy and Safety of Conjuran® After First and Second Cycle (Repeat) Administration in Patients With Knee Osteoarthritis

A Multicenter, Randomized, Double-Blind, Active-Controlled, Non-Inferiority Clinical Trial to Evaluate the Efficacy and Safety of Intra-Articular Conjuran® After First and Second Cycle (Repeat) Administration in Patients With Knee Osteoarthritis

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07646483

Enrollment

180

Registered

2026-06-12

Start date

2026-06-01

Completion date

2028-07-01

Last updated

2026-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Osteoarthritis

Keywords

Polynucleotide sodium, Osteoarthritis

Brief summary

This clinical trial aims to evaluate and compare the efficacy and safety of Conjuran® and Hyruan in patients with knee osteoarthritis following first and second cycle (repeat) administration.

Interventions

DEVICEConjuran

Once a week for 5 injections

DRUGHyruan

Once a week for 5 injections

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

40 Years to No maximum

Healthy volunteers

Inclusion criteria

* Age ≥40 years * Knee osteoarthritis diagnosed according to ACR criteria * KL grade I-III * Weight-bearing pain VAS ≥40 mm * Written informed consent

Exclusion criteria

* Inflammatory or secondary arthritis * Recent treatment in the target knee * Significant uncontrolled medical conditions * Hypersensitivity to study device components * Pregnancy or breastfeeding * Participation in another clinical trial

Design outcomes

Primary

Measure	Time frame	Description
Weight-Bearing Pain (WBP) Visual Analog Scale (VAS)	Week 16	Change from baseline in WBP after the first treatment assessed using a 100-mm Visual Analog Scale (VAS), ranging from 0 to 100. Higher scores indicate worse pain

Secondary

Measure	Time frame	Description
Weight-Bearing Pain (WBP), Resting Pain (RP), and Motion Pain (MP) VAS	Up to 56 weeks	Change from baseline in WBP, RP, and MP after the first and second treatment cycles, assessed using a 100-mm VAS (0-100). Higher scores indicate worse pain.
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score	Up to 56 weeks	Change from baseline in WOMAC total and subscale scores after the first and second treatment cycles. WOMAC is a 24-item questionnaire with scores ranging from 0 to 96. Higher scores indicate worse symptoms.
EQ-5D (EuroQol 5-Dimension Health Questionnaire)	Up to 56 weeks	Change from baseline in EQ-5D score after the first and second treatment cycles. EQ-5D consists of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and an EQ Visual Analog Scale (EQ VAS; 0-100). Higher scores indicate better health status.
Patient Global Assessment (PGA), Investigator Global Assessment (IGA)	Up to 56 weeks	Change from baseline in PGA and IGA after the first and second treatment cycles, assessed using a 100-mm Visual Analog Scale (VAS) (0-100). Higher scores indicate worse disease status.
WBP and OMERACT-OARSI Responder Rate	Up to 56 weeks	Proportion of participants meeting WBP responder criteria or OMERACT-OARSI responder criteria
Rescue Medication Use	Up to 56 weeks	Proportion (%) of participants using rescue medication and amount of rescue medication consumed.
Incidence of Adverse Events, Laboratory Abnormalities, Vital Sign Abnormalities, and Physical Examination Findings [Safety Evaluation]	Up to 56 weeks	Incidence of adverse events, local adverse events, laboratory abnormalities, vital sign abnormalities, and physical examination findings.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 13, 2026