Pivotal Clinical Trial to Evaluate the Efficacy and Safety After NPNP-001 Application in Patients with Knee Osteoarthritis.

NCT06779071 | Enrolling By Invitation Phase 3

• 1 other identifier: PR-NPNP001-P3-02
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 1

Brief Summary

This study was designed to demonstrate non-inferiority and safety in pain reduction after NPNP-001 application in patients with knee osteoarthritis.

Conditions

Knee Osteoarthritis

Keywords

Polynucleotide sodium; Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Change from baseline of Weight-bearing pain (WBP) - 100mm visual analogue scale (VAS)

  Weight-bearing pain (WBP) - 100mm visual analogue scale (VAS)

  20 weeks

Secondary Outcomes (10)

• Change from baseline of Weight-bearing pain (WBP) - 100mm visual analogue scale (VAS)

  3, 4, 8, 28 weeks

• Change from baseline of Rest pain - 100mm visual analogue scale (VAS)

  3, 4, 8, 20, 28 weeks

• Change from baseline of Motion pain - 100mm visual analogue scale (VAS)

  3, 4, 8, 20, 28 weeks

• Change from baseline of Patient Global Assessment (PGA) - 100mm visual analogue scale (VAS)

  3, 4, 8, 20, 28 weeks

• Change from baseline of Investigator Global Assessment (IGA) - 100mm visual analogue scale (VAS)

  3, 4, 8, 20, 28 weeks

Other Outcomes (4)

• The incidence rate of Pre-treatment adverse events (AEs), treatment-emergent adverse events (TEAEs), Solicited Local AEs and the Serious TEAEs

  From 0 to 28 weeks

• The incidence rate of abnormal CS at Post-Treatment on Laboratory

  From 0 to 28 weeks

• The incidence rate of abnormal clinical significance (CS) at Post-Treatment on Electrocardiogram

  From 0 to 28 weeks

Study Arms (2)

NPNP-001

EXPERIMENTAL

Device: NPNP-001

Conjuran

ACTIVE COMPARATOR

Device: Conjuran

Interventions

NPNP-001 DEVICE

Description: NPNP-001 2ml per injection, once a week for 3 injections. Placebo(saline) 2ml per injection, once a week for 2 injections.

Also known as: Polynucleotide sodium (PN)

NPNP-001

Conjuran DEVICE

Description: Conjuran 2ml per injection, once a week for 5 injections.

Also known as: Polynucleotide sodium (PN)

Conjuran

Eligibility Criteria

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

You may qualify if:

• Adult males and females aged 40 years or older as of the date of written consent
• Patients diagnosed with unilateral or bilateral knee osteoarthritis according to the American College of Rheumatology (ACR) clinical diagnostic criteria, experiencing knee joint pain, and meeting at least three of the following conditions:
• Age \> 50 years
• Morning stiffness \< 30 minutes
• Crepitus
• Bony tenderness
• Bony enlargement
• No palpable warmth of the synovium
• At least one knee joint with a Weight-Bearing Pain (100 mm-VAS) score ≥ 40 mm, measured at the screening visit
• X-ray results from within 6 months prior to screening or at the screening visit indicating that the target lesion of knee osteoarthritis corresponds to Kellgren Lawrence Grade 1 to 3.
• Patients with knee osteoarthritis who have not responded to conservative treatments such as pharmacotherapy or physical therapy for at least 3 months prior to screening.
• Patients who can adequately understand and complete the efficacy assessment questionnaires.
• Patients who voluntarily agree to the informed consent form after receiving an explanation of the purpose, methods, and effects of the clinical trial.
• Patients who agree to refrain from using any pharmacotherapy for knee osteoarthritis other than the rescue medication during the clinical trial period.
• Patients who are able to undergo allergy testing (skin prick test).

You may not qualify if:

• Patients with a Body Mass Index (BMI) ≥ 35 kg/m² at screening.
• Patients with rheumatoid arthritis or other types of arthritis such as traumatic, metabolic, etc.
• Patients with conditions that are deemed likely to affect the efficacy and safety assessment of this clinical trial (however, those who are considered eligible by the investigator may be enrolled):
• Patients with severe painful conditions such as septic arthritis, autoimmune diseases, gout, recurrent pseudogout, Paget's disease, etc.(e.g. Sudeck's atrophy, herniated discs, etc.), as well as those with joint fractures, ochronosis, acromegaly, hemochromatosis, Wilson's disease, primary osteochondrosis, genetic diseases (hyperkinesis, etc.), collagen gene abnormalities
• Patients with hemorrhagic disorders, hemostatic disorders, CNS diseases, cancer, AIDS, heart disease, kidney disease, uncontrolled diabetes and hypertension, severe medical or psychiatric conditions, and patients with hypersensitivity to local anesthetics.
• Patients with severe osteoarthritis symptoms in other joints (e.g., hip joint) that may affect pain assessment in the knee joint (polyarticular joint pain).
• Patients with skin abnormalities at the injection site that may affect invasive procedures, such as infections or skin diseases.
• Patients who have received the following medications prior to screening:
• A. Patients who have received sodium polynucleotide and/or hyaluronic acid(HA) injections into the target knee joint within 6 months prior to screening.
• B. Patients who have received steroid injections into the target knee joint within 3 months prior to screening.
• C. Patients who have used systemic steroids within 1 month prior to screening (topical and inhaled steroids are excluded).
• D. Patients who have received cell therapy or gene therapy into the target knee joint prior to screening.
• Patients with severe joint effusion confirmed through tests such as the patellar tap test.
• Patients who have undergone surgical procedures on the target knee joint or cartilage regeneration surgeries (such as microfracture, autologous chondrocyte implantation, etc.) within 6 months prior to screening (however, patients with surgical history on the opposite knee or hip joints will only be excluded if it is likely to impact the clinical evaluation of the target knee joint).
• Patients with a history of knee joint replacement surgery in the target joint.

Sponsors & Collaborators

• PharmaResearch Co.,Ltd: lead

Study Sites (1)

Seoul ST. Mary's Hospital

Seoul, 25452, South Korea

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2025
• First Posted: January 16, 2025
• Study Start: January 8, 2025
• Primary Completion: May 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: January 20, 2025

Record last verified: 2025-01

Locations

KR (1)