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Knee OsteoarthritisPhase 3NCT06779071

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

A Phase 3 study testing NPNP-001 and Conjuran in people with Knee Osteoarthritis, run by PharmaResearch Co.,Ltd at 1 site in South Korea.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

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

Who is it for?
Ages 40 years and older
Conditions the study is for
Knee Osteoarthritis
What is being tested?
NPNP-001 and Conjuran
Could I receive a placebo?
No, everyone receives an active treatment
How many people
260 participants
Where
1 siteSouth Korea
Study dates
8 Jan 2025to Jun 2026
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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).

Who cannot join

  • 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).
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  • 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:
  • Patients who have received sodium polynucleotide and/or hyaluronic acid(HA) injections into the target knee joint within 6 months prior to screening.
  • Patients who have received steroid injections into the target knee joint within 3 months prior to screening.
  • Patients who have used systemic steroids within 1 month prior to screening (topical and inhaled steroids are excluded).
  • 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.
  • Patients who have taken anticoagulants (including warfarin, NOACs [Non-vitamin K Oral Anti-Coagulants], antiplatelet agents [aspirin, clopidogrel; however, low-dose aspirin [100 mg, maximum 300 mg/day] is excluded], thrombolytics [urokinase, alteplase, etc.]) within 2 weeks prior to the application of the investigational device.
  • Patients with a positive allergy test (skin prick test) result for the investigational device conducted at screening or those with hypersensitivity to components of the investigational device used in this clinical trial (including allergies to salmon, shrimp, and crab).
  • Patients who have participated in another clinical trial and received investigational products or medical devices within 6 months prior to screening.
  • Pregnant or breastfeeding women, women of childbearing potential who plan to become pregnant during the clinical trial period and for 3 months after, or men who do not intend to use appropriate contraceptive methods*.
  • Hormonal contraceptives, intrauterine devices (such as Implanon), dual barrier methods (using both male condoms and cervical caps), and sterilization procedures (vasectomy, bilateral tubal ligation, etc.).
  • Patients with knee joint instability.
  • Patients who are expected to start medication for depression or anxiety disorders during the clinical trial period.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

South Korea1 site

  • Seoul ST. Mary's Hospital

    Seoul, 25452

Other trials in South Korea

About this study

Official title: A Multicenter, Randomized, Double-blinded, Active-controlled, Non-inferiority, Pivotal Clinical Trial to Evaluate the Efficacy and Safety in Pain Reduction After NPNP-001 Application in the Knee Joint of Patients with Knee Osteoarthritis

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

Being tested
NPNP-001, Conjuran
Keywords
Polynucleotide sodium, Osteoarthritis
Medical subject headings
Osteoarthritis, Knee, Osteoarthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NPNP-001Device

    Also called Polynucleotide sodium (PN)

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

  • ConjuranDevice

    Also called Polynucleotide sodium (PN)

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

Study groups in NCT06779071
Study groupRoleWhat they receive
NPNP-001ExperimentalNot described
Receives: Device: NPNP-001
ConjuranActive comparatorNot described
Receives: Device: Conjuran

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

    Measured: 20 weeks

Secondary outcomes (10)

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

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

    Measured: 3, 4, 8, 28 weeks

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

    Rest pain - 100mm visual analogue scale (VAS)

    Measured: 3, 4, 8, 20, 28 weeks

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

    Motion pain - 100mm visual analogue scale (VAS)

    Measured: 3, 4, 8, 20, 28 weeks

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

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

    Measured: 3, 4, 8, 20, 28 weeks

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

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

    Measured: 3, 4, 8, 20, 28 weeks

  6. Change from baseline of WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) total score and individual score evaluation (Pain, Function, Stiffness)

    Change from baseline of WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) total score and individual score evaluation (pain, stiffness, physical function, ) - WOMAC-Likert Assessment (5-point Likert scale: none(0), mild(1), moderate(2), severe(3), and extreme(4)).

    1. The pain subscale consists of 5 questions. The sum of all items of pain subscale ranges from 0 to 20. A higher score indicates worse pain.
    2. The stiffness subscale consists of 2 questions. The sum of all items of the stiffness subscale ranges from 0 to 8. A higher score on the stiffness indicates worse articular function.
    3. The physical function Subscale consists of 17 questions. The sum of all items of the physical function subscale ranges from 0 to 68. A higher score indicates worse functional limitations.

    Measured: 3, 4, 8, 20, 28 weeks

  7. Change from baseline in EQ-5D (EuroQol-5 Dimension Health Questionnaire) Index and EQ VAS(visual analogue scale) assessment to measure quality of life

    Change from baseline in EQ-5D (EuroQol-5 Dimension Health Questionnaire) Index - 5 Level score and EQ VAS(visual analogue scale) assessment to measure quality of life.

    EQ-5D Index score ranges from 0 to 1, with 0 representing death and 1.0 representing perfect health.

    EQ VAS records participant's self-rated health on a vertical VAS that range from where 0 (worst imaginable) to 100 (best imaginable).

    Measured: 3, 4, 8, 20, 28 weeks

  8. Proportion (%) of participants who took rescue medication at each visit following the application of the investigational device, and consumption

    Proportion (%) of participants who took rescue medication at each visit following the application of the investigational device, and consumption

    Measured: 0, 1, 2, 3, 4, 8, 20, 28 weeks

  9. Response Rate following the application of the investigational device

    Response Rate assessment following the application of the investigational device

    Measured: 8, 20, 28 weeks

  10. Physical assessments at each visit following the application of the investigational device: Swelling, Tenderness on pressure, Range of motion(ROM)

    Physical assessments at each visit following the application of the investigational device: Swelling, Tenderness on pressure, Range of motion(ROM)

    Measured: From 0 to 28 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jan 2025
  2. Study start8 Jan 2025
  3. Primary completionMay 2025 (estimated)
  4. Study completionJun 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
260 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06779071
Sponsor's protocol ID
PR-NPNP001-P3-02
Status last verified
Jan 2025
First submitted
7 Jan 2025
Last updated
20 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing NPNP-001 and Conjuran in people with Knee Osteoarthritis, run by PharmaResearch Co.,Ltd at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 20 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline of Weight-bearing pain (WBP) - 100mm visual analogue scale (VAS) (time frame: 20 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06779071.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2025.

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