Pivotal Study to Evaluate Efficacy and Safety of SP5M002 Inj. as Compared to Synovian Inj. in Patients With Mild to Moderate Knee Osteoarthritis

NCT06399042 | Active Not Recruiting Phase 3

• 1 other identifier: SP-HA-003-1
• Study Type: interventional
• Target: 297
• Locations: 1 country
• Sites: 16

Brief Summary

This is a randomized, double-blind, multicenter, Active Controlled, pivotal clinical trial to assess the efficacy and safety of the novel hexamethylenediamine (HMDA) cross-linked hyaluronate intra-articular injection (SP5M002) compared with an active comparator, the 1,4-butanediol diglycidyl ether (BDDE) cross-linked hyaluronate (Synovian) in patients with knee osteoarthritis.

Conditions

Osteoarthritis

Keywords

Knee osteoarthritis, Intra-articular injection, hexamethylenediamine(HMDA), Cross-linked hyaluronate

Outcome Measures

Primary Outcomes (2)

• Change in [Weight-Bearing Pain (WBP)-100mm-visual analogue scale (VAS)] at Week 12 from baseline (visit 2)

  \* Weight Bearing Pain (WBP) - 100mm-visual analogue scale (VAS)

  12 weeks

• Change in [Weight-Bearing Pain (WBP)-100mm-visual analogue scale (VAS)] at Week 6 from baseline (visit 2)

  \* Weight Bearing Pain (WBP) - 100mm-visual analogue scale (VAS)

  6 weeks

Secondary Outcomes (12)

• Changes in the following at each visit: Weight Bearing pain (WBP) (Weeks 2, 24, and 36) from baseline (Visit 2)

  week 2, 24, 36

• Changes in the following at each visit: Rest pain (RP) (Weeks 2, 6, 12, 24, and 36) from baseline (Visit 2)

  week 2,6,12, 24, 36

• Changes in the following at each visit: Night pain (NP) (Weeks 2, 6, 12, 24, and 36) from baseline (Visit 2)

  week 2,6,12, 24, 36

• Changes in the following at each visit: Motion pain (MP) (Weeks 2, 6, 12, 24, and 36) from baseline (Visit 2)

  week 2,6,12, 24, 36

• Changes in the following at each visit: Patient Global Assessment(PGA) (Weeks 2, 6, 12, 24, and 36) from baseline (Visit 2)

  week 2,6,12, 24, 36

Other Outcomes (9)

• The incidence rate of Pre-treatment AEs

  From Week 0 to week 24

• The incidence rate of Solicited Local AEs

  From Week 0 to week 24

• The incidence rate of treatment-emergent adverse event (TEAE)

  From Week 0 to week 24

Study Arms (2)

SP5M002 inj

EXPERIMENTAL

SP5M002 inj 3 ml pre-filled syringe into Knee joint cavity of osteoarthritis patients

Device: SP5M002 inj

Synovian inj

ACTIVE COMPARATOR

Synovian inj 3 ml pre-filled syringe into Knee joint cavity of osteoarthritis patients

Device: Synovian inj

Interventions

SP5M002 inj DEVICE

pre-filled syringe

SP5M002 inj

Synovian inj DEVICE

pre-filled syringe

Synovian inj

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• 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
• Subject with knee osteoarthritis whose X-ray test results within 6 months from the screening or at the screening visit correspond to grades I - III of the Kellgren \& Lawrence scale
• Subject diagnosed with unilateral or bilateral knee osteoarthritis according to the clinical diagnostic criteria of the American College of Rheumatology (ACR) at screening who have knee joint pain and meet three or more of the following conditions
• Over 50 years of age
• Less than 30 minutes of morning stiffness ③ Crepitus on active motion ④ Bony tenderness ⑤ Bony enlargement ⑥ No palpable warmth of synovium
• Weight bearing pain (WBP) of at least one of both knee joints on 100 mm-VAS ≥ 40 mm when measured at screening and baseline \[However, if both sides have symptoms, the knee joint with the higher WBP becomes the joint for evaluation, and the selected joint cannot be changed during the study period.\]
• Walk without relying on a walking aid such as a walker or cane (patients who have been using a walking aid every day since 6 months prior to the screening visit can use the walking aid, and must use the walking aid in the same way throughout the study period.)
• Ability to fully understand and complete the safety and efficacy measurement questionnaire
• Voluntary decision for participation and provision of written consent to comply with the precautions after hearing and fully understanding the detailed explanation of the purpose, method, and effects of this study

You may not qualify if:

• Body mass index (BMI) ≥ 35 kg/m2 at screening
• Hip osteoarthritis or osteoarthritis of another joint that is severe enough to preclude evaluation of knee osteoarthritis at the time of screening
• Having the following diseases that may affect the efficacy and safety evaluation but not being limited to the following
• Septic arthritis, rheumatoid arthritis, gout, recurrent pseudogout arthritis, trauma that may damage joint cartilage, congenital abnormalities, calcium deposition disease, diabetes, ochronosis, hemochromatosis, acromegaly, Wilson's disease, primary osteochondrosis, genetic diseases (e.g., hyperkinesis), secondary osteoarthritis caused by collagen gene abnormalities, etc.
• Sudek's atrophy or severe painful diseases such as Paget's disease
• Infection or skin disease in the joint area that is unsuitable for injection at the time of screening
• Active or suspected knee joint infection at the time of screening
• Complete loss of the Patello-femoral joint space
• Received the following treatments within 14 days of the screening visit (except those who have passed a 14-day wash-out) or scheduled to be administered during the study period
• Taking medicines containing ingredients such as glucosamine, chondroitin sulfate, and diacerhein
• Taking herbal medicines and herbal medicines for osteoarthritis
• Taking anti-inflammatory painkillers, non-steroidal anti-inflammatory drugs (NSAIDs, prescription/non-prescription drugs), etc. (administration of acetaminophen allowed if passing a 3 day wash-out)
• Taking oral steroids
• Hospital physical therapy or oriental medicine treatment (cupping, acupuncture, moxibustion, etc.)
• Intra-articular injection, such as intra-articular corticosteroid, at the injection site within 6 months from the time of screening

Sponsors & Collaborators

• Shin Poong Pharmaceutical Co. Ltd.: lead

Study Sites (16)

Kyungpook National University Hospital

Daegu, South Korea

Location

Yeungnam University Medical Center

Daegu, South Korea

Location

Chonnam National University Bitgoeul Hospital

Gwangju, South Korea

Location

Gachon University Gil Medical Center

Incheon, South Korea

Location

Jeonbuk National University Hospital

Jeonju, South Korea

Location

Gyeongsang National University Hospital

Jinju, South Korea

Location

Chungnam National University Hospital

Sejong, South Korea

Location

CHA University Bundang Medical Center

Seongnam, South Korea

Location

EWHA Womans University Mokdong Hospital

Seoul, South Korea

Location

Gangnam Severance Hospita

Seoul, South Korea

Location

Kyung Hee University Hospital at Gangdong

Seoul, South Korea

Location

Kyunghee University Hospital

Seoul, South Korea

Location

Samsung Medical Center

Seoul, South Korea

Location

Seoul National University Boramae Medical Center

Seoul, South Korea

Location

Seoul National University Hospital

Seoul, South Korea

Location

The Catholic University of Korea, Seoul St. Mary's Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Osteoarthritis; Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: masking : only blind investigator
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2024
• First Posted: May 3, 2024
• Study Start: June 14, 2023
• Primary Completion: June 1, 2024
• Study Completion: September 1, 2024
• Last Updated: May 3, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (16)