Clinical Trial of YYD302 (Phase3) for Treatment of Osteoarthritis of the Knee

NCT03561779 | Completed Phase 3 DMC

• 1 other identifier: YY_YYD302_003
• Study Type: interventional
• Target: 184
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, double-blind, active-controlled, multi-center, phase 3 study to evaluate the safety and efficacy of intraarticular hyaluronic acid(YYD302) for osteoarthritis of the knee after 12 weeks of treatment and retreatment

Conditions

Osteoarthritis, Knee

Keywords

Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Rate of change of the Weight-bearing pain(100mm-VAS) on 12 weeks after first injection in comparison with baseline

  Weight-bearing pain(100mm-VAS) assessed by the subject

  Change of the week 12 from baseline

Secondary Outcomes (14)

• Rate of change of the Weight-bearing pain(100mm-VAS) on 2, 4 weeks after administration in comparison with baseline

  Change of the week 2, 4 from baseline

• Rate of change of the KOOS scales on the 2, 4, 12 weeks after administration in comparison with baseline

  Change of the week 2, 4, 12 from baseline

• Rate of change of the rest pain(100mm-VAS) on the 2, 4, 12 weeks after administration in comparison with baseline

  Change of the week 2, 4, 12 from baseline

• Rate of change of the Motion pain (100mm-VAS) on the 2, 4, 12 weeks after administration in comparison with baseline

  Change of the week 2, 4, 12 from baseline

• Patient global assessment (100mm-VAS) on the 2, 4, 12 weeks after administration with baseline

  Change of the week 2, 4, 12 from baseline

Study Arms (2)

YYD302

EXPERIMENTAL

YYD302 (2ml)

Drug: YYD302 2ml

Synovian Inj.

ACTIVE COMPARATOR

Synovian Inj. (3ml)

Drug: Active comparator: Synovian Inj.

Interventions

YYD302 2ml DRUG

YYD302 2ml

YYD302

Active comparator: Synovian Inj. DRUG

Active comparator: Synovian Inj.

Also known as: Synovian Inj.

Synovian Inj.

Eligibility Criteria

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

You may qualify if:

• Males or Females 40 years and older
• According to the clinical diagnosis standard of the American College of Rheumatology (ACR), someone, diagnosed as a single/both sides of osteoarthritis, who corresponds to over 3 conditions of followings.
• \) Over 50 years of age 2) Less than 30 minutes of morning stiffness 3) Crepitus on active motion 4) 4 bony tenderness 5) Bony enlargement 6) Nopalpable warmth of synvium 3. Within 6 months from screening visit, someone who diagnosed with Kellgren \& Lawrence Grade I\~III by the radioactive examination.
• \. By the Weight-bearing pain(100mm-VAS) examination, someone who has a outcome of the single or both sides of the osteoarthritis is over 40mm 5. Patient (No-responder) who has experienced steady pain in spite of dosing NSAIDs or other pain-killers in the past.
• \. Patient who can walk by themselves without helper like cane or walker etc. (If the patient who has used helper routinely from previous 6 months, evaluating the patient including the helper is possible. In this case, patient needs to use same helper continuously by end of the clinical trial test.) 7. Patient who agrees to participate in this clinical trial by themselves.
• Over 50 years of age
• Less than 30 minutes of morning stiffness
• Crepitus on active motion
• bony tenderness
• Bony enlargement
• Nopalpable warmth of synvium 2. At Re-screening visit, someone who diagnosed with Kellgren \& Lawrence Grade I\~III by the radioactive examination.
• \. Patient who can walk by themselves without helper like cane or walker etc. (If the patient who has used helper routinely from previous 6 months, evaluating the patient including the helper is possible. In this case, patient needs to use same helper continuously by end of the clinical trial test.) 4. Patient who are confirmed for Responder by efficacy at visit 5.

You may not qualify if:

• Someone who has BMI≥32kg/m² at the screening visit.
• Patient who has an experience dosing psychoactive drug, narcotic analgesic which can have an effect on pain sense over 3 months habitually.
• Patient who has been administrated gastrointestinal drug(for example H₂-blockers, misoprostol or proton pump inhibitors) regularly, who can't stop injecting for clinical study period.
• Patient has attended abnormal values from screening test(2 times excess at upper limit of the normal values at ALT, AST, BUN, Serum Creatinine).
• Patient who has rheumarthritis or other inflammatory metabolic arthritis.
• Patients having serious gastrointestinal, liver, renal, heart disease.
• When the inflammatory disease is occurred on joint area to patient like septic arthritis.
• Patients having skin ailment at the injecting site of the joint region.
• Patients having secondary osteoarthritis according to the Ochronosis, Hemochromatosis or systemic disease.
• Patients who have severe pain like Sudek's atrophy, Paget's disease, Spinal disc herniation.
• Poly-articular patients who have suffered seriously by osteoarthritis at other parts affect judge of the knee joint pain.
• Patients who diagnosed clear interval disappearance at the knee joint by X-ray.
• Patients who were administrated below drugs before baseline visit. 1) Patients who were injected HA at the target knee joint or other parts of knee joint in recent 9 months.
• \) Patients who were injected steroids into the intra-articular knee joint in recent 3 months 3) Patients who were administrated steroids systemically by the oral medication (But, except inhalation) 4) Patients who were administerated Osteoarthritis nutrition such as glucosamine/chondroichin sulfate or physical therapy or herbal remedy(acupuncture, yellowish swelling, moxa cautery) for the purpose of pain relief in recent 2 weeks 5) Patients who have administerated steroid/No-steriod NSAIDs or other pain relief drugs (patch or other external medicine) in recents 2 weeks except Acetaminophen or below 300mg/day of Asprin 14. Patients who have joint effusion trouble were judged as a positive by tests like Patella tap test.
• \. Patients who have target knee joint gotten surgical operation history including Arthroscopy within past one year (In case of having other side of knee joint or hip joint gotten surgical operation history, excepting the patients if there is possibility which can influence the target knee joint's appraisal.

Sponsors & Collaborators

• Yooyoung Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

Location

Related Publications (1)

• Park YG, Ha CW, Yoo JH, Lee WS, Lee HJ, In Y, Bae KC, Shon OJ, Kim YM, Seon JK, Song SJ, Chang CB, Kim JM, Kim CW, Kim DH, Bae JH. Intra-Articular Injection of a Novel DVS Cross-Linked Hyaluronic Acid Manufactured by Biological Fermentation (YYD302) in Patients With Knee Osteoarthritis: A Double-Blind, Randomized, Multicenter, Noninferiority Study. Clin Ther. 2021 Nov;43(11):1843-1860. doi: 10.1016/j.clinthera.2021.09.005. Epub 2021 Nov 1.

  PMID: 34736768 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Chul-Won Ha, M.D

  Samsung Medical Center, Department of Internal Medicine

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: The Subjects are injected investigational Product (YYD302 or Synovian Inj.)

Study Record Dates

• First Submitted: June 4, 2018
• First Posted: June 19, 2018
• Study Start: February 21, 2018
• Primary Completion: June 14, 2019
• Study Completion: October 4, 2019
• Last Updated: May 10, 2021

Record last verified: 2021-05

Locations

KR (1)