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Tests treatment safety and results for Knee Osteoarthritis (Knee OA)
Official title A Study to Assess the Efficacy and Safety of Vutiglabridin in Knee Osteoarthritis Patients
ClinicalTrials.gov ID: NCT06845553
What this study is testing
What is Vutiglabridin?
Vutiglabridin is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for knee osteoarthritis (knee oa).
Also referred to as HSG4112,2-(8,8 dimethyl 2,3,4,8,9,10 hexahydropyrano[2,3 f]chromen 3 yl) 5 ethoxyphenol.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 1. Study Objective To Explore the Efficacy and Evaluate the Safety of Vutiglabridin in Knee Osteoarthritis Patients 2.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 75
You may be able to join if
- Voluntarily agreed to participate in the study after being informed about the nature of the trial and has signed the informed consent form approved...
- Adults aged 40 to 75 years at the time of screening.
- Meets the American College of Rheumatology (ACR) criteria for osteoarthritis and has symptoms lasting for more than 3 months requiring...
- Age 50 or older
- Morning stiffness less than 30 minutes
You likely can't join if
- BMI of 35.0 kg/m² or higher at screening.
- Developed a clinically significant new disease within 4 weeks before screening or during the screening period, as judged by the investigator.
- Has arthritis in joints other than the knee.
- Has any other joint disease except knee osteoarthritis (e.g., secondary osteoarthritis due to trauma, congenital defects, calcium deposition...
- Has a history of knee or other joint surgery.
- Has received injections in the affected knee before the administration of the study drug:
See the full eligibility criteria
Who can join
- Voluntarily agreed to participate in the study after being informed about the nature of the trial and has signed the informed consent form approved by the IRB.
- Adults aged 40 to 75 years at the time of screening.
- Meets the American College of Rheumatology (ACR) criteria for osteoarthritis and has symptoms lasting for more than 3 months requiring pharmacological treatment. Must have knee pain and radiographic evidence of...
- Age 50 or older
- Morning stiffness less than 30 minutes
- Crepitus on knee motion
- Has a Kellgren-Lawrence grade II or III in the knee joint on X-ray at the time of screening.
- Experiences a maximum pain of 50 mm or greater on the 100 mm VAS in activity over the past 24 hours at screening and baseline.
- For females, the following conditions apply:
- For women of childbearing potential, the serum hCG pregnancy test at screening must be negative, confirming not pregnant.
- Not currently breastfeeding.
- Has undergone surgical sterilization (documented bilateral tubal ligation, bilateral tubal occlusion, bilateral oophorectomy, or hysterectomy), or is postmenopausal.
- Definition of menopause:
- For women over 50 years: 12 months of natural amenorrhea.
- For women under 50 years: Serum FSH level over 40 IU/L and 12 months of natural amenorrhea.
What rules you out
- BMI of 35.0 kg/m² or higher at screening.
- Developed a clinically significant new disease within 4 weeks before screening or during the screening period, as judged by the investigator.
- Has arthritis in joints other than the knee.
- Has any other joint disease except knee osteoarthritis (e.g., secondary osteoarthritis due to trauma, congenital defects, calcium deposition diseases, rheumatoid arthritis, gouty arthritis, Paget's disease, systemic...
- Has a history of knee or other joint surgery.
- Has received injections in the affected knee before the administration of the study drug:
- Steroid injections within 3 months (13 weeks) to the knee osteoarthritis area.
- Short-acting hyaluronic acid injections within 3 months (13 weeks) to the knee osteoarthritis area.
- Long-acting hyaluronic acid injections within 6 months (26 weeks) to the knee osteoarthritis area.
- Has received drug therapy for pain control or symptom improvement in the knee joint area within 4 weeks before study drug administration (opioid analgesics, non-opioid analgesics, topical capsaicin, NSAIDs...
- Expected to undergo surgery during the clinical trial period that may affect study completion or adherence to the clinical protocol.
- Has neuropathic pain or has taken neuropathic pain medications (gabapentinoids, SNRIs, tricyclic antidepressants) within 4 weeks before screening.
- Has a history of myocardial infarction, unstable angina, stroke, transient ischemic attack, or deep vein thrombosis within 3 months (13 weeks) before screening.
- Has any clinically significant untreated or unstable diseases of the liver, kidney, nervous system, immune system, respiratory system, endocrine system, blood/oncologic diseases, cardiovascular diseases, psychiatric...
- For males, has a history of hypogonadism or known causes of hypogonadism (e.g., prostate cancer treatment), infertility, Klinefelter syndrome, or Kalman syndrome.
- Has used medications that can alter reproductive hormone levels (e.g., anabolic steroids, androgens, anti-estrogens, glucocorticoids, opiates, etc.) within 6 months (26 weeks) before screening.
- Has a history of organ transplantation.
- Has clinically significant liver dysfunction (e.g., AST or ALT more than 2.5 times the upper limit of normal, total bilirubin more than twice the upper limit of normal [except documented Gilbert's syndrome]) or kidney...
- Tests positive for HBsAg, HCV Ab, HIV Ag/Ab, or VDRL (RPR) at screening.
- Has a history of malignant tumors within the past 5 years (except for those with completely treated basal cell carcinoma, in situ carcinoma, thyroid cancer, or squamous cell carcinoma of the skin, based on the...
- Has used systemic steroids for 7 or more consecutive days within 3 months (13 weeks) before screening.
- Has taken immunosuppressive drugs including methotrexate or antimetabolites within 3 months (13 weeks) before screening.
- Taking drugs that are substrates of the breast cancer resistant protein (BCRP) (e.g., rosuvastatin, sulfasalazine) at screening (however, can be eligible if switched to a different drug in the same class).
- Has a history of alcohol or drug abuse within 2 years before screening or tests positive for substance abuse at screening (except for documented chronic pain treatment with prescribed medications approved by the...
- Has participated in another clinical trial or bioequivalence study within 6 months (26 weeks) before the first dose and received investigational medicinal products (except for placebo).
- Has a history of hypersensitivity or allergic reactions to any components of the investigational medicinal product.
- Has lactose intolerance.
- Unwilling to use medically acceptable contraception during the clinical trial period and for 90 days after the last dose.
- Medically acceptable contraception includes:
- Oral hormonal contraceptives for female partners of male people.
- Intrauterine devices with proven pregnancy failure rate.
- Surgical sterilization (e.g., vasectomy, tubal ligation, hysterectomy).
- Unwilling to donate sperm/eggs during the trial or for 90 days after the last dose.
- Deemed unsuitable for participation in the trial based on clinical laboratory results or other reasons determined by the investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Seongnam-si, Gyeonggi-do, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Seongnam-si, Gyeonggi-do, South Korea. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.