A Study to Assess the Efficacy and Safety of Vutiglabridin in Knee Osteoarthritis Patients
ConditionKnee Osteoarthritis (Knee OA)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age40-75
SponsorGlaceum
About this trial
1. Study Objective To Explore the Efficacy and Evaluate the Safety of Vutiglabridin in Knee Osteoarthritis Patients 2. Background Glaceum Inc. has evaluated the safety, tolerability, and pharmacokinetic/pharmacodynamic properties of vutiglabridin in healthy subjects through its Phase 1 trials, and is planning to perform this Phase 2a trial to assess the efficacy and safety of vutiglabridin in Knee Osteoarthritis Patients 3. Study Design and Protocol This study is a randomized, double-blind, placebo-controlled, parallel-group trial. Subjects deemed eligible to participate in this study based on the inclusion/exclusion criteria will be assigned a subject number and randomized to one of the 3 treatment groups - 1 group receiving a placebo - in a 1:1:1 ratio. Subjects will be randomized to double-blind treatments and will receive a once-daily oral dose of the investigational product for 26 weeks according to the study protocol. Several parameters (i.e., 100mm VAS, WOMAC pain subscale, X-ray, MRI, BMI) will be evaluated to assess the efficacy of vutiglabridin. Assessments including measurement of vital signs, 12-lead ECG, clinical laboratory test, pregnancy test, physical examination, and adverse event monitoring will be performed to evaluate the safety and tolerability of vutiglabridin. Blood samples will be collected for pharmacokinetic assessment.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Age 50 or older
Morning stiffness less than 30 minutes
Disqualifiers
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 inflammatory disorders, chondrocalcinosis, hemachromatosis, inflammatory arthritis, avascular necrosis, etc.).
Trial design
Design model
Parallel
Treatments tested in this trial
Vutiglabridin
DrugOnce-daily oral administration
Placebo
DrugOnce-daily oral administration
Treatment groups
60 Participants
are divided into 3 treatment groupsGroup A: Vutiglabridin 600 mg Multiple DoseExperimental treatment 1 intervention
Group B: Vutiglabridin 1000 mg Multiple DoseExperimental treatment 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change from baseline in 100 mm VAS
Change from baseline (Day 1) in the maximum pain experienced during daily activity in the past 24 hours, as assessed by the subject using a 100 mm VAS(Visual Analog Scale; 0=no pain, 100=pain as bad as you can imagine) , at Week 26 post-dosing.
Time frame
From baseline to Week 26Secondary outcomes
1
Change from baseline in 100 mm VAS
Change from baseline (Day 1) in the maximum pain experienced during daily activity in the past 24 hours, as assessed by the subject using a 100 mm VAS(Visual Analog Scale; 0=no pain, 100=pain as bad as you can imagine) , at Week 4,8,13 and 26 post-dosing.
Time frame
From baseline to Week 4, 8, 132
Change from baseline in 100 mm VAS (weight-bearing)
Change from baseline (Day 1) in pain experienced during weight-bearing, as assessed by the subject using a 100 mm VAS, at Weeks 4, 8, 13, and 26 post-dosing.
Time frame
From baseline to Week 4, 8, 13, 263
Change from baseline in 100 mm VAS (at rest)
Change from baseline (Day 1) in pain experienced at rest, as assessed by the subject using a 100 mm VAS, at Weeks 4, 8, 13, and 26 post-dosing.
Time frame
From baseline to Week 4, 8, 13, 264
Change from baseline in 100 mm VAS (at night)
Change from baseline (Day 1) in pain experienced at night, as assessed by the subject using a 100 mm VAS, at Weeks 4, 8, 13, and 26 post-dosing.
Time frame
From baseline to Week 4, 8, 13, 26Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Glaceum
Lead sponsor
Seoul National University Hospital
Collaborator
Seoul National University Bundang Hospital
Collaborator
Source ClinicalTrials.gov