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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
60
Once-daily oral administration
Once-daily oral administration
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
RECRUITINGChange 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 26
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, 13
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, 26
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, 26
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, 26
Change from baseline in WOMAC pain subscale
Change from baseline (Day 1) in the total WOMAC(Western Ontario and McMaster Universities Osteoarthritis Index) score and scores for each subscale (pain, function, and stiffness) as assessed by the subject, at Weeks 4, 8, 13, and 26 post-dosing.
Time frame: From baseline to Week 4, 8, 13, 26
Subjects who reached a score of 30 mm or less on the 100 mm VAS.
The proportion of subjects who reached a pain score of 30 mm or less on the 100 mm VAS at Weeks 4, 8, 13, and 26 post-dosing, as assessed by the subject.
Time frame: From baseline to Week 4, 8, 13, 26
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