The study is designed to investigate efficacy and safety of KBL697 in patients with Moderate Plaque Type Psoriasis. KBL697 has been developed as a potential new treatment for Psoriatic Plaque.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
80
Total Skin and Beauty Dermatology Center
Birmingham, Alabama, United States
Southern California Dermatology, Inc
Santa Ana, California, United States
Clinical Science Institute
Santa Monica, California, United States
Psoriasis Area and Severity Index (PASI)
Change from Baseline in PASI score
Time frame: Baseline to Week 12
Psoriasis Area and Severity Index (PASI)
Change from Baseline in PASI score
Time frame: Baseline to Weeks 2, 4 and 8
Psoriasis Area and Severity Index (PASI) -50
Percent of patients who achieved PASI-50
Time frame: Baseline to Week 12
Psoriasis Area and Severity Index (PASI) -75
Percent of patients who achieved PASI-75
Time frame: Baseline to Week 12
Physician's Global Assessment (PGA)
Change from Baseline in PGA score
Time frame: Baseline to Weeks 4, 8 and 12
Physician's Global Assessment (PGA)
Percent of patients who achieve PGA score of 0 or 1
Time frame: Week 12
Psoriasis-Affected Body Surface Area (BSA)
Change from Baseline in Psoriasis-Affected BSA
Time frame: Baseline to Weeks 4, 8 and 12
Safety measure through incidence of treatment-emergent adverse events (TEAEs)
The number of patients experiencing TEAEs and number of individual TEAEs will be summarized among treatment arms, by system organ class (SOC) and PT. TEAEs will also be summarized among treatment arms, by severity and by relationship to study drug.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Revival Research Institute
Doral, Florida, United States
Indago Research and Health Center
Hialeah, Florida, United States
Louisiana Dermatology Associates - Dermatology
Baton Rouge, Louisiana, United States
Premier Specialist
Kogarah, New South Wales, Australia
Westmead Hospital
Westmead, New South Wales, Australia
Veracity Clinical Trials Ltd
Woolloongabba, Queensland, Australia
Sinclair Dermatology
East Melbourne, Victoria, Australia
Time frame: Baseline to Week 16