This study is designed to evaluate efficacy, safety, pharmacokinetics (PK) and immunogenicity of subcutaneously administered DMB-3115 in comparison with Stelara for treatment of moderate to severe chronic plaque psoriasis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
598
Central Sooner Research
Norman, Oklahoma, United States
Jordan Valley Dermatology Center
West Jordan, Utah, United States
• To Evaluate Efficacy of DMB-3115 in Comparison With Stelara
Percent change in the Psoriasis Area and Severity Index (PASI) score. PASI score is calculated by evaluating the severity of symptoms in each regions of the subject, and produces a numeric score ranging from 0 to 72. The higher the number, the more severe the symptoms. In general, a PASI score of 5 to 10 is considered moderate disease, and a score over 10 is considered severe. The primary endpoint of this clinical trial is % change in PASI, which has a value between 0 and 100, with 100 indicating complete disappearance of symptoms and 0 indicating no improvement in symptoms. If the patient's Baseline PASI score was 10, and 5 at the measurement period, it means that the patient showed 50% reduction.
Time frame: Week 8 (For EMA) and 12 (For FDA)
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