Psoriasis Clinical Trial
Official title:
Multicenter, Double-Blind, Randomized, 2-Arm, Parallel-Group, Equivalence Study Evaluating Efficacy and Safety Similarity of Mylan Adalimumab (MYL-1401A) Compared With Humira® in Subjects With Moderate-to-Severe Chronic Plaque Psoriasis
To assess the equivalence of MYL-1401A to Humira® with regards to efficacy in subjects with moderate-to-severe chronic plaque psoriasis
Eligible subjects will be randomly assigned based on predefined stratification factors of weight, geographic region, and presence of psoriatic arthritis: Randomization is 2:1 to MYL-1401A or Humira®, respectively. The study will be conducted in the outpatient setting and comprises 3 periods: a screening period of up to 4 weeks, a 52-week treatment period, and a safety follow-up for 8 weeks. A subject will be considered to have completed the study once they have completed the 52-week treatment period and the 8-week follow-up visit. ;
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