This is a Phase IV, randomized, double-blind, parallel-group, multiple-dose, active comparator, multicenter clinical study to evaluate the pharmacokinetics, efficacy, safety, and immunogenicity of SB5 versus Humira in subjects with moderate to severe chronic plaque psoriasis.
The primary objective of this study is to assess the pharmacokinetic similarity in subjects with moderate to severe plaque psoriasis who switch between Humira and SB5 to those receiving Humira continuously. All entered subjects will be treated with Humira during a lead-in period of 13 weeks. At Week 13, subjects who achieved at least a 50% reduction in Psoriasis Area and Severity Index (PASI50) response will be randomized in a 1:1 ratio to either be switched between Humira and SB5 or continue on Humira.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
371
Subcutaneous (SC) injection
Subcutaneous (SC) injection
SB Investigative Site
Dupnitsa, Bulgaria
SB Investigative Site
Pleven, Bulgaria
Area under the concentration-time curve over the dosing interval (AUCtau)
Time frame: Week 23 to Week 25
Maximum serum concentration during the dosing interval (Cmax)
Time frame: Week 23 to Week 25
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SB Investigative Site
Sofia, Bulgaria
SB Investigative Site
Ostrava, Czechia
SB Investigative Site
Pardubice, Czechia
SB Investigative Site
Prague, Czechia
SB Investigative Site
Kaunas, Lithuania
SB Investigative Site
Vilnius, Lithuania
SB Investigative Site
Bialystok, Poland
SB Investigative Site
Bydgoszcz, Poland
...and 13 more locations