This is a randomised, double-blind, multicentre clinical study to evaluate the efficacy, safety, tolerability, PK, and immunogenicity of SB17 compared to Stelara® in subjects with moderate to severe plaque psoriasis.
Subjects will be randomised in a 1:1 ratio to receive either SB17 or Stelara® via subcutaneous injection. At Week 28, subjects receiving Stelara® will be randomised again in a 1:1 ratio to either continue on Stelara® or be transitioned to SB17. Investigational products (IPs) (SB17 or Stelara®) will be administered at Week 0, 4, and then every 12 weeks up to Week 40, and the last assessment will be done at Week 52.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
503
Subjects randomised into Stelara® group will receive Stelara® (45 mg) via subcutaneous injection at Week 0, 4, and then every 12 weeks up to Week 40.
Subjects randomised into SB17 group will receive SB17 (45 mg) via subcutaneous injection at Week 0, 4, and then every 12 weeks up to Week 40. Starting at Week 28, subjects transited from Stelara® to SB17 will receive SB17 via subcutaneous injection.
SB Investigative Site
Brno, Czechia
Percent Change From Baseline in PASI at Week 12
Psoriasis area severity index (PASI) measures the activity of psoriasis through erythema, induration and scaling and can range from 0 to 72. The degree of PASI improvement in terms of percent change from baseline at Week 12 is measured.
Time frame: Baseline and Week 12
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SB Investigative Site
Ostrava, Czechia
SB Investigative Site
Pardubice, Czechia
SB Investigative Site
Prague, Czechia
SB investigative site
Tallinn, Estonia
SB Investigative Site
Tartu, Estonia
SB Investigative Site
Zalaegerszeg, Hungary
SB Investigative Site
Riga, Latvia
SB Investigative Site
Talsi, Latvia
SB Investigative Site
Kaunas, Lithuania
...and 22 more locations