A Study to Compare SB17 (Proposed Ustekinumab Biosimilar) to Stelara® in Subject With Moderate to Severe Plaque Psoriasis
brief summary
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.
detailed description
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.
official title
A Phase III, Randomised, Double-blind, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Immunogenicity of SB17 (Proposed Ustekinumab Biosimilar) Compared to Stelara® in Subjects With Moderate to Severe Plaque Psoriasis