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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms

  • Moderate to Severe Plaque Psoriasis
  • Psoriasis

NCT number NCT04967508
Study type Interventional
Source Samsung Bioepis Co., Ltd.
Contact
Status Completed
Phase Phase 3
Start date July 6, 2021
Completion date November 25, 2022

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