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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

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Trial Profile

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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 29 May 2025

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At a glance

  • Drugs Ustekinumab (Primary)
  • Indications Plaque psoriasis
  • Focus Registrational; Therapeutic Use
  • Sponsors Samsung Bioepis

Most Recent Events

  • 01 Dec 2024 Results assessing efficacy, safety, and immunogenicity of SB17 to UST up to Week 52,published in the Journal of Dermatological Treatment
  • 01 Jul 2024 According to a Samsung Bioepis media release, announced today that the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for PYZCHIVA (ustekinumab-ttwe) subcutaneous injection and intravenous infusion as a biosimilar to Stelara based on phase 1 clinical study (NCT04772274) & Phase 3 clinical study (NCT04967508).
  • 01 Jul 2024 According to a Samsung Bioepis media release, primary results of this study were published in the Journal of the American Academy of Dermatology.

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