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A Randomized, Active-Controlled, Double-Blind, Phase 3 Study to Compare the Efficacy and Safety of CT-P43 to Stelara in Patients With Moderate to Severe Plaque Psoriasis

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Trial Profile

A Randomized, Active-Controlled, Double-Blind, Phase 3 Study to Compare the Efficacy and Safety of CT-P43 to Stelara in Patients With Moderate to Severe Plaque Psoriasis

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 20 Jun 2025

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At a glance

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

Most Recent Events

  • 15 Jun 2025 According to a Celltrion media release, the U.S. Food and Drug Administration (FDA) has approved a new presentation of STEQEYMA (ustekinumab-stba), a biosimilar to STELARA (ustekinumab), in a 45mg/0.5mL solution in a single-dose vial for subcutaneous injection. The additional presentation is approved for the treatment of pediatric patients aged 6 to 17 years, weighing less than 60kg, with plaque psoriasis (PsO) or psoriatic arthritis (PsA).
  • 12 Mar 2025 According to a Celltrion media release, company announced the U.S. launch of STEQEYMA(ustekinumab-stba), a biosimilar to STELARA (ustekinumab), following approval by the U.S. Food and Drug Administration (FDA) in December 2024 based on result of this trial.
  • 17 Dec 2024 According to a Celltrion media release, company announced that the U.S. Food and Drug Administration (FDA) has approved STEQEYMA and the The FDA approval of STEQEYMA was based on the totality of evidence, including the results from a phase III study in adults with moderate to severe plaque psoriasis.

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