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An Efficacy and Safety Study of GNR-068 (Ustekinumab Biosimilar) and Stelara® in the Treatment of Patients With Moderate to Severe Plaque Psoriasis

StatusCompleted
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Trial completed Show 4 more changesShow less
    • Study completion date changed from estimate of Sep 30, 2025 to Nov 26, 2025
    • Eligibility criteria expanded, about 28 words
    • Secondary endpoints: details revised at 8 of 9 entries
    • Site details revised at 32 of 34 sites
  2. Primary completion date changed from estimate of Dec 20, 2024 to Apr 30, 2025
    • Study completion date: Mar 20, 2025 to Sep 30, 2025
    • Site details revised at 24 of 34 sites
    v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
AO GENERIUM
9 trials monitored
See 1 trial at risk
Psoriasis
591 trials monitored
See 24 trials at risk
This is a randomized single-blind comparative parallel group efficacy and safety study of ustekinumab biosimilar GNR-068 (45 mg) and reference product Stelara® (45 mg) in the treatment of patients with moderate and severe forms of plaque psoriasis. Participants received a subcutaneous dose of ustekinumab 45 mg (GNR-068 or Stelara®) at weeks 0 and 4 weeks then every 12 weeks thereafter until week 28 and then all patients receive GNR-068 45 mg. For patients with partially respond to the initial regimen the regimen can be adjusted.
Trial Details
NCT Number NCT06488664
Lead Sponsor AO GENERIUM
Conditions
(from sponsor)		 Plaque Psoriasis
Enrollment 422 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov