A Phase 3 Study of UGN-103 for Treatment of Patients With Low-grade Intermediate-risk Non-muscle Invasive Bladder Cancer

Study acronym: UTOPIA
StatusActive, Not Recruiting
PhasePhase 3
Started

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Record History

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  1. Results posted: Sep 28, 2026 Show 5 more changesShow less
    • Eligibility criteria expanded, about 39 words
    • Secondary endpoints: 5 to 7
    • Primary endpoint revised
    • Study description expanded, about 33 words
    • Site details revised at 7 of 48 sites
  2. Trial status: Recruiting to Active, Not Recruitingv9 Show 5 more changesShow less
    • Enrollment target: estimated 92 to confirmed 99
    • Study sites: 14 to 48
    • Primary completion date changed from estimate of Aug 2025 to Sep 11, 2025
    • Study completion date: Aug 2026 to Sep 2026
    • Study description revised
  3. Enrollment target: 87 to 92
    • Primary completion date: Jul 2025 to Aug 2025
    • Study completion date: Jul 2026 to Aug 2026
    • Site contacts updated at 1 of 14 sites
    v8
  4. Study sites: 10 to 14v7
  5. Study sites: 5 to 10
    • Primary completion date: Mar 2025 to Jul 2025
    • Study completion date: Mar 2026 to Jul 2026
    v6
Show 4 earlier versionsHide 4 earlier versions
  1. Study sites: 3 to 5
    • Start date changed from estimate of Sep 2024 to Aug 29, 2024
    v5
  2. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Jul 2024 to Sep 2024
    • Study sites: 0 to 3
    v4
  3. Secondary endpoints: details revised at 2 of 5 entriesv3
  4. Eligibility criteria revised
    • Study description expanded, about 14 words
    • Study title shortened, about 1 word
    v2
  1. Study First Submitted
  • 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.
This Phase 3, single-arm, multicenter study was designed to evaluate the efficacy and safety of UGN-103, a novel formulation of UGN-102, instilled in the urinary bladder of patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC).
Trial Details
NCT Number NCT06331299
Lead Sponsor UroGen Pharma Ltd.
Conditions
(from sponsor)		 Bladder Cancer, Urothelial Carcinoma, Urothelial Carcinoma Bladder
Related terms Carcinoma, Transitional Cell, Non-Muscle Invasive Bladder Neoplasms, Urinary Bladder Neoplasms
Enrollment 99 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov