NCT06331299Phase 3Active not recruiting

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

UroGen Pharma Ltd. · URGN

Primary completion2025-09-11ACTUAL
Enrollment99ACTUAL
Source updated2026-09-28Values from available record
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Primary OutcomesText edit · unverified significance
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measure: Complete response rate (CRR); description: CRR is defined as the proportion of patients who achieved CR at the 3-month Visit.; timeFrame: 3 months

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measure: Complete Response Rate (CRR); description: CRR is defined as the proportion of patients who achieved a complete response (CR) at the 3-month Visit. A patient was considered a CR if there was no detectable disease in the bladder based on visual observation (white light cystoscopy), biopsy of remaining lesions (if applicable), and voiding urine cytology.; timeFrame: 3 months

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Enrollment TypeRecorded edit
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ESTIMATED

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ACTUAL

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EnrollmentRecorded edit
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count: 92; type: ESTIMATED

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count: 99; type: ACTUAL

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Completion TypeRecorded edit
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ESTIMATED

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ACTUAL

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Primary CompletionRecorded edit
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2025-08

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2025-09-11

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StatusRecorded edit
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RECRUITING

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ACTIVE_NOT_RECRUITING

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