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NCT05243550 · ClinicalTrials.gov registry record · Phase 3

A Phase 3 Single-Arm Study of UGN-102 for Treatment of Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer

A Phase 3 study of Bladder Cancer and Urothelial Carcinoma, sponsored by UroGen Pharma.

Active
Registry status
Phase 3
Development phase
240
Enrollment target
20
Study locations

NCT05243550 is a Phase 3 study of Bladder Cancer and Urothelial Carcinoma that is active but no longer recruiting, run by UroGen Pharma. The registered enrollment target is 240 participants, below the 12,752-participant average among 175 other Bladder Cancer trials with a reported enrollment target (98% lower). The trial reports 20 study locations across 11 states.

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The verdict

NCT05243550, a Phase 3 study of Bladder Cancer and Urothelial Carcinoma, is active but no longer recruiting, sponsored by UroGen Pharma.

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
240 participants
Enrollment target
20
Study locations

Study Summary

This Phase 3, multinational, single-arm study was designed to evaluate the efficacy and safety of UGN-102 as primary chemoablative therapy in patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC).

Conditions Studied

Bladder Cancer Urothelial Carcinoma Urothelial Carcinoma Bladder

Interventions

  • DRUG UGN-102

Study Locations (20)

New York

  • Great Lakes Physician dba WNY Urology Associates - Cheektowaga
  • AccuMed Research Associates - Garden City
  • Manhattan Medical Research - New York
  • NYU Langone Health - New York
  • Mount Sinai - New York

Other

  • Medical University Vienna, Department of Urology - Vienna
  • Multiprofile Hospital for Active Treatment - Blagoevgrad - Blagoevgrad
  • Multiprofile Hospital for Active Treatment "Dr. Tota Venkova", Gabrovo, Department of Urology - Gabrovo
  • Multiprofile Hospital for Active Treatment "Sveti Nikolai Chudotvorets", Lom - Lom

California

  • Loma Linda University Medical Center - Loma Linda
  • Genesis Research - San Diego

Maryland

  • John Hopkins University - Baltimore
  • Chesapeake Urology Research Associates - Hanover

Arizona

  • Arizona Urology Specialists - Tucson

Kansas

  • Wichita Urology Group - Wichita

Missouri

  • University of Missouri - Columbia

New Jersey

  • Atlantic Health System - Morristown

Trial Details

FieldValue
Enrollment Target 240 participants
Start Date 2022-03-01
Est. Completion 2028-02
Phase Phase 3

Sponsor

UroGen Pharma

9 total trials

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What the Registry Record Tells You About NCT05243550

The ClinicalTrials.gov registry entry for NCT05243550 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 240 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 12,752-participant average among 175 other Bladder Cancer trials with a reported enrollment target (98% lower). The listed sponsor is UroGen Pharma, which has 9 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Bladder Cancer appearing as the primary indexed condition, and to 1 intervention - of which UGN-102 is the first listed.

NCT05243550 reports 20 study locations spanning 11 distinct geographic areas - top geographies include New York, Other, California.

Frequently Asked Questions

What is clinical trial NCT05243550 about?

NCT05243550 is a clinical study titled "A Phase 3 Single-Arm Study of UGN-102 for Treatment of Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer". This Phase 3, multinational, single-arm study was designed to evaluate the efficacy and safety of UGN-102 as primary chemoablative therapy in patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC).

What is the current status of trial NCT05243550?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 240 participants. The study started on 2022-03-01. Estimated completion is 2028-02.

What conditions does trial NCT05243550 study?

This clinical trial studies the following conditions: Bladder Cancer, Urothelial Carcinoma, Urothelial Carcinoma Bladder.

What interventions are being tested in trial NCT05243550?

The interventions under investigation include: UGN-102 (DRUG).

Who is sponsoring clinical trial NCT05243550?

This trial is sponsored by UroGen Pharma, which has 9 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05243550 being conducted?

This trial has 20 study locations across Arizona, California, Kansas, Maryland, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.