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ACTIVE NOT RECRUITING Phase 3

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

NCT05243550 · View on ClinicalTrials.gov ↗

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).

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

34 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05243550

The ClinicalTrials.gov registry entry for NCT05243550 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 240 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is UroGen Pharma, which has 34 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05243550 reports 20 study locations spanning 11 distinct geographic areas — top geographies include New York, Other, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05243550?

The interventions under investigation include: UGN-102 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05243550?

This trial is sponsored by UroGen Pharma, which has 34 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial