Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Active Phase 3 study of Bladder Cancer and Urothelial Carcinoma, sponsored by UroGen Pharma.
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. According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
CRR is defined as the percentage 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.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 240 participants |
| Start Date | 2022-03-01 |
| Est. Completion | 2028-02 |
| Phase | Phase 3 |
What the registry record for NCT05243550 still lists
NCT05243550 is an interventional study that assigns participants to a tested intervention. The registered 240 participants enrollment target is mid-sized for trials with a published cap, below the 12,752-participant average among 175 other Bladder Cancer trials with a reported enrollment target (98% lower).
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 names 20 study sites across 11 states, led by 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.
Learn More About Clinical Trials
Similar trials for Bladder Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05243550's enrollment target sits among peer trials
240 52nd of 175 higher than 124 of 175 other Bladder Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Bladder Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Outcomes of High-risk Non-muscle Invasive Bladder Cancer Treated With Blue Light Resection
RECRUITING · Phase 3
-
A Study of Surgical Techniques During Cystectomy
RECRUITING · Phase 3
-
Alvimopan Versus Placebo in Patients Undergoing Radical Cystectomy on an Enhanced Recovery Protocol
RECRUITING · Phase 3
-
A Study of TAR-200 in Combination With Cetrelimab or TAR-200 Alone Versus Intravesical Bacillus Calmette-Guérin (BCG) in Participants With BCG-naïve High-risk Non-muscle Invasive Bladder Cancer (HR-NMIBC)
ACTIVE NOT RECRUITING · Phase 3
-
A Phase 3 Study of UGN-103 for Treatment of Patients With Low-grade Intermediate-risk Non-muscle Invasive Bladder Cancer
ACTIVE NOT RECRUITING · Phase 3
-
A Study of Adjuvant Cretostimogene Grenadenorepvec for Treatment of Intermediate Risk NMIBC Following TURBT
ACTIVE NOT RECRUITING · Phase 3
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02855554 · 240 participants · NA
Quantitative Cardiac Parametric Mapping
- NCT03230565 · 240 participants · Phase 4
Continuous Infusions vs Scheduled Bolus Infusions
- NCT03399929 · 240 participants
Traumatic Brain Injury and Stroke Long Term Outcome
- NCT03583710 · 240 participants · Phase 3
Mitotane With or Without Cisplatin and Etoposide After Surgery in Treating Patients With Stage I-III Adrenocortical Cancer With High Risk of Recurrence
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI