A Phase 3 Study of UGN-103 for Treatment of Patients With Low-grade Intermediate-risk Non-muscle Invasive Bladder Cancer
NCT06331299 · UTOPIA Phase 3Completed
- Lead sponsor
- UroGen Pharma Ltd. (Industry)
- Enrollment
- 99 (actual)
- Start date
- 29 Aug 2024
- Primary completion
- 11 Sep 2025 (actual)
- Study completion
- 15 Sep 2026
- Last update posted
- 22 Oct 2026
Design
- Study type
- Interventional
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None
- Arms
- 1
Interventions
- UGN-103 Drug
Conditions and primary outcome
- Bladder Cancer
- Urothelial Carcinoma
- Urothelial Carcinoma Bladder
Primary outcome
Complete Response Rate (CRR) (3 months)
Posted results on ClinicalTrials.gov
Source: ClinicalTrials.gov results for NCT06331299 (opens in a new tab)· Licence: public-domain
First posted · Last update posted · Imported from ClinicalTrials.gov download 2026-10-25
Primary outcomes with a statistical analysis
No primary outcome with a statistical analysis is posted for this study.
Serious adverse events
Time frame: Up to 15 months. Study conduct is ongoing and data are summarized through a cutoff date of 18 Mar 2026. As of the data cutoff date, ongoing patients were followed through at least Study Month 9, with the earliest enrolled patients followed through Study Month 15.
| Group | Affected | At risk |
|---|---|---|
| UGN-103 | 2 | 99 |
Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately.
Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.
Results from company and journal sources
No editor-confirmed results are on record for this study.
Publications
No PubMed citation lists NCT06331299.
CT-VCA trial quality
About CT-VCALoading CT-VCA scores…
Data integrity
Compare what the registry, company releases, FDA documents and publications say about this study.
Drugs on HealthTrade
Source
- NCT06331299 on ClinicalTrials.gov (opens in a new tab) Licence: public-domain. Read
Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.
Nothing on this page is medical or investment advice.