Extension Study of Vibegron in Men With Overactive Bladder (OAB) Symptoms on Pharmacological Therapy for Benign Prostatic Hyperplasia (BPH)

A Phase 3 Open-Label Extension Study to Evaluate the Long-Term Safety and Efficacy of Vibegron in Men With Overactive Bladder (OAB) Symptoms on Pharmacological Therapy for Benign Prostatic Hyperplasia (BPH)

This study will assess the long-term safety of vibegron when dosed up to 52 weeks in men with overactive bladder (OAB) symptoms on pharmacological therapy for Benign Prostatic Hyperplasia (BPH) who previously completed treatment in Study URO-901-3005 (NCT03902080).

Study Overview

• Status: Completed
• Conditions: Overactive Bladder
• Intervention / Treatment: Drug: Vibegron

• Study Type: Interventional
• Enrollment (Actual): 276
• Phase: Phase 3

Contacts and Locations

Study Locations

• Poland
  • Krakow, Poland
    • Centrum Medyczne Linden
  • Krakow, Poland
    • Centrum Medyczne Promed
  • Oswiecim, Poland
    • Medicome Sp. z o.o.
  • Piaseczno, Poland
    • NZOZ Heureka
• United States
  • Alabama
    • Huntsville, Alabama, United States, 35801
      • Private Practice
  • California
    • Lincoln, California, United States, 95648
      • Clinical Trials Research
    • Los Angeles, California, United States, 90017
      • American Institute of Research
    • Murrieta, California, United States, 92562
      • Tri Valley Urology Medical Group
    • Sacramento, California, United States, 95821
      • Northern California Research Corp
    • San Diego, California, United States, 91942
      • San Diego Clinical Trials
    • Torrance, California, United States, 90505
      • Skyline Urology
  • Florida
    • Boynton Beach, Florida, United States, 33435
      • Imagine Research of Palm Beach County - Urology
    • Clearwater, Florida, United States, 33761
      • Tampa Bay Medical Research
    • Miami, Florida, United States, 33140
      • Quantum Clinical Trials
    • Pompano Beach, Florida, United States, 33060
      • Urology Center Of Florida
    • Sunrise, Florida, United States, 33351
      • Precision Clinical Research
    • Winter Haven, Florida, United States, 33880
      • Clinical Research of Central Florida
  • Louisiana
    • New Orleans, Louisiana, United States, 70115
      • Delricht Research
    • Shreveport, Louisiana, United States, 71106
      • Regional Urology, LLC
  • Massachusetts
    • Boston, Massachusetts, United States, 02131
      • Boston Clinical Trials Inc - Urology
    • Watertown, Massachusetts, United States, 02472
      • Bay State Clinical Trials, Inc.
  • Michigan
    • Royal Oak, Michigan, United States, 48703
      • Beaumont Hospital Royal Oak - Urology Research
  • Minnesota
    • Sartell, Minnesota, United States, 56377
      • CentraCare Clinic - Adult & Pediatric Urology
  • Missouri
    • Poplar Bluff, Missouri, United States, 63901
      • Poplar Bluff Urology
  • Nebraska
    • Omaha, Nebraska, United States, 68114
      • Adult & Pediatric Urology P.C. - Urology
  • Nevada
    • Las Vegas, Nevada, United States, 89109
      • Excel Clinical Research - Internal Medicine
    • Las Vegas, Nevada, United States, 89144
      • Private Practice
  • New Jersey
    • Edison, New Jersey, United States, 08837
      • Premier Urology Group, LLC
    • Englewood, New Jersey, United States, 07631
      • New Jersey Urology NJU
  • New York
    • Garden City, New York, United States, 11530
      • AccuMed Research Associates
    • Garden City, New York, United States, 11530
      • Urological Surgeons of Long Island
  • Ohio
    • Middleburg Heights, Ohio, United States, 44130
      • Clinical Research Solutions
  • Texas
    • Houston, Texas, United States, 77030
      • Advances in Health, Inc.
  • Utah
    • Salt Lake City, Utah, United States, 84107
      • Wasatch Clinical Research LLC
  • Washington
    • Burien, Washington, United States, 98166
      • Seattle Urology Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Participant has completed participation of the 24-week double-blind treatment period in Study URO-901-3005 (NCT03902080) and demonstrated compliance with the study procedures and study medication schedule in the opinion of the investigator.
• Participant is capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
• Participant has the ability to continue to receive a stable dose of Benign Prostatic Hyperplasia (BPH) treatment with either a) alpha blocker monotherapy or b) alpha blocker +5-ARI.
• In the opinion of the investigator, the participant is able and willing to comply with the requirements of the protocol, including completing study questionnaires and the Bladder Diary.

Exclusion Criteria:

• Participant experienced any Serious Adverse Event in Study URO-901-3005 that was reported as "possibly or probably related" to study treatment by the investigator.
• Participant is using any prohibited medications
• Participant has uncontrolled hyperglycemia (defined as fasting blood glucose >150 milligrams per deciliter [mg/dL] or 8.33 millimoles per Liter [mmol/L] and/or non-fasting blood glucose >200 mg/dL or 11.1 mmol/L) based on most recent available lab results in Study URO-901-3005 or uncontrolled in the opinion of the investigator.
• Participant has uncontrolled hypertension (systolic blood pressure of ≥180 millimeters of mercury [mmHg] and/or diastolic blood pressure of ≥100 mmHg) or has a resting heart rate (by pulse) >100 beats per minute.
• Participant has systolic blood pressures ≥160 mmHg but <180 mmHg, unless deemed by the investigator as safe to proceed in this study and able to complete the study per protocol.
• Participant has current evidence of any clinically significant condition, therapy, lab abnormality, or other circumstances that might, in the opinion of the investigator, confound the results of the study, interfere with the participant's ability to comply with study procedures, or make participation in the study not in the participant's best interest.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vibegron; Participants will receive 75 milligrams (mg) vibegron orally once daily (QD).	Drug: Vibegron; oral administration; Other Names: RVT-901; MK-4618; KRP-114V; URO-901

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of Participants with any Adverse Event	From signing of informed consent up to 21 days after the last dose of study drug (up to approximately 52 weeks)
Number of Participants with any Clinically Significant Clinical Laboratory Value	From signing of informed consent up to 21 days after the last dose of study drug (up to approximately 52 weeks)
Number of Participants with any Clinically Significant Vital Sign Assessment	From signing of informed consent up to 21 days after the last dose of study drug (up to approximately 52 weeks)

Secondary Outcome Measures

Outcome Measure	Time Frame
Change from Baseline at Week 52 in the Average Number of Micturition Episodes per Day	Baseline; Week 52
Change from Baseline at Week 52 in the Average Number of Urgency Episodes per Day	Baseline; Week 52
Change from Baseline at Week 52 in the Average Number of Nocturia Episodes per Night	Baseline; Week 52
Change from Baseline at Week 52 in the Average Number of Urge Urinary Incontinence Episodes per Day in Participants with Incontinence at Study URO-901-3005 Baseline	Baseline; Week 52
Change from Baseline at Week 52 in the Average of the International Prostate Symptom Score (IPSS) Storage Score (1-week recall)	Baseline; Week 52
Change from Baseline at Week 52 in the Average Volume Voided per Micturition	Baseline; Week 52

Collaborators and Investigators

• Sponsor: Urovant Sciences GmbH
• Investigators: Study Director: Study Director, Urovant Sciences

Study record dates

Study Major Dates

• Study Start (Actual): September 19, 2019
• Primary Completion (Actual): July 29, 2022
• Study Completion (Actual): July 29, 2022

Study Registration Dates

• First Submitted: September 23, 2019
• First Submitted That Met QC Criteria: September 23, 2019
• First Posted (Actual): September 25, 2019

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: February 28, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Benign Prostatic Hyperplasia; Overactive Bladder; Vibegron; Beta-3 adrenergic receptor (β3-AR); β3-AR agonist
• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Prostatic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Urinary Bladder, Overactive; Prostatic Hyperplasia; Hyperplasia
• Other Study ID Numbers: URO-901-3006; 2018-003136-72 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Urovant is committed to sharing patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Data requests will be reviewed and approved on the basis of scientific merit. All data provided will be anonymized according to applicable laws and regulations.
• IPD Sharing Time Frame: The data will be made available within 24 months after study completion and will be accessible for a time frame appropriate for the approved proposal.
• IPD Sharing Access Criteria: Access to these clinical trial data can be requested by emailing medinfo@urovant.com and will be provided following Urovant review and approval of a research proposal and execution of a Data Sharing Agreement (DSA).
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No