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

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	Measure Description	Time Frame
Number of Participants With Any Serious Adverse Event, and Treatment Emergent Adverse Event (>5%)	Adverse events were collected in participants from time each participant provided informed consent in parent study through Follow-up Visit (approximately 5 days after the last dose of study drug) in this extension study (URO-901-3006 [NCT03902080]). For the 28-Week Vibegron group, AEs recorded prior to initiation of vibegron (ie, while receiving placebo in the parent study) were reported as AEs in the parent study. An SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, associated with liver injury and impaired liver function or any other situations as per medical or scientific judgement. A TEAE was defined as an adverse event which occurred on or after the first dose of study drug and no more than 30 days after the last dose of study drug. TEAE of >5% has been reported.	Up to Week 52
Number of Participants With Clinically Significant Changes in Hematology Parameters	Blood samples were collected for the analysis of hematology parameters - Hematocrit, hemoglobin, platelet count, white blood cells (WBC [total and differential]), and red blood cells (RBC).	Up to Week 52
Number of Participants With Clinically Significant Changes in Chemistry Parameters	Blood samples were collected for the analysis of chemistry parameters - Albumin, alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), bicarbonate, calcium, chloride, creatininea, glucose (fasting or nonfasting), potassium, sodium, total bilirubin, direct bilirubin, blood urea nitrogen (BUN), and total cholesterol.	Up to Week 52
Number of Participants With Clinically Significant Changes in Urinary Parameters	Urine samples were collected for the analysis of urinary parameters- Blood, glucose, protein, specific gravity, microscopic exam (RBCs, WBCs, epithelial cells, and bacteria), potential of hydrogen (pH) and color	Up to Week 52
Number of Participants With Clinically Significant Changes in Coagulation Parameter	Blood samples were collected for the analysis of coagulation parameters- international normalized ratio (INR), prothrombin time (PT) and activated partial thromboplastin time (APTT).	Up to Week 52
Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)	Blood pressure measurements were taken with the participant in the sitting position. Baseline is defined as the last recorded value on or prior to the date of randomization in the parent study URO-901-3005. Change from Baseline was calculated as maximum post-Baseline value minus Baseline value.	Baseline; Week 52
Change From Baseline in Heart Rate	Heart Rate was measured with the participant in the sitting position. Baseline is defined as the last recorded value on or prior to the date of randomization in the parent study URO-901-3005. CFB was calculated as maximum post-Baseline value minus Baseline value.	Baseline; Week 52

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline at Week 52 in the Average Number of Micturition Episodes Per Day	Micturition is defined as "Urinated in Toilet" as indicated on Bladder Diary. Micturition episodes are the number of times participants voided in the toilet as indicated on the Bladder Diary, either by marking the 'urinated in toilet' question as yes or recording non-zero volume voided. Average number of micturition episodes/day was calculated using records within the diary analysis visit divided by non-missing diary days (diary days with at least one void reported). A "Diary Day" is defined as the time between when the participants gets up for the day (ie, the time the participant got up for the day yesterday to the time participant got up for the day today; approximately a 24-hour period). The last recorded value on or prior to the date of randomization in the parent study URO-901-3005 is defined as Baseline. Change from Baseline was calculated as post-Baseline value minus Baseline value.	Baseline; Week 52
Change From Baseline at Week 52 in the Average Number of Urgency Episodes Per Day	The number of urgency episodes was defined as the number of times a participant checked that they had the need to urinate immediately as indicated on the Bladder Diary. Average number of daily urgency episodes at each study visit was calculated as the total number of urgency episodes using records within the diary analysis visit windows divided by non-missing diary days. The last recorded value on or prior to the date of randomization in the parent study URO-901-3005 is defined as Baseline. Change from Baseline was calculated as post-Baseline value minus Baseline value.	Baseline; Week 52
Change From Baseline at Week 52 in the Average Number of Nocturia Episodes Per Night	A nocturia episode is defined as waking to pass urine during the main sleep period as indicated on the Bladder diary. Average number of nocturia episode at each study visit was calculated as the total number of nocturia episode recorded within the diary analysis visit windows divided by non-missing diary days. The last recorded value on or prior to the date of randomization in the parent study URO-901-3005 is defined as Baseline. Change from Baseline was calculated as post-Baseline value minus Baseline value.	Baseline; Week 52
Change From Baseline at Week 52 in the Average Number of Urge Urinary Incontinence (UUI) Episodes Per Day in Participants With Incontinence	The number of UUI episodes was defined as the number of times a participant checked that they had "urge" as the main reason for leakage. Average UUI episodes per day at each study visit was calculated as total number of UUI episodes within the diary analysis visit windows divided by non-missing diary days. The UUI was analyzed for participants with UI at Baseline. The last recorded value on or prior to the date of randomization in the parent study URO-901-3005 is defined as Baseline. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.	Baseline; Week 52
Change From Baseline at Week 52 in the Average of the International Prostate Symptom Score (IPSS) Storage Score (1-week Recall)	The International Prostate Symptom Score (IPSS) is a rating scale for severity of lower urinary tract symptoms (LUTS). The IPSS is based on 7 questions concerning urinary symptoms and 1 question concerning quality of life. Each question concerning urinary symptoms allows the participant to choose 1 out of 6 answers indicating increasing severity of the symptom. The answers are assigned points from 0 to 5. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic). Higher scores represent greater severity of symptoms. The last recorded value on or prior to the date of randomization in the parent study URO-901-3005 is defined as Baseline. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.	Baseline; Week 52
Change From Baseline at Week 52 in the Average Volume Voided Per Micturition	Total volume voided was calculated using all urinary volumes collected regardless of whether participant checked "Urinated in Toilet" or not. Average volume voided per micturition at each study visit was calculated as the total volume voided recorded divided by the number of micturitions with volume recorded. The last recorded value on or prior to the date of randomization in the parent study URO-901-3005 is defined as Baseline. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.	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): August 21, 2024
• Last Update Submitted That Met QC Criteria: July 29, 2024
• Last Verified: June 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