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

Study Overview
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Brief Summary
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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).

Official Title
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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)

Conditions
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Overactive Bladder

Intervention / Treatment
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* Drug: Vibegron


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Long-term extension
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vibegron<br>Participants will receive 75 milligrams (mg) vibegron orally once daily (QD). | Drug: Vibegron<br>* oral administration<br>* Other names: URO-901;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Overactive Bladder, Benign Prostatic Hyperplasia, Vibegron, Beta-3 adrenergic receptor (β3-AR), β3-AR agonist