Study to Evaluate the Efficacy, Safety and Tolerability of Vibegron in Men With Overactive Bladder (OAB) Symptoms on Pharmacological Therapy for Benign Prostatic Hyperplasia (BPH)

• ClinicalTrials.gov Identifier: NCT03902080
• Recruitment Status: Recruiting
• First Posted: April 3, 2019
• Last Update Posted: February 21, 2021
• Sponsor: Urovant Sciences GmbH
• Information provided by (Responsible Party): Urovant Sciences GmbH

Tracking Information

• First Submitted Date: April 1, 2019
• First Posted Date: April 3, 2019
• Last Update Posted Date: February 21, 2021
• Actual Study Start Date: March 26, 2019
• Estimated Primary Completion Date: June 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 1, 2019)

• Change from Baseline at Week 12 in the average number of micturition episodes per day [ Time Frame: Baseline; Week 12 ]
• Change from Baseline at Week 12 in the average number of urgency episodes (need to urinate immediately) per day [ Time Frame: Baseline; Week 12 ]

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: February 17, 2021)

• Change from Baseline at Week 12 in the average number of nocturia episodes per night [ Time Frame: Baseline; Week 12 ]
• Change from Baseline at Week 12 in the average number of urge urinary incontinence episodes per day for participants with urinary incontinence at Baseline [ Time Frame: Baseline; Week 12 ]
• Change from Baseline at Week 12 in the International Prostate Symptom Score (IPSS) Storage score (1-week recall) [ Time Frame: Baseline; Week 12 ]
• Change from Baseline at Week 12 in the average volume voided per micturition [ Time Frame: Baseline; Week 12 ]

Original Secondary Outcome Measures (submitted: April 1, 2019)

• Change from Baseline at Week 12 in the average number of nocturia episodes per night [ Time Frame: Baseline; Week 12 ]
• Change from Baseline at Week 12 in the average number of urge urinary incontinence episodes per day for participants with urinary incontinence at Baseline [ Time Frame: Baseline; Week 12 ]
• Change from Baseline at Week 12 in the average of International Prostate Symptom Score (IPSS) Storage score (1-week recall) [ Time Frame: Baseline; Week 12 ]
• Change from Baseline at Week 12 in the average volume voided per micturition [ Time Frame: Baseline; Week 12 ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Study to Evaluate the Efficacy, Safety and Tolerability of Vibegron in Men With Overactive Bladder (OAB) Symptoms on Pharmacological Therapy for Benign Prostatic Hyperplasia (BPH)
• Official Title: A Phase 3 Double-Blind, Randomized, Placebo-Controlled, Multi-Center Study to Evaluate the Efficacy, Safety and Tolerability of Vibegron in Men With Overactive Bladder (OAB) Symptoms on Pharmacological Therapy for Benign Prostatic Hyperplasia (BPH)
• Brief Summary: This study will assess the efficacy of vibegron compared with placebo in men with overactive bladder (OAB) symptoms on pharmacological therapy for benign prostatic hyperplasia (BPH) as defined by micturition and urgency episodes.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Overactive Bladder

Intervention

• Drug: Vibegron
  oral administration
  Other Names:

  • RVT-901
  • MK-4618
  • KRP-114V
  • URO-901
• Drug: Placebo
  oral administration

Study Arms

• Experimental: Vibegron 75 mg
  Participants will receive vibegron 75 milligrams (mg) orally once daily for 24 weeks.
  Intervention: Drug: Vibegron
• Placebo Comparator: Placebo
  Participants will receive matching placebo orally once daily for 24 weeks.
  Intervention: Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: April 1, 2019): 1088
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: June 2022
• Estimated Primary Completion Date: June 2022 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Participant should have been on and agree to continue to stay on a stable dose of benign prostatic hyperplasia (BPH) treatment with either a) alpha blocker monotherapy or b) alpha blocker + 5 alpha reductase inhibitor.
• Participant has an International Prostate Symptom Score total score of ≥ 8
• Participant has a prostate-specific antigen level < 4 nanograms per milliliter (ng/mL), or if ≥ 4 ng/mL but ≤ 10 ng/mL, prostate cancer has been ruled out to the satisfaction of the investigator
• Participant must have both additional qualifications based on the 3-day Bladder Diary period: a) having an average of ≥ 8 but ≤ 20 micturition episodes per day over the 3-day diary period, and (b) having an average of ≥ 3 urgency episodes per day over the 3-day diary period
• Participant must have a post void residual volume value of < 100 mL
• Having at least 2 average nocturia episodes per night based on 3-day Bladder Diary at baseline. Nocturia is defined as waking to pass urine during the main sleep period.

Exclusion Criteria:

• Participant has a history of 24-hour urine volume greater than 3,000 mL
• Has lower urinary tract pathology that could, in the opinion of the investigator, be responsible for urgency, frequency, or incontinence
• Has a history of prostate surgery, including minimally invasive transurethral or transrectal procedures, procedural treatments for BPH within 6 months of Screening or has a planned prostate surgery
• Has a history of urinary retention requiring an intervention (e.g., catheterization) for any reason
• Has maximum urinary flow (Qmax) < 5.0 mL/second with a minimum voided volume of 125 mL
• Has a history of or current nocturnal polyuria
• Has an active or recurrent (> 3 episodes per year) urinary tract infection by clinical symptoms or laboratory criteria (≥ 5 white blood cells/high power field [hpf] with presence of red blood cell [RBC] and/or a positive urine culture, defined as ≥ 10^5 colony forming units (CFU)/mL (i.e., 100 × 10^3 CFU/mL in a single specimen)
• Has uncontrolled hyperglycemia (defined as fasting blood glucose > 150 milligrams per deciliter (mg/dL) or 8.33 millimoles per liter (mmol/L) or non-fasting blood glucose > 200 mg/dL or 11.1 mmol/L) or, if in the opinion of the investigator, is uncontrolled
• 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 (min)
• Has a history of cerebral vascular accident, transient ischemic attack, unstable angina, myocardial infarction, coronary artery interventions (e.g., coronary artery bypass grafting or percutaneous coronary interventions [e.g., angioplasty, stent insertion]), or neurovascular interventions (e.g., carotid artery stenting) within 6 months prior to the Screening Visit
• Has alanine aminotransferase or aspartate aminotransferase > 2.0 times the upper limit of normal (ULN), or bilirubin (total bilirubin) > 1.5 × ULN (or > 2.0 × ULN if secondary to Gilbert syndrome or pattern consistent with Gilbert syndrome)
• Has an estimated glomerular filtration rate < 30 mL/min/1.73 meters squared (m^2)
• Has a history or current evidence of any condition, therapy, laboratory 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 the study procedure, or make participation in the study not in the participant's best interest

Sex/Gender

• Sexes Eligible for Study: Male

• Ages: 45 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Urovant Call Center; (833) 876-8268; clinicaltrials@urovant.com

• Listed Location Countries: Belgium, Canada, Hungary, Lithuania, Poland, Portugal, Spain, United States

Administrative Information

• NCT Number: NCT03902080
• Other Study ID Numbers: URO-901-3005; 2018-003135-30 ( EudraCT Number )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Yes
• 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.
• Supporting Materials: Study Protocol
• Supporting Materials: Statistical Analysis Plan (SAP)
• Supporting Materials: Clinical Study Report (CSR)
• 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.
• 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).

• Responsible Party: Urovant Sciences GmbH
• Study Sponsor: Urovant Sciences GmbH
• Collaborators: Not Provided

Investigators

• Study Director: Rachael Jankowich, RN, MSN; Urovant Sciences

• PRS Account: Urovant Sciences GmbH
• Verification Date: February 2021