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    Summary
    EudraCT Number:2018-003135-30
    Sponsor's Protocol Code Number:URO-901-3005
    National Competent Authority:Portugal - INFARMED
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-02-05
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedPortugal - INFARMED
    A.2EudraCT number2018-003135-30
    A.3Full title of the trial
    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)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to evaluate vibegron in men taking stable BPH medications who have overactive bladder symptoms
    A.3.2Name or abbreviated title of the trial where available
    Vibegron in Men with BPH with OAB
    A.4.1Sponsor's protocol code numberURO-901-3005
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorUrovant Sciences GmbH
    B.1.3.4CountrySwitzerland
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportUrovant Sciences GmbH
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUrovant Sciences GmbH
    B.5.2Functional name of contact pointClinical Trial Information Contact
    B.5.3 Address:
    B.5.3.1Street AddressGrosspeter Tower, Grosspeteranlage 29, suites 2006-2010
    B.5.3.2Town/ cityBasel
    B.5.3.3Post code4052
    B.5.3.4CountrySwitzerland
    B.5.6E-mailinfo@urovant.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameVibegron
    D.3.2Product code URO-901, RVT-901
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNVIBEGRON
    D.3.9.1CAS number 1190389-15-1
    D.3.9.2Current sponsor codeURO-901, RVT-901
    D.3.9.4EV Substance CodeSUB189006
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Overactive Bladder (OAB) in men with Benign Prostatic Hyperplasia (BPH)
    E.1.1.1Medical condition in easily understood language
    Overactive bladder (OAB)
    E.1.1.2Therapeutic area Diseases [C] - Symptoms and general pathology [C23]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.1
    E.1.2Level LLT
    E.1.2Classification code 10059617
    E.1.2Term Overactive bladder
    E.1.2System Organ Class 100000004857
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the efficacy, safety, and tolerability of vibegron versus placebo in men with OAB symptoms on pharmacological therapy for BPH
    E.2.2Secondary objectives of the trial
    To assess the efficacy of vibegron compared with placebo in men with OAB symptoms on pharmacological therapy for BPH as defined by other key measures
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    SUB-STUDY IS APPLICABLE ONLY FOR THE UNITED STATES

    Urodynamics Assessments
    For the 60 subjects participating in the urodynamics sub-study in Part 2, urodynamics will be taken at Baseline and Week 12 to measure certain parameters
    E.3Principal inclusion criteria
    1. Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
    2. Male subjects of 45 years of age and above.
    3. Body weight ≥ 50 kg (inclusive).
    4. Subject should have been on and agree to continue to stay on a stable dose of BPH treatment with either a) alpha blocker monotherapy or b) alpha blocker + 5 ARI. Subjects on alpha blockers should have started their therapy at least 3 months prior to screening and be on a stable dose at the start of screening. Subjects on a 5-ARI should have started therapy at least 6 months prior to screening and be on a stable dose at screening.
    5. Has a history of overactive bladder symptoms (frequency of ≥ 8 micturition episodes per day and urgency episodes of ≥ 3 per day with or without incontinence) while taking pharmacological therapy for at least 2 months to treat LUTS due to BPH.
    6. Subject has an IPSS total score of ≥ 8 at Screening and Visit 3 (Baseline).
    7. Subject has a prostate-specific antigen (PSA) level < 4 ng/mL, or if ≥ 4 ng/mL but ≤ 10 ng/mL, prostate cancer has been ruled out to the satisfaction of the investigator.
    8. Subjects agrees to not participate in another interventional drug or device clinical trial during the study.
    9. In the opinion of the investigator, is able and willing to comply with the requirements of the protocol, including completing study questionnaires and the Bladder Diary.
    10. At Visit 2 (Run-in) and Visit 3 (Baseline) visits, subject 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.
    11. Subject must have a post void residual (PVR) volume value of < 100 mL at Screening, Visit 2 (Run-In) and Visit 3 (Baseline).
    12. At Visit 2 (Run-in) and Visit 3 (Baseline) visits, 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.
    E.4Principal exclusion criteria
    1. Subject has a history of 24-hour urine volume greater than 3,000 mL or over 3,000 mL based on 3-day Bladder Diary at Visit 2 (Run-In ) or Visit 3 (Baseline) visits.
    2. Has lower urinary tract pathology that could, in the opinion of the investigator, be responsible for urgency, frequency, or incontinence; including, but not limited to, bladder stones, interstitial cystitis, prostate cancer, persistent urethral stricture, urogenital tuberculosis, and urothelial tumor.
    3. 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, including minimally invasive prostate procedures, during the study period. Has a previous or planned pelvic radiation, low anterior resections (LAR), or any abdominoperineal resections (APR) during the study period.
    4. Has a history of urinary retention requiring an intervention (eg, catheterization) for any reason.
    5. Has maximum urinary flow (Qmax) < 5.0 mL/second with a minimum voided volume of 125 mL at Screening and Visit 3 (Baseline).
    6. Has a history of or current nocturnal polyuria at Visit 2 (Run-In ) or Visit 3 (Baseline) visits, based on 3-day Bladder Diary. Nocturnal polyuria is defined as more than one third of the total urine output per 24 hours occurring at night time.
    7. Has an active or recurrent (> 3 episodes per year) urinary tract
    infection by clinical symptoms or laboratory criteria (≥ 5 white blood
    cells [WBC]/hpf with presence of red blood cell [RBC] and/or a positive urine culture, defined as ≥ 10^5 colony forming units [CFU]/mL [ie, 100 × 10^3 CFU/mL] in a single specimen). Subjects diagnosed with a urinary tract infection (UTI) at the Screening Visit may be treated until the infection has resolved.
    8. Has an implanted sacral neurostimulation (SNS) or use of any posterior tibial nerve stimulation (PTNS) device.
    9. Has uncontrolled hyperglycemia (defined as fasting blood glucose > 150 mg/dL or 8.33 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.
    10. Has uncontrolled hypertension (systolic blood pressure of ≥ 180 mmHg and/or diastolic blood pressure of ≥ 100 mmHg) or has a resting heart rate (by pulse) > 100 beats per minute.
    11. Subjects who have systolic blood pressures ≥ 160 mmHg but < 180 mmHg are excluded, unless deemed by the investigator as safe to proceed in this study and able to complete the study per protocol; these subjects must be on stable hypertension medication for at least 3 months prior to Screening Visit.

    For the complete list of exclusion criteria please refer to Study Protocol
    E.5 End points
    E.5.1Primary end point(s)
    • CFB in the average number of micturition episodes per day
    • CFB in the average number of urgency episodes (urgency: need to urinate immediately) per day
    E.5.1.1Timepoint(s) of evaluation of this end point
    at Week 12
    E.5.2Secondary end point(s)
    • CFB in the average number of nocturia episodes per night
    • CFB in the average number of urge urinary incontinence episodes per day for subjects with urinary incontinence at baseline
    • CFB in the IPSS Storage score (1-week recall)
    • CFB in the average volume voided per micturition
    E.5.2.1Timepoint(s) of evaluation of this end point
    at Week 12
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    tolerability
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA57
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Canada
    United States
    Belgium
    Hungary
    Lithuania
    Poland
    Portugal
    Spain
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LPLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 725
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 363
    F.2 Gender
    F.2.1Female No
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 683
    F.4.2.2In the whole clinical trial 1088
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Subjects who complete the study through the Week 24 Visit will return to standard of care or may be offered the opportunity to enroll in a 28-week extension study, described in a separate protocol (URO-901-3006), in which open-label vibegron will be provided.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-03-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-05-04
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-06-15
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