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URO-902 in Female Subjects With Overactive Bladder and Urge Urinary Incontinence

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04211831
Recruitment Status : Recruiting
First Posted : December 26, 2019
Last Update Posted : August 17, 2020
Sponsor:
Information provided by (Responsible Party):
Urovant Sciences GmbH

Study Description
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Brief Summary:
This study will evaluate the efficacy, safety, and tolerability of a single dose of URO-902 24 milligrams (mg) and 48 mg (administered via intradetrusor injection), compared with placebo, in participants with overactive bladder (OAB) and urge urinary incontinence (UUI) up to 48 weeks post-dose.

Condition or disease Intervention/treatment Phase
Overactive Bladder With Urge Urinary Incontinence Drug: URO-902 Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: An Exploratory Phase 2a Study Evaluating the Efficacy and Safety of URO-902 in Subjects With Overactive Bladder and Urge Urinary Incontinence
Actual Study Start Date : December 16, 2019
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : December 2021

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Cohort 1: URO-902 24 mg; Placebo
Participants will receive either a single treatment of URO-902 24 milligrams (mg) or matching placebo.
 Drug: URO-902
intradetrusor injection
Other Names:
  • hMaxi-K
  • pVAX/hSlo

Drug: Placebo
intradetrusor injection
Experimental: Cohort 2: URO-902 48 mg; Placebo
Participants will receive either a single treatment of URO-902 48 mg or matching placebo.
 Drug: URO-902
intradetrusor injection
Other Names:
  • hMaxi-K
  • pVAX/hSlo

Drug: Placebo
intradetrusor injection


Outcome Measures
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Primary Outcome Measures :
  1. Change from Baseline at Week 12 in average daily number of Urge Urinary Incontinence (UUI) episodes [ Time Frame: Baseline; Week 12 ]

Secondary Outcome Measures :
  1. Number of participants with any adverse event [ Time Frame: up to Week 48 ]

Eligibility Criteria
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Ages Eligible for Study:   40 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participant has symptoms of Overactive Bladder (OAB) (frequency and urgency) with Urge Urinary Incontinence (UUI) for a period of at least 6 months prior to screening.
  • Participant experiences ≥ 1 episode of UUI per day.
  • Participant has not been adequately managed with ≥ 1 oral or transdermal pharmacologic therapies for the treatment of their OAB symptoms.

Exclusion Criteria:

  • Participant has symptoms of OAB due to any known neurological reason (e.g., spinal cord injury, multiple sclerosis, cerebrovascular accident, Alzheimer's disease, Parkinson's disease, etc).
  • Participant has a predominance of stress incontinence in the opinion of the investigator, determined by participant history.
  • Participant currently uses or plans to use medications or therapies to treat symptoms of OAB, including nocturia.
  • Participants who have previously been treated with onabotulinumtoxinA for urological indications within 12 months of starting the Screening Bladder Diary, or any other toxin for urological indications, regardless of when treated (participants treated with onabotulinumtoxinA or other toxins for non-urological indications are eligible, regardless of when treated)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04211831


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

Locations
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Sponsors and Collaborators
Urovant Sciences GmbH
Investigators
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Study Director: Jihao Zhou, MD, PhD Urovant Sciences
More Information
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Responsible Party: Urovant Sciences GmbH
ClinicalTrials.gov Identifier: NCT04211831    
Other Study ID Numbers: URO-902-2001
First Posted: December 26, 2019    Key Record Dates
Last Update Posted: August 17, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Urovant Sciences GmbH:
URO-902
hMaxi-K
pVAX/hSlo
Overactive Bladder
Urge Urinary Incontinence
Additional relevant MeSH terms:
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Urinary Incontinence
Enuresis
Urinary Bladder, Overactive
Urinary Incontinence, Urge
Urination Disorders
Urologic Diseases
 Lower Urinary Tract Symptoms
Urological Manifestations
Behavioral Symptoms
Elimination Disorders
Mental Disorders
Urinary Bladder Diseases