Study to Evaluate the Efficacy and Safety of Vibegron Administered Orally for 12 Weeks to Women With Irritable Bowel Syndrome

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Vibegron Administered Orally for 12 Weeks to Women With Irritable Bowel Syndrome

This study will evaluate the efficacy and safety of vibegron, a beta-3 adrenergic receptor (β3-AR) agonist, in the treatment of pain associated with irritable bowel syndrome (IBS) due to IBS with predominant diarrhea (IBS-D) or mixed episodes of diarrhea and constipation (IBS-M).

Study Overview

• Status: Completed
• Conditions: Irritable Bowel Syndrome
• Intervention / Treatment: Drug: Vibegron; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 222
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35211
      • Synexus Clinical Research US, Inc.-Simon Williamson Clinic
    • Huntsville, Alabama, United States, 35801
      • Clinical Research Associates
    • Mobile, Alabama, United States, 36693
      • Alabama Medical Group, PC
  • Arizona
    • Chandler, Arizona, United States, 85224
      • Hope Research Institute
    • Chandler, Arizona, United States, 85224
      • Synexus Clinical Research US, Inc. - East Valley Family Physicians, PLC
    • Mesa, Arizona, United States, 85206
      • Synexus Clinical Research US, Inc. - Central Arizona Medical Associates, PC
    • Mesa, Arizona, United States, 85213
      • Synexus Clinical Research US, Inc. - Desert Clinical Research, LLC
    • Phoenix, Arizona, United States, 85020
      • Synexus - Clinical Research Advantage, Inc. - Central Phoenix Medical Clinic LLC
  • California
    • Chula Vista, California, United States, 91910
      • GW Research Inc - ClinEdge-PPDS
    • La Mesa, California, United States, 91942
      • TriWest Research Associates, LLC
    • Long Beach, California, United States, 90822
      • VA Long Beach Healthcare System - NAVREF
    • Los Angeles, California, United States, 90045
      • Southern California Research Institute Medical Group, Inc.
    • San Diego, California, United States, 92123
      • Medical Associates Research Group, Inc.
    • San Diego, California, United States, 92114
      • Desta Digestive Disease Medical Center
    • Torrance, California, United States, 90505
      • Torrance Clinical Research
  • Connecticut
    • Hamden, Connecticut, United States, 06518
      • Medical Research Center of Connecticut LLC
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic - Division of Gastroenterology
    • Largo, Florida, United States, 33777
      • Florida Center for Gastroenterology
    • Pompano Beach, Florida, United States, 33060
      • Clinical Research Center of Florida
    • West Palm Beach, Florida, United States, 33409
      • Palm Beach Research - ClinEdge - PPDS
  • Georgia
    • Sugar Hill, Georgia, United States, 30518
      • RNA America, LLC
  • Indiana
    • Indianapolis, Indiana, United States, 46268
      • Investigators Research Group, LLC
  • Louisiana
    • Mandeville, Louisiana, United States, 70471
      • Mandeville Private Physician Group, LLC
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan
    • Chesterfield, Michigan, United States, 48047
      • Clinical Research Institute of Michigan
  • Nevada
    • Henderson, Nevada, United States, 89502
      • Synexus Clinical Research US, Inc. - Rita B. Chuang, MD, LLC
    • Reno, Nevada, United States, 89511
      • Advanced Research Institute
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Atrium Healthcare Center for Digestive Health
    • Greenville, North Carolina, United States, 27834
      • Carolina Digestive Diseases
    • Jacksonville, North Carolina, United States, 28546
      • East Carolina Gastroenterology
  • Ohio
    • Beavercreek, Ohio, United States, 45440
      • Dayton Gastroenterology, Inc.
  • Oklahoma
    • Norman, Oklahoma, United States, 73071
      • Central Sooner Research
  • South Carolina
    • Anderson, South Carolina, United States, 29621
      • Synexus Clinical Research US, Inc. - Anderson
  • Tennessee
    • Chattanooga, Tennessee, United States, 37404
      • Chattanooga Medical Research Inc
    • Jackson, Tennessee, United States, 38305
      • Clinical Research Solutions PC
  • Texas
    • Garland, Texas, United States, 75044
      • DHAT Research Institute
    • Houston, Texas, United States, 77030
      • University of Texas Health Science Center at Houston
    • Plano, Texas, United States, 75093
      • Synexus Clinical Research US, Inc.-Plano
  • Utah
    • Layton, Utah, United States, 84041
      • Synexus Clinical Research US, Inc. - Wasatch Peak Family Practice
    • South Ogden, Utah, United States, 84405
      • Advanced Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Diagnosis of irritable bowel syndrome (IBS) with predominantly diarrhea (IBS-D) or IBS with mixed episodes of diarrhea and constipation (IBS-M) according to the Rome IV criteria
• Has completed a colonoscopy according to the American Gastroenterological Association criteria, with no clinically significant findings in the last 5 years
• Has no clinically significant findings on a physical examination or clinical laboratory tests that could interfere with study participation or confound study assessments, in the opinion of the Investigator. Serum tissue transglutaminase antibody (IgA) must be negative. Fecal calprotectin testing is optional and should only be considered if there is a strong suspicion that the participant has inflammatory bowel disease (IBD) (eg, family history in a 1st degree relative, other genetic factors, etc.) or other organic disease, according to the clinical judgement of the investigator.

Exclusion Criteria:

• Diagnosis of IBS-C or IBS-U per Rome IV criteria
• History of chronic idiopathic constipation or functional constipation
• Structural abnormality of the gastrointestinal tract or a disease (e.g., known small intestine bacterial overgrowth) or condition that can affect gastrointestinal motility
• History of a gastrointestinal motility disorder other than IBS (e.g., gastroparesis, intestinal pseudo-obstruction, achalasia, Parkinsons disease, multiple sclerosis, spinal cord injury)
• Prior history of a gastrointestinal malignancy, inflammatory bowel disease, celiac disease
• Planned gastrointestinal or abdominal surgery within the next 6 months
• Co-existing gastroesophageal reflux disease or functional dyspepsia with symptoms predominant to IBS symptoms
• Symptoms or diagnosis of a medical condition other than IBS that may contribute to abdominal pain (e.g., interstitial cystitis; fibromyalgia currently being treated with pregabalin or gabapentin; and endometriosis with uncontrolled abdominal pain)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vibegron 75 mg; Participants will receive vibegron 75 milligrams (mg) orally once daily for 12 weeks.	Drug: Vibegron; oral administration; Other Names: RVT-901; MK-4618; KRP-114V; URO-901
Placebo Comparator: Placebo; Participants will receive matching placebo orally once daily for 12 weeks.	Drug: Placebo; oral administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Irritable Bowel Syndrome (IBS) With Predominantly Diarrhea (IBS-D) Participants Who Were Abdominal Pain Intensity (API) Weekly Responders at Week 12	An API Weekly Responder was defined as a participant who experienced a decrease in the weekly average of "worst abdominal pain in the past 24 hours" scores of at least 30% compared with the Baseline weekly average. A participant was considered a responder over Weeks 1 to 12 if they met the criteria for at least 50% of the weeks assessed (i.e., ≥6 weeks).	Baseline; Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Global Improvement Scale (GIS) Responders at Week 12 for All IBS Participants, Including IBS-D and IBS-M Participants	Global improvement assessment asks participants to evaluate their current IBS status by asking the following question: How would you rate your IBS signs or symptoms overall over the past 7 days?: (1) significantly relieved; (2) moderately relieved; (3) slightly relieved; (4) unchanged; (5) slightly worse; (6) moderately worse; (7) significantly worse. A responder was defined as a participant who answered that their symptoms were either moderately relieved or significantly relieved. A participant with a missing GIS response was considered to be a non-responder.	Week 12
Number of IBS-D Participants Who Were API Weekly Responders With ≥ 40% Improvement Over 12 Weeks	An API Weekly Responder was defined as a participant who experienced a decrease in the weekly average of "worst abdominal pain in the past 24 hours" scores of at least 40% compared with the Baseline weekly average. A participant was considered a responder over Weeks 1 to 12 if they met the criteria for at least 50% of the weeks assessed (i.e., ≥6 weeks).	Baseline; 12 weeks
Number of IBS-D Participants Who Were API Weekly Responders With ≥ 50% Improvement Over 12 Weeks	An API Weekly Responder was defined as a participant who experienced a decrease in the weekly average of "worst abdominal pain in the past 24 hours" scores of at least 50% compared with the Baseline weekly average. A participant was considered a responder over Weeks 1 to 12 if they met the criteria for at least 50% of the weeks assessed (i.e., ≥6 weeks).	Baseline; 12 weeks
Number of Participants With Any Treatment-emergent Adverse Event (TEAE)	TEAEs are defined as events that began or worsened in severity after the first dose of the double-blind study treatment through 14 days after the last dose of study treatment.	from the time the participant provided informed consent to participate in the study at the Screening Visit until completion of the Safety Follow-up Call (up to Day 113 or Early Withdrawal plus 28 days)
Number of Participants With Clinically Meaningful Changes From Baseline in Clinical Laboratory Values at Week 12	The investigator determined whether a change was clinically meaningful.	Baseline; Week 12
Number of Participants With Clinically Relevant Changes From Baseline in Vital Sign Values at Week 12	Clinical relevance was determined by the investigator.	Baseline; Week 12

Collaborators and Investigators

• Sponsor: Urovant Sciences GmbH

Study record dates

Study Major Dates

• Study Start (Actual): December 31, 2018
• Primary Completion (Actual): September 25, 2020
• Study Completion (Actual): October 6, 2020

Study Registration Dates

• First Submitted: January 14, 2019
• First Submitted That Met QC Criteria: January 14, 2019
• First Posted (Actual): January 16, 2019

Study Record Updates

• Last Update Posted (Actual): August 2, 2021
• Last Update Submitted That Met QC Criteria: July 29, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Irritable Bowel Syndrome; Pain; Irritable Bowel Syndrome with predominantly diarrhea (IBS-D); Irritable Bowel Syndrome with mixed episodes of diarrhea and constipation (IBS-M); Vibegron; Beta-3 adrenergic receptor (β3-AR)
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Syndrome; Irritable Bowel Syndrome
• Other Study ID Numbers: URO-901-2001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No