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

NCT03806127 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: URO-901-2001
• Study Type: interventional
• Target: 222
• Locations: 1 country
• Sites: 41

Brief Summary

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).

Conditions

Irritable Bowel Syndrome

Keywords

Irritable Bowel Syndrome; 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); Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Number of Global Improvement Scale (GIS) Responders at Week 12 for All IBS Participants, Including IBS-D and IBS-M Participants

  Week 12

• Number of IBS-D Participants Who Were API Weekly Responders With ≥ 40% Improvement Over 12 Weeks

  Baseline; 12 weeks

• Number of IBS-D Participants Who Were API Weekly Responders With ≥ 50% Improvement Over 12 Weeks

  Baseline; 12 weeks

• Number of Participants With Any Treatment-emergent Adverse Event (TEAE)

  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

  Baseline; Week 12

Study Arms (2)

Vibegron 75 mg

EXPERIMENTAL

Participants will receive vibegron 75 milligrams (mg) orally once daily for 12 weeks.

Drug: Vibegron

Placebo

PLACEBO COMPARATOR

Participants will receive matching placebo orally once daily for 12 weeks.

Drug: Placebo

Interventions

Vibegron DRUG

oral administration

Also known as: RVT-901, MK-4618, KRP-114V, URO-901

Vibegron 75 mg

Placebo DRUG

oral administration

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Urovant Sciences GmbH: lead

Study Sites (41)

Synexus Clinical Research US, Inc.-Simon Williamson Clinic

Birmingham, Alabama, 35211, United States

Location

Clinical Research Associates

Huntsville, Alabama, 35801, United States

Location

Alabama Medical Group, PC

Mobile, Alabama, 36693, United States

Location

Hope Research Institute

Chandler, Arizona, 85224, United States

Location

Synexus Clinical Research US, Inc. - East Valley Family Physicians, PLC

Chandler, Arizona, 85224, United States

Location

Synexus Clinical Research US, Inc. - Central Arizona Medical Associates, PC

Mesa, Arizona, 85206, United States

Location

Synexus Clinical Research US, Inc. - Desert Clinical Research, LLC

Mesa, Arizona, 85213, United States

Location

Synexus - Clinical Research Advantage, Inc. - Central Phoenix Medical Clinic LLC

Phoenix, Arizona, 85020, United States

Location

GW Research Inc - ClinEdge-PPDS

Chula Vista, California, 91910, United States

Location

Triwest Research Associates, LLC

La Mesa, California, 91942, United States

Location

VA Long Beach Healthcare System - NAVREF

Long Beach, California, 90822, United States

Location

Southern California Research Institute Medical Group, Inc.

Los Angeles, California, 90045, United States

Location

Desta Digestive Disease Medical Center

San Diego, California, 92114, United States

Location

Medical Associates Research Group, Inc.

San Diego, California, 92123, United States

Location

Torrance Clinical Research

Torrance, California, 90505, United States

Location

Medical Research Center of Connecticut LLC

Hamden, Connecticut, 06518, United States

Location

Mayo Clinic - Division of Gastroenterology

Jacksonville, Florida, 32224, United States

Location

Florida Center For Gastroenterology

Largo, Florida, 33777, United States

Location

Clinical Research Center of Florida

Pompano Beach, Florida, 33060, United States

Location

Palm Beach Research - ClinEdge - PPDS

West Palm Beach, Florida, 33409, United States

Location

RNA America, LLC

Sugar Hill, Georgia, 30518, United States

Location

Investigators Research Group, LLC

Indianapolis, Indiana, 46268, United States

Location

Mandeville Private Physician Group, LLC

Mandeville, Louisiana, 70471, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Clinical Research Institute of Michigan

Chesterfield, Michigan, 48047, United States

Location

Synexus Clinical Research US, Inc. - Rita B. Chuang, MD, LLC

Henderson, Nevada, 89502, United States

Location

Advanced Research Institute

Reno, Nevada, 89511, United States

Location

Atrium Healthcare Center for Digestive Health

Charlotte, North Carolina, 28204, United States

Location

Carolina Digestive Diseases

Greenville, North Carolina, 27834, United States

Location

East Carolina Gastroenterology

Jacksonville, North Carolina, 28546, United States

Location

Dayton Gastroenterology, Inc.

Beavercreek, Ohio, 45440, United States

Location

Central Sooner Research

Norman, Oklahoma, 73071, United States

Location

Synexus Clinical Research US, Inc. - Anderson

Anderson, South Carolina, 29621, United States

Location

Chattanooga Medical Research Inc

Chattanooga, Tennessee, 37404, United States

Location

Clinical Research Solutions PC

Jackson, Tennessee, 38305, United States

Location

DHAT Research Institute

Garland, Texas, 75044, United States

Location

University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

Synexus Clinical Research US, Inc.-Plano

Plano, Texas, 75093, United States

Location

Synexus Clinical Research US, Inc. - Wasatch Peak Family Practice

Layton, Utah, 84041, United States

Location

Advanced Research Institute

South Ogden, Utah, 84405, United States

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome; Constipation; Pain

Interventions

N-(4-((5-(hydroxy(phenyl)methyl)pyrrolidin-2-yl)methyl)phenyl)-4-oxo-4,6,7,8-tetrahydropyrrolo(1,2-a)pyrimidine-6-carboxamide

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations

Results Point of Contact

• Title: Information, Clinical Trial Results
• Organization: Urovant Sciences

info@urovant.com

949-226-6029

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2019
• First Posted: January 16, 2019
• Study Start: December 31, 2018
• Primary Completion: September 25, 2020
• Study Completion: October 6, 2020
• Last Updated: August 2, 2021
• Results First Posted: July 30, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (41)