Study of V117957 in Interstitial Cystitis/Bladder Pain Syndrome

Multicenter, Randomized, Double-blind Placebo-controlled, Crossover Study to Investigate Effects of V117957 in Female Subjects With Interstitial Cystitis/Bladder Pain Syndrome

The purpose of this study is to evaluate the safety, tolerability and efficacy of V117957 in subjects with interstitial cystitis/bladder pain syndrome, compared to placebo.

Study Overview

• Status: Completed
• Conditions: Interstitial Cystitis/Bladder Pain Syndrome
• Intervention / Treatment: Drug: V117957; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 47
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Homewood, Alabama, United States, 35209
      • Urology Centers of Alabama, PC
  • Arizona
    • Tucson, Arizona, United States, 85715
      • Urological Associates of Southern Arizona
  • Arkansas
    • Little Rock, Arkansas, United States, 72212
      • Applied Research Center of Arkansas
  • California
    • Escondido, California, United States, 92025
      • Investigational Site
    • Los Angeles, California, United States, 90017
      • Urology Group of Southern California
    • Los Angeles, California, United States, 91303
      • Hope Clinical Research, LLC
    • Murrieta, California, United States, 92562
      • Tri Valley Urology Medical Group
  • Florida
    • DeLand, Florida, United States, 32720
      • Accel Research Sites
  • Georgia
    • Decatur, Georgia, United States, 30033
      • Accel Research Site - Neurostudies
  • Illinois
    • Evergreen Park, Illinois, United States, 60805
      • Providea Health Partners LLC
  • Kentucky
    • Edgewood, Kentucky, United States, 41017
      • Otrimed Clinical Research
  • Louisiana
    • Metairie, Louisiana, United States, 70001
      • Southern Clinical Research Associates
    • Shreveport, Louisiana, United States, 71106
      • Ochsner Louisiana State University Health Shreveport - Regional University
  • Maryland
    • Owings Mills, Maryland, United States, 21117
      • Chesapeake Urology Research Associates
  • Massachusetts
    • Boston, Massachusetts, United States, 02131
      • Boston Clinical Trials
    • Watertown, Massachusetts, United States, 02472
      • Bay State Clinical Trials, Inc.
  • Michigan
    • Dearborn Heights, Michigan, United States, 48127
      • Revive Research Institute, Inc
  • Minnesota
    • Sartell, Minnesota, United States, 56377
      • CentraCare - Urology Clinic
  • Nebraska
    • Omaha, Nebraska, United States, 68114
      • Adult & Pediatric Urology P.C.
  • New York
    • Garden City, New York, United States, 11530
      • AccuMed Research Associates
    • New York, New York, United States, 10016
      • Manhattan Medical Research Practice
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27103
      • Unified Women's Clinical Research-Lyndhurst Clinical Research
  • Ohio
    • Cleveland, Ohio, United States, 44109
      • MetroHealth System
  • Pennsylvania
    • Bala-Cynwyd, Pennsylvania, United States, 19004
      • MidLantic Urology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Key Inclusion Criteria include:

1. Female, age ≥18 years and capable of voiding independently. Able to comply with acceptable methods of contraception.
2. Diagnosis of IC/BPS or meets criteria for IC/BPS as defined by the American Urology Association as "an unpleasant sensation (pain, pressure, discomfort) perceived to be related to the urinary bladder, associated with lower urinary tract symptoms for more than six weeks duration, in the absence of infection or other identifiable causes".
3. Subject has Bladder Pain/Interstitial Cystitis Symptom Scale (BPIC-SS) total score of ≥19 and worst bladder pain/discomfort sub-score of ≥4 to ≤9.
4. Has undergone evaluation to rule out other conditions that cause bladder pain/discomfort. Any microscopic or gross hematuria that has not been evaluated in the past 12 months will require appropriate clinical evaluation to determine study eligibility.

Key Exclusion Criteria include:

1. Pelvic floor tenderness in the absence of bladder tenderness on physical examination by primary investigator.
2. Urinary tract infection (UTI) within the past 30 days, or history of recurrent UTI.
3. Hematuria determined to be associated with bladder malignancy or other significant pathology.
4. Had surgical procedure at any time that affected bladder function.
5. Received intravesical therapy or had bladder hydrodistension, fulguration, botulinum toxin, or triamcinolone bladder injection, percutaneous nerve stimulation. A subject receiving such treatment(s) prior to screening is eligible if in the opinion of the investigator the procedure/ treatment resulted in no notable or enduring effect and subject continues to exhibit stable symptomology.
6. Has current or history of clinically significant kidney disease or abnormal kidney function, or nephrolithiasis.

Other protocol-specific inclusion and exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Placebo to match V117957 tablets - 1 tablet taken orally at bedtime.
Experimental: V117957	Drug: V117957; V117957 1 mg - 1 tablet taken orally at bedtime.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline for Worst Bladder Pain/Discomfort Scores Overnight / Over-the-day	Each evening and morning the subject responded to the question "Please indicate the worst bladder pain/discomfort you have had overnight/over-the-day" using an 11-point numerical rating scale (NRS) that ranges from 0 = "no bladder pain/discomfort" to 10 = "as bad as you can imagine bladder pain/discomfort."	Assessed at Baseline, Weeks 2 and 8. Change from Baseline to Week 2 (Period 1) and Week 8 (Period 2) reported.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in mean number of micturitions per 12 hours (morning and evening)		Baseline, Weeks 2, 4, 6, 8, and 9
Change from baseline in Patient Perception of Intensity of Urgency Scale (PPIUS)	The PPIUS is a 5-point scale designed for measurement of both urinary urgency and urge incontinence. Subjects are asked to indicate their micturition episode type (urinated= passed urine in the toilet, incontinence= involuntary release of urine) and then rate the episode urgency on a 5-point scale (0= no urgency, 1= mild urgency, 2= moderate urgency, 3= severe urgency, 4= urge incontinence).	Baseline, Weeks 2, 4, 6, 8, and 9
Change from baseline in Bladder Pain / Interstitial Cystitis Symptom Score (BPIC-SS)	The BPIC-SS contains 8 questions concerning bladder pain over the previous 7 days. Questions 1-5 assess how often subject urinated because of pain, needed to urinate just after a previous urination, urinated to avoid pain, had pressure in their bladder, and had pain in their bladder, are rated on a 5-point scale from 1= "never" to 5= "always." Question 6 and 7 assess how bothered the subject was by frequent urination during daytime and during the night, rated on a 5-point scale from 1= "not at all" to 5= "a great deal." Question 8 assesses subject's worst bladder pain in past 7 days, rated on an 11-point NRS with range 0= "no bladder pain" to 10= "worst possible bladder pain." The BPIC-SS total score is the sum of the individual question scores and range from 0 to 38 with higher scores indicating a worse situation; a score of ≥19 may represent moderate/severe disease activity.	Baseline, Weeks 2, 4, 6, 8, and 9
Change from baseline in O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI)	The ICSI contains 4 questions that measure urgency and frequency of urination, nighttime urination, and pain or burning. Each question is rated using a 6- or 5-point scale. Total scores range from 0 to 21.	Baseline, Weeks 2, 4, 6, 8, and 9
Change from baseline in O'Leary-Sant Interstitial Cystitis Problem Index (ICPI)	The ICPI contains 4 questions that assesses and how much of a problem the symptoms cause for the subject. Each question is rated using a 5-point scale. Total scores range from 0 to 16.	Baseline, Weeks 2, 4, 6, 8, and 9
Change from baseline in Subject Global Response Assessment (SGRA)	The SGRA is a self-rated balanced measure of subject's clinical condition relative to baseline. There is 1 question: "Compared to your last visit, how would you rate your overall overactive bladder symptoms now?" A 7-point rating scale is used: 1= "markedly worse", 2= "moderately worse", 3= "slightly worse", 4= "no change", 5= "slightly improved", 6= "moderately improved" or 7= "markedly improved".	Baseline, Weeks 2, 4, 6, 8, and 9
Change from baseline in Symptom Impact Sleep Questionnaire (SISQ)	The SISQ contains 2 questions that assess the quality of sleep and the impact of the subject's symptoms of IC/BPS on sleep and is to be completed each morning.	Baseline, Weeks 2, 4, 6, 8, and 9

Collaborators and Investigators

• Sponsor: Imbrium Therapeutics
• Collaborators: Purdue Pharma LP

Study record dates

Study Major Dates

• Study Start (Actual): May 26, 2022
• Primary Completion (Actual): January 28, 2025
• Study Completion (Actual): January 28, 2025

Study Registration Dates

• First Submitted: February 22, 2024
• First Submitted That Met QC Criteria: February 22, 2024
• First Posted (Actual): February 29, 2024

Study Record Updates

• Last Update Posted (Actual): March 9, 2026
• Last Update Submitted That Met QC Criteria: February 16, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urinary Bladder Diseases; Cystitis; Cystitis, Interstitial
• Other Study ID Numbers: OAG1050

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