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Study of V117957 in Interstitial Cystitis/Bladder Pain Syndrome | Clinical Trials | Clareo Health

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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

NCT06285214•Imbrium Therapeutics

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•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.
•6. Has current or history of clinically significant kidney disease or abnormal kidney function, or nephrolithiasis.

Exclusion Criteria

•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.

Locations (24)

Urology Centers of Alabama, PC

Homewood, Alabama, United States

Urological Associates of Southern Arizona

Tucson, Arizona, United States

Applied Research Center of Arkansas

Little Rock, Arkansas, United States

Investigational Site

Escondido, California, United States

Urology Group of Southern California

Los Angeles, California, United States

Hope Clinical Research, LLC

Los Angeles, California, United States

Tri Valley Urology Medical Group

Murrieta, California, United States

Accel Research Sites

DeLand, Florida, United States

Accel Research Site - Neurostudies

Decatur, Georgia, United States

Providea Health Partners LLC

Evergreen Park, Illinois, United States

Key Dates

Start Date

May 26, 2022

Primary Completion Date

January 28, 2025

Completion Date

January 28, 2025

Last Updated

March 9, 2026

Enrollment

ACTUAL participants

Conditions

Interstitial Cystitis/Bladder Pain Syndrome

Interventions

V117957

DRUG

Placebo

DRUG