Study of V117957 in Interstitial Cystitis/Bladder Pain Syndrome

NCT06285214 | Completed Phase 1 Results FDA Drug

• 1 other identifier: OAG1050
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 24

Brief 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.

Conditions

Interstitial Cystitis/Bladder Pain Syndrome

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

V117957

EXPERIMENTAL

Drug: V117957

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

V117957 DRUG

V117957 1 mg - 1 tablet taken orally at bedtime.

V117957

Placebo DRUG

Placebo to match V117957 tablets - 1 tablet taken orally at bedtime.

Placebo

Eligibility Criteria

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

You may qualify if:

• Female, age ≥18 years and capable of voiding independently. Able to comply with acceptable methods of contraception.
• 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".
• 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.
• 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.

You may not qualify if:

• Pelvic floor tenderness in the absence of bladder tenderness on physical examination by primary investigator.
• Urinary tract infection (UTI) within the past 30 days, or history of recurrent UTI.
• Hematuria determined to be associated with bladder malignancy or other significant pathology.
• Had surgical procedure at any time that affected bladder function.
• 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.
• Has current or history of clinically significant kidney disease or abnormal kidney function, or nephrolithiasis.

Sponsors & Collaborators

• Imbrium Therapeutics: lead
• Purdue Pharma LP: collaborator

Study Sites (24)

Urology Centers of Alabama, PC

Homewood, Alabama, 35209, United States

Location

Urological Associates of Southern Arizona

Tucson, Arizona, 85715, United States

Location

Applied Research Center of Arkansas

Little Rock, Arkansas, 72212, United States

Location

Investigational Site

Escondido, California, 92025, United States

Location

Urology Group of Southern California

Los Angeles, California, 90017, United States

Location

Hope Clinical Research, LLC

Los Angeles, California, 91303, United States

Location

Tri Valley Urology Medical Group

Murrieta, California, 92562, United States

Location

Accel Research Sites

DeLand, Florida, 32720, United States

Location

Accel Research Site - Neurostudies

Decatur, Georgia, 30033, United States

Location

Providea Health Partners LLC

Evergreen Park, Illinois, 60805, United States

Location

Otrimed Clinical Research

Edgewood, Kentucky, 41017, United States

Location

Southern Clinical Research Associates

Metairie, Louisiana, 70001, United States

Location

Ochsner Louisiana State University Health Shreveport - Regional University

Shreveport, Louisiana, 71106, United States

Location

Chesapeake Urology Research Associates

Owings Mills, Maryland, 21117, United States

Location

Boston Clinical Trials

Boston, Massachusetts, 02131, United States

Location

Bay State Clinical Trials, Inc.

Watertown, Massachusetts, 02472, United States

Location

Revive Research Institute, Inc

Dearborn Heights, Michigan, 48127, United States

Location

CentraCare - Urology Clinic

Sartell, Minnesota, 56377, United States

Location

Adult & Pediatric Urology P.C.

Omaha, Nebraska, 68114, United States

Location

AccuMed Research Associates

Garden City, New York, 11530, United States

Location

Manhattan Medical Research Practice

New York, New York, 10016, United States

Location

Unified Women's Clinical Research-Lyndhurst Clinical Research

Winston-Salem, North Carolina, 27103, United States

Location

MetroHealth System

Cleveland, Ohio, 44109, United States

Location

MidLantic Urology

Bala-Cynwyd, Pennsylvania, 19004, United States

Location

MeSH Terms

Conditions

Cystitis, Interstitial

Condition Hierarchy (Ancestors)

Cystitis; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Clinical Leader
• Organization: Imbrium Therapeutics L.P.

Medinfo@imbriumthera.com

1-888-827-0622

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2024
• First Posted: February 29, 2024
• Study Start: May 26, 2022
• Primary Completion: January 28, 2025
• Study Completion: January 28, 2025
• Last Updated: March 9, 2026
• Results First Posted: March 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (24)