Study of V117957 in Interstitial Cystitis/Bladder Pain Syndrome

Imbrium Therapeutics

Status and phase: Enrolling; Phase 1

Conditions: Interstitial Cystitis/Bladder Pain Syndrome

Treatments: Drug: V117957; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06285214

OAG1050

Details and patient eligibility

About

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.

Enrollment: 44 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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44 participants in 2 patient groups, including a placebo group

V117957

Experimental group

Treatment:

Drug: V117957

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo