NCT06285214

Study of V117957 in Interstitial Cystitis/Bladder Pain Syndrome

Completed Phase 1 Results posted Last updated 9 March 2026

What this trial tests

Phase 1 trial testing V117957 in Interstitial Cystitis/Bladder Pain Syndrome in 47 participants. Completed in 28 January 2025.

Timeline

26 May 2022

Primary endpoint
28 January 2025

28 January 2025

Quick facts

Lead sponsor	Imbrium Therapeutics
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	triple
Primary purpose	treatment
Enrollment	47
Start date	26 May 2022
Primary completion	28 January 2025
Estimated completion	28 January 2025
Sites	24 locations across United States

Drugs / interventions tested

• V117957 — full drug profile →
• Placebo

Conditions studied

• Interstitial Cystitis/Bladder Pain Syndrome — all drugs for Interstitial Cystitis/Bladder Pain Syndrome →

Sponsor

Imbrium Therapeutics — full company profile →

Who can join

18 and older, female only, with Interstitial Cystitis/Bladder Pain Syndrome. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change From Baseline for Worst Bladder Pain/Discomfort Scores Overnight / Over-the-day Primary · Assessed at Baseline, Weeks 2 and 8. Change from Baseline to Week 2 (Period 1) and Week 8 (Period 2) reported.

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."

Worst Pain Overnight

Group	Value	95% CI
Double-blind Treatment (Period 1)	-0.7	± 1.41
Double-blind Treatment (Period 2)	-1.6	± 2.08

Worst Pain Over-the-Day

Group	Value	95% CI
Double-blind Treatment (Period 1)	-0.8	± 1.52
Double-blind Treatment (Period 2)	-1.7	± 2.00

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events (AEs) were reported starting from the time informed consent for study participation was provided up to 14 weeks. All-cause mortality and serious adverse events were reported from the start of study participation up to 30 days after last study drug dose (approximately 18 weeks).. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Single-blind Run-in

Serious: 0/46 (0%)

Deaths: 0/46

Double-blind Treatment (Period 1)

Serious: 0/46 (0%)

Deaths: 0/46

Double-blind Treatment (Period 2)

Serious: 0/42 (0%)

Deaths: 0/42

Single-blind Follow-up

Serious: 0/39 (0%)

Deaths: 0/39

Other adverse events (2 terms — click to expand)

Reaction	System	Single-blind Run-in	Double-blind Treatment (Pe…	Double-blind Treatment (Pe…	Single-blind Follow-up
Urinary tract infection	Infections and infestations	—	—	—	—
Somnolence	Nervous system disorders	—	—	—	—

Data from ClinicalTrials.gov NCT06285214 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.