A Phase 1 interventional study of V117957 and Placebo in Interstitial Cystitis/Bladder Pain Syndrome, sponsored by Imbrium Therapeutics. Completed at 24 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-09.
Sponsored by Imbrium Therapeutics · Phase 1, Interventional, and Treatment
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.
236 studies on the registry are indexed under Cystitis, Interstitial; 35 are open to participants now.
This study's enrollment of 47 is close to the median of 51 across 158 interventional studies indexed under Cystitis, Interstitial.
Browse Cystitis, Interstitial studies →Imbrium Therapeutics is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria include:
Key Exclusion Criteria include:
Other protocol-specific inclusion and exclusion criteria may apply.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: V117957
Drug: Placebo
V117957 1 mg - 1 tablet taken orally at bedtime.
Placebo to match V117957 tablets - 1 tablet taken orally at bedtime.
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."
Time frame: Assessed at Baseline, Weeks 2 and 8. Change from Baseline to Week 2 (Period 1) and Week 8 (Period 2) reported.
Phase 1b multi-center translational study conducted in the US.
| Milestone | All Study Participants |
|---|---|
| Started | 47 |
| Completed | 47 |
| Not completed | 0 |
| Milestone | All Study Participants |
|---|---|
| Started | 46 |
| Completed | 39 |
| Not completed | 7 |
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."
| score on a scale | Double-blind Treatment (Period 1) | Double-blind Treatment (Period 2) |
|---|---|---|
| Worst Pain Overnight | -0.7 ± 1.41 | -1.6 ± 2.08 |
| Worst Pain Over-the-Day | -0.8 ± 1.52 | -1.7 ± 2.00 |
Collected over 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).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Single-blind Run-in | 0/46 (0%) | 0/46 (0%) | 2/46 (4.3%) |
| Double-blind Treatment (Period 1) | 0/46 (0%) | 0/46 (0%) | 2/46 (4.3%) |
| Double-blind Treatment (Period 2) | 0/42 (0%) | 0/42 (0%) | 6/42 (14.3%) |
| Single-blind Follow-up | 0/39 (0%) | 0/39 (0%) | 0/39 (0%) |
| Event | Single-blind Run-in | Double-blind Treatment (Period 1) | Double-blind Treatment (Period 2) | Single-blind Follow-up |
|---|---|---|---|---|
| Urinary tract infectionInfections and infestations | 1/46 | 0/46 | 3/42 | 0/39 |
| SomnolenceNervous system disorders | 1/46 | 2/46 | 3/42 | 0/39 |
The group of subjects who received at least 1 dose of study drug during double-blind treatment.
| Age, Continuous(years) | All Study Participants |
|---|---|
| Mean | 48.5 ± 11.95 |
| Sex: Female, Male(Participants) | All Study Participants |
|---|---|
| Female | 46 |
| Male | 0 |
| Ethnicity (NIH/OMB)(Participants) | All Study Participants |
|---|---|
| Hispanic or Latino | 11 |
| Not Hispanic or Latino | 35 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | All Study Participants |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 5 |
| White | 39 |
| More than one race | 1 |
| Unknown or Not Reported | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from May 2022 to primary completion in Jan 2025, 32 months.
Results were first posted in Mar 2026, 1 year 1 month after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Sunobinop