V117957 for Interstitial Cystitis

No longer recruiting at 23 trial locations

Overseen By Medical Information

Age: 18+

Sex: Female

Trial Phase: Phase 1

Sponsor: Imbrium Therapeutics

Disqualifiers: Recurrent UTI, Bladder malignancy, Kidney disease, others

Compensation: Varies

Number of Visits: 2

Duration: 9 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called V117957 to determine its safety and effectiveness for individuals with interstitial cystitis or bladder pain syndrome, a condition causing long-term bladder pain and urinary issues without infection. Participants will receive either the experimental treatment or a placebo (a harmless pill resembling the medicine but containing no active ingredients) for comparison. Women who have experienced bladder pain or discomfort for more than six weeks, without other known causes, may qualify to join. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive it.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that V117957 is likely to be safe for humans?

Research has shown that V117957 has been tested for conditions like interstitial cystitis and overactive bladder. In one study, 51 women received V117957 to assess its safety and tolerability. This study is crucial to ensure the treatment does not cause harmful side effects.

As an early-stage trial, the primary focus is on safety. Complete information on side effects is not yet available, but this phase evaluates how well participants tolerate the treatment. Researchers closely monitor participants to identify any issues. If these early results demonstrate safety, the treatment will advance to more comprehensive studies to further confirm its safety and effectiveness. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Most treatments for interstitial cystitis, like oral medications or bladder instillations, work by reducing bladder inflammation or pain. But V117957 stands out because it targets a different pathway. Researchers are excited about V117957 because it introduces a novel active ingredient that may offer relief by specifically addressing underlying mechanisms not targeted by current options. This unique approach holds the promise of providing more effective symptom relief for patients who have not responded well to existing therapies.

What evidence suggests that V117957 might be an effective treatment for interstitial cystitis?

Research has shown that V117957, also known as sunobinop, may help treat interstitial cystitis, a long-term bladder condition causing pain and pressure. In an earlier study, 41% of patients who took sunobinop experienced noticeable or moderate symptom improvement, while only 9% of those receiving a placebo (a treatment with no active ingredients) saw similar improvements. In this trial, participants will receive either V117957 or a placebo. These early results suggest that V117957 could effectively manage this challenging condition. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

This trial is for individuals with bladder pain syndrome, also known as interstitial cystitis. Participants should have symptoms like bladder pain and frequent urination. Specific eligibility details are not provided, but typically participants must meet certain health requirements and not be taking conflicting medications.

Inclusion Criteria

My bladder pain is severe, scoring 19 or more overall and between 4 to 9 at its worst.

I have been diagnosed with interstitial cystitis/bladder pain syndrome.

I've been checked for other causes of my bladder pain.

Exclusion Criteria

I have had a urinary tract infection in the last 30 days or often get them.

I have pelvic pain but no bladder pain, confirmed by a doctor's exam.

I have a history of significant kidney problems or kidney stones.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive V117957 or placebo in a double-blind, crossover design

9 weeks

Visits at baseline, Weeks 2, 4, 6, 8, and 9

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• V117957

Trial Overview The study is testing the effectiveness of a new medication called V117957 in relieving symptoms of bladder pain syndrome compared to a placebo (a substance with no active drug). The goal is to see if V117957 is safe, well-tolerated by patients, and better than taking nothing at all.

How Is the Trial Designed?

Group I: V117957 Experimental Treatment 1 Intervention

Group II: Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Imbrium Therapeutics

Lead Sponsor

Trials

5

Recruited

450+

Purdue Pharma LP

Industry Sponsor

Trials

80

Recruited

15,800+

Dr. Craig Landau

Purdue Pharma LP

Chief Executive Officer since 2017

MD from Albany Medical College

Dr. Marcelo Bigal

Purdue Pharma LP

Chief Medical Officer since 2018

MD from Federal University of Rio de Janeiro

Citations

1. urologytimes.com urologytimes.com/view/sunobinop-shows-promising-efficacy-in-interstitial-cystitis-bladder-pain-syndrome

Sunobinop shows promising efficacy in interstitial cystitis ... Data showed a marked or moderate improvement in IC/BPS symptoms in 41% of patients who received sunobinop vs 9% of patients who received placebo ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06285214?term=V117957&rank=2

NCT06285214 | Study of V117957 in Interstitial Cystitis ... The purpose of this study is to evaluate the safety, tolerability and efficacy of V117957 in subjects with interstitial cystitis/bladder pain syndrome, ...

3. imbriumthera.com imbriumthera.com/news/imbrium-therapeutics-achieves-last-patient-last-visit-in-clinical-trial-of-potential-treatment-for-interstitial-cystitis-bladder-syndrome/

News “Patients with interstitial cystitis experience very disruptive symptoms that can severely affect daily activities, work productivity, and ...

4. urologytimes.com urologytimes.com/view/study-progresses-of-oral-compound-for-overactive-bladder

Study progresses of oral compound for overactive bladder The phase 1b trial enrolled 51 female patients with OAB to assess the safety, tolerability, and preliminary efficacy of V117957.

5. auajournals.org auajournals.org/doi/10.1097/JU.0000000000003229.09

PD05-09 EFFECTS OF SUNOBINOP (V117957) IN A ... The objective of these studies was to examine the effect of sunobinop on visceral pain in a model of interstitial cystitis in female rats.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12037478/

Safety and efficacy of intravesical instillation of botulinum toxin ... The meta-analysis was performed to assess the efficacy and safety of a novel intravesical instillation of BTX-A for managing overactive bladder ...