Interstitial CystitisPhase 2NCT06394830
Safety, Efficacy, and Frequency of Administration of VNX001 in the Treatment of Interstitial Cystitis / Bladder Pain Syndrome (IC/BPS)
A Phase 2 study testing VNX001 in people with Interstitial Cystitis and Bladder Pain Syndrome, run by Vaneltix Pharma, Inc. at 5 sites in United States.
Trial summary
This is an open-label study that will enroll participants with Interstitial Cystitis / Bladder Pain Syndrome (IC/BPS). The study will assess PRN (as needed) dosing of up to 6 intravesical (via catheter) doses of VNX001 (study drug) to treat acute instances of moderate to severe bladder pain over a 14-day period. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Interstitial Cystitis, Bladder Pain Syndrome
- What is being tested?
- VNX001
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 5 sitesUnited States
- Study dates
- 13 Dec 2024to Jun 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Enrolled and completed Study VNX001-111 (i.e., at any site that is concurrently conducting the VNX001-111 study, a subject must have previously enrolled and completed Study VNX001-111 to be eligible for entry into the VNX001-110 study) and meet all other inclusion/exclusion criteria.
- Be able and willing to give a signed informed consent and to follow study instructions.
- Be male or female, ≥ 18 years of age.
- Have a history of IC/BPS for at least 9 months prior to the study, either treated (e.g. Elmiron®, RIMSO-50®), or untreated.
- Have received a cystoscopy in association with their diagnosis of IC/BPS within 1 year of screening.
- Have a score of ≥ 14 and ≤ 30 on the PUF questionnaire, completed at screening.
- Have an episode of acute bladder pain of moderate to severe intensity with a minimum score of 4 on the 11-point bladder pain NRS at time of screening and 15 minutes post void immediately prior to study drug administration.
Who cannot join
- For females, have a positive pregnancy test at screening or be pregnant or lactating.
- Note: Females considered to be of child-bearing potential must commit to using a consistent and medically acceptable method of birth control for the duration of the study: hormonal (i.e., oral, transdermal patch, implant, or injection) on a stable dose for at least 3 months prior to screening; double barrier (i.e., condom with spermicide or diaphragm with spermicide) consistently for at least 2 weeks prior to screening; and intrauterine device for at least 3 months prior to screening; or only have a partner who has been vasectomized for at least 6 months prior to screening or exclusively has same-sex partners. Female participants who are abstinent from heterosexual intercourse as part of their usual lifestyle will also be eligible for participation. Females considered to be of non-childbearing potential include: At least 1 year postmenopausal; surgically sterile (tubal ligation, bilateral oophorectomy, salpingectomy, of hysterectomy); congenitally sterile; diagnosed as infertile and not undergoing treatment to reverse infertility.
- Males who are sexually active with females and are not willing to commit to an acceptable method of birth control for the duration of the study.
- Postmenopausal women who, if taking hormone replacement therapy, have not been stabilized on a regimen of hormone replacement therapy within 3 months of screening.
- Have a known hypersensitivity to heparin or lidocaine.
- Have used any local anesthetic by any route (other than intravesical instillation) within 48-hours prior to study drug administration, or used a lidocaine patch or lidocaine containing topical compounds within 14 days prior to study drug administration.
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- Have used a tricyclic antidepressant, or a gamma-aminobutyric acid (GABA) analogue (gabapentin or pregabalin), unless taking a stable dose of the medication for ≥ 3 weeks. The stable dose of gabapentin may not exceed 1,200 mg per day, and the stable dose of pregabalin may not exceed 150 mg per day.
- Have used prohibited drugs as determined by self-report, positive urine drug screen, or in the opinion of the investigator be under the influence of drugs affecting mentation precluding their ability to follow the study protocol or bias study results.
- Have a known abnormal laboratory test value that, in the investigator's judgement, is clinically significant.
- Have a neurogenic bladder or other disorder that, in the opinion of the investigator, may cause neurogenic bladder (including Parkinson's disease, multiple sclerosis, epilepsy, myasthenia gravis, movement disorders, spinal cord damage).
- Have pain or a pain disorder that, in the opinion of the investigator, would make it difficult to discriminate pelvic pain of bladder origin from the other pain.
- Have any of the following central nervous system (CNS) conditions that in the opinion of the investigator would impact the subject's study participation due to their ability to follow the study protocol or bias study results, severe diagnosed: major depressive disorder, bipolar disorder, schizophrenia, general anxiety disorder, attention deficit disorder, obsessive compulsive disorder, or other major CNS disorder.
- Have history of arrhythmias, conduction disturbances, or cardiac disease, or any coexisting medical condition that, in the opinion of the investigator, may be significant or interfere with study procedures or interpretation of study results.
- Had bladder instillation therapy within 14 days prior to study entry.
- Had an in-office cystoscopy within 7 days prior to study drug administration.
- Had dilatation (hydrodistension) of bladder within 3 months of study entry.
- Evidence or suspected presence of cancer detected during cystoscopy.
- Has received any investigational drug or device within 30 days prior to screening.
- Is currently enrolled in another investigational drug or device study.
- Is unwilling or unable to abide by the requirements of the study.
- Have an actively bleeding lesion or area in the bladder as detected by dipstick urinalysis and investigator assessment, immediately prior to randomization (Section 9.5.1.6). If the investigator determines that active bleeding is not occurring and that it is safe for the subject, the subject may continue in the study.
- Have a history of coagulopathy or taking anticoagulants.
- Are taking any of the following medications:
- Phenytoin
- Carbamazepine
- St. John's Wort
- Phenobarbital
- Rifampin
- Have had any of the following:
- Bacterial cystitis within 30 days as demonstrated by a positive urine culture (≥ 105 bacteria per mL)
- History of pelvic irradiation or radiation cystitis
- History or presence of uterine, cervical, pelvic, rectal, ovarian, or vaginal cancer
- History of benign or malignant bladder tumors
- Current chemotherapy
- History or presence of tuberculous cystitis
- History or presence of chemical cystitis, including that due to cyclophosphamide
- History or presence of urinary schistosomiasis
- Bladder or ureteral calculi
- Clinically significant infectious vaginitis
- Currently uncontrolled genital herpes
- History or presence of urethral diverticulum
- Presence of bladder fistulae
- History of ketamine use
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites, 2 recruiting
- Recruiting
Georgia Urology
Cartersville, Georgia, 30120
- Suspended
Valley Urology, Inc.
Fresno, California, 93710
- Recruiting
Oregon Urology Institute
Springfield, Oregon, 97477
- Completed
Arizona Urology Specialists
Tucson, Arizona, 85715
- Suspended
Prestige Medical Group
Tustin, California, 92780
About this study
Official title: A Phase 2b, Open Label, Single-Arm, Multi-Center, Multiple Dose, 14-Day Study to Evaluate the Safety, Efficacy, and Frequency of Intravesical Administration of VNX001 in Acute Treatment of Subjects With Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS) Who Have an Episode of Acute Bladder Pain of Moderate to Severe Intensity
This is an open-label study that will enroll participants with Interstitial Cystitis / Bladder Pain Syndrome (IC/BPS).
The study will assess PRN (as needed) dosing of up to 6 intravesical (via catheter) doses of VNX001 (study drug) to treat acute instances of moderate to severe bladder pain over a 14-day period. The main aim of the study is to tally the number of doses and assess pain before and after doses. The study will review the safety and tolerability of VNX001.
Participants will need to attend up to seven (7) clinic visits (1 for screening and up to 6 visits for VNX001 dosing) or at least one (1) clinic visit (for a combined screening/dosing visit) and 5 telephone visits over the course of 14 days. Participants will also be asked complete a diary or telephone call each day of the study, in order to record bladder pain, urinary urgency, side effects, and medications taken.
- Conditions
- Interstitial Cystitis, Bladder Pain Syndrome
- Being tested
- VNX001
- Keywords
- interstitial cystitis (IC), bladder pain syndrome (BPS), alkalinized lidocaine, heparin, intravesical, VNX001
- Medical subject headings
- Cystitis, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VNX001Drug
Intravesical administration of VNX001
| Study group | Role | What they receive |
|---|---|---|
| Open Label Arm | Experimental | VNX001 intravesical administration PRN up to 6 doses over 14 days. The VNX001 effective dose is 15 mL of buffered lidocaine HCl (200 mg) and sodium heparin (50,000 USPU). Receives: Drug: VNX001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of PRN intravesical administrations of VNX001
Measured: 14 Days
Secondary outcomes (6)
Change in bladder pain from first dose baseline to 1, 2, 6, 12, and 24 hours post-dose
Average absolute change and average percentage change in bladder pain from baseline to 1, 2, 6, 12, and 24 hours post-dose, as determined using an 11-point numerical rating scale (NRS) for bladder pain. The 11-point NRS for bladder pain is a scale from 0 to 10, with 0 indicating no bladder pain and 10 indicating the worst imaginable bladder pain.
Measured: Through 24 Hours
Change in bladder pain after each repeat dose to 1, 6, 12, and 24 hours post-dose
Average absolute change and average percentage change in bladder pain from after each repeat dose to 1, 6, 12, and 24 hours post-dose, as determined using an 11-point numerical rating scale (NRS) for bladder pain. The 11-point NRS for bladder pain is a scale from 0 to 10, with 0 indicating no bladder pain and 10 indicating the worst imaginable bladder pain.
Measured: Through 24 Hours
Sum of bladder pain intensity differences from baseline to 6, 10, and 24 hours post-dose (SPID-6, SPID-10, and SPID-24, respectively)
A measure of the sum of bladder pain intensity differences from baseline to 6, 10, and 24 hours post-dose (SPID-6, SPID-10, and SPID-24, respectively), as determined using an 11-point numerical rating scale (NRS) for bladder pain. The 11-point NRS for bladder pain is a scale from 0 to 10, with 0 indicating no bladder pain and 10 indicating the worst imaginable bladder pain.
Measured: Through 24 Hours
Change in the Patient Overall Rating of Improvement of Symptoms (PORIS) questionnaire
Change in percentage of subjects achieving ≥ 50% improvement in pain, urgency and overall improvement using the PORIS questionnaire at 1, 12, and 24 hours post-dose. The PORIS questionnaire is an assessment of the subject's condition after treatment compared to before treatment. Subjects will be asked to select the category that best describes the overall change in their condition compared to before receiving study medication; the choices are: worse, no better (0% improvement), slightly improved (25% improvement), moderately improved (50% improvement), greatly improved (75% improvement), or symptoms gone (100% improvement).
Measured: Through 24 Hours
Pain scale threshold associated with subjects seeking repeat dosing
The average NRS pain assessment threshold before each PRN repeat intravesical VNX001 treatment. The 11-point NRS for bladder pain is a scale from 0 to 10, with 0 indicating no bladder pain and 10 indicating the worst imaginable bladder pain.
Measured: 14 Days
Adverse events (AEs)
Incidence of treatment-emergent adverse events (TEAEs), drug-related adverse events (AEs), and discontinuations due to AEs through the last follow up call at 48-72 hours after the last clinic or telephone visit.
Measured: up to 17 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2024
- Study start13 Dec 2024
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interstitial CystitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vaneltix Pharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Prevail Infoworks
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06394830
- Sponsor's protocol ID
- VNX001-110
- Status last verified
- Jan 2026
- First submitted
- 24 Apr 2024
- Last updated
- 22 Jan 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2b, Open Label, Single-Arm, Multi-Center, Multiple Dose, 14-Day Study to Evaluate the Safety, Efficacy, and Frequency of Intravesical Administration of VNX001 in Acute Treatment of Subjects With Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS) Who Have an Episode of Acute Bladder Pain of Moderate to Severe Intensity
- ClinicalTrials.gov ID
- NCT06394830
- Acronym / sponsor ID
- VNX001-110
- Conditions
- Interstitial Cystitis, Bladder Pain Syndrome
- Keywords
- interstitial cystitis (IC), bladder pain syndrome (BPS), alkalinized lidocaine, heparin, intravesical, VNX001
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Vaneltix Pharma, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Prevail Infoworks
- Study start
- 13 Dec 2024 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 1 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label study that will enroll participants with Interstitial Cystitis / Bladder Pain Syndrome (IC/BPS).
The study will assess PRN (as needed) dosing of up to 6 intravesical (via catheter) doses of VNX001 (study drug) to treat acute instances of moderate to severe bladder pain over a 14-day period. The main aim of the study is to tally the number of doses and assess pain before and after doses. The study will review the safety and tolerability of VNX001.
Participants will need to attend up to seven (7) clinic visits (1 for screening and up to 6 visits for VNX001 dosing) or at least one (1) clinic visit (for a combined screening/dosing visit) and 5 telephone visits over the course of 14 days. Participants will also be asked complete a diary or telephone call each day of the study, in order to record bladder pain, urinary urgency, side effects, and medications taken.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open Label Arm | Experimental | Drug: VNX001VNX001 intravesical administration PRN up to 6 doses over 14 days. The VNX001 effective dose is 15 mL of buffered lidocaine HCl (200 mg) and sodium heparin (50,000 USPU). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Enrolled and completed Study VNX001-111 (i.e., at any site that is concurrently conducting the VNX001-111 study, a subject must have previously enrolled and completed Study VNX001-111 to be eligible for entry into the VNX001-110 study) and meet all other inclusion/exclusion criteria.
- Be able and willing to give a signed informed consent and to follow study instructions.
- Be male or female, ≥ 18 years of age.
- Have a history of IC/BPS for at least 9 months prior to the study, either treated (e.g. Elmiron®, RIMSO-50®), or untreated.
- Have received a cystoscopy in association with their diagnosis of IC/BPS within 1 year of screening.
Key exclusion criteria (43 listed)
- For females, have a positive pregnancy test at screening or be pregnant or lactating.
- Note: Females considered to be of child-bearing potential must commit to using a consistent and medically acceptable method of birth control for the duration of the study: hormonal (i.e., oral, transdermal patch, implant, or injection) on a stable dose for at least 3 months prior to screening; double barrier (i.e., condom with spermicide or diaphragm with spermicide) consistently for at least 2 weeks prior to screening; and intrauterine device for at least 3 months prior to screening; or only have a partner who has been vasectomized for at least 6 months prior to screening or exclusively has same-sex partners. Female participants who are abstinent from heterosexual intercourse as part of their usual lifestyle will also be eligible for participation. Females considered to be of non-childbearing potential include: At least 1 year postmenopausal; surgically sterile (tubal ligation, bilateral oophorectomy, salpingectomy, of hysterectomy); congenitally sterile; diagnosed as infertile and not undergoing treatment to reverse infertility.
- Males who are sexually active with females and are not willing to commit to an acceptable method of birth control for the duration of the study.
- Postmenopausal women who, if taking hormone replacement therapy, have not been stabilized on a regimen of hormone replacement therapy within 3 months of screening.
- Have a known hypersensitivity to heparin or lidocaine.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VNX001Intravesical administration of VNX001 | Drug | Open Label Arm |
Primary outcome
Frequency of PRN intravesical administrations of VNX001
Time frame: 14 Days
6 secondary outcomes
Change in bladder pain from first dose baseline to 1, 2, 6, 12, and 24 hours post-dose
Time frame: Through 24 Hours
Change in bladder pain after each repeat dose to 1, 6, 12, and 24 hours post-dose
Time frame: Through 24 Hours
Sum of bladder pain intensity differences from baseline to 6, 10, and 24 hours post-dose (SPID-6, SPID-10, and SPID-24, respectively)
Time frame: Through 24 Hours
Change in the Patient Overall Rating of Improvement of Symptoms (PORIS) questionnaire
Time frame: Through 24 Hours
Pain scale threshold associated with subjects seeking repeat dosing
Time frame: 14 Days
Adverse events (AEs)
Time frame: up to 17 Days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing VNX001 in people with Interstitial Cystitis and Bladder Pain Syndrome, run by Vaneltix Pharma, Inc. at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 43 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vaneltix Pharma, Inc. (732-354-3217, info@vaneltix.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of PRN intravesical administrations of VNX001 (time frame: 14 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026.