Safety, Efficacy, and Frequency of Administration of VNX001 in the Treatment of Interstitial Cystitis / Bladder Pain Syndrome (IC/BPS)

NCT06394830 | Recruiting Phase 2 FDA Drug

• 1 other identifier: VNX001-110
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 5

Brief 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. 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

Keywords

interstitial cystitis (IC); bladder pain syndrome (BPS); alkalinized lidocaine; heparin; intravesical; VNX001

Outcome Measures

Primary Outcomes (1)

• Frequency of PRN intravesical administrations of VNX001

  14 Days

Secondary Outcomes (6)

• Change in bladder pain from first dose baseline to 1, 2, 6, 12, and 24 hours post-dose

  Through 24 Hours

• Change in bladder pain after each repeat dose to 1, 6, 12, and 24 hours post-dose

  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)

  Through 24 Hours

• Change in the Patient Overall Rating of Improvement of Symptoms (PORIS) questionnaire

  Through 24 Hours

• Pain scale threshold associated with subjects seeking repeat dosing

  14 Days

Study Arms (1)

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).

Drug: VNX001

Interventions

VNX001 DRUG

Intravesical administration of VNX001

Open Label Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.
• 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.
• 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.

Sponsors & Collaborators

• Vaneltix Pharma, Inc.: lead
• Prevail Infoworks: collaborator

Study Sites (5)

Arizona Urology Specialists

Tucson, Arizona, 85715, United States

COMPLETED

Valley Urology, Inc.

Fresno, California, 93710, United States

SUSPENDED

Prestige Medical Group

Tustin, California, 92780, United States

SUSPENDED

Georgia Urology

Cartersville, Georgia, 30120, United States

RECRUITING

Oregon Urology Institute

Springfield, Oregon, 97477, United States

RECRUITING

MeSH Terms

Conditions

Cystitis, Interstitial

Condition Hierarchy (Ancestors)

Cystitis; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Central Study Contacts

Vaneltix Pharma, Inc.

CONTACT

732-354-3217; info@vaneltix.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2024
• First Posted: May 1, 2024
• Study Start: December 13, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: January 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)