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NCT06394830 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Interstitial Cystitis and Bladder Pain Syndrome, sponsored by Vaneltix Pharma.

Recruiting
Registry status
Phase 2
Development phase
50
Enrollment target
5
Study locations

NCT06394830 is a Phase 2 study of Interstitial Cystitis and Bladder Pain Syndrome that is actively recruiting participants, run by Vaneltix Pharma. The registered enrollment target is 50 participants, below the 360-participant average among 26 other Interstitial Cystitis trials with a reported enrollment target (86% lower). The trial reports 5 study locations across 4 states.

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The verdict

NCT06394830, a Phase 2 study of Interstitial Cystitis and Bladder Pain Syndrome, is actively recruiting participants, sponsored by Vaneltix Pharma.

RECRUITING
Registry status
Phase 2
Development phase
50 participants
Enrollment target
5
Study locations

Study 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 Studied

Interstitial Cystitis Bladder Pain Syndrome

Interventions

  • DRUG VNX001

Study Locations (5)

California

  • Valley Urology, Inc. - Fresno
  • Prestige Medical Group - Tustin

Arizona

  • Arizona Urology Specialists - Tucson

Georgia

  • Georgia Urology - Cartersville

Oregon

  • Oregon Urology Institute - Springfield

Trial Details

FieldValue
Enrollment Target 50 participants
Start Date 2024-12-13
Est. Completion 2026-06
Phase Phase 2

Sponsor

Vaneltix Pharma

2 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06394830

The ClinicalTrials.gov registry entry for NCT06394830 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 360-participant average among 26 other Interstitial Cystitis trials with a reported enrollment target (86% lower). The listed sponsor is Vaneltix Pharma, which has 2 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Interstitial Cystitis appearing as the primary indexed condition, and to 1 intervention - of which VNX001 is the first listed.

NCT06394830 reports 5 study locations spanning 4 distinct geographic areas - top geographies include California, Arizona, Georgia.

Frequently Asked Questions

What is clinical trial NCT06394830 about?

NCT06394830 is a clinical study titled "Safety, Efficacy, and Frequency of Administration of VNX001 in the Treatment of Interstitial Cystitis / Bladder Pain Syndrome (IC/BPS)". 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 ...

What is the current status of trial NCT06394830?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 50 participants. The study started on 2024-12-13. Estimated completion is 2026-06.

What conditions does trial NCT06394830 study?

This clinical trial studies the following conditions: Interstitial Cystitis, Bladder Pain Syndrome.

What interventions are being tested in trial NCT06394830?

The interventions under investigation include: VNX001 (DRUG).

Who is sponsoring clinical trial NCT06394830?

This trial is sponsored by Vaneltix Pharma, which has 2 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06394830 being conducted?

This trial has 5 study locations across Arizona, California, Georgia, Oregon. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.