NCT07391306

The Study is Being Conducted to Find a New Treatment for Patients Suffering From Interstitial Cystitis Without Hunner's Lesions.

Double-blind, Placebo-controlled, Adaptive, Multicenter, Prospective, Randomized, Comparative, Parallel-group Study of the Efficacy and Safety of Neovasculgen (Plasmid Supercoiled Deoxyribonucleic Acid pCMV-VEGF165) in Painful Bladder Syndrome/Interstitial Cystitis (BPS/IC)

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: JSC NextGen · Academic / Other
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the efficacy and safety of Neovasculgen in interstitial cystitis and the prevention of secondary bladder shrinkage with a decrease in its volume.

Conditions

• IC
• Interstitial Cystitis and Bladder Pain Syndrome
• Interstitial Cystitis, Chronic

Interventions

Type	Name	Description
DRUG	Neovasculgen®	The bladder is hydro-bougienaged, followed by intradetrusor injections using a cystoscopic injection needle inserted into a rigid or flexible cystoscope inserted through the urethra into the bladder, under direct visualization. The drug is administered as 30 injections, evenly throughout the bladder.
DRUG	Placebo	The bladder is hydro-bougienaged, followed by intradetrusor injections using a cystoscopic injection needle inserted into a rigid or flexible cystoscope inserted through the urethra into the bladder, under direct visualization. The drug is administered as 30 injections, evenly throughout the bladder.

Timeline

• Start date: 2024-02-16
• Primary completion: 2027-05-31
• Completion: 2027-05-31
• First posted: 2026-02-05
• Last updated: 2026-02-05

Locations

1 site across 1 country: Russia