NCT03282318

A Study to Investigate Efficacy, Safety, Pharmacodynamics and Pharmacokinetics of ASP6294 in the Treatment of Female Subjects With Bladder Pain Syndrome/Interstitial Cystitis

A Phase 2a, Randomized, Double-blind, Placebo-controlled, Parallel-group, Proof of Concept Study to Investigate Efficacy, Safety, Pharmacodynamics and Pharmacokinetics of ASP6294 in the Treatment of Female Subjects With Bladder Pain Syndrome/Interstitial Cystitis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 119 (actual)
• Sponsor: Astellas Pharma Europe B.V. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to investigate efficacy, safety and tolerability of ASP6294 in female participants with Bladder Pain Syndrome/Interstitial Cystitis (BPS/IC). This study will also investigate the pharmacokinetics (PK) and pharmacodynamics (PD) of ASP6294 in female participants with BPS/IC.

Conditions

• Bladder Pain Syndrome
• Interstitial Cystitis

Interventions

Type	Name	Description
DRUG	ASP6294	Participants will receive 320 mg ASP6294 subcutaneous injection at 4-week intervals at baseline (Day 1/Week 0), Week 4 and Week 8.
DRUG	Placebo	Participants will receive placebo to match 320 mg ASP6294 subcutaneous injection at 4-week intervals at baseline (Day 1/Week 0), Week 4 and Week 8.

Timeline

• Start date: 2017-09-28
• Primary completion: 2019-03-21
• Completion: 2019-03-21
• First posted: 2017-09-13
• Last updated: 2024-10-31

Locations

28 sites across 10 countries: Belgium, Czechia, Germany, Hungary, Latvia, Netherlands, Poland, Russia, Spain, United Kingdom