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LEADERSHIP 301 Trial For People With Interstitial Cystitis/Bladder Pain Syndrome


clinical trial recruitment

Purpose

The purpose of the LEADERSHIP 301 Trial is to evaluate if an investigational drug, AQX-1125, reduces the bladder pain that comes with interstitial cystitis/bladder pain syndrome (IC/BPS) or relieves other symptoms such as urinary frequency. The study drug is a new type of medication that may help reduce inflammation and pain in the bladder.

An earlier clinical study in women with IC/BPS showed that those who took the study drug every day for 6 weeks experienced reduced bladder pain and improved symptoms compared to those who took placebo.1

Eligibility

You may qualify if you:

  • Are male or female between the ages of 18 and 80 years
  • Have been diagnosed with IC/BPS for more than 3 months but no more than 20 years
  • Have consistently experienced moderate to severe bladder pain, urinary urgency, and/or urinary frequency

What will Happen During the Study

As a study participant, you will have regular contact with our study team who will monitor your health closely. There will be 13-14 visits during the study, which will last 22 months:   

  • 12-week, double-blind treatment period (2 in 3 chance of receiving study drug)
  • 52-week extension study period during which all participants will receive active study drug
  • Final follow-up visit 6 months after the last dose of study medication

Research Study Title

The LEADERSHIP 301 Trial: A 12-Week, Randomized, Multi-center, Double-Blind, Placebo-Controlled, 3-Arm, Parallel-Group, Phase 3 Trial to Evaluate the Efficacy and Safety of 2 Doses of AQX-1125 Targeting the SHIP1 Pathway in Subjects with Interstitial Cystitis/Bladder Pain Syndrome Followed by an Extension Period

Sponsor

Aquinox Pharmaceuticals (Canada) Inc.

 For additional study information:

clinicaltrials.gov

www.LEADERSHIP301.com

1. Nickel JC, et al. A Phase II study of the efficacy and safety of the novel oral SHIP1 activator AQX-1125 in subjects with moderate to severe interstitial cystitis/bladder pain syndrome. J Urol. 2016;196(3):747-754.