Women and men needed to participate in a clinical research study of an oral investigational drug for interstitial cystitis/bladder pain syndrome (IC/BPS).

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 a 40-Week Extension Period

Sponsor

Aquinox Pharmaceuticals (Canada) Inc.

Purpose

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

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

Eligibility

You may qualify if you:

  • Are between the ages of 18 and 80
  • Have been diagnosed with interstitial cystitis/bladder pain syndrome (IC/BPS) for at least 3 months
  • 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 11-12 visits during the study, which will last 16 months.  There will be a 12-week treatment period and a 40-week extension.

During the treatment period there will be a 1 in 3 chance you will receive placebo. After completing the treatment period, you will be randomized into an extension period where all patients receive active study drug.

Contact to learn more

To learn more about the Leadership 301 Trial and to find a participating study site close to you, visit http://www.leadership301.com/.

For additional study information:

https://clinicaltrials.gov/ct2/show/NCT02858453