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
Phase of Trial: Phase III
Latest Information Update: 11 Nov 2017
At a glance
- Drugs Rosiptor (Primary)
- Indications Interstitial cystitis
- Focus Registrational; Therapeutic Use
- Acronyms LEADERSHIP 301
- Sponsors Aquinox Pharmaceuticals
- 08 Nov 2017 According to an Aquinox Pharmaceuticals media release, an anticipated minimum of 300 female patients, up to a maximum of 600 patients including males, are currently being enrolled
- 08 Aug 2017 According to an Aquinox Pharmaceuticals media release, as of August 7, 2017, 195 patients have been enrolled in this trial. Top-line data from this trial are expected in the third quarter of 2018.
- 09 May 2017 According to an Aquinox Pharmaceuticals media release, the company plans to provide an enrollment update with additional guidance on expected timing of top-line data at its mid-year financial conference call in early August 2017.