AQX-1125-301:Ph3 study of AQX-1125 for IC/BPS
Research type
Research Study
Full 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
IRAS ID
211430
Contact name
Christopher Chapple
Contact email
Sponsor organisation
Aquinox Pharmaceuticals (Canada) Inc.
Eudract number
2016-000906-12
Duration of Study in the UK
1 years, 11 months, days
Research summary
Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS) is a chronic condition of unknown causes that involves bladder pain, urinary urgency, urinary frequency and/or nocturia. People may experience mild discomfort, pressure, tenderness, or intense pain in the bladder and pelvic area. Although the disease is more prevalent in women than men, its frequency seems to be increasing with more defined approaches to diagnosis. IC/BPS is difficult to diagnose and is usually based on exclusion of other potential diseases or causality of symptoms. There are currently limited treatment options for IC/BPS.
Aquinox Pharmaceuticals (Canada) Inc. is developing an oral, small-molecule, anti-inflammatory agent (AQX-1125) for the treatment of IC/BPS. AQX-1125 has shown meaningful reductions in pain and other urinary symptoms while being generally well tolerated after 6 weeks of treatment (200 mg/day) in an earlier trial of 69 women with moderate to severe IC/BPS.
Up to 600 (total) men and women with moderate to severe IC/BPS will take part in the study at up to 120 research sites in 9 different countries. The two-phase study is expected to last for either 30 weeks or 56 weeks depending on which group the participant is assigned to. The blinded-treatment phase is 12 weeks with participants randomly assigned to receive either 100 mg AQX-1125, 200 mg AQX-1125 or placebo. Neither the study participants, the study site, nor Aquinox will know which treatment the participant is receiving. The open label extension will last an additional 14 or 40 weeks wherein all participants will receive either 100 mg AQX-1125 or 200 mg AQX-1125. Study-related tests and procedures will include: physical examination, cystoscopy (examination of the bladder), ophthalmic examinations, completion of questionnaires, blood & urine analyses and ECG.
REC name
East Midlands - Derby Research Ethics Committee
REC reference
16/EM/0376
Date of REC Opinion
23 Nov 2016
REC opinion
Further Information Favourable Opinion