Efficacy and Safety of 2 Doses of AQX-1125 in Subjects With Interstitial Cystitis / Bladder Pain Syndrome
Unknown statusPhase 3NCT02858453
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Brief summary (from the registry)
This study evaluates the effects of two doses of oral AQX-1125 on bladder pain and other urinary symptoms in subjects with interstitial cystitis/bladder pain syndrome. Participants will receive either 100 mg AQX-1125, 200 mg AQX-1125 or placebo for the first 12 weeks of the study. After 12 weeks, all participants will receive either 100 mg or 200 mg AQX-1125 for 52 weeks.
Study details
- Official 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 Src Homology 2-containing Inositol-5'-Phosphatase 1 (SHIP1) Pathway in Subjects With Interstitial Cystitis/Bladder Pain Syndrome Followed by an Extension Period
- Conditions
- Interstitial Cystitis
- Bladder Pain Syndrome
- Painful Bladder Syndrome
- Chronic Interstitial Cystitis
- Interventions
- Drug: AQX-1125 100 mg
- Drug: AQX-1125 200 mg
- Drug: Placebo
- Sponsor
- Aquinox Pharmaceuticals (Canada) Inc.
- Start date
- 2016-07
- Primary completion
- 2018-08
- Sex
- All
- Age range
- from 18 Years to 80 Years
- Results posted
- No results posted in this snapshot
- Countries
- Belgium, Canada, Czechia, Denmark, Hungary, Latvia, Netherlands, Poland, Romania, Spain, United Kingdom, United States
- Total sites listed
- 120
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Be male or female, ≥18 and ≤80 years of age who have had symptoms of bladder pain in addition to urinary urgency and/or urinary frequency for more than 6 months * Have had a clinical diagnosis, or history consistent with the diagnosis, of interstitial cystitis/bladder pain syndrome for \>3 months but ≤20 years * Must be capable of voiding independently * Have undergone a cystoscopy within the last 36 months prior to Baseline * Women of child bearing potential must have a negative pregnancy test, be non-lactating and agree to avoid pregnancy and use a highly effective method of contraception with one additional barrier method of contraception from screening until at least 28 days after the last dose of study drug has been taken * Men must use a condom for sexual intercourse from screening until at least 90 days after last dose of study drug has been taken, unless they have been surgically sterilized (vasectomy) Exclusion Criteria * Have had a urinary tract infection (UTI) including bacterial cystitis within the past 30 days * Microscopic hematuria that has not been adequately evaluated as per local standard of care * Have a history of chronic substance abuse, dependency or abuse of opiates, or other narcotics within the last 2 years * History of previous procedure(s) (augmentation cystoplasty, cystectomy, cytolysis, botulinum toxin or bladder catheterization) that has significantly affected bladder function * History of cyclophosphamide or chemical cystitis, urinary tuberculosis or radiation cystitis * Women: History of bladder tumors; uterine, cervical, vaginal or urethral cancer * Men: History of prostate surgery (transurethral resection of the prostate \[TURP\], transurethral resection tumor \[TURT\], transurethral incision of the prostate \[TUIP\], transurethral needle ablation \[TUNA\] etc.), a history of prostate cancer or currently being treated for chronic bacterial prostatitis * Major surgery within 3 months prior to Screening
Canadian sites (11)
| Facility | City | Province |
|---|---|---|
| Site 1013 | Kelowna | British Columbia |
| Site 1005 | Brampton | Ontario |
| Site 1006 | Burlington | Ontario |
| Site 1002 | Kingston | Ontario |
| Site 1003 | Kitchener | Ontario |
| Site 1015 | Oakville | Ontario |
| Site 1010 | Toronto | Ontario |
| Site 1017 | Québec | Quebec |
| Site 1017 | Québec | Quebec |
| Site 1008 | Sherbrooke | Quebec |
| Site 1016 | Sherbrooke | Quebec |
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT02858453