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Efficacy and Safety of 2 Doses of AQX-1125 in Subjects With Interstitial Cystitis / Bladder Pain Syndrome

Unknown statusPhase 3NCT02858453
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

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
Interventions
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)

FacilityCityProvince
Site 1013KelownaBritish Columbia
Site 1005BramptonOntario
Site 1006BurlingtonOntario
Site 1002KingstonOntario
Site 1003KitchenerOntario
Site 1015OakvilleOntario
Site 1010TorontoOntario
Site 1017QuébecQuebec
Site 1017QuébecQuebec
Site 1008SherbrookeQuebec
Site 1016SherbrookeQuebec
Canadian sites for NCT02858453KelownaBramptonBurlingtonKingstonKitchenerOakvilleTorontoQuébec
Canadian sites for NCT02858453. 9 mapped locations with coordinates in the registry. Schematic plot, not to scale.

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT02858453