Efficacy and Safety of 2 Doses of AQX-1125 in Subjects With Interstitial Cystitis / Bladder Pain Syndrome
Public ClinicalTrials.gov record NCT02858453. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT02858453
- Recruitment status
- Not listed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 433 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 80 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 2016 (Actual)
- Primary completion
- Aug 2018 (Estimated)
- Completion
- Feb 2020 (Estimated)
- Last update posted
- Mar 15, 2018
2016 – 2020
United States locations
- U.S. sites
- 56
- U.S. states
- 24
- U.S. cities
- 50
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Site 9035 | Homewood | Alabama | 35209 | — |
| Site 9026 | Tucson | Arizona | 85715 | — |
| Site 9064 | Little Rock | Arkansas | 72212 | — |
| Site 9010 | Beverly Hills | California | 90211 | — |
| Site 9060 | Escondido | California | 92025 | — |
| Site 9011 | Los Angeles | California | 90017 | — |
| Site 9021 | Los Angeles | California | 90027 | — |
| Site 9019 | Los Angeles | California | 90048 | — |
| Site 9023 | Murrieta | California | 92562 | — |
| Site 9015 | Orange | California | 92868 | — |
| Site 9039 | Palo Alto | California | 94304 | — |
| Site 9003 | San Diego | California | 92130 | — |
| Site 9046 | Sherman Oaks | California | 91411 | — |
| Site 9070 | Whittier | California | 90603 | — |
| Site 9004 | Farmington | Connecticut | 06032 | — |
| Site 9029 | Middlebury | Connecticut | 06762 | — |
| Site 9013 | Noblesville | Indiana | 46062 | — |
| Site 9049 | West Des Moines | Iowa | 50266 | — |
| Site 9054 | Metairie | Louisiana | 70001 | — |
| Site 9007 | Shreveport | Louisiana | 71106 | — |
| Site 9038 | Owings Mills | Maryland | 21114 | — |
| Site 9005 | Boston | Massachusetts | 02131 | — |
| Site 9028 | Watertown | Massachusetts | 02472 | — |
| Site 9034 | Grand Rapids | Michigan | 49546 | — |
| Site 9020 | Royal Oak | Michigan | 48073 | — |
| Site 9042 | Troy | Michigan | 48084 | — |
| Site 9072 | Omaha | Nebraska | 68114 | — |
| Site 9062 | Cranford | New Jersey | 07016 | — |
| Site 9001 | Edison | New Jersey | 08837 | — |
| Site 9025 | Albuquerque | New Mexico | 87109 | — |
| Site 9016 | Brooklyn | New York | 11215 | — |
| Site 9066 | Cheektowaga | New York | 14225 | — |
| Site 9037 | New Hyde Park | New York | 11042 | — |
| Site 9041 | The Bronx | New York | 10457 | — |
| Site 9068 | Morehead City | North Carolina | 28557 | — |
| Site 9002 | Raleigh | North Carolina | 27612 | — |
| Site 9055 | Wilmington | North Carolina | 28401 | — |
| Site 9045 | Winston-Salem | North Carolina | 27103 | — |
| Site 9058 | Winston-Salem | North Carolina | 27103 | — |
| Site 9048 | Cleveland | Ohio | 44109 | — |
| Site 9033 | Cleveland | Ohio | 44195 | — |
| Site 9047 | Gahanna | Ohio | 43230 | — |
| Site 9051 | Toledo | Ohio | 43614 | — |
| Site 9053 | Oklahoma City | Oklahoma | 73104 | — |
| Site 9071 | Oklahoma City | Oklahoma | 73120 | — |
| Site 9050 | Bala-Cynwyd | Pennsylvania | 19004 | — |
| Site 9031 | Bryn Mawr | Pennsylvania | 19010 | — |
| Site 9036 | Newtown | Pennsylvania | 18940 | — |
| Site 9032 | Philadelphia | Pennsylvania | 19140 | — |
| Site 9040 | Greer | South Carolina | 29650 | — |
| Site 9027 | Franklin | Tennessee | 37067 | — |
| Site 9069 | Houston | Texas | 77002 | — |
| Site 9030 | Houston | Texas | 77030 | — |
| Site 9052 | Temple | Texas | 76508 | — |
| Site 9012 | Richmond | Virginia | 23235 | — |
| Site 9008 | Mountlake Terrace | Washington | 98043 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 64 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02858453, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 15, 2018 · Synced Oct 21, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02858453 live on ClinicalTrials.gov.