NCT02858453: LEADERSHIP 301

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

Status unknown Phase 3 Last updated 13 March 2018

What this trial tests

Phase 3 trial testing AQX-1125 100 mg in Interstitial Cystitis in 433 participants. Status unknown.

Timeline

1 July 2016

Primary endpoint
1 August 2018

1 February 2020

Quick facts

Lead sponsor	Aquinox Pharmaceuticals (Canada) Inc.
Phase	Phase 3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	433
Start date	1 July 2016
Primary completion	1 August 2018
Estimated completion	1 February 2020
Sites	120 locations across United States, Belgium, Canada, Czechia, Denmark, Hungary, Latvia, Netherlands

Drugs / interventions tested

• AQX-1125 100 mg — full drug profile →
• AQX-1125 200 mg — full drug profile →
• Placebo

Conditions studied

• Interstitial Cystitis — all drugs for Interstitial Cystitis →
• Bladder Pain Syndrome — all drugs for Bladder Pain Syndrome →
• Painful Bladder Syndrome — all drugs for Painful Bladder Syndrome →
• Chronic Interstitial Cystitis — all drugs for Chronic Interstitial Cystitis →

Sponsor

Aquinox Pharmaceuticals (Canada) Inc. — full company profile →

Who can join

Adults 18 to 80, any sex, with Interstitial Cystitis or Bladder Pain Syndrome. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Change from Baseline in Maximum Daily Bladder Pain Score
  Time frame: Baseline to 12 weeks
  Change from Baseline for AQX-1125 100 mg or 200 mg compared to placebo in the maximum daily bladder pain score based on a standardized 11-point numeric rating scale (NRS) recorded by electronic diary (e-diary)

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Interventions for treating people with symptoms of bladder pain syndrome: a network meta-analysis.
   Imamura M, Scott NW, Wallace SA, Ogah JA, et al · · 2020 · cited 13× · PMID 32734597 · DOI 10.1002/14651858.cd013325.pub2