Efficacy and Safety of 2 Doses of AQX-1125 in Subjects With Interstitial Cystitis / Bladder Pain Syndrome (LEADERSHIP 301)
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| ClinicalTrials.gov Identifier: NCT02858453 |
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Recruitment Status : Unknown
Verified March 2018 by Aquinox Pharmaceuticals (Canada) Inc..
Recruitment status was: Active, not recruiting
First Posted : August 8, 2016
Last Update Posted : March 15, 2018
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Sponsor:
Aquinox Pharmaceuticals (Canada) Inc.
Information provided by (Responsible Party):
Aquinox Pharmaceuticals (Canada) Inc.
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Brief Summary:
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Interstitial Cystitis Bladder Pain Syndrome Painful Bladder Syndrome Chronic Interstitial Cystitis | Drug: AQX-1125 100 mg Drug: AQX-1125 200 mg Drug: Placebo | Phase 3 |
This multi-center Phase 3 trial includes a randomized, double-blind, placebo-controlled, parallel-group, treatment phase to evaluate the efficacy and safety of 2 doses of oral AQX-1125 in up to 600 subjects with interstitial cystitis/bladder pain syndrome.
The primary objective of this study is to evaluate the effect of 12 weeks of treatment of AQX-1125 (100 mg or 200 mg) administered once daily compared to placebo on the change from Baseline to Week 12 in maximum daily bladder pain using a standardized 11-point numerical rating scale pain score recorded daily by electronic diary (e-diary).
The 12-week Treatment Period is followed by an Extension Period of 52 weeks. Randomization and start of dosing occurs at Baseline and is followed by visits at Week 6 and Week 12. At the end of Week 12, subjects will be randomized into the 52-week Extension Period. Subjects on active treatment during the Treatment Period will continue on that same dose for the Extension Period, while subjects receiving placebo during the Treatment Period will be randomized to one of the active doses of 100 mg or 200 mg AQX-1125 for 52 weeks.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 433 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| 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 |
| Actual Study Start Date : | July 2016 |
| Estimated Primary Completion Date : | August 2018 |
| Estimated Study Completion Date : | February 2020 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Interstitial Cystitis
| Arm | Intervention/treatment |
|---|---|
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Experimental: AQX-1125 100 mg
2 tablets, by mouth, once per day for 12 weeks; followed by a 52-week Extension Period
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Drug: AQX-1125 100 mg
Synthetic SHIP1 activator |
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Experimental: AQX-1125 200 mg
2 tablets, by mouth, once per day for 12 weeks; followed by a 52-week Extension Period
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Drug: AQX-1125 200 mg
Synthetic SHIP1 activator |
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Placebo Comparator: Placebo
2 placebo tablets, by mouth, once per day for 12 weeks; followed by randomization to 100 mg or 200 mg AQX-1125 for a 52-week Extension Period
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Drug: Placebo
Appearance and weight matched placebo tablets |
Primary Outcome Measures :
- 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)
Secondary Outcome Measures :
- Change from Baseline in Voiding Frequency Measured Over a 24 hr Period [ Time Frame: Baseline to 12 weeks ]Change from Baseline for AQX-1125 100 mg or 200 mg compared to placebo in voiding frequency measured over a 24-hour period
- Change from Baseline Interstitial Cystitis Symptom Index Score [ Time Frame: Baseline to 12 weeks ]Change from Baseline for AQX-1125 100 mg or 200 mg compared to placebo in Interstitial Cystitis Symptom Index Score
- Change from Baseline in Bladder Pain/Interstitial Cystitis Symptom Score [ Time Frame: Baseline to 12 weeks ]Change from Baseline for AQX-1125 100 mg or 200 mg compared to placebo in Bladder Pain/Interstitial Cystitis Symptom Score
- Change from Baseline in Subject's Global Response Assessment [ Time Frame: Baseline to 12 weeks ]Change from Baseline for AQX-1125 100 mg or 200 mg compared to placebo in subject's Global Response Assessment
Other Outcome Measures:
- Frequency and Severity of Adverse Events [ Time Frame: Baseline to 12-weeks; during 52-week EP and baseline to 64-weeks, with a 4-week post-dose, and 6 month post-dose (ocular only), follow-up ]Adverse events and abnormal clinically significant vital signs, laboratory tests, electrocardiogram, weight, physical examination findings and ophthalmological examination findings
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| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02858453
Locations
Show 120 study locations
Sponsors and Collaborators
Aquinox Pharmaceuticals (Canada) Inc.
Investigators
| Principal Investigator: | Robert Moldwin, MD | Hofstra Northwell School of Medicine |
| Responsible Party: | Aquinox Pharmaceuticals (Canada) Inc. |
| ClinicalTrials.gov Identifier: | NCT02858453 |
| Other Study ID Numbers: |
AQX-1125-301 |
| First Posted: | August 8, 2016 Key Record Dates |
| Last Update Posted: | March 15, 2018 |
| Last Verified: | March 2018 |
Keywords provided by Aquinox Pharmaceuticals (Canada) Inc.:
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Interstitial cystitis Bladder pain syndrome Painful bladder syndrome Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS) |
AQX-1125 SHIP1 Chronic interstitial cystitis |
Additional relevant MeSH terms:
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Cystitis Cystitis, Interstitial Syndrome Somatoform Disorders Disease Pathologic Processes Mental Disorders |
Urinary Bladder Diseases Urologic Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Urogenital Diseases Male Urogenital Diseases |