Interstitial CystitisPhase 3LEADERSHIP 301NCT02858453
Efficacy and Safety of 2 Doses of AQX-1125 in Subjects With Interstitial Cystitis / Bladder Pain Syndrome
A Phase 3 study testing AQX-1125 100 mg and AQX-1125 200 mg in people with Interstitial Cystitis and Bladder Pain Syndrome, run by Aquinox Pharmaceuticals (Canada) Inc. at 120 sites in 12 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Interstitial Cystitis, Bladder Pain Syndrome, Painful Bladder Syndrome
- What is being tested?
- AQX-1125 100 mg and AQX-1125 200 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 433 participants
- Where
- 120 sitesin 12 countries
- Study dates
- Jul 2016to Feb 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
120 sites in 12 countries.
120 sites in 12 countries
United States56 sites
Site 9025
Albuquerque, New Mexico, 87109
Site 9050
Bala-Cynwyd, Pennsylvania, 19004
Site 9010
Beverly Hills, California, 90211
Site 9005
Boston, Massachusetts, 02131
Site 9016
Brooklyn, New York, 11215
Site 9031
Bryn Mawr, Pennsylvania, 19010
Site 9066
Cheektowaga, New York, 14225
Site 9048
Cleveland, Ohio, 44109
Site 9033
Cleveland, Ohio, 44195
Site 9062
Cranford, New Jersey, 07016
Site 9001
Edison, New Jersey, 08837
Site 9060
Escondido, California, 92025
Site 9004
Farmington, Connecticut, 06032
Site 9027
Franklin, Tennessee, 37067
Site 9047
Gahanna, Ohio, 43230
Site 9034
Grand Rapids, Michigan, 49546
Site 9040
Greer, South Carolina, 29650
Site 9035
Homewood, Alabama, 35209
Site 9069
Houston, Texas, 77002
Site 9030
Houston, Texas, 77030
Site 9064
Little Rock, Arkansas, 72212
Site 9011
Los Angeles, California, 90017
Site 9021
Los Angeles, California, 90027
Site 9019
Los Angeles, California, 90048
Site 9054
Metairie, Louisiana, 70001
Site 9029
Middlebury, Connecticut, 06762
Site 9068
Morehead City, North Carolina, 28557
Site 9008
Mountlake Terrace, Washington, 98043
Site 9023
Murrieta, California, 92562
Site 9037
New Hyde Park, New York, 11042
Site 9036
Newtown, Pennsylvania, 18940
Site 9013
Noblesville, Indiana, 46062
Site 9053
Oklahoma City, Oklahoma, 73104
Site 9071
Oklahoma City, Oklahoma, 73120
Site 9072
Omaha, Nebraska, 68114
Site 9015
Orange, California, 92868
Site 9038
Owings Mills, Maryland, 21114
Site 9039
Palo Alto, California, 94304
Site 9032
Philadelphia, Pennsylvania, 19140
Site 9002
Raleigh, North Carolina, 27612
Site 9012
Richmond, Virginia, 23235
Site 9020
Royal Oak, Michigan, 48073
Site 9003
San Diego, California, 92130
Site 9046
Sherman Oaks, California, 91411
Site 9007
Shreveport, Louisiana, 71106
Site 9052
Temple, Texas, 76508
Site 9041
The Bronx, New York, 10457
Site 9051
Toledo, Ohio, 43614
Site 9042
Troy, Michigan, 48084
Site 9026
Tucson, Arizona, 85715
Site 9028
Watertown, Massachusetts, 02472
Site 9049
West Des Moines, Iowa, 50266
Site 9070
Whittier, California, 90603
Site 9055
Wilmington, North Carolina, 28401
Site 9045
Winston-Salem, North Carolina, 27103
Site 9058
Winston-Salem, North Carolina, 27103
Canada11 sites
Site 1005
Brampton, Ontario, L6T 4S5
Site 1006
Burlington, Ontario, L7N 3V2
Site 1013
Kelowna, British Columbia, V1W 4V5
Site 1002
Kingston, Ontario, K7L 2V7
Site 1003
Kitchener, Ontario, N2N 2B9
Site 1015
Oakville, Ontario, I6J 3P1
Site 1017
Québec, Quebec, G1N 4V3
Site 1017
Québec, Quebec, G1S2L6
Site 1016
Sherbrooke, Quebec, J1H 1Z1
Site 1008
Sherbrooke, Quebec, J1H 5N4
Site 1010
Toronto, Ontario, M3N 3M5
Romania11 sites
Site 7007
Brasov, 500152
Site 7010
Bucharest, 020125
Site 7008
Bucharest, 022328
Site 7002
Bucharest, 14452
Site 7005
Bucharest, 21655
Site 7009
Bucharest, 41345
Site 7004
Bucharest, 50659
Site 7006
Craiova, 200349
Site 7011
Craiova, 200642
Site 7003
Sibiu, 550245
Site 7001
Târgu Mureş, 540353
Poland9 sites
Site 6011
Bydgoszcz, 85-312
Site 6009
Gdynia, 81-148
Site 6004
Gdynia, 81-366
Site 6005
Piaseczno, 05-500
Site 6001
Poznan, 60-586
Site 6007
Poznan, 61-512
Site 6002
Siedlce, 08-110
Site 6008
Warsaw, 00-714
Site 6003
Warsaw, 03889
United Kingdom8 sites
8005
Coventry, Warwickshire, CV2 2DX
Site 8009
London, W1G 8HU
Site 8004
London, W2 1NY
Site 8008
Plymouth, Devon, PL6 8DH
Site 8002
Reading, RG1 5AN
Site 8001
Sheffield, South Yorkshire, S10 2JF
Site 8003
Wakefield, WF1 4DG
Site 8007
Wolverhampton, West Midlands, WV10 0QP
Czechia7 sites
Site 2002
Hradec Králové, 50005
Site 2006
Jablonec nad Nisou, 46601
Site 2003
Kolín, 28002
Site 2001
Pilsen, 30100
Site 2007
Prague, 130 00
Site 2004
Prague, 160 00
Site 2005
Uherské Hradiště, 68668
Latvia5 sites
Site 5005
Daugavpils, LV-5401
Site 5001
Jelgava, LV-3001
Site 5002
Liepāja, LV-3402
Site 5003
Riga, LV-1002
Site 5004
Riga, LV-1038
Spain4 sites
Site 1401
Aravaca, 28023
Site 1402
Córdoba, 14004
Site 1405
Elche, 03203
Site 1403
Vic, 08500
Belgium3 sites
Site 1103
Edegem, 2650
Site 1102
Ghent, 9000
Site 1101
Roeselare, 8800
Hungary3 sites
Site 4004
Budapest, 1204
Site 4001
Csongrád, 6640
Site 4003
Sopron, 9400
Netherlands2 sites
Site 1301
Rotterdam, South Holland, 3015 CE
Site 1302
The Hague, 2594 AB
About this study
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
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.
Read the detailed description
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.
- Conditions
- Interstitial Cystitis, Bladder Pain Syndrome, Painful Bladder Syndrome, Chronic Interstitial Cystitis
- Being tested
- AQX-1125 100 mg, AQX-1125 200 mg, Placebo
- Keywords
- Interstitial cystitis, Bladder pain syndrome, Painful bladder syndrome, Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS), AQX-1125, SHIP1, Chronic interstitial cystitis
- Medical subject headings
- Cystitis, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AQX-1125 100 mgDrug
Synthetic SHIP1 activator
AQX-1125 200 mgDrug
Synthetic SHIP1 activator
PlaceboDrug
Appearance and weight matched placebo tablets
| Study group | Role | What they receive |
|---|---|---|
| AQX-1125 100 mg | Experimental | 2 tablets, by mouth, once per day for 12 weeks; followed by a 52-week Extension Period Receives: Drug: AQX-1125 100 mg |
| AQX-1125 200 mg | Experimental | 2 tablets, by mouth, once per day for 12 weeks; followed by a 52-week Extension Period Receives: Drug: AQX-1125 200 mg |
| Placebo | Placebo comparator | 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 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Maximum Daily Bladder Pain Score
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)
Measured: Baseline to 12 weeks
Secondary outcomes (4)
Change from Baseline in Voiding Frequency Measured Over a 24 hr Period
Change from Baseline for AQX-1125 100 mg or 200 mg compared to placebo in voiding frequency measured over a 24-hour period
Measured: Baseline to 12 weeks
Change from Baseline Interstitial Cystitis Symptom Index Score
Change from Baseline for AQX-1125 100 mg or 200 mg compared to placebo in Interstitial Cystitis Symptom Index Score
Measured: Baseline to 12 weeks
Change from Baseline in Bladder Pain/Interstitial Cystitis Symptom Score
Change from Baseline for AQX-1125 100 mg or 200 mg compared to placebo in Bladder Pain/Interstitial Cystitis Symptom Score
Measured: Baseline to 12 weeks
Change from Baseline in Subject's Global Response Assessment
Change from Baseline for AQX-1125 100 mg or 200 mg compared to placebo in subject's Global Response Assessment
Measured: Baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2016 (estimated)
- Study startJul 2016
- Primary completionAug 2018 (estimated)
- Study completionFeb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interstitial CystitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 433 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aquinox Pharmaceuticals (Canada) Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Moldwin, MD, Principal investigator, Hofstra Northwell School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02858453
- Sponsor's protocol ID
- AQX-1125-301
- Acronym
- LEADERSHIP 301
- Status last verified
- Mar 2018
- First submitted
- 19 Apr 2016
- Last updated
- 15 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02858453
- Acronym / sponsor ID
- LEADERSHIP 301 / AQX-1125-301
- Conditions
- Interstitial Cystitis, Bladder Pain Syndrome, Painful Bladder Syndrome, Chronic Interstitial Cystitis
- Keywords
- Interstitial cystitis, Bladder pain syndrome, Painful bladder syndrome, Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS), AQX-1125, SHIP1, Chronic interstitial cystitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 433 participants (actual)
- Lead sponsor
- Aquinox Pharmaceuticals (Canada) Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2016 (actual)
- Primary completion
- Aug 2018 (estimated)
- Study completion
- Feb 2020 (estimated)
- First posted
- 8 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AQX-1125 100 mg | Experimental | Drug: AQX-1125 100 mg2 tablets, by mouth, once per day for 12 weeks; followed by a 52-week Extension Period |
| AQX-1125 200 mg | Experimental | Drug: AQX-1125 200 mg2 tablets, by mouth, once per day for 12 weeks; followed by a 52-week Extension Period |
| Placebo | Placebo comparator | Drug: Placebo2 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AQX-1125 100 mgSynthetic SHIP1 activator | Drug | AQX-1125 100 mg |
| AQX-1125 200 mgSynthetic SHIP1 activator | Drug | AQX-1125 200 mg |
| PlaceboAppearance and weight matched placebo tablets | Drug | Placebo |
Primary outcome
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)
4 secondary outcomes
Change from Baseline in Voiding Frequency Measured Over a 24 hr Period
Time frame: Baseline to 12 weeks
Change from Baseline Interstitial Cystitis Symptom Index Score
Time frame: Baseline to 12 weeks
Change from Baseline in Bladder Pain/Interstitial Cystitis Symptom Score
Time frame: Baseline to 12 weeks
Change from Baseline in Subject's Global Response Assessment
Time frame: Baseline to 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Moldwin, MD principal investigator
Hofstra Northwell School of Medicine
120 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing AQX-1125 100 mg and AQX-1125 200 mg in people with Interstitial Cystitis and Bladder Pain Syndrome, run by Aquinox Pharmaceuticals (Canada) Inc. at 120 sites in 12 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 120 sites in United States, Canada, Romania, Poland, United Kingdom and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Maximum Daily Bladder Pain Score (time frame: Baseline to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2018.