Ulcerative ColitisPhase 2NCT01612039
Safety, Efficacy, and Tolerability Study of ASP3291 in Patients With Active Ulcerative Colitis
A Phase 2 study testing ASP3291 in people with Ulcerative Colitis, run by Telsar Pharma Inc..
Trial summary
This is a Phase 2, randomized, double-blind, multicenter, parallel, placebo controlled study. Approximately 120 eligible patients with mild-to-moderate active ulcerative colitis will be randomized to double blind treatment of either 1,000 mg twice daily (b.i.d.) ASP3291 (2,000 mg/d) or matching placebo in a 1:1 ratio… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- ASP3291
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 112 participants
- Where
- No sites listed yet
- Study dates
- Jul 2012to Apr 2014
- Phase
- Phase 2
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Documented diagnosis of ulcerative colitis by endoscopy and histology consistent with diagnosis
- Must be able to provide informed consent
- Has a Modified Baron Score of at least 2 (as determined by the investigator) at 15 cm or more from the anal verge as assessed during the screening period
- Has an Ulcerative Colitis Clinical Score (UCCS) of at least 4, with a stool frequency and rectal bleeding score of at least 1 as assessed during the screening period
- If female, is at least 2 years postmenopausal, surgically sterile per documentation provided by a medical professional, agrees to sexual abstinence, or uses two approved highly effective methods of birth control during the study period and for 30 days after the last dose of study drug
- If male, agrees to sexual abstinence or to use two highly effective methods of birth control during the study period and for 90 days after last dose; agrees to not donate sperm during the study period and for 90 days after last dose
- Willing and able to comply with the study requirements
Who cannot join
- Has a history of any clinically significant neurological, renal, hepatic, gastrointestinal, pulmonary, metabolic, cardiovascular, psychiatric, endocrine, hematological disorder or disease, or any other medical condition that, in the investigator's opinion, would preclude participation in the study
- Has severe Ulcerative Colitis as defined by an average bloody stool frequency of >6 per day and at least one of the following:
- Resting heart rate >90 bpm
- Oral temperature of >38°C (>100.4°F)
- Hemoglobin of <10.5 g/dL
- Has has undergone previous resective colonic surgery
Show all 20Show fewer
- Has a significant or immediate risk for toxic megacolon
- Has previous diagnosis with Crohn's disease, indeterminate colitis, microscopic colitis or acute diverticulitis based on medical history
- Has an extension of disease limited to ulcerative proctitis (i.e., disease extension less than 15 cm from the anal verge)
- Has an active peptic ulcer disease based on medical history
- Shows a stool culture positive for enteric pathogens during the screening period
- Had previous treatment with tumor necrosis factor-α (TNF α) inhibitors
- Had treatment with rectal corticosteroid within 2 weeks before Day -2
- Has active liver disease or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2 times the upper limit of normal (ULN) at screening
- Has an estimated glomerular filtration rate (using Cockroft-Gault formula corrected for body surface area) of <60 mL/min at screening
- Known history of human immunodeficiency virus antibody
- History of severe allergic or anaphylactic reactions requiring medical attention
- Has participated in another investigational study within 30 days before Visit 3
- History of drug or alcohol abuse in the past 2 years
- Has previously participated in a study with ASP3291
About this study
Official title: A Phase 2, Randomized, Double-Blind, Parallel, Placebo-Controlled, Proof-of-Concept Study to Assess the Efficacy, Safety, and Tolerability of ASP3291 in Patients With Active Ulcerative Colitis
This is a Phase 2, randomized, double-blind, multicenter, parallel, placebo controlled study. Approximately 120 eligible patients with mild-to-moderate active ulcerative colitis will be randomized to double blind treatment of either 1,000 mg twice daily (b.i.d.) ASP3291 (2,000 mg/d) or matching placebo in a 1:1 ratio for 8 weeks.
The study hypothesis is that treatment with ASP3291 compared to placebo will improve a patient's ulcerative colitis endoscopic score from baseline to Week 8.
- Conditions
- Ulcerative Colitis
- Being tested
- ASP3291, Placebo
- Keywords
- ulcerative colitis
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASP3291Drug
Tablet, 1,000 mg (four 250-mg tablets), twice a day, 8 weeks
PlaceboDrug
Matching placebo tablets
| Study group | Role | What they receive |
|---|---|---|
| ASP3291 | Experimental | Not described Receives: Drug: ASP3291 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline (Visit 2) to Week 8 (Visit 7) in Modified Baron Score
Measured: Baseline to Week 8
Secondary outcomes (3)
Proportion of subjects with Modified Baron Score of 0 or 1 at Week 8 (Visit 7)
Measured: Week 8
Change in Ulcerative Colitis Clinical Score of >3
Measured: Basline to Week 8
Ulcerative Colitis Clinical Score stool frequency and rectal bleeding score of 0
Measured: Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2012 (estimated)
- Study startJul 2012
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Telsar Pharma Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Schinagl, Ph.D., Study director, Drais Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01612039
- Sponsor's protocol ID
- 3291-CL-0004
- Status last verified
- Sep 2016
- First submitted
- 1 Jun 2012
- Last updated
- 28 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Double-Blind, Parallel, Placebo-Controlled, Proof-of-Concept Study to Assess the Efficacy, Safety, and Tolerability of ASP3291 in Patients With Active Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT01612039
- Acronym / sponsor ID
- 3291-CL-0004
- Conditions
- Ulcerative Colitis
- Keywords
- ulcerative colitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Telsar Pharma Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2012
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 5 Jun 2012 (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 is a Phase 2, randomized, double-blind, multicenter, parallel, placebo controlled study. Approximately 120 eligible patients with mild-to-moderate active ulcerative colitis will be randomized to double blind treatment of either 1,000 mg twice daily (b.i.d.) ASP3291 (2,000 mg/d) or matching placebo in a 1:1 ratio for 8 weeks.
The study hypothesis is that treatment with ASP3291 compared to placebo will improve a patient's ulcerative colitis endoscopic score from baseline to Week 8.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ASP3291 | Experimental | Drug: ASP3291 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Documented diagnosis of ulcerative colitis by endoscopy and histology consistent with diagnosis
- Must be able to provide informed consent
- Has a Modified Baron Score of at least 2 (as determined by the investigator) at 15 cm or more from the anal verge as assessed during the screening period
- Has an Ulcerative Colitis Clinical Score (UCCS) of at least 4, with a stool frequency and rectal bleeding score of at least 1 as assessed during the screening period
- If female, is at least 2 years postmenopausal, surgically sterile per documentation provided by a medical professional, agrees to sexual abstinence, or uses two approved highly effective methods of birth control during the study period and for 30 days after the last dose of study drug
Key exclusion criteria (20 listed)
- Has a history of any clinically significant neurological, renal, hepatic, gastrointestinal, pulmonary, metabolic, cardiovascular, psychiatric, endocrine, hematological disorder or disease, or any other medical condition that, in the investigator's opinion, would preclude participation in the study
- Has severe Ulcerative Colitis as defined by an average bloody stool frequency of >6 per day and at least one of the following:
- Has has undergone previous resective colonic surgery
- Has a significant or immediate risk for toxic megacolon
- Has previous diagnosis with Crohn's disease, indeterminate colitis, microscopic colitis or acute diverticulitis based on medical history
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 |
|---|---|---|
| ASP3291Tablet, 1,000 mg (four 250-mg tablets), twice a day, 8 weeks | Drug | ASP3291 |
| PlaceboMatching placebo tablets | Drug | Placebo |
Primary outcome
Change from baseline (Visit 2) to Week 8 (Visit 7) in Modified Baron Score
Time frame: Baseline to Week 8
3 secondary outcomes
Proportion of subjects with Modified Baron Score of 0 or 1 at Week 8 (Visit 7)
Time frame: Week 8
Change in Ulcerative Colitis Clinical Score of >3
Time frame: Basline to Week 8
Ulcerative Colitis Clinical Score stool frequency and rectal bleeding score of 0
Time frame: Week 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2016.
- Individual participant dataSharing planned: No
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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 Schinagl, Ph.D. study director
Drais Pharmaceuticals, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ASP3291 in people with Ulcerative Colitis, run by Telsar Pharma Inc..
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 7 inclusion and 20 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: finished, as of the sponsor's last update on 28 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 (Visit 2) to Week 8 (Visit 7) in Modified Baron Score (time frame: Baseline to Week 8). 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 28 Sep 2016.