Comparing 3 approaches for inflammatory bowel disease (IBD)
Official title: A Phase 2 Study to Evaluate Therapies for Inflammatory Bowel Disease
A Phase 2, Multi-Center, Platform Study to Evaluate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics With Multiple Therapies in Participants With Active Crohn's Disease or Active Ulcerative Colitis (ASCEND-IBD)
- Phase 2
- 3 groups
- One site, in Toronto
- Recruiting
Interventions
- Medication
MT-501
MT-501
- Medication
MT-201
MT-201
Canadian Sites (1)
1 of 1 recruiting
- Recruiting
Mirador Therapeutics Selected Site
Toronto
Eligibility Criteria
See who this study is looking for28 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Crohn's Disease:
- +Diagnosis of Crohn's Disease (CD), as confirmed by endoscopy and histopathology
- +Moderately to severely active CD as defined by Clinical Disease Activity Index (CDAI) and Simple Endoscopic Score (SES-CD)
- +Meets drug stabilization requirements
- +Inclusion CriteriaInclusion criteriaThe things you must have or be for a study to consider you.Read more →-Ulcerative Colitis:
- +Diagnosis of Ulcerative Colitis (UC), as confirmed by endoscopy and histopathology
- +Moderately to severely active UC as defined by a 3-component MMCS
- +Meets drug stabilization requirements
- +Exclusion CriteriaExclusion criteriaThe things that would prevent someone from taking part.Read more →-Crohn's Disease:
- +Diagnosis of indeterminate colitis
- +Suspected or diagnosed intra-abdominal or perianal abscess at ScreeningScreeningThe checks done before joining, to see whether a study fits.Read more →
- +Previous small bowel resection with combined resected length of \> 100 cm or previous colonic resection of \> 2 segments
- +CD isolated to the stomach, duodenum, jejunum, or perianal region, without colonic and/or ileal involvement
- +Exclusion Criteria-Ulcerative Colitis:
- +Current evidence or within recent history (within last 6 months) of fulminant colitis, toxic megacolon, or bowel perforation
- +Current stoma or impending need for colostomy or ileostomy
- +Received IV corticosteroids within 14 days prior to Screening or during the Screening Phase
- +Previous total proctocolectomy or subtotal colectomy
Exclusion
- −Crohn's Disease:
- −Diagnosis of indeterminate colitis
- −Suspected or diagnosed intra-abdominal or perianal abscess at ScreeningScreeningThe checks done before joining, to see whether a study fits.Read more →
- −Previous small bowel resection with combined resected length of \> 100 cm or previous colonic resection of \> 2 segments
- −CD isolated to the stomach, duodenum, jejunum, or perianal region, without colonic and/or ileal involvement
- −Exclusion CriteriaExclusion criteriaThe things that would prevent someone from taking part.Read more →-Ulcerative Colitis:
- −Current evidence or within recent history (within last 6 months) of fulminant colitis, toxic megacolon, or bowel perforation
- −Current stoma or impending need for colostomy or ileostomy
- −Received IV corticosteroids within 14 days prior to Screening or during the Screening Phase
- −Previous total proctocolectomy or subtotal colectomy
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 2Phase 2A middle-stage study looking at what a treatment does and watching for side effects.Read more → — a middle-stage study in a few hundred people at most, looking at what the treatment does and watching for side effectsSide effectAn unwanted effect thought to be caused by the treatment itself.Read more →.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 3 groups in this study.
Groups A and B receive MT-501.
Registry label: A: Intervention Specific Appendix- Crohn's Disease · B: Intervention Specific Appendix- Ulcerative Colitis
Group C receives MT-201.
Registry label: C: Intervention Specific Appendix- Crohn's Disease with Standard of Care
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
One group of people involved — usually the participants — is not told which treatment is which.
From the trial registry
Built from this field:
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists an age range of 18 years to 80 years.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 140 people.
The study is currently expected to finish around February 2028.
The main measurement is taken over: Up to 13 weeks.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Assess the proportion of participants reporting treatment emergent adverse eventsAdverse eventAny medical problem that happens during a study, whether or not the treatment caused it.Read more → (TEAEs), serious adverse eventsSerious adverse eventAn adverse event meeting a formal severity threshold, such as requiring hospital admission.Read more → (SAEs), adverse events (AEs) leading to discontinuation, and markedly abnormal laboratory values — measured over Up to 13 weeks.
Assess the Proportion of Participants with Endoscopic Response (CD) — measured over 13 weeks.
Assess the Proportion of Participants Endoscopic Improvement (UC) — measured over 12 weeks.
Assess the Proportion of Participants with Clinical Remission (CD) — measured over 13 weeks.
The study lists 1 further main measurements.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT07113522 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About MT-501Drug
MT-501
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About MT-201Drug
MT-201
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: an age range of 18 years to 80 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
One group of people involved — usually the participants — is not told which treatment is which.
There is only one group in this study, so there is no assignment to different treatments.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists an age range of 18 years to 80 years.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: Up to 13 weeks.
The study as a whole is currently expected to finish around 2028-02-04.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 140 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 7 locations, including: Toronto, Canada; Ypsilanti, Michigan, United States; New York, New York, United States; Rochester, New York, United States; Bellevue, Washington, United States; Silverdale, Washington, United States, and 1 more.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
This is a Phase 2, multicenter, platform study in adult participants with IBD (moderately to severely active Crohn's Disease or Ulcerative Colitis). The primary goal of this study is to assess the safety and efficacy of multiple investigational drugs.
Other Sites (6)
Mirador Therapeutics Selected Site
Ypsilanti, Michigan, United States
Mirador Therapeutics Selected Site
New York, New York, United States
Mirador Therapeutics Selected Site
Rochester, New York, United States
Mirador Therapeutics Selected Site
Bellevue, Washington, United States
Mirador Therapeutics Selected Site
Silverdale, Washington, United States
Mirador Therapeutics Selected Site
Tacoma, Washington, United States
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.