Crohn's Disease · Inflammatory Bowel Disease (IBD) · Ulcerative Colitis (UC)
Phase 2 Study of MT-501 and MT-201 for Active Crohn’s Disease or Ulcerative Colitis
This Phase 2 platform study is assessing the safety, activity, drug levels, and biological effects of MT-501 and MT-201 in adults with moderately to severely active Crohn’s disease or ulcerative colitis.
Registry title: A Phase 2 Study to Evaluate Therapies for Inflammatory Bowel Disease
46 recruiting U.S. sites ↓Study at a glance
- Age
- 18 Years–80 Years
- Treatment
- MT-501 or MT-201
- Design
- Single
- Central study contact
- ASCEND-IBD Trial Center844-206-4980clinicaltrials@miradortx.com
- Sponsor
- Mirador Therapeutics, Inc.
Research question
What are the safety, clinical activity, pharmacokinetics, and pharmacodynamics of the study’s experimental therapies in adults with moderately to severely active Crohn’s disease or ulcerative colitis?
Participant snapshot
Who the study is looking for
- The study is looking for adults ages 18 through 80.
- The study is looking for people with Crohn’s disease or ulcerative colitis confirmed by endoscopy and histopathology.
- The study is looking for people whose Crohn’s disease or ulcerative colitis is moderately to severely active according to specified clinical and endoscopic measures.
- The study is looking for participants who meet its drug-stabilization requirements.
- Recruiting locations are listed in the United States, Canada, Georgia, Moldova, and Ukraine, but the study team must confirm whether a particular site and disease cohort are currently open.
Participation overview
What participation may involve
Participation may involve MT-501 tablets for Crohn’s disease or ulcerative colitis, or multiple intravenous doses of MT-201 with standard of care for Crohn’s disease. Assessments examine safety, symptoms, clinical activity, endoscopy, histology, drug levels, and immune response. What participation may involve: - Participants in the MT-501 groups receive MT-501 tablets. - Participants in the MT-201 group receive multiple intravenous doses of MT-201 with standard of care. - The study assesses adverse events and markedly abnormal laboratory values. - Disease assessments include endoscopy, symptom and clinical activity measures, and histology measures that differ between Crohn’s disease and ulcerative colitis. - The study assesses pharmacokinetics, including trough drug concentration, and immunogenicity.
Study interventions
What participants may receive or do
- MT-501: Participants assigned to either the Crohn’s disease or ulcerative colitis MT-501 group receive MT-501 tablets. The registry does not report the dose or dosing schedule.
- MT-201: Participants in the Crohn’s disease MT-201 group receive multiple intravenous doses of MT-201 together with standard of care. The registry does not report the dose, infusion schedule, or permitted standard-of-care treatments.
Study design
How the comparison works
This is a Phase 2, multicenter platform study with three experimental groups: MT-501 tablets for Crohn’s disease, MT-501 tablets for ulcerative colitis, and intravenous MT-201 with standard of care for Crohn’s disease. The registry also labels the intervention model as single-group. The registry lists allocation as not applicable and does not describe random assignment among the experimental groups. The study is single-masked: the outcomes assessor is masked, using a prospective observer-blinded endpoint design.
Reported activities
Procedures and tests
- Endoscopy is used to assess Crohn’s disease with the Simple Endoscopic Score for Crohn’s Disease and ulcerative colitis with the Mayo Endoscopic Score.
- Histology assessments use named scoring systems, including the Robarts Histopathology Index and other disease-specific histology scores.
- Crohn’s disease activity is assessed with the Crohn’s Disease Activity Index.
- Ulcerative colitis activity is assessed using endoscopy, rectal bleeding, stool frequency, and a modified Mayo score.
- Patient-reported outcomes are used to assess symptomatic remission.
- Safety monitoring includes treatment-emergent adverse events, serious adverse events, adverse events leading to discontinuation, and markedly abnormal laboratory values.
- Pharmacokinetic assessments characterize study-drug levels, including trough concentration.
- The study assesses immunogenicity, meaning immune responses to the investigational drug, although the registry does not describe the specific test.
- Screening must confirm the diagnosis by endoscopy and histopathology and verify the required level of disease activity.
Eligibility highlights
Details that may affect whether you contact the study
These are selected highlights, not a complete eligibility check. Exact criteria remain in the full registry record below.
Common requirements
- For the Crohn’s disease cohort, Crohn’s disease must be confirmed by endoscopy and histopathology.
- Crohn’s disease must be moderately to severely active according to both the Crohn’s Disease Activity Index and Simple Endoscopic Score for Crohn’s Disease.
- People entering the Crohn’s disease cohort must meet the study’s drug-stabilization requirements.
- For the ulcerative colitis cohort, ulcerative colitis must be confirmed by endoscopy and histopathology.
- Ulcerative colitis must be moderately to severely active according to a three-component modified Mayo Clinic Score.
- People entering the ulcerative colitis cohort must meet the study’s drug-stabilization requirements.
- Participants must be 18 through 80 years old.
Possible reasons someone may not be able to join
- People with indeterminate colitis are excluded from the Crohn’s disease cohort.
- A suspected or diagnosed abdominal or perianal abscess at screening excludes a person from the Crohn’s disease cohort.
- The Crohn’s disease cohort excludes people who previously had more than 100 cm of small bowel removed or more than two colon segments removed.
- The Crohn’s disease cohort excludes disease isolated to the stomach, duodenum, jejunum, or perianal region without colon or ileum involvement.
- The ulcerative colitis cohort excludes current or recent fulminant colitis, toxic megacolon, or bowel perforation within the last six months.
- A current stoma or an impending need for a colostomy or ileostomy excludes a person from the ulcerative colitis cohort.
- The ulcerative colitis cohort excludes people who received intravenous corticosteroids within 14 days before screening or during screening.
- Previous total removal of the colon and rectum or subtotal removal of the colon excludes a person from the ulcerative colitis cohort.
Important unknowns
What the record does not make clear
- The registry does not state how many study visits are required, how often they occur, or whether hospitalization is involved.
- Outcome measures are assessed through 12 or 13 weeks, but the registry does not state each participant’s total participation or follow-up duration.
- The MT-201 arm includes standard of care and eligibility requires drug stabilization, but permitted medications and whether current treatment continues are not specified.
- The record gives a 14-day restriction for intravenous corticosteroids in the ulcerative colitis cohort but does not report timing rules for other medications or define its drug-stabilization requirements.
- The registry does not describe rescue treatment if symptoms worsen during the study.
- Endoscopy is used for eligibility and outcome assessment, but the registry does not state the number, timing, preparation, sedation, or biopsy requirements.
- The registry does not explain which study-related or routine-care costs are covered or billed to insurance.
- The registry does not report whether participants receive compensation.
- The registry does not report whether transportation, lodging, or other travel support is available.
- The registry does not state whether any visits or assessments can be completed remotely.
- The registry does not describe access to MT-501 or MT-201 after study participation ends.
- The registry lists three experimental groups but labels the intervention model as single-group and does not explain how participants enter a particular therapy or disease cohort.
Before contacting the site
Questions for the study team
- Which disease and treatment cohorts are currently enrolling at the site I would contact?
- How would the study determine whether I enter an MT-501 or MT-201 cohort?
- What are the dose and dosing schedule for MT-501 or MT-201, and how long does treatment continue?
- What is the complete visit schedule, including screening, treatment, endoscopy, and follow-up visits?
- Which current medications must remain stable, stop, or change before and during the study?
- How many endoscopies and biopsies are required, and what preparation and sedation are used?
- What happens if my symptoms worsen, and what rescue treatments or withdrawal options are available?
- Which costs are covered, and are compensation or travel assistance available?
Before changing care
Questions for your gastroenterologist
- How stable is my Crohn’s disease or ulcerative colitis now, and what risks would a treatment change create in my situation?
- Which of my current medications could safely remain stable, and which study-required changes should we discuss with the research team?
- What approved treatment alternatives are reasonable for me if I do not pursue this study?
- Are there concerns about repeated endoscopy, biopsy, intravenous treatment, or study-drug monitoring given my medical history?
- How should my regular gastroenterology care be coordinated with the research team if I contact the study?
This plain-language digest is provided by the Aidy clinical trials API. It may omit details and is not medical advice or an eligibility decision. Review the full registry record and confirm details with the study team.
Source record
Full registry record
The sections below preserve the study information supplied through ClinicalTrials.gov, including complete descriptions, criteria, outcomes, and locations.
About this study
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.
The purpose of this platform study is to assess the safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) to evaluate multiple oral or parenteral experimental therapies for moderately to severely active Crohn's Disease or Ulcerative Colitis.
Study design and administration
- Organization
- Mirador Therapeutics, Inc.
- Organization class
- Industry
- Organization study ID
- MT-100-201
- Lead sponsor
- Mirador Therapeutics, Inc.
- Sponsor class
- Industry
- Enrollment type
- Estimated
- Allocation
- Na
- Intervention model
- Single Group
- Primary purpose
- Treatment
- Masking
- Single
- Who is masked
- Outcomes Assessor
- Standard age groups
- Adult, Older Adult
Study arms
Experimental
Intervention Specific Appendix- Crohn's Disease
Participants will receive MT-501 Tablets
Interventions: Drug: MT-501
Experimental
Intervention Specific Appendix- Ulcerative Colitis
Participants will receive MT-501Tablets
Interventions: Drug: MT-501
Experimental
Intervention Specific Appendix- Crohn's Disease with Standard of Care
Participants will receive multiple intravenous doses of MT-201 with standard of care
Interventions: Drug: MT-201
Interventions
Drug
MT-501
MT-501
Drug
MT-201
MT-201
Eligibility
18 Years–80 Years
All
Not accepted
Inclusion criteria (6)
- Diagnosis of Crohn's Disease (CD), as confirmed by endoscopy and histopathologyRegistry-derived · unreviewed
- Moderately to severely active CD as defined by Clinical Disease Activity Index (CDAI) and Simple Endoscopic Score (SES-CD)Registry-derived · unreviewed
- Meets drug stabilization requirementsRegistry-derived · unreviewed
- Diagnosis of Ulcerative Colitis (UC), as confirmed by endoscopy and histopathologyRegistry-derived · unreviewed
- Moderately to severely active UC as defined by a 3-component MMCSRegistry-derived · unreviewed
- Meets drug stabilization requirementsRegistry-derived · unreviewed
Exclusion criteria (8)
- Diagnosis of indeterminate colitisRegistry-derived · unreviewed
- Suspected or diagnosed intra-abdominal or perianal abscess at ScreeningRegistry-derived · unreviewed
- Previous small bowel resection with combined resected length of \> 100 cm or previous colonic resection of \> 2 segmentsRegistry-derived · unreviewed
- CD isolated to the stomach, duodenum, jejunum, or perianal region, without colonic and/or ileal involvementRegistry-derived · unreviewed
- Current evidence or within recent history (within last 6 months) of fulminant colitis, toxic megacolon, or bowel perforationRegistry-derived · unreviewed
- Current stoma or impending need for colostomy or ileostomyRegistry-derived · unreviewed
- Received IV corticosteroids within 14 days prior to Screening or during the Screening PhaseRegistry-derived · unreviewed
- Previous total proctocolectomy or subtotal colectomyRegistry-derived · unreviewed
This information can identify a possible match, conflict, or item needing confirmation. Only the study team can determine eligibility.
Study outcomes
Primary outcome
Assess the proportion of participants reporting treatment emergent adverse events (TEAEs), serious adverse events (SAEs), adverse events (AEs) leading to discontinuation, and markedly abnormal laboratory values
Time frame: Up to 13 weeks
Primary outcome
Assess the Proportion of Participants with Endoscopic Response (CD)
Time frame: 13 weeks
Endoscopic response as assessed by SES-CD score.
Primary outcome
Assess the Proportion of Participants Endoscopic Improvement (UC)
Time frame: 12 weeks
Endoscopic improvement as assessed by MES.
Primary outcome
Assess the Proportion of Participants with Clinical Remission (CD)
Time frame: 13 weeks
Clinical remission as assessed by CDAI score.
Primary outcome
Assess the Proportion of Participants with Clinical Remission (UC)
Time frame: 12 weeks
Clinical remission as assessed by endoscopy, rectal bleeding and stool frequency.
Secondary outcome
Assess the Proportion of Participants with Clinical Remission (CD)
Time frame: 13 weeks
CD: Clinical remission as assessed by CDAI score.
Secondary outcome
Assess the Proportion of Participants with Clinical Remission (UC)
Time frame: 12 weeks
Clinical remission as assessed by endoscopy, rectal bleeding, and stool frequency.
Secondary outcome
Assess the Proportion of Participants with Symptomatic Remission (CD and UC)
Time frame: Up to 13 weeks
Symptomatic remission as assessed by patient reported outcomes.
Secondary outcome
Assess the Proportion of Participants with Clinical Response (CD)
Time frame: 13 weeks
CD: Clinical response as assessed by CDAI score.
Secondary outcome
Assess the Proportion of Participants with Clinical Response (UC)
Time frame: 12 weeks
UC: Clinical response as assessed by MMCS.
Secondary outcome
Assess the Proportion of Participants with Endoscopic and Clinical Response (CD Only)
Time frame: 13 weeks
Endoscopy as assessed by SES-CD and clinical response as assessed by CDAI score.
Secondary outcome
Assess the Proportion of Participants with Histologic Response (UC Only)
Time frame: 12 weeks
Histologic response as assessed by the RHI.
Secondary outcome
Assess the Proportion of Participants with Histologic Remission (UC only)
Time frame: 12 weeks
Histologic remission as assessed by the RHI.
Secondary outcome
Assess the Proportion of Participants with Histologic-Endoscopic Mucosal Improvement (UC only)
Time frame: 12 weeks
Histologic-endoscopic mucosal improvement as assessed by the Geboes score and MES.
Secondary outcome
Characterize the Change in Endoscopy Score (CD)
Time frame: 13 weeks
CD: Endoscopy score as assessed by SES-CD.
Secondary outcome
Characterize the Change in Endoscopy Score (UC)
Time frame: 12 weeks
Endoscopy score as assessed by MES.
Secondary outcome
Characterize the Change in Histology Score (CD)
Time frame: 13 weeks
Histology as assessed by GHAS and RHI.
Secondary outcome
Characterize the Change in Histology Score (UC)
Time frame: 12 weeks
Histology as assessed by Geobes, RHI and NHI
Secondary outcome
Asses the Pharmacokinetics (PK) (e.g., Trough Concentration [Ctrough]) of Investigational Drug
Time frame: Up to 13 weeks
Secondary outcome
Assess immunogenicity
Time frame: 13 weeks
Recruiting locations in the United States
Mirador Therapeutics Selected Site
RecruitingBirmingham, Alabama, 35235, United States
ASCEND-IBD Trial Center844-206-4980clinicaltrials@miradortx.com
Mirador Therapeutics Selected Site
RecruitingScottsdale, Arizona, 85258, United States
ASCEND-IBD Trial Center844-206-4980clinicaltrials@miradortx.com
Mirador Therapeutics Selected Site
RecruitingSun City, Arizona, 85351, United States
ASCEND-IBD Trial Center844-206-4980clinicaltrials@miradortx.com
Mirador Therapeutics Selected Site
RecruitingLittle Rock, Arkansas, 72205, United States
ASCEND-IBD Trial Center844-206-4980clinicaltrials@miradortx.com
Mirador Therapeutics Selected Site
RecruitingLittle Rock, Arkansas, 72211, United States
ASCEND-IBD Trial Center844-206-4980clinicaltrials@miradortx.com
Mirador Therapeutics Selected Site
RecruitingColorado Springs, Colorado, 80921, United States
ASCEND-IBD Trial Center844-206-4980clinicaltrials@miradortx.com
Mirador Therapeutics Selected Site
RecruitingLittleton, Colorado, 80120, United States
ASCEND-IBD Trial Center844-206-4980clinicaltrials@miradortx.com
Mirador Therapeutics Selected Site
RecruitingMiami, Florida, 33134, United States
ASCEND-IBD Trial Center844-206-4980clinicaltrials@miradortx.com
Mirador Therapeutics Selected Site
RecruitingMiami, Florida, 33165, United States
ASCEND-IBD Trial Center844-206-4980clinicaltrials@miradortx.com
Mirador Therapeutics Selected Site
RecruitingMiami, Florida, 33176, United States
ASCEND-IBD Trial Center844-206-4980clinicaltrials@miradortx.com
Mirador Therapeutics Selected Site
RecruitingOrlando, Florida, 32825, United States
ASCEND-IBD Trial Center844-206-4980clinicaltrials@miradortx.com
Mirador Therapeutics Selected Site
RecruitingPalmetto Bay, Florida, 33176, United States
ASCEND-IBD Trial Center844-206-4980clinicaltrials@miradortx.com
Mirador Therapeutics Selected Site
RecruitingPensacola, Florida, 32504, United States
ASCEND-IBD Trial Center844-206-4980clinicaltrials@miradortx.com
Mirador Therapeutics Selected Site
RecruitingAtlanta, Georgia, 30342, United States
ASCEND-IBD Trial Center844-206-4980clinicaltrials@miradortx.com
Mirador Therapeutics Selected Site
RecruitingSnellville, Georgia, 30078, United States
ASCEND-IBD Trial Center844-206-4980clinicaltrials@miradortx.com
Mirador Therapeutics Selected Site
RecruitingGlenview, Illinois, 60026, United States
ASCEND-IBD Trial Center844-206-4980clinicaltrials@miradortx.com
Mirador Therapeutics Selected Site
RecruitingGurnee, Illinois, 60031, United States
ASCEND-IBD Trial Center844-206-4980clinicaltrials@miradortx.com
Mirador Therapeutics Selected Site
RecruitingLafayette, Louisiana, 70503, United States
ASCEND-IBD Trial Center844-206-4980clinicaltrials@miradortx.com
Mirador Therapeutics Selected Site
RecruitingMarrero, Louisiana, 70072, United States
ASCEND-IBD Trial Center844-206-4980clinicaltrials@miradortx.com
Mirador Therapeutics Selected Site
RecruitingShreveport, Louisiana, 71105, United States
ASCEND-IBD Trial Center844-206-4980clinicaltrials@miradortx.com
Mirador Therapeutics Selected Site
RecruitingYpsilanti, Michigan, 48197, United States
ASCEND-IBD Trial Center844-206-4980clinicaltrials@miradortx.com
Mirador Therapeutics Selected Site
RecruitingBridgeton, Missouri, 63044, United States
ASCEND-IBD Trial Centerclinicaltrials@miradortx.com
Mirador Therapeutics Selected Site
RecruitingKansas City, Missouri, 64114, United States
ASCEND-IBD Trial Center844-206-4980clinicaltrials@miradortx.com
Mirador Therapeutics Selected Site
RecruitingLiberty, Missouri, 64068, United States
ASCEND-IBD Trial Center844-206-4980clinicaltrials@miradortx.com
Mirador Therapeutics Selected Site
RecruitingLas Vegas, Nevada, 89128, United States
ASCEND-IBD Trial Center844-206-4980clinicaltrials@miradortx.com
Mirador Therapeutics Selected Site
RecruitingNew York, New York, 10016, United States
ASCEND-IBD Trial Center844-206-4980clinicaltrials@miradortx.com
Mirador Therapeutics Selected Site
RecruitingRochester, New York, 14618, United States
ASCEND-IBD Trial Center844-206-4980clinicaltrials@miradortx.com
Mirador Therapeutics Selected Site
RecruitingHigh Point, North Carolina, 27262, United States
ASCEND-IBD Trial Center844-206-4980clinicaltrials@miradortx.com
Mirador Therapeutics Selected Site
RecruitingRaleigh, North Carolina, 27612, United States
ASCEND-IBD Trial Center844-206-4980clinicaltrials@miradortx.com
Mirador Therapeutics Selected Site
RecruitingCincinnati, Ohio, 45219, United States
ASCEND-IBD Trial Center844-206-4980clinicaltrials@miradortx.com
Mirador Therapeutics Selected Site
RecruitingLiberty Township, Ohio, 45044, United States
ASCEND-IBD Trial Center844-206-4980clinicaltrials@miradortx.com
Mirador Therapeutics Selected Site
RecruitingProvidence, Rhode Island, 02904, United States
ASCEND-IBD Trial Center844-206-4980clinicaltrials@miradortx.com
Mirador Therapeutics Selected Site
RecruitingGreenville, South Carolina, 29607, United States
ASCEND-IBD Trial Center844-206-4980clinicaltrials@miradortx.com
Mirador Therapeutics Selected Site
RecruitingCordova, Tennessee, 38018, United States
ASCEND-IBD Trial Center844-206-4980clinicaltrials@miradortx.com
Mirador Therapeutics Selected Site
RecruitingDallas, Texas, 75230, United States
ASCEND-IBD Trial Center844-206-4980clinicaltrials@miradortx.com
Mirador Therapeutics Selected Site
RecruitingGarland, Texas, 75044, United States
ASCEND-IBD Trial Center844-206-4980clinicaltrials@miradortx.com
Mirador Therapeutics Selected Site
RecruitingGeorgetown, Texas, 78628, United States
ASCEND-IBD Trial Center844-206-4980clinicaltrials@miradortx.com
Mirador Therapeutics Selected Site
RecruitingHouston, Texas, 77090, United States
ASCEND-IBD Trial Center844-206-4980clinicaltrials@miradortx.com
Mirador Therapeutics Selected Site
RecruitingLubbock, Texas, 79424, United States
ASCEND-IBD Trial Center844-206-4980clinicaltrials@miradortx.com
Mirador Therapeutics Selected Site
RecruitingSouthlake, Texas, 76092, United States
ASCEND-IBD Trial Center844-206-4980clinicaltrials@miradortx.com
Mirador Therapeutics Selected Site
RecruitingTyler, Texas, 75701, United States
ASCEND-IBD Trial Center844-206-4980clinicaltrials@miradortx.com
Mirador Therapeutics Selected Site
RecruitingWebster, Texas, 77598, United States
ASCEND-IBD Trial Center844-206-4980clinicaltrials@miradortx.com
Mirador Therapeutics Selected Site
RecruitingBellevue, Washington, 98004, United States
ASCEND-IBD Trial Center844-206-4980clinicaltrials@miradortx.com
Mirador Therapeutics Selected Site
RecruitingSilverdale, Washington, 98383, United States
ASCEND-IBD Trial Center844-206-4980clinicaltrials@miradortx.com
Mirador Therapeutics Selected Site
RecruitingTacoma, Washington, 98405, United States
ASCEND-IBD Trial Center844-206-4980clinicaltrials@miradortx.com
Mirador Therapeutics Selected Site
RecruitingMilwaukee, Wisconsin, 53215, United States
ASCEND-IBD Trial Center844-206-4980clinicaltrials@miradortx.com
This study also lists 20 locations outside the United States. They are not shown here.
Central study contacts
Registry dates
- First posted
- Aug 8, 2025
- Primary completion
- Apr 30, 2027
- Overall completion
- Feb 4, 2028
Trial information comes from ClinicalTrials.gov and may change. Confirm current status, eligibility, and site details with the study team. Aidy does not provide medical advice or determine eligibility.