Inflammatory Bowel Disease (IBD)Phase 2ASCEND-IBDNCT07113522
A Phase 2 Study to Evaluate Therapies for Inflammatory Bowel Disease
A Phase 2 study testing MT-501 and MT-201 in people with Inflammatory Bowel Disease (IBD) and Ulcerative Colitis (UC), run by Mirador Therapeutics, Inc. at 66 sites in 5 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Inflammatory Bowel Disease (IBD), Ulcerative Colitis (UC), Crohn's Disease
- What is being tested?
- MT-501 and MT-201
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 66 sitesin 5 countries
- Study dates
- 26 Jun 2025to 4 Feb 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- 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
- 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
Who cannot join
- Diagnosis of indeterminate colitis
- Suspected or diagnosed intra-abdominal or perianal abscess at Screening
- 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
- 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
Trial locations and contacts
66 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
66 sites in 5 countries
United States46 sites, 46 recruiting
- Recruiting
Mirador Therapeutics Selected Site
Atlanta, Georgia, 30342
ASCEND-IBD Trial Center, 844-206-4980, clinicaltrials@miradortx.com
- Recruiting
Mirador Therapeutics Selected Site
Bellevue, Washington, 98004
ASCEND-IBD Trial Center, 844-206-4980, clinicaltrials@miradortx.com
- Recruiting
Mirador Therapeutics Selected Site
Birmingham, Alabama, 35235
ASCEND-IBD Trial Center, 844-206-4980, clinicaltrials@miradortx.com
- Recruiting
Mirador Therapeutics Selected Site
Bridgeton, Missouri, 63044
ASCEND-IBD Trial Center, clinicaltrials@miradortx.com
- Recruiting
Mirador Therapeutics Selected Site
Cincinnati, Ohio, 45219
ASCEND-IBD Trial Center, 844-206-4980, clinicaltrials@miradortx.com
- Recruiting
Mirador Therapeutics Selected Site
Colorado Springs, Colorado, 80921
ASCEND-IBD Trial Center, 844-206-4980, clinicaltrials@miradortx.com
- Recruiting
Mirador Therapeutics Selected Site
Cordova, Tennessee, 38018
ASCEND-IBD Trial Center, 844-206-4980, clinicaltrials@miradortx.com
- Recruiting
Mirador Therapeutics Selected Site
Dallas, Texas, 75230
ASCEND-IBD Trial Center, 844-206-4980, clinicaltrials@miradortx.com
- Recruiting
Mirador Therapeutics Selected Site
Garland, Texas, 75044
ASCEND-IBD Trial Center, 844-206-4980, clinicaltrials@miradortx.com
- Recruiting
Mirador Therapeutics Selected Site
Georgetown, Texas, 78628
ASCEND-IBD Trial Center, 844-206-4980, clinicaltrials@miradortx.com
- Recruiting
Mirador Therapeutics Selected Site
Glenview, Illinois, 60026
ASCEND-IBD Trial Center, 844-206-4980, clinicaltrials@miradortx.com
- Recruiting
Mirador Therapeutics Selected Site
Greenville, South Carolina, 29607
ASCEND-IBD Trial Center, 844-206-4980, clinicaltrials@miradortx.com
- Recruiting
Mirador Therapeutics Selected Site
Gurnee, Illinois, 60031
ASCEND-IBD Trial Center, 844-206-4980, clinicaltrials@miradortx.com
- Recruiting
Mirador Therapeutics Selected Site
High Point, North Carolina, 27262
ASCEND-IBD Trial Center, 844-206-4980, clinicaltrials@miradortx.com
- Recruiting
Mirador Therapeutics Selected Site
Houston, Texas, 77090
ASCEND-IBD Trial Center, 844-206-4980, clinicaltrials@miradortx.com
- Recruiting
Mirador Therapeutics Selected Site
Kansas City, Missouri, 64114
ASCEND-IBD Trial Center, 844-206-4980, clinicaltrials@miradortx.com
- Recruiting
Mirador Therapeutics Selected Site
Lafayette, Louisiana, 70503
ASCEND-IBD Trial Center, 844-206-4980, clinicaltrials@miradortx.com
- Recruiting
Mirador Therapeutics Selected Site
Las Vegas, Nevada, 89128
ASCEND-IBD Trial Center, 844-206-4980, clinicaltrials@miradortx.com
- Recruiting
Mirador Therapeutics Selected Site
Liberty, Missouri, 64068
ASCEND-IBD Trial Center, 844-206-4980, clinicaltrials@miradortx.com
- Recruiting
Mirador Therapeutics Selected Site
Liberty Township, Ohio, 45044
ASCEND-IBD Trial Center, 844-206-4980, clinicaltrials@miradortx.com
- Recruiting
Mirador Therapeutics Selected Site
Little Rock, Arkansas, 72205
ASCEND-IBD Trial Center, 844-206-4980, clinicaltrials@miradortx.com
- Recruiting
Mirador Therapeutics Selected Site
Little Rock, Arkansas, 72211
ASCEND-IBD Trial Center, 844-206-4980, clinicaltrials@miradortx.com
- Recruiting
Mirador Therapeutics Selected Site
Littleton, Colorado, 80120
ASCEND-IBD Trial Center, 844-206-4980, clinicaltrials@miradortx.com
- Recruiting
Mirador Therapeutics Selected Site
Lubbock, Texas, 79424
ASCEND-IBD Trial Center, 844-206-4980, clinicaltrials@miradortx.com
- Recruiting
Mirador Therapeutics Selected Site
Marrero, Louisiana, 70072
ASCEND-IBD Trial Center, 844-206-4980, clinicaltrials@miradortx.com
- Recruiting
Mirador Therapeutics Selected Site
Miami, Florida, 33134
ASCEND-IBD Trial Center, 844-206-4980, clinicaltrials@miradortx.com
- Recruiting
Mirador Therapeutics Selected Site
Miami, Florida, 33165
ASCEND-IBD Trial Center, 844-206-4980, clinicaltrials@miradortx.com
- Recruiting
Mirador Therapeutics Selected Site
Miami, Florida, 33176
ASCEND-IBD Trial Center, 844-206-4980, clinicaltrials@miradortx.com
- Recruiting
Mirador Therapeutics Selected Site
Milwaukee, Wisconsin, 53215
ASCEND-IBD Trial Center, 844-206-4980, clinicaltrials@miradortx.com
- Recruiting
Mirador Therapeutics Selected Site
New York, New York, 10016
ASCEND-IBD Trial Center, 844-206-4980, clinicaltrials@miradortx.com
- Recruiting
Mirador Therapeutics Selected Site
Orlando, Florida, 32825
ASCEND-IBD Trial Center, 844-206-4980, clinicaltrials@miradortx.com
- Recruiting
Mirador Therapeutics Selected Site
Palmetto Bay, Florida, 33176
ASCEND-IBD Trial Center, 844-206-4980, clinicaltrials@miradortx.com
- Recruiting
Mirador Therapeutics Selected Site
Pensacola, Florida, 32504
ASCEND-IBD Trial Center, 844-206-4980, clinicaltrials@miradortx.com
- Recruiting
Mirador Therapeutics Selected Site
Providence, Rhode Island, 02904
ASCEND-IBD Trial Center, 844-206-4980, clinicaltrials@miradortx.com
- Recruiting
Mirador Therapeutics Selected Site
Raleigh, North Carolina, 27612
ASCEND-IBD Trial Center, 844-206-4980, clinicaltrials@miradortx.com
- Recruiting
Mirador Therapeutics Selected Site
Rochester, New York, 14618
ASCEND-IBD Trial Center, 844-206-4980, clinicaltrials@miradortx.com
- Recruiting
Mirador Therapeutics Selected Site
Scottsdale, Arizona, 85258
ASCEND-IBD Trial Center, 844-206-4980, clinicaltrials@miradortx.com
- Recruiting
Mirador Therapeutics Selected Site
Shreveport, Louisiana, 71105
ASCEND-IBD Trial Center, 844-206-4980, clinicaltrials@miradortx.com
- Recruiting
Mirador Therapeutics Selected Site
Silverdale, Washington, 98383
ASCEND-IBD Trial Center, 844-206-4980, clinicaltrials@miradortx.com
- Recruiting
Mirador Therapeutics Selected Site
Snellville, Georgia, 30078
ASCEND-IBD Trial Center, 844-206-4980, clinicaltrials@miradortx.com
- Recruiting
Mirador Therapeutics Selected Site
Southlake, Texas, 76092
ASCEND-IBD Trial Center, 844-206-4980, clinicaltrials@miradortx.com
- Recruiting
Mirador Therapeutics Selected Site
Sun City, Arizona, 85351
ASCEND-IBD Trial Center, 844-206-4980, clinicaltrials@miradortx.com
- Recruiting
Mirador Therapeutics Selected Site
Tacoma, Washington, 98405
ASCEND-IBD Trial Center, 844-206-4980, clinicaltrials@miradortx.com
- Recruiting
Mirador Therapeutics Selected Site
Tyler, Texas, 75701
ASCEND-IBD Trial Center, 844-206-4980, clinicaltrials@miradortx.com
- Recruiting
Mirador Therapeutics Selected Site
Webster, Texas, 77598
ASCEND-IBD Trial Center, 844-206-4980, clinicaltrials@miradortx.com
- Recruiting
Mirador Therapeutics Selected Site
Ypsilanti, Michigan, 48197
ASCEND-IBD Trial Center, 844-206-4980, clinicaltrials@miradortx.com
Ukraine9 sites, 9 recruiting
- Recruiting
Mirador Therapeutics Selected Site
Ivano-Frankivsk
ASCEND-IBD Trial Center, 844-206-4980, clinicaltrials@miradortx.com
- Recruiting
Mirador Therapeutics Selected Site
Kyiv, 02002
ASCEND-IBD Trial Center, 844-206-4980, clinicaltrials@miradortx.com
- Recruiting
Mirador Therapeutics Selected Site
Kyiv, 02091
ASCEND-IBD Trial Center, 844-206-4980, clinicaltrials@miradortx.com
- Recruiting
Mirador Therapeutics Selected Site
Kyiv, 03037
ASCEND-IBD Trial Center, 844-206-4980, clinicaltrials@miradortx.com
- Recruiting
Mirador Therapeutics Selected Site
Kyiv
ASCEND-IBD Trial Center, 844-206-4980, clinicaltrials@miradortx.com
- Recruiting
Mirador Therapeutics Selected Site
Lutsk
ASCEND-IBD Trial Center, 844-206-4980, clinicaltrials@miradortx.com
- Recruiting
Mirador Therapeutics Selected Site
Lviv
ASCEND-IBD Trial Center, 844-206-4980, clinicaltrials@miradortx.com
- Recruiting
Mirador Therapeutics Selected Site
Poltava
ASCEND-IBD Trial Center, 844-206-4980, clinicaltrials@miradortx.com
- Recruiting
Mirador Therapeutics Selected Site
Vinnytsia
ASCEND-IBD Trial Center, 844-206-4980, clinicaltrials@miradortx.com
Georgia8 sites, 8 recruiting
- Recruiting
Mirador Therapeutics Selected Site
Kutaisi
ASCEND-IBD Trial Center, 844-206-4980, clinicaltrials@miradortx.com
- Recruiting
Mirador Therapeutics Selected Site
Marneuli
ASCEND-IBD Trial Center, 844-206-4980, clinicaltrials@miradortx.com
- Recruiting
Mirador Therapeutics Selected Site
Tbilisi, 0102
ASCEND-IBD Trial Center, clinicaltrials@miradortx.com
- Recruiting
Mirador Therapeutics Selected Site
Tbilisi, 0144
ASCEND-IBD Trial Center, 844-206-4980, clinicaltrials@miradortx.com
- Recruiting
Mirador Therapeutics Selected Site
Tbilisi, 0159
ASCEND-IBD Trial Center, 844-206-4980, clinicaltrials@miradortx.com
- Recruiting
Mirador Therapeutics Selected Site
Tbilisi, 0178
ASCEND-IBD Trial Center, 844-206-4980, clinicaltrials@miradortx.com
- Recruiting
Mirador Therapeutics Selected Site
Tbilisi, 0180
ASCEND-IBD Trial Center, 844-206-4980, clinicaltrials@miradortx.com
- Recruiting
Mirador Therapeutics Selected Site
Tbilisi, 4600
ASCEND-IBD Trial Center, 844-206-4980, clinicaltrials@miradortx.com
Moldova2 sites, 2 recruiting
- Recruiting
Mirador Therapeutics Selected Site
Chisinau
ASCEND-IBD Trial Center, 844-206-4980, clinicaltrials@miradortx.com
- Recruiting
Mirador Therapeutics Selected Site
Chisinau
844-206-4980, clinicaltrials@miradortx.com
Canada1 site, 1 recruiting
- Recruiting
Mirador Therapeutics Selected Site
Toronto
ASCEND-IBD Trial Center, 844-206-4980, clinicaltrials@miradortx.com
About this study
Official title: 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)
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.
Read the detailed description
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.
- Being tested
- MT-501, MT-201
- Keywords
- Inflammatory Bowel Diseases, ASCEND-IBD, Ulcerative Colitis, UC, CD, Crohn's Disease
- Medical subject headings
- Inflammatory Bowel Diseases, Colitis, Ulcerative, Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MT-501Drug
MT-501
MT-201Drug
MT-201
| Study group | Role | What they receive |
|---|---|---|
| Intervention Specific Appendix- Crohn's Disease | Experimental | Participants will receive MT-501 Tablets Receives: Drug: MT-501 |
| Intervention Specific Appendix- Ulcerative Colitis | Experimental | Participants will receive MT-501Tablets Receives: Drug: MT-501 |
| Intervention Specific Appendix- Crohn's Disease with Standard of Care | Experimental | Participants will receive multiple intravenous doses of MT-201 with standard of care Receives: Drug: MT-201 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 13 weeks
Assess the Proportion of Participants with Endoscopic Response (CD)
Endoscopic response as assessed by SES-CD score.
Measured: 13 weeks
Assess the Proportion of Participants Endoscopic Improvement (UC)
Endoscopic improvement as assessed by MES.
Measured: 12 weeks
Assess the Proportion of Participants with Clinical Remission (CD)
Clinical remission as assessed by CDAI score.
Measured: 13 weeks
Assess the Proportion of Participants with Clinical Remission (UC)
Clinical remission as assessed by endoscopy, rectal bleeding and stool frequency.
Measured: 12 weeks
Secondary outcomes (15)
Assess the Proportion of Participants with Clinical Remission (CD)
CD: Clinical remission as assessed by CDAI score.
Measured: 13 weeks
Assess the Proportion of Participants with Clinical Remission (UC)
Clinical remission as assessed by endoscopy, rectal bleeding, and stool frequency.
Measured: 12 weeks
Assess the Proportion of Participants with Symptomatic Remission (CD and UC)
Symptomatic remission as assessed by patient reported outcomes.
Measured: Up to 13 weeks
Assess the Proportion of Participants with Clinical Response (CD)
CD: Clinical response as assessed by CDAI score.
Measured: 13 weeks
Assess the Proportion of Participants with Clinical Response (UC)
UC: Clinical response as assessed by MMCS.
Measured: 12 weeks
Assess the Proportion of Participants with Endoscopic and Clinical Response (CD Only)
Endoscopy as assessed by SES-CD and clinical response as assessed by CDAI score.
Measured: 13 weeks
Assess the Proportion of Participants with Histologic Response (UC Only)
Histologic response as assessed by the RHI.
Measured: 12 weeks
Assess the Proportion of Participants with Histologic Remission (UC only)
Histologic remission as assessed by the RHI.
Measured: 12 weeks
Assess the Proportion of Participants with Histologic-Endoscopic Mucosal Improvement (UC only)
Histologic-endoscopic mucosal improvement as assessed by the Geboes score and MES.
Measured: 12 weeks
Characterize the Change in Endoscopy Score (CD)
CD: Endoscopy score as assessed by SES-CD.
Measured: 13 weeks
Characterize the Change in Endoscopy Score (UC)
Endoscopy score as assessed by MES.
Measured: 12 weeks
Characterize the Change in Histology Score (CD)
Histology as assessed by GHAS and RHI.
Measured: 13 weeks
Characterize the Change in Histology Score (UC)
Histology as assessed by Geobes, RHI and NHI
Measured: 12 weeks
Asses the Pharmacokinetics (PK) (e.g., Trough Concentration [Ctrough]) of Investigational Drug
Measured: Up to 13 weeks
Assess immunogenicity
Measured: 13 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 2025
- Study start26 Jun 2025
- Primary completion30 Apr 2027 (estimated)
- Study completion4 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel Disease (IBD)Studies 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
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mirador Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07113522
- Sponsor's protocol ID
- MT-100-201
- Acronym
- ASCEND-IBD
- Status last verified
- Mar 2026
- First submitted
- 15 Jul 2025
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07113522
- Acronym / sponsor ID
- ASCEND-IBD / MT-100-201
- Keywords
- Inflammatory Bowel Diseases, ASCEND-IBD, Ulcerative Colitis, UC, CD, Crohn's Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Mirador Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 26 Jun 2025 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 4 Feb 2028 (estimated)
- First posted
- 8 Aug 2025 (actual)
- 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, 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.
Detailed description
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intervention Specific Appendix- Crohn's Disease | Experimental | Drug: MT-501Participants will receive MT-501 Tablets |
| Intervention Specific Appendix- Ulcerative Colitis | Experimental | Drug: MT-501Participants will receive MT-501Tablets |
| Intervention Specific Appendix- Crohn's Disease with Standard of Care | Experimental | Drug: MT-201Participants will receive multiple intravenous doses of MT-201 with standard of care |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
- Diagnosis of Ulcerative Colitis (UC), as confirmed by endoscopy and histopathology
- Moderately to severely active UC as defined by a 3-component MMCS
Key exclusion criteria (8 listed)
- Diagnosis of indeterminate colitis
- Suspected or diagnosed intra-abdominal or perianal abscess at Screening
- 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
- Current evidence or within recent history (within last 6 months) of fulminant colitis, toxic megacolon, or bowel perforation
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 |
|---|---|---|
| MT-501MT-501 | Drug | Intervention Specific Appendix- Crohn's Disease, Intervention Specific Appendix- Ulcerative Colitis |
| MT-201MT-201 | Drug | Intervention Specific Appendix- Crohn's Disease with Standard of Care |
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
Assess the Proportion of Participants with Endoscopic Response (CD)
Time frame: 13 weeks
Endoscopic response as assessed by SES-CD score.
Assess the Proportion of Participants Endoscopic Improvement (UC)
Time frame: 12 weeks
Endoscopic improvement as assessed by MES.
Assess the Proportion of Participants with Clinical Remission (CD)
Time frame: 13 weeks
Clinical remission as assessed by CDAI score.
Assess the Proportion of Participants with Clinical Remission (UC)
Time frame: 12 weeks
Clinical remission as assessed by endoscopy, rectal bleeding and stool frequency.
15 secondary outcomes
Assess the Proportion of Participants with Clinical Remission (CD)
Time frame: 13 weeks
Assess the Proportion of Participants with Clinical Remission (UC)
Time frame: 12 weeks
Assess the Proportion of Participants with Symptomatic Remission (CD and UC)
Time frame: Up to 13 weeks
Assess the Proportion of Participants with Clinical Response (CD)
Time frame: 13 weeks
Assess the Proportion of Participants with Clinical Response (UC)
Time frame: 12 weeks
Assess the Proportion of Participants with Endoscopic and Clinical Response (CD Only)
Time frame: 13 weeks
Assess the Proportion of Participants with Histologic Response (UC Only)
Time frame: 12 weeks
Assess the Proportion of Participants with Histologic Remission (UC only)
Time frame: 12 weeks
Assess the Proportion of Participants with Histologic-Endoscopic Mucosal Improvement (UC only)
Time frame: 12 weeks
Characterize the Change in Endoscopy Score (CD)
Time frame: 13 weeks
Characterize the Change in Endoscopy Score (UC)
Time frame: 12 weeks
Characterize the Change in Histology Score (CD)
Time frame: 13 weeks
Characterize the Change in Histology Score (UC)
Time frame: 12 weeks
Asses the Pharmacokinetics (PK) (e.g., Trough Concentration [Ctrough]) of Investigational Drug
Time frame: Up to 13 weeks
Assess immunogenicity
Time frame: 13 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
- 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.
66 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MT-501 and MT-201 in people with Inflammatory Bowel Disease (IBD) and Ulcerative Colitis (UC), run by Mirador Therapeutics, Inc. at 66 sites in 5 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: looking for participants now, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 66 sites in United States, Ukraine, Georgia, Moldova, Canada. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ASCEND-IBD Trial Center (844-206-4980, clinicaltrials@miradortx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 5 primary outcomes in all. 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 12 Mar 2026.