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Phase 2 testing of new therapies for moderate-to-severe 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)

PHASE2 · Mirador Therapeutics, Inc. · NCT07113522

The study will try two experimental medicines, MT-501 and MT-201, to see if they are safe and help adults with moderately to severely active Crohn's disease or ulcerative colitis.

Quick facts

PhasePHASE2
Study typeInterventional
Enrollment140 (estimated)
Ages18 Years to 80 Years
SexAll
SponsorMirador Therapeutics, Inc. (industry)
Locations66 sites (Birmingham, Alabama and 65 other locations)
Trial IDNCT07113522 on ClinicalTrials.gov

What this trial studies

This is a Phase 2, multicenter platform study enrolling adults with moderately to severely active Crohn's disease or ulcerative colitis to test multiple investigational oral or parenteral therapies. Participants must have diagnosis confirmed by endoscopy and histopathology and meet disease-activity thresholds (CDAI and SES-CD for Crohn's; a 3-component MMCS for UC) along with protocol drug-stabilization requirements. The trial will collect safety, efficacy, pharmacokinetic, and pharmacodynamic data across treatment arms including MT-501 and MT-201. Mirador Therapeutics sponsors the study with initial sites in Birmingham, Alabama and Scottsdale/Sun City, Arizona.

Who should consider this trial

Good fit: Adults with endoscopy- and histology-confirmed moderately to severely active Crohn's disease or ulcerative colitis who meet the protocol's activity scores and medication-stabilization rules are the intended participants.

Not a fit: Patients with indeterminate colitis, isolated small-bowel or perianal disease without colonic involvement, recent intra-abdominal or perianal abscess, extensive prior bowel resections beyond the protocol limits, or only mild disease are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, the investigational treatments could provide new options that safely induce remission and reduce inflammation for people with moderate-to-severe IBD.

How similar studies have performed: Other Phase 2 programs in IBD using oral and parenteral agents have produced both successes and failures, so the platform approach is established but each investigational drug's outcome is uncertain.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria-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 Criteria-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 Criteria-Crohn's Disease:

* 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

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

Where this trial is running

Birmingham, Alabama and 65 other locations

+16 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Inflammatory Bowel Disease, Ulcerative Colitis, Crohn's Disease, Inflammatory Bowel Diseases, ASCEND-IBD, UC, CD

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.