RecruitingPhase 2NCT07113522
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)
Sponsor
Mirador Therapeutics, Inc.
Enrollment
140 participants
Start Date
Jun 26, 2025
Study Type
INTERVENTIONAL
Conditions
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.
Eligibility
Min Age: 18 YearsMax Age: 80 Years
Inclusion Criteria6
- 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
Exclusion Criteria8
- 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
Interventions
DRUGMT-501
MT-501
DRUGMT-201
MT-201
Locations(66)
View Full Details on ClinicalTrials.gov
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NCT07113522
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