A Phase 2 Study to Evaluate Therapies for Inflammatory Bowel Disease

Launched by MIRADOR THERAPEUTICS, INC. · Aug 4, 2025

Keywords

ClinConnect Summary

This clinical trial is studying new treatments for adults with moderate to severe inflammatory bowel disease (IBD), specifically Crohn’s Disease or Ulcerative Colitis. The main goal is to see how safe and effective several new drugs are in helping control the symptoms of these conditions.

Adults diagnosed with either Crohn’s Disease or Ulcerative Colitis through medical tests may be eligible, as long as their disease is active at a moderate to severe level and their current medications have been stable. People with certain complications, like recent serious infections, extensive bowel surgery, or needing an ostomy (a surgical opening for waste), are not eligible. If you join the study, you will receive one of the new treatments being tested and be closely monitored by doctors to track how well the medicine works and if there are any side effects. This study is currently recruiting participants and includes adults of any gender.

Gender

ALL

Eligibility 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