A Phase 2 Study to Evaluate Therapies for Inflammatory Bowel Disease (ASCEND-IBD)

Mirador Therapeutics, Inc.

Status and phase: Enrolling; Phase 2

Conditions: Inflammatory Bowel Disease (IBD); Ulcerative Colitis (UC); Crohn's Disease

Treatments: Drug: MT-501

Study type: Interventional

Funder types: Industry

Identifiers

NCT07113522

MT-100-201

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: Single Blind

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90 participants in 2 patient groups

Intervention Specific Appendix- Crohn's Disease

Experimental group

Description:

Participants will receive MT-501

Treatment:

Drug: MT-501

Intervention Specific Appendix- Ulcerative Colitis

Experimental group

Description:

Participants will receive MT-501

Treatment:

Drug: MT-501