Recruiting

Phase 2

Investigational DrugsA Phase 2 Study to Evaluate Therapies for Inflammatory Bowel Disease

Sponsor:

Mirador Therapeutics, Inc.

Code:

NCT07113522

Conditions

Inflammatory Bowel Disease (IBD)

Ulcerative Colitis (UC)

Crohn's Disease

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

MT-501

MT-201

Study Details

Brief 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.

Conditions

Inflammatory Bowel Disease (IBD)

Ulcerative Colitis (UC)

Crohn's Disease

Study ID

NCT07113522

Start date

Jun 26, 2025

Status verified date

Mar, 2026

Completion date

Feb 4, 2028

Anticipated

Primary completion date

Apr 30, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

140 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Intervention Specific Appendix- Crohn's Disease

Participants will receive MT-501 Tablets

experimental: Intervention Specific Appendix- Ulcerative Colitis

Participants will receive MT-501Tablets

experimental: Intervention Specific Appendix- Crohn's Disease with Standard of Care

Participants will receive multiple intravenous doses of MT-201 with standard of care

Interventions

MT-501

MT-201

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 ]
Assess the Proportion of Participants with Endoscopic Response (CD) [ Time Frame: 13 weeks ]
Assess the Proportion of Participants Endoscopic Improvement (UC) [ Time Frame: 12 weeks ]
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 ]

Central Contacts and Locations

Central contacts

ASCEND-IBD Trial Center

844-206-4980 clinicaltrials@miradortx.com

Locations