A Phase 2 Study to Evaluate Therapies for Inflammatory Bowel Disease

Conditions

• Crohn's Disease
• Inflammatory Bowel Disease (IBD)
• Ulcerative Colitis (UC)

Eligibility Criteria

Sex

ALL

Age

18 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

• MT-501 — DRUG
  MT-501
• MT-201 — DRUG
  MT-201

Study Details

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.

Key Dates

Start date

Jun 26, 2025

Status verified

Mar 2026

Primary completion

Apr 30, 2027

Completion

Feb 4, 2028

Study Design

Enrollment

140 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

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

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 ]

Central Contacts

• ASCEND-IBD Trial Center
  844-206-4980
  [email protected]

Locations (46)

Find similar trials in Birmingham, AL

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