A Phase 2 Study to Evaluate Therapies for Inflammatory Bowel Disease

Condition(s) studied

Investigational drug(s) / intervention(s)

MT-501: MT-501

MT-201: MT-201

Study 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

Primary outcome measure(s)

• 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 — Up to 13 weeks
• Assess the Proportion of Participants with Endoscopic Response (CD) — 13 weeks
  Endoscopic response as assessed by SES-CD score.
• Assess the Proportion of Participants Endoscopic Improvement (UC) — 12 weeks
  Endoscopic improvement as assessed by MES.
• Assess the Proportion of Participants with Clinical Remission (CD) — 13 weeks
  Clinical remission as assessed by CDAI score.
• Assess the Proportion of Participants with Clinical Remission (UC) — 12 weeks
  Clinical remission as assessed by endoscopy, rectal bleeding and stool frequency.

Trial sites (66)

+ 26 more sites — see the full list on the official registry below.

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