Menu
Recruiting NCT07113522

A Phase 2 Study to Evaluate Therapies for Inflammatory Bowel Disease

Phase II Interventional Inflammatory Bowel Disease (IBD) Ulcerative Colitis (UC) Crohn's Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: MT-501, MT-201.
Who it may be relevant to
Registry conditions: Inflammatory Bowel Disease (IBD), Ulcerative Colitis (UC), Crohn's Disease. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Canada, Georgia, Moldova, Ukraine
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase 2, Multi-Center, Platform Study to Evaluate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics With Multiple Therapies in Participants With Active Crohn's Disease or Active Ulcerative Colitis (ASCEND-IBD)

Overview

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.

Detailed 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.

Interventions

  • Drug MT-501
    MT-501
  • Drug MT-201
    MT-201

Primary outcome measures

  • 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]
Secondary outcome measures (12)
  • 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]
  • Assess the Proportion of Participants with Symptomatic Remission (CD and UC) [Time frame: Up to 13 weeks]
  • Assess the Proportion of Participants with Clinical Response (CD) [Time frame: 13 weeks]
  • Assess the Proportion of Participants with Clinical Response (UC) [Time frame: 12 weeks]
  • Assess the Proportion of Participants with Endoscopic and Clinical Response (CD Only) [Time frame: 13 weeks]
  • Assess the Proportion of Participants with Histologic Response (UC Only) [Time frame: 12 weeks]
  • Assess the Proportion of Participants with Histologic Remission (UC only) [Time frame: 12 weeks]
  • Assess the Proportion of Participants with Histologic-Endoscopic Mucosal Improvement (UC only) [Time frame: 12 weeks]
  • Characterize the Change in Endoscopy Score (CD) [Time frame: 13 weeks]
  • Characterize the Change in Endoscopy Score (UC) [Time frame: 12 weeks]
  • Characterize the Change in Histology Score (CD) [Time frame: 13 weeks]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 46 centers
  • Mirador Therapeutics Selected Site — Birmingham
  • Mirador Therapeutics Selected Site — Scottsdale
  • Mirador Therapeutics Selected Site — Sun City
  • Mirador Therapeutics Selected Site — Little Rock
  • Mirador Therapeutics Selected Site — Little Rock
  • Mirador Therapeutics Selected Site — Colorado Springs
  • Mirador Therapeutics Selected Site — Littleton
  • Mirador Therapeutics Selected Site — Miami
  • … and 38 more centers
Ukraine · 9 centers
  • Mirador Therapeutics Selected Site — Ivano-Frankivsk
  • Mirador Therapeutics Selected Site — Kyiv
  • Mirador Therapeutics Selected Site — Kyiv
  • Mirador Therapeutics Selected Site — Kyiv
  • Mirador Therapeutics Selected Site — Kyiv
  • Mirador Therapeutics Selected Site — Lutsk
  • Mirador Therapeutics Selected Site — Lviv
  • Mirador Therapeutics Selected Site — Poltava
  • … and 1 more center
Georgia · 8 centers
  • Mirador Therapeutics Selected Site — Kutaisi
  • Mirador Therapeutics Selected Site — Marneuli
  • Mirador Therapeutics Selected Site — Tbilisi
  • Mirador Therapeutics Selected Site — Tbilisi
  • Mirador Therapeutics Selected Site — Tbilisi
  • Mirador Therapeutics Selected Site — Tbilisi
  • Mirador Therapeutics Selected Site — Tbilisi
  • Mirador Therapeutics Selected Site — Tbilisi
Moldova · 2 centers
  • Mirador Therapeutics Selected Site — Chisinau
  • Mirador Therapeutics Selected Site — Chisinau
Canada · 1 center
  • Mirador Therapeutics Selected Site — Toronto

Identifiers

NCT: NCT07113522 · MT-100-201

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗