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New treatment option for Inflammatory Bowel Disease (IBD)
Official title A Phase 2 Study to Evaluate Therapies for Inflammatory Bowel Disease
ClinicalTrials.gov ID: NCT07113522
What this study is testing
What is MT-501?
MT-501 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for inflammatory bowel disease (ibd).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- -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 -Ulcerative Colitis:
- Diagnosis of Ulcerative Colitis (UC), as confirmed by endoscopy and histopathology
You likely can't join if
- -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
See the full eligibility 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 -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
- -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
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Scottsdale, Arizona, United States
- Sun City, Arizona, United States
- Little Rock, Arkansas, United States
- Colorado Springs, Colorado, United States
- Littleton, Colorado, United States
- Miami, Florida, United States
- Orlando, Florida, United States
- Palmetto Bay, Florida, United States
- Pensacola, Florida, United States
- Atlanta, Georgia, United States
- Snellville, Georgia, United States
- Glenview, Illinois, United States
- Gurnee, Illinois, United States
- Lafayette, Louisiana, United States
- Marrero, Louisiana, United States
- Shreveport, Louisiana, United States
- Ypsilanti, Michigan, United States
- Bridgeton, Missouri, United States
- Kansas City, Missouri, United States
+ 34 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Scottsdale, Arizona, United States; Sun City, Arizona, United States; Little Rock, Arkansas, United States; Colorado Springs, Colorado, United States; Littleton, Colorado, United States and 48 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.