Inflammatory Bowel Disease study: MT-501 vs MT-201
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 drug being studied as a potential treatment for moderately to severely active Crohn's disease or ulcerative colitis.
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
- The study is looking to find out if several investigational drugs are safe and work for people with active inflammatory bowel disease.
- Who it's for
- Adults who have moderately to severely active Crohn's disease or ulcerative colitis.
- What's involved
- Participants will be given one of the study drugs and will have regular clinic visits for safety checks and tests to see how the disease responds.
- 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
- 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)
- 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
You likely can't join if
- 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
- 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
See the full eligibility criteria
- 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)
- 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
- 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
- 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 is enrolling
- 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, but 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?
This study is enrolling now at 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 locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.