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New treatment option for Colitis, Ulcerative
Official title A Master Protocol (IIBD): A Study of Multiple Drugs in Adults With Ulcerative Colitis or Crohn's Disease
ClinicalTrials.gov ID: NCT07483073
What this study is testing
What is Mirikizumab - Intravenous (IV)?
Mirikizumab - Intravenous (IV) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for colitis, ulcerative.
Also referred to as LY3074828.
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
- Study IIBD is a master protocol that will support a collection of individual sub studies that share key design components. Participants will be assigned to the appropriate study prior to randomization to a treatment group.
- 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
- Must have an established diagnosis of Ulcerative Colitis (UC) or Crohn's Disease (CD) for at least 3 month duration, which includes clinical and...
- For UC:
- Have moderately to severely active UC as defined by a modified Mayo score (mMS) of 5-9 points and Endoscopic Subscore (ES) greater than or equal to...
- For CD:
- Have moderately to severely active CD as defined by a Crohn's disease activity index (CDAI) score ≥ 220 and less than or equal to (≤) 450. Have a...
You likely can't join if
- Must not have a current diagnosis of inflammatory bowel disease (IBD)-unclassified or primary sclerosing cholangitis
- For UC - must not have a current diagnosis of CD
- For CD - must not have a current diagnosis of UC
- Must not have had or will need bowel resection or intestinal or intra-abdominal surgery as specified in the protocol
- Must not have complications of UC or CD, including but not limited to stricture or stenosis (some exceptions allowed for CD) or short bowel syndrome
- Must not have a significant uncontrolled illness that in the opinion of the investigator may compromise the participant's safety or interfere with...
See the full eligibility criteria
- Must have an established diagnosis of Ulcerative Colitis (UC) or Crohn's Disease (CD) for at least 3 month duration, which includes clinical and endoscopic evidence of UC or CD and a histopathology report that supports...
- For UC:
- Have moderately to severely active UC as defined by a modified Mayo score (mMS) of 5-9 points and Endoscopic Subscore (ES) greater than or equal to (≥) 2, confirmed by the central reader and rectal bleeding (RB)≥1, with...
- For CD:
- Have moderately to severely active CD as defined by a Crohn's disease activity index (CDAI) score ≥ 220 and less than or equal to (≤) 450. Have a centrally read Simple Endoscopic Score for Crohn's Disease (SES-CD) score...
- Must have demonstrated an inadequate response, loss of response, or intolerance to at least one of the following: corticosteroids, immunomodulators, or an advanced therapy for UC or CD
- Have screening laboratory test results within the protocol specified parameters.
- Must not have a current diagnosis of inflammatory bowel disease (IBD)-unclassified or primary sclerosing cholangitis
- For UC - must not have a current diagnosis of CD
- For CD - must not have a current diagnosis of UC
- Must not have had or will need bowel resection or intestinal or intra-abdominal surgery as specified in the protocol
- Must not have complications of UC or CD, including but not limited to stricture or stenosis (some exceptions allowed for CD) or short bowel syndrome
- Must not have a significant uncontrolled illness that in the opinion of the investigator may compromise the participant's safety or interfere with interpretation of data
- Must not have failed more than 5 approved advanced treatments for UC or CD with different mechanisms of action
- Must not have failed an anti-interleukin-23p19 (anti-IL-23p19) antibody treatment
- Must not have received or will need any prohibited medications for UC or CD as specified in the protocol
The study team makes the final eligibility decision.
Where it's taking place
- Scottsdale, Arizona, United States
- Los Angeles, California, United States
- Oxnard, California, United States
- Englewood, Colorado, United States
- Miami, Florida, United States
- Miami Lakes, Florida, United States
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- Topeka, Kansas, United States
- Wyoming, Michigan, United States
- St Louis, Missouri, United States
- Las Vegas, Nevada, United States
- Wilmington, North Carolina, United States
- Kingwood, Texas, United States
- San Antonio, Texas, United States
- Ghent, Belgium
- Leuven, Belgium
- Roeselare, Belgium
- Campinas, Brazil
- Caxias do Sul, Brazil
+ 43 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 Scottsdale, Arizona, United States; Los Angeles, California, United States; Oxnard, California, United States; Englewood, Colorado, United States; Miami, Florida, United States; Miami Lakes, Florida, United States and 57 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.