BridgeMD
J6Z-MC-IIBD - A Master Protocol (IIBD): A Study of Multiple Drugs in Adults With Ulcerative Colitis or Crohn’s Disease J6Z-MC-CD01 - A Study of LY4395089 and Mirikizumab (LY3074828) Given Together and Mirikizumab (Alone) in Adults With Crohn’s Disease
EU CTIS ID: 2025-524112-11-00
What this study is testing
J6Z-MC-IIBD - To evaluate the 12-week efficacy of the study intervention compared with mirikizumab via endoscopic outcomes in adult participants with moderately to severely active UC or CD J6Z-MC-CD01 - To evaluate the 12-week efficacy of the study intervention compared with mirikizumab via endoscopic outcomes in adult participants with moderately to severely active Crohn’s Disease
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- J6Z-MC-CD01 - Participants must meet all the inclusion criteria in the IIBD master protocol, except the UC-specific criteria. In addition, they must meet the criteria below:
- J6Z-MC-CD01 - Participants taking glucagon-like peptide-1 (GLP-1) receptor agonists (RAs), GLP-1/glucose-dependent insulinotropic polypeptide (GIP) RAs, GLP-1/glucagon (Gcg) RAs, GLP-1/GIP/Gcg RAs, or similar medications for approved indications will be permitted to enroll provided they are on a stable dose at the time of screening
- J6Z-MC-IIBD - 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 a diagnosis of UC or CD. • 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 endoscopy performed within 21 days prior to Visit 2. • For CD: • Have moderately to severely active CD as defined by a Crohn’s disease activity index (CDAI) score ≥ 220 and ≤ 450. Have a centrally read Simple Endoscopic Score for Crohn’s Disease (SES-CD) score ≥6 for participants with ileal-colonic or ≥4 for participants with isolated ileal disease within 21 days before the randomization
- J6Z-MC-IIBD - 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
- J6Z-MC-IIBD - Have screening laboratory test results within the protocol specified parameters
You likely can't join if
- J6Z-MC-IIBD - 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
- J6Z-MC-CD01 - Must not have a history of any other bone disease that affects bone metabolism
- J6Z-MC-CD01 - Must not have had any of the following within the past 180 days before screening: acute myocardial infarction cerebrovascular incident hospitalization for unstable angina hospitalization due to congestive heart failure, or coronary revascularization
- J6Z-MC-CD01 - Must not have received or will need any other prohibited medications as specified in the protocol
- J6Z-MC-IIBD - Must not have had or will need bowel resection or intestinal or intra-abdominal surgery as specified in the protocol
- J6Z-MC-IIBD - 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
See the full eligibility criteria
Who can join
- J6Z-MC-CD01 - Participants must meet all the inclusion criteria in the IIBD master protocol, except the UC-specific criteria. In addition, they must meet the criteria below:
- J6Z-MC-CD01 - Participants taking glucagon-like peptide-1 (GLP-1) receptor agonists (RAs), GLP-1/glucose-dependent insulinotropic polypeptide (GIP) RAs, GLP-1/glucagon (Gcg) RAs, GLP-1/GIP/Gcg RAs, or similar medications for approved indications will be permitted to enroll provided they are on a stable dose at the time of screening
- J6Z-MC-IIBD - 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 a diagnosis of UC or CD. • 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 endoscopy performed within 21 days prior to Visit 2. • For CD: • Have moderately to severely active CD as defined by a Crohn’s disease activity index (CDAI) score ≥ 220 and ≤ 450. Have a centrally read Simple Endoscopic Score for Crohn’s Disease (SES-CD) score ≥6 for participants with ileal-colonic or ≥4 for participants with isolated ileal disease within 21 days before the randomization
- J6Z-MC-IIBD - 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
- J6Z-MC-IIBD - Have screening laboratory test results within the protocol specified parameters
What rules you out
- J6Z-MC-IIBD - 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
- J6Z-MC-CD01 - Must not have a history of any other bone disease that affects bone metabolism
- J6Z-MC-CD01 - Must not have had any of the following within the past 180 days before screening: acute myocardial infarction cerebrovascular incident hospitalization for unstable angina hospitalization due to congestive heart failure, or coronary revascularization
- J6Z-MC-CD01 - Must not have received or will need any other prohibited medications as specified in the protocol
- J6Z-MC-IIBD - Must not have had or will need bowel resection or intestinal or intra-abdominal surgery as specified in the protocol
- J6Z-MC-IIBD - 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
- J6Z-MC-IIBD - 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
- J6Z-MC-IIBD - Must not have failed more than 5 approved advanced treatments for UC or CD with different mechanisms of action
- J6Z-MC-IIBD - Must not have failed an anti-interleukin-23p19 (anti-IL-23p19) antibody treatment
- J6Z-MC-IIBD - Must not have received or will need any prohibited medications for UC or CD as specified in the protocol
- J6Z-MC-CD01 - Participants must meet all the exclusion criteria in the IIBD master protocol, except the UC-specific criteria. In addition, they must meet the criteria below:
- J6Z-MC-CD01 - Must not have a hepatic disease
The study team makes the final eligibility decision.
Where it's taking place
- Canada
- United States
- Israel
- Brazil
- China
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Canada; United States; Israel; Brazil; China. 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 EU CTIS; the study team decides eligibility.