Colitis, Ulcerative · Crohn Disease
Phase 2 Study of Mirikizumab With or Without LY4395089 for UC or Crohn's
This Phase 2 study is evaluating the efficacy and safety of mirikizumab with or without oral LY4395089 in adults with moderately to severely active ulcerative colitis or Crohn's disease.
Registry title: A Master Protocol (IIBD): A Study of Multiple Drugs in Adults With Ulcerative Colitis or Crohn's Disease
13 recruiting U.S. sites ↓Study at a glance
- Age
- 18 Years–80 Years
- Treatment
- Mirikizumab - Intravenous (IV) or Mirikizumab - Subcutaneous (SC)
- Design
- Randomized
- Central study contact
- There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or1-317-615-4559clinical_inquiry_hub@lilly.com
- Sponsor
- Eli Lilly and Company
Research question
In adults with moderately to severely active ulcerative colitis or Crohn's disease, what are the efficacy and safety of the treatments evaluated under this master protocol?
Participant snapshot
Who the study is looking for
- The study is looking for adults ages 18 through 80.
- Participants must have an established diagnosis of ulcerative colitis or Crohn's disease for at least 3 months, supported by clinical, endoscopic, and histopathology evidence.
- The study is looking for people whose ulcerative colitis or Crohn's disease meets the protocol's criteria for moderately to severely active disease.
- Participants must have had an inadequate response, loss of response, or intolerance to at least one corticosteroid, immunomodulator, or advanced therapy.
Participation overview
What participation may involve
Participation lasts at least 62 weeks and involves assignment to a substudy followed by randomization to mirikizumab alone or mirikizumab with LY4395089. What participation may involve: - During Study Period 1, participants receive intravenous mirikizumab; the experimental group also takes oral LY4395089. - Participants who respond during Study Period 1 receive subcutaneous mirikizumab during Study Period 2; those in the experimental group stop LY4395089. - Screening must confirm protocol-defined disease activity, recent endoscopy findings, diagnostic evidence, and laboratory results within specified limits. The registry states that the studies will last at least 62 weeks.
Study interventions
What participants may receive or do
- Mirikizumab - Intravenous (IV): Mirikizumab is administered into a vein during Study Period 1 in both treatment groups.
- Mirikizumab - Subcutaneous (SC): Participants who respond in Study Period 1 receive mirikizumab by injection under the skin during Study Period 2.
- LY4395089: LY4395089 is taken by mouth with intravenous mirikizumab during Study Period 1 in the experimental group; responders then stop LY4395089.
Study design
How the comparison works
This is an open-label, randomized, parallel-group Phase 2 study. Before randomization, participants are assigned to an appropriate substudy under the master protocol. Participants are randomly assigned to parallel treatment groups after assignment to the appropriate substudy. The registry reports no masking, meaning the study is open-label. The active-comparator group receives mirikizumab alone, while the experimental group receives LY4395089 with mirikizumab during Study Period 1.
Reported activities
Procedures and tests
- Intravenous administration of mirikizumab during Study Period 1.
- Subcutaneous administration of mirikizumab during Study Period 2 for participants who respond.
- Oral administration of LY4395089 during Study Period 1 in the experimental group.
- Screening laboratory tests must fall within protocol-specified limits.
- Screening may involve confirming clinical, endoscopic, and histopathology evidence supporting the diagnosis.
- For ulcerative colitis, disease activity is assessed using the modified Mayo score, endoscopic subscore, rectal bleeding score, and centrally read endoscopy.
- For Crohn's disease, disease activity is assessed using the Crohn's Disease Activity Index and a centrally read Simple Endoscopic Score for Crohn's Disease.
Eligibility highlights
Details that may affect whether you contact the study
These are selected highlights, not a complete eligibility check. Exact criteria remain in the full registry record below.
Common requirements
- Participants must be 18 through 80 years old.
- Ulcerative colitis or Crohn's disease must have been diagnosed for at least 3 months and supported by clinical, endoscopic, and histopathology evidence.
- For ulcerative colitis, the modified Mayo score must be 5 to 9, the centrally confirmed endoscopic subscore must be at least 2, and the rectal bleeding score must be at least 1; endoscopy must occur within 21 days before Visit 2.
- For Crohn's disease, the Crohn's Disease Activity Index must be 220 to 450, with a centrally read endoscopy score of at least 6 for ileal-colonic disease or at least 4 for isolated ileal disease within 21 days before randomization.
- Participants must have had an inadequate response, loss of response, or intolerance to at least one corticosteroid, immunomodulator, or advanced therapy for their condition.
- Screening laboratory results must be within limits specified by the protocol.
Possible reasons someone may not be able to join
- People with inflammatory bowel disease-unclassified or primary sclerosing cholangitis are excluded; the diagnosis must also match the ulcerative colitis or Crohn's disease substudy.
- People who have had or will need protocol-specified bowel resection or intestinal or intra-abdominal surgery are excluded.
- Certain complications, including stricture or stenosis and short bowel syndrome, are excluded, although the protocol allows some exceptions for Crohn's disease.
- A significant uncontrolled illness that could affect safety or interpretation of the data may exclude someone, based on the investigator's judgment.
- People who have failed more than five approved advanced treatments with different mechanisms of action for ulcerative colitis or Crohn's disease are excluded.
- Prior failure of an anti-interleukin-23p19 antibody treatment is an exclusion.
- Participants cannot have received or be expected to need medications prohibited by the protocol for ulcerative colitis or Crohn's disease.
Important unknowns
What the record does not make clear
- The registry does not state the number, timing, or length of study visits.
- The registry says participation lasts at least 62 weeks but does not report the exact duration or timing of each study period.
- No placebo group is described, but the registry does not explicitly state the probability of receiving each treatment group.
- The registry does not explain which current ulcerative colitis or Crohn's disease treatments may continue during the study.
- The eligibility criteria mention prohibited medications but do not name them or provide required stopping intervals.
- The registry does not describe rescue treatment if disease symptoms worsen or the assigned treatment does not control disease activity.
- Recent centrally read endoscopy is required for eligibility, but the registry does not describe whether additional endoscopies are required during the study.
- The registry does not identify which treatment, tests, procedures, or routine-care costs are paid by the study or billed to insurance.
- The registry does not state whether participants receive compensation.
- The registry does not state whether travel, lodging, meals, or parking are reimbursed.
- The registry does not state whether any visits or assessments can be completed remotely.
- The registry does not describe access to study treatment after participation ends.
- The overall study is recruiting, but listed locations have recruiting, not-yet-recruiting, and suspended statuses.
Before contacting the site
Questions for the study team
- Which substudy would apply to my diagnosis, and how is that assignment made before randomization?
- What is the chance of assignment to each treatment group, and is placebo used in the applicable substudy?
- What is the complete visit schedule, including infusion visits, injections, tests, and any hospital or clinic time?
- Which medications must be stopped, when must they be stopped, and which current treatments may continue?
- How many endoscopies are required, and can my existing endoscopy and pathology records be used for screening?
- What happens if I do not respond during Study Period 1 or if my disease worsens?
- Which costs are covered, and is compensation or travel support available?
- Is the applicable substudy actively recruiting at the site nearest me?
Before changing care
Questions for your gastroenterologist
- How stable is my ulcerative colitis or Crohn's disease now, and what are the clinical risks of changing treatment for screening or participation?
- How does this study compare with approved treatment options that remain available for my disease and treatment history?
- Could my prior response to advanced therapies, especially an anti-interleukin-23p19 treatment, affect whether the study team will proceed with screening?
- How should my regular gastroenterology care be coordinated with the research team if I am screened or enrolled?
This plain-language digest is provided by the Aidy clinical trials API. It may omit details and is not medical advice or an eligibility decision. Review the full registry record and confirm details with the study team.
Source record
Full registry record
The sections below preserve the study information supplied through ClinicalTrials.gov, including complete descriptions, criteria, outcomes, and locations.
About this study
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. The studies aim to evaluate the efficacy and safety of new treatments in adults with moderately to severely active ulcerative colitis or Crohn's disease and will last at least 62 weeks.
Study design and administration
- Organization
- Eli Lilly and Company
- Organization class
- Industry
- Organization study ID
- 27807
- Lead sponsor
- Eli Lilly and Company
- Sponsor class
- Industry
- Enrollment type
- Estimated
- Allocation
- Randomized
- Intervention model
- Parallel
- Primary purpose
- Treatment
- Masking
- None
- Who is masked
- Not provided
- Standard age groups
- Adult, Older Adult
Study arms
Active Comparator
Mirikizumab
Study Period 1: mirikizumab administered via IV. Study Period 2: Responders will receive mirikizumab SC.
Interventions: Drug: Mirikizumab - Intravenous (IV), Drug: Mirikizumab - Subcutaneous (SC)
Experimental
LY4395089 and Mirikizumab Co-Administration
Study Period 1: Co-administration of LY4395089 administered orally and mirikizumab administered IV. Study Period 2: Responders will stop LY4395089 and receive mirikizumab SC.
Interventions: Drug: Mirikizumab - Intravenous (IV), Drug: Mirikizumab - Subcutaneous (SC), Drug: LY4395089
Interventions
Drug
Mirikizumab - Intravenous (IV)
Administered IV
Drug
Mirikizumab - Subcutaneous (SC)
Administered SC
Drug
LY4395089
Administered orally
Eligibility
18 Years–80 Years
All
Not accepted
Inclusion criteria (7)
- 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.Registry-derived · unreviewed
- For UC:Registry-derived · unreviewed
- 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.Registry-derived · unreviewed
- For CD:Registry-derived · unreviewed
- 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 ≥6 for participants with ileal-colonic or ≥4 for participants with isolated ileal disease within 21 days before the randomizationRegistry-derived · unreviewed
- 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 CDRegistry-derived · unreviewed
- Have screening laboratory test results within the protocol specified parameters.Registry-derived · unreviewed
Exclusion criteria (9)
- Must not have a current diagnosis of inflammatory bowel disease (IBD)-unclassified or primary sclerosing cholangitisRegistry-derived · unreviewed
- For UC - must not have a current diagnosis of CDRegistry-derived · unreviewed
- For CD - must not have a current diagnosis of UCRegistry-derived · unreviewed
- Must not have had or will need bowel resection or intestinal or intra-abdominal surgery as specified in the protocolRegistry-derived · unreviewed
- Must not have complications of UC or CD, including but not limited to stricture or stenosis (some exceptions allowed for CD) or short bowel syndromeRegistry-derived · unreviewed
- 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 dataRegistry-derived · unreviewed
- Must not have failed more than 5 approved advanced treatments for UC or CD with different mechanisms of actionRegistry-derived · unreviewed
- Must not have failed an anti-interleukin-23p19 (anti-IL-23p19) antibody treatmentRegistry-derived · unreviewed
- Must not have received or will need any prohibited medications for UC or CD as specified in the protocolRegistry-derived · unreviewed
This information can identify a possible match, conflict, or item needing confirmation. Only the study team can determine eligibility.
Study outcomes
Primary outcome
Number of Participants Allocated to Each of the Intervention-Specific Appendices (ISA)
Time frame: Baseline, Up to Day 42
Recruiting locations in the United States
Biopharma Informatic, LLC
RecruitingLos Angeles, California, 90035, United States
Morris Silver, MD
South Denver Gastroenterology
RecruitingEnglewood, Colorado, 80113, United States
Marcelo Kugelmas
Gastro Health Research - Miami
RecruitingMiami, Florida, 33176, United States
Lukasz Kwapisz
Ezy Medical Research
RecruitingMiami Lakes, Florida, 33015, United States
Hendry Perez-Pascual
Atlanta Gastroenterology Associates - Peachtree Dunwoody
RecruitingAtlanta, Georgia, 30342, United States
Nitin Gupta
Rush University Medical Center
Not Yet RecruitingChicago, Illinois, 60612, United States
Atsushi Sakuraba
Cotton O'Neil Digestive Health Center
RecruitingTopeka, Kansas, 66606, United States
Curtis Baum
Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinical Research Center
RecruitingWyoming, Michigan, 49519, United States
Allan Coates
KAD Clinical Research
RecruitingSt Louis, Missouri, 63123, United States
Adrian Di Bisceglie
One of a Kind Clinical Research Center - Kingwood
Not Yet RecruitingKingwood, Texas, 77339, United States
Sushovan Guha
Southern Star Research Institute
RecruitingSan Antonio, Texas, 78229, United States
Jeff Bullock
This study also lists 56 locations outside the United States. They are not shown here.
Central study contacts
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Contact
Registry dates
- First posted
- Mar 19, 2026
- Primary completion
- Jun 2027
- Overall completion
- Mar 2028
Trial information comes from ClinicalTrials.gov and may change. Confirm current status, eligibility, and site details with the study team. Aidy does not provide medical advice or determine eligibility.