12‑week efficacy study of ly4395089 and mirikizumab versus mirikizumab alone in adults with moderately to severely active Crohn’s disease

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What is this study about?

The study focuses on adults with moderately to severely active Ulcerative Colitis or Crohn’s Disease. The treatments being tested are a medicine called Mirikizumab, given by an IV infusion (through a vein) and later as small injections under the skin, and an oral tablet known as LY4395089. The combination of the tablet and the injection is compared with the injection alone.

The purpose of the study is to see whether the combination improves the condition of the intestines better than the injection alone after 12 weeks. Participants are randomly placed into one of the two groups and receive the assigned medication(s) for about three months, with regular clinic visits for safety checks and to collect information.

To measure improvement, doctors use an endoscopic exam, which means a tiny camera is used to look inside the bowel and check for healing. The study follows participants for the 12‑week treatment period and records any changes in the bowel lining.

1 enrollment and baseline assessments

after joining the study you sign the consent form and provide personal health information.

baseline procedures include a physical exam, laboratory tests, and an endoscopic examination to record the condition of the intestines.

2 initial intravenous infusion

on day one you receive an intravenous infusion of mirikizumab at a dose of 900 mg. intravenous means the medication is delivered directly into a vein through a small needle.

3 subcutaneous injections

following the initial infusion you receive subcutaneous injections of mirikizumab at a dose of 300 mg. subcutaneous means the medication is injected into the fatty tissue just under the skin.

these injections are given at regular intervals as instructed by the study team, continuing for a total treatment period of 12 weeks.

4 oral tablet administration (combination group only)

if you are assigned to the combination group you also take an oral tablet of ly4395089 each day. oral means the medication is swallowed and absorbed through the digestive system.

the exact amount of the tablet is determined by the study protocol and is taken as directed throughout the 12‑week treatment period.

5 regular follow‑up visits

throughout the 12 weeks you attend scheduled clinic visits for safety checks, blood tests, and assessment of any side effects.

the study team may perform additional endoscopic examinations to monitor changes in the intestinal lining.

6 final assessment at week 12

at the end of week 12 you undergo a final endoscopic examination and laboratory testing to evaluate the effectiveness of the treatment.

the results are used to determine whether the study objectives have been met.

Who Can Join the Study?

You must be an adult (usually 18 years or older) and can be either male or female.
You must have a confirmed diagnosis of Ulcerative Colitis (UC) or Crohn’s Disease (CD) for at least 3 months, proven by doctor’s evaluation, an endoscopy (a camera exam of the intestine), and a tissue (histopathology) report.
If you have UC, your disease must be moderately to severely active, which means a modified Mayo score between 5 and 9, an Endoscopic Subscore of 2 or higher, and rectal bleeding of at least mild severity (score ≥ 1). These findings must be confirmed by a central reviewer and the endoscopy must have been done within 21 days before the study visit.
If you have CD, your disease must be moderately to severely active, which means a Crohn’s disease activity index (CDAI) score between 220 and 450, and an endoscopic score called the Simple Endoscopic Score for Crohn’s Disease (SES‑CD) that is 6 or higher for disease affecting both the ileum and colon, or 4 or higher for disease limited to the ileum. The endoscopy must have been performed within 21 days before you are randomly assigned to a treatment group.
You must have tried at least one of the following medicines for UC or CD and not gotten enough benefit, stopped working, or caused you to be unable to tolerate them: corticosteroids (steroid anti‑inflammatories), immunomodulators (drugs that change the immune system), or an advanced therapy such as biologic agents.
If you are currently taking medications that act on the glucagon‑like peptide‑1 (GLP‑1) receptor (or similar drugs that also affect related hormones), you may still join the study as long as the dose has been stable (unchanged) at the time of screening.
Your screening blood and other laboratory tests must be within the limits set by the study protocol.
You must meet all other general inclusion requirements of the overall IIBD master protocol, except for any criteria that are specific only to ulcerative colitis.

Who Cannot Join the Study?

Must not have a current diagnosis of an unclassified form of inflammatory bowel disease (IBD) or a liver condition called primary sclerosing cholangitis.
If you have ulcerative colitis (UC), you must not also be diagnosed with Crohn’s disease (CD), and vice‑versa.
Must not have a history of any other bone disease that changes how bone is built or broken down (bone metabolism).
Must not have had any of the following heart or brain problems in the 180 days before screening: a heart attack (acute myocardial infarction), a stroke (cerebrovascular incident), a hospital stay for unstable chest pain (unstable angina), a hospital stay for weakened heart pumping (congestive heart failure), or a procedure to restore blood flow to the heart (coronary revascularization).
Must not be taking, or need to take, any medicines that the study lists as not allowed (prohibited medications).
Must not have had, and must not need, any major bowel surgery such as removal of part of the intestine (bowel resection) or other abdominal operations described in the study.
Must not have complications of UC or CD such as a narrowing of the intestine (stricture or stenosis) or a condition where a large portion of the intestine is missing (short bowel syndrome).
Must not have a serious illness that is not well controlled and that the doctor believes could put your safety at risk or make the study results hard to understand.
Must not have failed more than five approved advanced treatments for UC or CD that work in different ways (different mechanisms of action).
Must not have failed a treatment that blocks a protein called interleukin‑23p19 (anti‑IL‑23p19 antibody).
Must not be using, and must not need to start, any other medicines that the study says are not allowed for UC or CD.
You must meet all other exclusion rules set out in the main IIBD study protocol (these are additional safety requirements not listed here).
Must not have any liver disease (hepatic disease).

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
IRCCS Humanitas Research Hospital	Rozzano	Italy
Azienda Ospedaliero Universitaria Careggi	Florence	Italy
Katholieke Universiteit te Leuven	Leuven	Belgium

Other Sites

Site Name	City	Country
IRCCS Ospedale Sacro Cuore Don Calabria	Negrar di Valpolicella	Italy
Ospedale San Raffaele S.r.l.	Milan	Italy
Universitair Ziekenhuis Gent	Gent	Belgium
Algemeen Ziekenhuis Delta	Roeselare	Belgium
Az Maria Middelares Gent	Gent	Belgium
Fondazione IRCCS San Gerardo Dei Tintori	Monza	Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy

Trial status

Country	Status	Recruitment Start
Belgium	Not yet recruiting	18.05.2026
Italy	Not yet recruiting	18.05.2026

Trial locations

Investigated drugs:

Mirikizumab

Mirikizumab is a medicine given by injection that helps reduce inflammation in the gut. In this study it is being used to treat adults who have moderate to severe ulcerative colitis or Crohn’s disease. The drug is tested both as an intravenous infusion and as a subcutaneous (under‑the‑skin) injection, and it is compared with other treatment options to see how well it improves the lining of the intestine after 12 weeks.

LY4395089 is an experimental oral tablet that is being studied for the first time in people with Crohn’s disease. In this trial participants take the tablet together with an injection of mirikizumab, and the combination is compared to mirikizumab alone. The goal is to find out if adding this new pill helps the gut heal faster or more completely.

Investigated diseases:

Ulcerative colitis – It is a chronic inflammation of the colon lining that creates sores and ulceration. The condition usually begins in the rectum and may spread upward through the colon. Common early signs include frequent bowel movements, rectal bleeding, and abdominal cramping. Over time the inflammation can become more extensive, leading to persistent diarrhea and weight loss. The disease typically follows a pattern of flare‑ups and periods of relative calm.
Crohn disease – It is a long‑lasting inflammation that can affect any part of the digestive tract, most often the end of the small intestine and the start of the colon. Inflammation thickens the bowel wall, causing pain, diarrhea, and fatigue. Affected areas may develop strictures that narrow the intestine and fistulas that connect nearby organs. As the condition continues, episodes of flare‑ups alternate with quieter phases, and the bowel can become scarred or narrowed.

Trial ID:

2025-524112-11-00

Protocol code:

J6Z-MC-CD01

Trial Phase:

Therapeutic exploratory (Phase II)

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12‑week efficacy study of ly4395089 and mirikizumab versus mirikizumab alone in adults with moderately to severely active Crohn’s disease

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?