A study of LY4268989 and mirikizumab in adults with moderately to severely active ulcerative colitis

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What is this study about?

This study investigates treatments for Ulcerative Colitis, a condition characterized by long-lasting inflammation and sores in the lining of the large intestine. The purpose of the study is to evaluate the effectiveness of combining two different medicines compared to using just one. The medications being studied include mirikizumab, which is given through intravenous injection (delivered directly into a vein) or subcutaneous injection (delivered just under the skin), and LY4268989, which is an oral capsule. Some participants may also receive a placebo.

During the study, participants will be assigned to different groups to receive either the combination of LY4268989 and mirikizumab or mirikizumab alone. The process is double-blind, meaning neither the participants nor the researchers know which specific treatment is being administered. The course of the study involves monitoring the participants over a 12-week period to observe how they respond to the medications.

Who Can Join the Study?

  • You must have been diagnosed with Ulcerative Colitis, which is a condition that causes long-term inflammation and sores in the lining of your large intestine, for at least 3 months before starting the study.
  • Your Ulcerative Colitis must be moderately to severely active, meaning your symptoms are significant and currently causing noticeable issues.
  • The inflammation from your Ulcerative Colitis must extend proximal to the rectum, which means the affected area is located further up in the large intestine, beyond the rectum.
  • If you have had symptoms of Ulcerative Colitis for more than 8 years, you must have had a surveillance colonoscopy (a procedure where a doctor uses a camera to look inside the colon) within the last year, or according to your local medical rules, to check for polyps (small growths on the colon lining), dysplasia (abnormal cell changes that could lead to cancer), or malignancy (cancer).
  • You must be up-to-date with all required colorectal cancer surveillance, which refers to regular medical check-ups and screenings to look for signs of cancer in the large intestine.
  • You must have had an inadequate response (the medicine did not work well enough), a loss of response (the medicine used to work but stopped working), or an intolerance (you experienced bad side effects) to conventional therapy, immunomodulators (medicines that change how your immune system works), or advanced therapy.
  • You must be between the ages of 18 and 65 years old.

Who Cannot Join the Study?

  • You have a diagnosis of Crohn’s disease, which is a type of long-term swelling in the digestive tract, unclassified inflammatory bowel disease, or primary sclerosing cholangitis, which is a chronic disease that causes inflammation in the bile ducts in your liver.
  • You have an inherited immunodeficiency syndrome, which is a condition passed down through families that makes your immune system (the body’s defense against germs) not work properly, or a known monogenic cause of inflammation that looks like ulcerative colitis.
  • You have already had, or will need to have, bowel resection, which means a part of your intestine is surgically removed, or any other intestinal or intra-abdominal surgery.
  • You are likely to need surgery to treat your ulcerative colitis during the time you are in the study.
  • You have signs of toxic megacolon, which is a severe and dangerous swelling of the colon, an intra-abdominal abscess, which is a pocket of infection inside the belly, or a stricture or stenosis, which are narrowings in your small bowel or colon that make it difficult for a colonoscope (a thin tube with a camera used to look inside the bowel) to pass through or cause symptoms.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
IRCCS Humanitas Research Hospital Rozzano Italy
Medical University Of Vienna Vienna Austria
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Italy
Clinexpert Kft. Gyongyos Hungary
Gyncentrum Sp. z o.o. Katowice Poland

Other Sites

Site Name City Country Status
Odense University Hospital Odense Denmark
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico Milan Italy
Ospedale San Raffaele S.r.l. Milan Italy
ASST Grande Ospedale Metropolitano Niguarda Milan Italy
Semmelweis University Budapest Hungary
Aalborg University Hospital Aalborg Denmark
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH Ulm Germany
Delta Health Care S.R.L. Bucharest Romania
Spitalul Clinic Colentina Bucuresti Bucharest Romania
Wsd Medi Clinical Sp. z o.o. Warsaw Poland
Obudai Egeszseguegyi Centrum Kft. Dunaújváros Hungary
Universitaetsklinikum Regensburg AöR Regensburg Germany
Spitalul Clinic Judetean De Urgenta Sfantul Apostol Andrei Constanta Constanta Romania
Pratia S.A. Skorzewo Poland
Javorszky Odon Korhaz Vac Hungary
Spital Judetean De Urgenta Satu Mare Satu Mare Romania
Uniwersyteckie Centrum Stomatologii I Medycyny Specjalistycznej Sp. z o.o. Poznan Poland
Centro Medico Teknon-Grupo Quironsalud Barcelona Spain
Spitalul De Oncologie Monza S.R.L. Bucharest Romania
Charite Research Organisation GmbH Berlin Germany
Twoja Przychodnia Szczecinskie Centrum Medyczne Sp. z o.o. Szczecin Poland
Bekes Varmegyei Koezponti Korhaz Gyula Hungary
Komarom-Esztergom Varmegyei Szent Borbala Korhaz Tatabanya Hungary
Sonomed Sp. z o.o. Szczecin Poland
Irmed Klimkiewicz Rudziewicz-Kowalska sp. j. Piotrkow Trybunalski Poland
Hospital Universitario De Fuenlabrada Fuenlabrada Spain
Cabinet Particular Policlinic Algomed S.R.L. Timisoara Romania
Pannonia Maganorvosi Centrum Kft. Budapest Hungary
Hxumuk Hcweghbx Herlev Denmark
Fwzocyqvz Pgsg Lq Ivkyfzsowueze Bxlcspxzt Dhj Hbsdrvvw Unfhkncsapxgk Ln Pri Madrid Spain
Eud Zpxnmo Zamosc Poland
Wqi Worgma Ixv Pgltf Ppihpfxv Kiqryyi Warsaw Poland
Slqunlyicvvwde Mck Dpfigl Dachau Germany
Sxrjzflkb Reiiceg Uwhcvtmllp Mmrbhlm Cxzncc Nijmegen The Netherlands
Sin Etfgfhmmh Hsoknstz Tncutxc Tilburg The Netherlands

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Recruiting
01.04.2026
Denmark Denmark
Recruiting
01.04.2026
Germany Germany
Recruiting
01.04.2026
Hungary Hungary
Recruiting
01.04.2026
Italy Italy
Recruiting
01.04.2026
Poland Poland
Recruiting
01.04.2026
Romania Romania
Recruiting
01.04.2026
Spain Spain
Recruiting
01.04.2026
The Netherlands The Netherlands
Recruiting
01.04.2026

Trial locations

Investigated Drugs:

Mirikizumab is a medication given by injection into a vein or under the skin to help treat people with moderately to severely active ulcerative colitis, an inflammatory bowel disease.

LY4268989 is an experimental medication taken in capsule form by mouth that is being studied for its ability to be used alongside Mirikizumab to treat ulcerative colitis.

Investigated Diseases:

Ulcerative Colitis – This is a condition that causes inflammation and sores in the lining of the large intestine and rectum. The inflammation typically starts in the rectum and can spread upward through the rest of the colon. As the disease progresses, the swelling in the intestinal wall can lead to frequent changes in bowel habits. The condition often involves periods of active inflammation followed by periods of calm. It is a chronic condition that affects the digestive system.

Trial ID:
2025-522338-30-00
Protocol code:
J6E-MC-KWAN
Trial Phase:
Therapeutic exploratory (Phase II)

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