LY4268989 (MORF-057) with mirikizumab for adults with moderate-to-severe ulcerative colitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2 interventional study compares co-administration of LY4268989 plus mirikizumab against mirikizumab with LY4268989 placebo in adults who have moderately to severely active ulcerative colitis. Eligible participants must have documented endoscopic and histologic evidence of UC and meet specified clinical severity scores confirmed by a central reader. Treatment lasts up to 104 weeks within a total participation time of about 118 weeks and may include around 21 clinic visits. Safety and effectiveness outcomes will be tracked throughout the treatment period.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Have had an established diagnosis of UC of ≥3 months in before baseline, which includes endoscopic evidence of UC and a histopathology report that supports a diagnosis of UC
* Have moderately to severely active UC as defined by a mMS of 5 to 9 with an ES ≥2 confirmed by central reader at screening endoscopy and RB ≥1.
* Participants with greater than 8 years of UC symptoms have documented evidence of having had a surveillance colonoscopy within 1 year, or according to local country or regional medical guidelines, to evaluate for polyps, dysplasia, or malignancy, prior to randomization
* Are up-to-date on colorectal cancer surveillance per local society guidelines
* Have an inadequate response to, loss of response to, or intolerance to at least 1 of the medications:
* Conventional-failed participants: Participants who have had an inadequate response to or a loss of response to or are intolerant to at least 1 of the following medications: corticosteroids or immunomodulators (Does not apply to US)

NOTE: After the interim analysis, participants with inadequate response, loss of response, or intolerance to conventional UC therapy without prior exposure to biologics may be enrolled if deemed appropriate (Applies to the US)

* Advanced therapy-failed participants: Participants who have an inadequate response to or a loss of response to, or are intolerant to advanced therapy for UC, defined as:

  * a biologic or biosimilar medication such as anti-tumor necrosis factor (anti-TNF) antibodies or anti-interleukin antibodies (IL-12/23, or IL-23p19), except for

    * mirikizumab.
  * Janus kinase inhibitors (JAK) such as filgotinib, tofacitinib, or upadacitinib
  * sphingosine 1-phosphate receptor 1 inhibitors (S1PR) such as etrasimod or ozanimod

Exclusion Criteria:

* Have a current diagnosis of

  * Crohn's disease
  * Inflammatory Bowel Disease (IBD) unclassified (formerly known as indeterminate colitis), or
  * primary sclerosing cholangitis
* Have had or will need bowel resection or intestinal or intra-abdominal surgery
* Have evidence of toxic megacolon, intra-abdominal abscess, or stricture or stenosis within small bowel or colon that cannot be traversed by a colonoscope or that are symptomatic
* Have any adenomatous polyp occurring in areas of the colon not involved by colitis, that has not been removed

Note: If such an adenomatous polyp has been completely removed and shows only low-grade dysplasia, this criterion would no longer apply

* Have a current or recent acute, active infection

Where it's running

• Mayo Clinic in Arizona - Scottsdale
  Scottsdale, Arizona, United States Recruiting
• Clinnova Research - Anaheim
  Anaheim, California, United States Recruiting
• Om Research LLC
  Lancaster, California, United States Recruiting
• Biopharma Informatic, LLC
  Los Angeles, California, United States Recruiting
• Peak Gastroenterology Associates
  Colorado Springs, Colorado, United States Recruiting
• NeoClinical Research
  Hialeah, Florida, United States Recruiting

+97 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
• Email: LillyTrials@Lilly.com
• Phone: 1-317-615-4559

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Mirikizumab given at the same time as tirzepatide for adults with moderate-to-severe ulcerative colitis who are overweight or have obesity

  This will test whether giving mirikizumab together with tirzepatide helps adults with moderate-to-severe ulcerative colitis who are overweight or obese reduce UC symptoms and lose at least 10% of their body weight.

  Recruiting at 179 sites Phase 3 Eli Lilly and Company · Dothan, Alabama and 185 other locations · NCT06937086

• Evaluating Mirikizumab for Children with Ulcerative Colitis or Crohn's Disease

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• Innovative Multidisciplinary and Virtual Care for IBD in Pregnancy

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• A Probiotic Approach to Modulating Gut Microbiota in Mild-to-Moderate Ulcerative Colitis

  A specific probiotic given rectally will be tested in adults with mild-to-moderate ulcerative colitis to see if it can help manage symptoms.

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• Advanced therapies for moderately to severely active Crohn's disease or ulcerative colitis in adults

  This study tests combinations of risankizumab with either trosunilimab or ABBV-701 in adults with moderately to severely active Crohn's disease or ulcerative colitis.

  Recruiting at 66 sites Phase 2 AbbVie · Dothan, Alabama and 65 other locations · NCT07697456

• Longitudinal Immunophenotyping of People with Inflammatory Bowel Disease

  This study will follow adults with Crohn's disease or ulcerative colitis (and some healthy relatives) over three years to see how their immune cells change over time and how genetics and diet relate to their disease.

  Recruiting National Institutes of Health Clinical Center (CC) · Bethesda, Maryland · NCT07619547

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.