🔎 Trials Near Me

Home › Ulcerative Colitis › NCT07186101

LY4268989 (MORF-057) Co-Administered With Mirikizumab in Adults With Moderately to Severely Active Ulcerative Colitis:

RecruitingPhase 2

A Phase 2, Multicenter, Randomized, Double-Blind, Active-Controlled Study of LY4268989 (MORF-057) Co-Administered With Mirikizumab in Adults With Moderately to Severely Active Ulcerative Colitis

Who can join

Ages 18 to 80 · All sexes

Full eligibility criteria
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

About the study

The main purpose of the study is to evaluate the effectiveness and safety of LY4268989 when given with mirikizumab compared to mirikizumab alone in adult participants with moderately to severely active ulcerative colitis (UC).

Study participation will last approximately 118 weeks, including 104 weeks of treatment and may include up to 21 visits.

What is being tested

Sponsor: Eli Lilly and Company · Participants: 252 · Started: Nov 10, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT07186101

Locations in the U.S.

ArizonaMayo Clinic in Arizona - Scottsdale, Scottsdale
CaliforniaClinnova Research - Anaheim, Anaheim
Om Research LLC, Lancaster
Biopharma Informatic, LLC, Los Angeles
ColoradoPeak Gastroenterology Associates, Colorado Springs
FloridaNeoClinical Research, Hialeah
Encore Borland-Groover Clinical Research, Jacksonville
Clinical Research of Osceola, Kissimmee
Florida Research Institute, Lakewood Rch
Alliance Medical Research, Lighthouse PT
Atlantic Medical Research, Margate
Digestive and Liver Center of Florida, Orlando
IllinoisCenter for Gastrointestinal Health - Fairview Heights, Belleville (Not yet recruiting)
Northwestern University, Chicago (Not yet recruiting)
Midtown Gastroenterology and Liver Disease, Des Plaines
GI Alliance - Glenview, Glenview
Gi Alliance - Gurnee, Gurnee
IndianaGastroenterology Health Partners, New Albany
KentuckyGastroenterology Health Partners, Louisville
MassachusettsBrigham and Women's Hospital, Boston
MichiganClinical Research Institute of Michigan, LLC, Clinton Township
MississippiGI Associates - GIA and Endoscopy Center - Flowood, Flowood
New YorkDigestive Disease Medicine of Central New York, Utica
OhioDayton Gastroenterology, LLC, Dayton
Rhode IslandUniversity Gastroenterology - Providence - West River Street, Providence
South CarolinaGastroenterology Associates, P.A. of Greenville, Greenville
TennesseeGastro One - Walnut Run Road, Cordova
TexasTexas Digestive Disease Consultants - Cedar Park, Cedar Park
GI Alliance - Dallas - Gaston Avenue, Dallas (Not yet recruiting)
GI Alliance - Fort Worth, Fort Worth
GI Alliance - Garland, Garland
GI Alliance - Lubbock, Lubbock
Southern Star Research Institute, San Antonio
Tyler Research Institute, Tyler
GI Alliance-Webster, Webster
UtahCare Access - Ogden, Ogden
VirginiaClinical Research Partners, LLC, Richmond
GI Alliance - Richmond, Richmond
Carilion Clinic, Roanoke
WashingtonWashington Gastroenterology - Bellevue, Bellevue

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.