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

Purpose

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.

Condition

  • Ulcerative Colitis

Eligibility

Eligible Ages
Between 18 Years and 80 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Care Provider)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
LY4268989 + Mirikizumab 		LY4268989 administered orally (PO) + Mirikizumab administered intravenously (IV), then subcutaneously (SC). Responders will be re-randomized for Study Period 2.
  • Drug: LY4268989
    Administered PO
    Other names:
    • MORF-057
    • zotemtegrast
  • Drug: Mirikizumab
    Administered IV then SC
    Other names:
    • LY3074828
Experimental
Mirikizumab + LY4268989 Placebo 		Mirikizumab administered IV, then SC + LY4268989 placebo administered PO. Responders and Non-responders will re-randomized for Study Period 2.
  • Drug: Mirikizumab
    Administered IV then SC
    Other names:
    • LY3074828
  • Drug: LY4268989 Placebo
    Administered PO

Recruiting Locations

Mayo Clinic in Arizona - Scottsdale
Scottsdale, Arizona 85259
Contact:
480-301-8000

Clinnova Research - Anaheim
Anaheim, California 92805

Om Research LLC
Lancaster, California 93534
Contact:
661-388-2239

Biopharma Informatic, LLC
Los Angeles, California 90035
Contact:
281-944-3610

Peak Gastroenterology Associates
Colorado Springs, Colorado 80907
Contact:
719-310-6719

NeoClinical Research
Hialeah, Florida 33016
Contact:
305-456-9062

Encore Borland-Groover Clinical Research
Jacksonville, Florida 32256
Contact:
904-680-0871

Clinical Research of Osceola
Kissimmee, Florida 34741
Contact:
407-954-4016

Florida Research Institute
Lakewood Rch, Florida 34211
Contact:
941-727-7772

Alliance Medical Research
Lighthouse PT, Florida 33064
Contact:
954-428-2480

Atlantic Medical Research
Margate, Florida 33063
Contact:
954-850-0589

Digestive and Liver Center of Florida
Orlando, Florida 32825
Contact:
407-384-7388

Midtown Gastroenterology and Liver Disease
Des Plaines, Illinois 60016
Contact:
262-925-1280

GI Alliance - Glenview
Glenview, Illinois 60026

Gi Alliance - Gurnee
Gurnee, Illinois 60031

Gastroenterology Health Partners
New Albany, Indiana 47150
Contact:
812-206-1702

Gastroenterology Health Partners
Louisville, Kentucky 40218
Contact:
502-888-1988

Brigham and Women's Hospital
Boston, Massachusetts 02215
Contact:
617-732-6389

Clinical Research Institute of Michigan, LLC
Clinton Township, Michigan 48038
Contact:
586-598-3329

GI Associates - GIA and Endoscopy Center - Flowood
Flowood, Mississippi 39232
Contact:
601-863-0395

Digestive Disease Medicine of Central New York
Utica, New York 13502

Gastroenterology & Hepatology Specialists
Canton, Ohio 44718
Contact:
330-305-2020

Dayton Gastroenterology, LLC
Dayton, Ohio 45415
Contact:
937-320-5050

University Gastroenterology - Providence - West River Street
Providence, Rhode Island 02904
Contact:
401-227-8393

Gastroenterology Associates, P.A. of Greenville
Greenville, South Carolina 29607
Contact:
864-451-5026

Gastro One - Walnut Run Road
Cordova, Tennessee 38018

Texas Digestive Disease Consultants - Cedar Park
Cedar Park, Texas 78613
Contact:
512-341-0900

GI Alliance - Fort Worth
Fort Worth, Texas 76104
Contact:
817-612-5575

GI Alliance - Garland
Garland, Texas 75044
Contact:
972-265-8201

GI Alliance - Lubbock
Lubbock, Texas 79410
Contact:
806-793-3141

Southern Star Research Institute
San Antonio, Texas 78229
Contact:
210-581-2812

Tyler Research Institute
Tyler, Texas 75701
Contact:
903-630-6211

GI Alliance-Webster
Webster, Texas 77598
Contact:
281-626-7035

Care Access - Ogden
Ogden, Utah 84403
Contact:
801-614-0010

Clinical Research Partners, LLC
Richmond, Virginia 23226

GI Alliance - Richmond
Richmond, Virginia 23229
Contact:
804-362-0954

Washington Gastroenterology - Bellevue
Bellevue, Washington 98004
Contact:
425-454-4768

More Details

Status
Recruiting
Sponsor
Eli Lilly and Company

Study Contact

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