Ulcerative Colitis
Conditions
Brief summary
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.
Interventions
DRUGLY4268989
Administered PO
DRUGMirikizumab
Administered IV then SC
DRUGLY4268989 Placebo
Administered PO
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Achieve Clinical Remission with Modified Mayo Score (mMS) | Week 12 | The mMS is a composite score reported by participants and physician and is comprised of the following 3 subscores: Stool Frequency (SF); Rectal Bleeding (RB), and Endoscopic Subscore (ES). Clinical remission (mMS) is defined as: * SF subscore = 0 or 1 and no greater than baseline * RB subscore = 0 * Centrally read ES = 0 or 1; score of 1 modified to exclude friability |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of Participants Who Achieve Clinical Response with mMS | Week 12 |
| Percentage of Participants Who Achieve Endoscopic Improvement | Week 12 |
| Percentage of Participants Who Achieve Symptomatic Remission | Week 12 |
| Percentage of Participants Who Achieve Clinical Remission with mMS | Week 24 |
| Percentage of Participants Who Achieve Clinical Remission with mMS + Physician's Global Assessment (PGA) | Week 48 |
| Percentage of Participants Who Achieve Clinical Response with mMS + PGA | Week 48 |
Countries
Austria, Brazil, Canada, China, Denmark, Germany, Hungary, India, Italy, Japan, Mexico, Netherlands, Poland, Romania, Spain, Turkey (Türkiye), United States
Contacts
CONTACTTrial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACTPhysicians interested in becoming principal investigators please contact
STUDY_DIRECTORCall 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Outcome results
None listed