Recruiting NCT07186101

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

Phase II Interventional Ulcerative Colitis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: LY4268989, Mirikizumab, LY4268989 Placebo.
Who it may be relevant to: Registry conditions: Ulcerative Colitis. Basic parameters: 18 years — 80 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Austria, Brazil, Canada, China +12
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Drug LY4268989
Administered PO
Drug Mirikizumab
Administered IV then SC
Drug LY4268989 Placebo
Administered PO

Primary outcome measures

Percentage of Participants Who Achieve Clinical Remission with Modified Mayo Score (mMS) [Time frame: Week 12]

Secondary outcome measures (9)

Percentage of Participants Who Achieve Clinical Response with mMS [Time frame: Week 12]
Percentage of Participants Who Achieve Endoscopic Improvement [Time frame: Week 12]
Percentage of Participants Who Achieve Symptomatic Remission [Time frame: Week 12]
Percentage of Participants Who Achieve Clinical Remission with mMS [Time frame: Week 24]
Percentage of Participants Who Achieve Clinical Response with mMS [Time frame: Week 24]
Percentage of Participants Who Achieve Clinical Remission with mMS [Time frame: Week 48]
Percentage of Participants Who Achieve Clinical Response with mMS [Time frame: Week 48]
Percentage of Participants Who Achieve Clinical Remission with mMS + Physician's Global Assessment (PGA) [Time frame: Week 48]
Percentage of Participants Who Achieve Clinical Response with mMS + PGA [Time frame: Week 48]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Double blind
Primary purpose: Treatment

Study locations

United States · 40 centers

Mayo Clinic in Arizona - Scottsdale — Scottsdale
Clinnova Research - Anaheim — Anaheim
Om Research LLC — Lancaster
Biopharma Informatic, LLC — Los Angeles
Peak Gastroenterology Associates — Colorado Springs
NeoClinical Research — Hialeah
Encore Borland-Groover Clinical Research — Jacksonville
Clinical Research of Osceola — Kissimmee
… and 32 more centers

Brazil · 14 centers

Chronos Pesquisa Clínica — Brasília
CAEP - Synvia Labs — Campinas
Fundação Universidade de Caxias do Sul (FUCS) — Caxias do Sul
Centro Digestivo de Curitiba — Curitiba
Galileo Medical Research — Juiz de Fora
NewData Clinical Research - Maceió — Maceió
Hospital Ernesto Dornelles — Porto Alegre
Centro Internacional de Pesquisa Clínica (CIPES) — São José dos Campos
… and 6 more centers

China · 12 centers

Changzhou Second People's Hospital — Changzhou
Chongqing General Hospital — Chongqing
The First Affiliated Hospital Of Fujian Medical University — Fuzhou
Sir Run Run Shaw Hospital of Zhejiang University School of Medicine — Hangzhou
First Affiliated Hospital of Kunming Medical University — Kunming
Jiangsu Province Hospital — Nanjing
The Affiliated Hospital of Qingdao University — Qingdao
Shengjing Hospital of China Medical University — Shenyang
… and 4 more centers

Mexico · 12 centers