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RecruitingPhase 2

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

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

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 80 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Visits mentioned: 21 visits

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Study participation will last approximately 118 weeks, including 104 weeks of treatment and may include up to 21 visits."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how well LY4268989 (MORF-057) works and how safe it is when given with mirikizumab, compared with mirikizumab alone. It is for adults with moderate to severe active ulcerative colitis (UC), a disease that causes swelling and sores in the large bowel. The study lasts about 118 weeks, including 104 weeks of treatment, and may include up to 21 visits.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have had UC for at least 3 months, confirmed by a camera exam of the bowel and a tissue sample report.
  • Have moderate to severe active UC that meets the study’s scoring rules, including bowel swelling seen on a camera exam and bleeding from the rectum.
  • If you have had UC symptoms for more than 8 years, have had a colonoscopy to check for growths, abnormal cells, or cancer within the past year, or as local guidelines require.
  • Be up to date on colon and rectal cancer checks under local guidelines.
  • Have tried at least one eligible UC medicine that did not work well enough, stopped working, or caused side effects you could not tolerate.
  • Outside the US, qualifying medicines may include steroids or medicines that change how the immune system works.
  • In the US, people who have tried only standard UC medicines and no biologic medicines may qualify after an early review of study results, if the study team finds it appropriate.
  • Qualifying advanced UC medicines include certain biologic medicines, which target the immune system, but not mirikizumab; JAK inhibitors, such as tofacitinib; or S1PR inhibitors, such as ozanimod.

Who can't join

  • Have Crohn’s disease, bowel inflammation that cannot be clearly labeled as UC or Crohn’s disease, or primary sclerosing cholangitis, a disease that scars the bile ducts.
  • Have had or will need surgery to remove part of the bowel, or other surgery on the intestines or inside the belly.
  • Have a dangerously swollen large bowel, a pocket of infection inside the belly, or a narrowed bowel that causes symptoms or blocks passage of a colonoscopy camera.
  • Have an unremoved adenomatous polyp, a growth that may become cancer, in a part of the colon not affected by UC. A fully removed growth with only mildly abnormal cells does not rule you out under this rule.
  • Have a current or recent active infection.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (40)

AZ

CA

CO

FL

IL

IN

KY

MA

MI

MS

NY

  • Digestive Disease Medicine of Central New York · Utica, NY 13502Harvey Allen · Principal investigatorMore trials in Utica

OH

RI

SC

TN

TX

UT

VA

WA