Recruiting NCT07415044

LY4268989 in Adults With Moderately to Severely Active Ulcerative Colitis

Phase II Interventional Ulcerative Colitis (UC) Ulcerative Colitis, Active Moderate Ulcerative Colitis, Active Severe

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, Placebo.
Who it may be relevant to: Registry conditions: Ulcerative Colitis (UC), Ulcerative Colitis, Active Moderate, Ulcerative Colitis, Active Severe. 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, Argentina, Brazil, Canada, China +23
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 Randomized, Multicenter, Double-Blind, Placebo-Controlled Development Program to Evaluate the Efficacy and Safety of LY4268989 (MORF-057) for the Treatment of Adults With Moderately to Severely Active Ulcerative Colitis (EMERALD-3)

Overview

The main purpose of this study is to evaluate the safety and effectiveness of LY4268989 when compared to placebo in adult participants with moderately to severely active ulcerative colitis (UC). The study drug will be administered orally. The study will last up to approximately 108 weeks, excluding screening.

Interventions

Drug LY4268989
Administered orally
Drug Placebo
Administered orally

Primary outcome measures

Percentage of Participants Who Achieve Clinical Remission with Modified Mayo Score (mMS) [Time frame: Week 10]
Percentage of Participants Who Achieve Clinical Remission with mMS Among Participants Who Achieved Clinical Response with LY4268989 at Week 10 [Time frame: Week 52]

Secondary outcome measures (6)

Percentage of Participants Who Achieve Clinical Response with mMS [Time frame: Week 10]
Percentage of Participants Who Achieve Clinical Response with mMS Among Participants Who Achieved Clinical Response with LY4268989 at Week 10 [Time frame: Week 10 Up to Week 52]
Percentage of Participants Who Achieve Symptomatic Response [Time frame: Baseline Up to Week 8]
Percentage of Participants Who Achieve Symptomatic Response Among Participants Who Achieved Clinical Response with LY4268989 at Week 10 [Time frame: Week 10 Up to Week 52]
Pharmacokinetics (PK): Plasma Concentrations of LY4268989 [Time frame: Baseline Up to Approximately Week 52]
Percentage of Participants Who Achieve Clinical Remission Among Participants Who Achieved Clinical Remission with LY4268989 at Week 10 [Time frame: Week 52]

Eligibility criteria

Inclusion criteria

Have had an established diagnosis of ulcerative colitis (UC) for ≥3 months prior to randomization, which includes endoscopic evidence of UC
Have moderately to severely active UC defined by a Modified Mayo Score (mMS) of 5 to 9 with an Endoscopic Score (ES)≥2 confirmed by central reader and rectal bleeding (RB)≥1
Have evidence of UC extending proximal to the rectum
Have documented evidence of having had a surveillance colonoscopy within 1 year, or according to local guidelines, to evaluate for polyps, dysplasia, or malignancy, prior to randomization, if the participant has a history of UC symptoms for more than 8 years
Have an inadequate response to, loss of response to, or intolerance to at least one conventional medication (including corticosteroids) or one advanced therapy (including biologics, Janus Kinase (JAK) inhibitors, or sphingosine-1-phosphate (S1P) immunomodulators). Participants with inadequate response to vedolizumab are excluded
Must meet contraception requirements

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 an inherited immunodeficiency syndrome or known monogenic cause of UC-like colonic inflammation
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 prior or current evidence of cancer gastrointestinal (GI) tract, or specified lesions with increased risk of GI malignancies
Have a diagnosis or history of malignant disease within 5 years prior to randomization

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 · 52 centers

Valleywise Health Medical Center — Phoenix
One of a Kind Clinical Research Center — Scottsdale
Clinnova Research — Anaheim
GMC Clinical Research — Folsom
Om Research LLC — Temple City
Om Research LLC — Victorville
Peak Gastroenterology Associates — Colorado Springs
Advanced Research Institute - Denver — Denver
… and 44 more centers

China · 22 centers

Binzhou Medical University Hospital — Binzhou
Changzhou Second People's Hospital — Changzhou
Sichuan Provincial People's Hospital — Chengdu
Chongqing General Hospital — Chongqing
The First People's Hospital of Foshan — Foshan
The Sixth Affiliated Hospital of Sun Yat-sen University — Guangzhou
… and 16 more centers

India · 16 centers