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New treatment option for Ulcerative Colitis (UC)
Official title LY4268989 in Adults With Moderately to Severely Active Ulcerative Colitis
ClinicalTrials.gov ID: NCT07415044
What this study is testing
What is LY4268989?
LY4268989 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for ulcerative colitis (uc).
Also referred to as MORF-057, zotemtegrast.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- 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...
- 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...
- Have an inadequate response to, loss of response to, or intolerance to at least one conventional medication (including corticosteroids) or one...
You likely can't join if
- 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
See the full eligibility 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...
- 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...
- Must meet contraception requirements
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Scottsdale, Arizona, United States
- Anaheim, California, United States
- Folsom, California, United States
- Temple City, California, United States
- Victorville, California, United States
- Colorado Springs, Colorado, United States
- Denver, Colorado, United States
- Lakewood, Colorado, United States
- Hamden, Connecticut, United States
- Daytona Beach, Florida, United States
- Kissimmee, Florida, United States
- Lakewood Rch, Florida, United States
- Orlando, Florida, United States
- Boise, Idaho, United States
- Idaho Falls, Idaho, United States
- Chicago, Illinois, United States
- Des Plaines, Illinois, United States
- Springfield, Illinois, United States
- New Albany, Indiana, United States
+ 194 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; Scottsdale, Arizona, United States; Anaheim, California, United States; Folsom, California, United States; Temple City, California, United States; Victorville, California, United States and 208 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.