LY4268989 (MORF-057) Co-Administered With Mirikizumab in Adults With Moderately to Severely Active Ulcerative Colitis:
- Conditions
- Ulcerative Colitis
- Interventions
- Registration Number
- NCT07186101
- Lead Sponsor
- Eli Lilly and Company
- 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 114 weeks, including 104 weeks of treatment and may include up to 21 visits.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 252
- Have had an established diagnosis of ulcerative colitis (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 Modified Mayo Score (mMS) of 5 to 9 with an Endoscopic Score (ES) ≥2 confirmed by central reader and rectal bleeding (RB) ≥1, with endoscopy performed within 14 days before baseline
- 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
-
-
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
-
Have a current or recent acute, active infection
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description LY4268989 + Mirikizumab LY4268989 LY4268989 administered orally (PO) + Mirikizumab administered intravenously (IV), then subcutaneously (SC). Responders will be re-randomized for Study Period 2. LY4268989 + Mirikizumab Mirikizumab LY4268989 administered orally (PO) + Mirikizumab administered intravenously (IV), then subcutaneously (SC). Responders will be re-randomized for Study Period 2. Mirikizumab + LY4268989 Placebo Mirikizumab Mirikizumab administered IV, then SC + LY4268989 placebo administered PO. Responders and Non-responders will re-randomized for Study Period 2. Mirikizumab + LY4268989 Placebo LY4268989 Placebo Mirikizumab administered IV, then SC + LY4268989 placebo administered PO. Responders and Non-responders will re-randomized for Study Period 2.
- Primary Outcome Measures
Name Time Method Percentage of Participants Who Achieve Clinical Remission with Modified Mayo Score (mMS) Week 12 The mMS is a composite sore 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 Outcome Measures
Name Time Method Percentage of Participants Who Achieve Clinical Response with Modified Mayo Score (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 Response with mMS Week 24
Trial Locations
- Locations (143)
Mayo Clinic in Arizona - Scottsdale
🇺🇸Scottsdale, Arizona, United States
Clinnova Research - Anaheim
🇺🇸Anaheim, California, United States
Om Research LLC
🇺🇸Lancaster, California, United States
Biopharma Informatic, LLC
🇺🇸Los Angeles, California, United States
Peak Gastroenterology Associates
🇺🇸Colorado Springs, Colorado, United States
NeoClinical Research
🇺🇸Hialeah, Florida, United States
Encore Borland-Groover Clinical Research
🇺🇸Jacksonville, Florida, United States
Clinical Research of Osceola
🇺🇸Kissimmee, Florida, United States
Florida Research Institute
🇺🇸Lakewood Rch, Florida, United States
Alliance Medical Research
🇺🇸Lighthouse PT, Florida, United States
Scroll for more (133 remaining)Mayo Clinic in Arizona - Scottsdale🇺🇸Scottsdale, Arizona, United StatesManreet KaurPrincipal Investigator