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

NCT07186101 · Eli Lilly and Company
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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
About this study
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.
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 and RB ≥1, with endoscopy performed within 21 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 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 design
Enrollment target: 252 participants
Allocation: randomized
Masking: double
Age groups: adult, older_adult
Timeline
Starts: 2025-11-10
Estimated completion: 2029-03
Last updated: 2026-04-17
Interventions
Drug: LY4268989Drug: MirikizumabDrug: LY4268989 Placebo
Primary outcomes
  • Percentage of Participants Who Achieve Clinical Remission with Modified Mayo Score (mMS) (Week 12)
Sponsor
Eli Lilly and Company · industry
Contacts & investigators
ContactTrial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or · contact · LillyTrials@Lilly.com · 1-317-615-4559
ContactPhysicians interested in becoming principal investigators please contact · contact · clinical_inquiry_hub@lilly.com
InvestigatorCall 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) · study_director, Eli Lilly and Company
All locations (149)
Mayo Clinic in Arizona - ScottsdaleNot Yet Recruiting
Scottsdale, Arizona, United States
Clinnova Research - AnaheimRecruiting
Anaheim, California, United States
Om Research LLCRecruiting
Lancaster, California, United States
Biopharma Informatic, LLCRecruiting
Los Angeles, California, United States
Peak Gastroenterology AssociatesRecruiting
Colorado Springs, Colorado, United States
NeoClinical ResearchRecruiting
Hialeah, Florida, United States
Encore Borland-Groover Clinical ResearchRecruiting
Jacksonville, Florida, United States
Clinical Research of OsceolaRecruiting
Kissimmee, Florida, United States
Florida Research InstituteRecruiting
Lakewood Rch, Florida, United States
Alliance Medical ResearchRecruiting
Lighthouse PT, Florida, United States
Atlantic Medical ResearchRecruiting
Margate, Florida, United States
Digestive and Liver Center of FloridaRecruiting
Orlando, Florida, United States
Center for Gastrointestinal Health - Fairview HeightsNot Yet Recruiting
Belleville, Illinois, United States
Northwestern UniversityNot Yet Recruiting
Chicago, Illinois, United States
Midtown Gastroenterology and Liver DiseaseRecruiting
Des Plaines, Illinois, United States
GI Alliance - GlenviewRecruiting
Glenview, Illinois, United States
Gi Alliance - GurneeRecruiting
Gurnee, Illinois, United States
Gastroenterology Health PartnersRecruiting
New Albany, Indiana, United States
Gastroenterology Health PartnersRecruiting
Louisville, Kentucky, United States
Brigham and Women's HospitalRecruiting
Boston, Massachusetts, United States
Clinical Research Institute of Michigan, LLCRecruiting
Clinton Township, Michigan, United States
GI Associates - GIA and Endoscopy Center - FlowoodRecruiting
Flowood, Mississippi, United States
Digestive Disease Medicine of Central New YorkRecruiting
Utica, New York, United States
Gastroenterology & Hepatology SpecialistsRecruiting
Canton, Ohio, United States
Dayton Gastroenterology, LLCRecruiting
Dayton, Ohio, United States
University Gastroenterology - Providence - West River StreetRecruiting
Providence, Rhode Island, United States
Gastroenterology Associates, P.A. of GreenvilleRecruiting
Greenville, South Carolina, United States
Gastro One - Walnut Run RoadRecruiting
Cordova, Tennessee, United States
Texas Digestive Disease Consultants - Cedar ParkRecruiting
Cedar Park, Texas, United States
GI Alliance - Dallas - Gaston AvenueSuspended
Dallas, Texas, United States
GI Alliance - Fort WorthRecruiting
Fort Worth, Texas, United States
GI Alliance - GarlandRecruiting
Garland, Texas, United States
GI Alliance - LubbockRecruiting
Lubbock, Texas, United States
Southern Star Research InstituteRecruiting
San Antonio, Texas, United States
Tyler Research InstituteRecruiting
Tyler, Texas, United States
GI Alliance-WebsterRecruiting
Webster, Texas, United States
Care Access - OgdenRecruiting
Ogden, Utah, United States
Clinical Research Partners, LLCRecruiting
Richmond, Virginia, United States
GI Alliance - RichmondRecruiting
Richmond, Virginia, United States
Carilion ClinicNot Yet Recruiting
Roanoke, Virginia, United States
Washington Gastroenterology - BellevueRecruiting
Bellevue, Washington, United States
Uniklinikum SalzburgSuspended
Salzburg, Austria
Medizinische Universität WienNot Yet Recruiting
Vienna, Austria
Chronos Pesquisa ClínicaNot Yet Recruiting
Brasília, Brazil
CAEP - Synvia LabsNot Yet Recruiting
Campinas, Brazil
Fundação Universidade de Caxias do Sul (FUCS)Not Yet Recruiting
Caxias do Sul, Brazil
Centro Digestivo de CuritibaNot Yet Recruiting
Curitiba, Brazil
Galileo Medical ResearchNot Yet Recruiting
Juiz de Fora, Brazil
NewData Clinical Research - MaceióNot Yet Recruiting
Maceió, Brazil
Hospital Ernesto DornellesNot Yet Recruiting
Porto Alegre, Brazil
Centro Internacional de Pesquisa Clínica (CIPES)Not Yet Recruiting
São José dos Campos, Brazil
CPQuali Pesquisa ClínicaNot Yet Recruiting
São Paulo, Brazil
Solare TrialsNot Yet Recruiting
São Paulo, Brazil
Hospital Santa Catarina - PaulistaNot Yet Recruiting
São Paulo, Brazil
Clínica Hepatogastro JKNot Yet Recruiting
São Paulo, Brazil
Universidade Federal Do Piaui - Campos UniversitarioNot Yet Recruiting
Teresina, Brazil
Charlton Digestive Disease CentreRecruiting
Hamilton, Canada
Victoria Hospital & Children's Hospital - London Health Sciences CentreNot Yet Recruiting
London, Canada
London Digestive Disease InstituteRecruiting
London, Canada
West GTA Research Inc.Not Yet Recruiting
Mississauga, Canada
C.I.C. Mauricie inc.Recruiting
Trois-Rivières, Canada
Changzhou Second People's HospitalRecruiting
Changzhou, China
Chongqing General HospitalRecruiting
Chongqing, China
The First Affiliated Hospital Of Fujian Medical UniversityRecruiting
Fuzhou, China
Sir Run Run Shaw Hospital of Zhejiang University School of MedicineRecruiting
Hangzhou, China
First Affiliated Hospital of Kunming Medical UniversityNot Yet Recruiting
Kunming, China
Jiangsu Province HospitalNot Yet Recruiting
Nanjing, China
The Affiliated Hospital of Qingdao UniversityRecruiting
Qingdao, China
Shengjing Hospital of China Medical UniversityNot Yet Recruiting
Shenyang, China
The Second Afilliated Hospital of Hebei Medical UniversityRecruiting
Shijiazhuang, China
Taian City Central HospitalRecruiting
Taian, China
Wuhan Union HospitalNot Yet Recruiting
Wuhan, China
Wuxi People's HospitalRecruiting
Wuxi, China
Herlev and Gentofte HospitalNot Yet Recruiting
Copenhagen, Denmark
Aalborg Universitetshospital, SydNot Yet Recruiting
Gistrup, Denmark
Odense UniversitetshospitalNot Yet Recruiting
Odense, Denmark
Charité Universitaetsmedizin Berlin - Campus MitteNot Yet Recruiting
Berlin, Germany
Studienzentrum MVZ DachauNot Yet Recruiting
Dachau, Germany
Universitätsklinikum RegensburgNot Yet Recruiting
Regensburg, Germany
Universitaetsklinikum UlmNot Yet Recruiting
Ulm, Germany
Békés Megyei Központi Kórház Dr. Réthy Pál TagkórházNot Yet Recruiting
Békéscsaba, Hungary
Óbudai Egészségügyi CentrumNot Yet Recruiting
Budapest, Hungary
Semmelweis EgyetemNot Yet Recruiting
Budapest, Hungary
Pannónia Magánorvosi CentrumNot Yet Recruiting
Budapest, Hungary
Clinexpert GyöngyösNot Yet Recruiting
Gyöngyös, Hungary
Komarom-Esztergom Varmegyei Szent Borbala KorhazNot Yet Recruiting
Tatabánya, Hungary
Jávorszky Ödön KórházNot Yet Recruiting
Vác, Hungary
Sardar Vallabhbhai Patel Institute of Medical Sciences and ResearchNot Yet Recruiting
Ahmedabad, India
Rajiv Gandhi Government General HospitalNot Yet Recruiting
Chennai, India
Ashwin HospitalNot Yet Recruiting
Coimbatore, India
Sushruta Multispeciality Hospital & Research CentreNot Yet Recruiting
Hubli, India
Mahavir Hospital & Research Centre - HyderabadNot Yet Recruiting
Hyderabad, India
All India Institute of Medical SciencesNot Yet Recruiting
New Delhi, India
Medipoint Hospitals Pvt. Ltd.Not Yet Recruiting
Pune, India
Shree Giriraj Multispeciality HospitalNot Yet Recruiting
Rajkot, India
ASST Grande Ospedale Metropolitano NiguardaNot Yet Recruiting
Milan, Italy
Fondazione IRCCS Cà Granda Ospedale Maggiore PoliclinicoNot Yet Recruiting
Milan, Italy
Ospedale San RaffaeleNot Yet Recruiting
Milan, Italy
Fondazione Policlinico Universitario Agostino GemelliNot Yet Recruiting
Roma, Italy
HumanitasNot Yet Recruiting
Rozzano, Italy
Fukuoka University HospitalRecruiting
Fukuoka, Japan
Gokeikai Ofuna Chuo HospitalRecruiting
Kamakura, Japan
Tsujinaka Hospital - KashiwanohaRecruiting
Kashiwa, Japan
National Hospital Organization Osaka National HospitalRecruiting
Osaka, Japan
Toho University Sakura Medical CenterRecruiting
Sakura, Japan
Sapporo Tokushukai HospitalRecruiting
Sapporo, Japan
Scientia Investigacion Clinica S.C.Not Yet Recruiting
Chihuahua City, Mexico
Instituto de Investigaciones Aplicadas a la Neurociencia A.C.Not Yet Recruiting
Durango, Mexico
Boca Clinical Trials Mexico S.C.Not Yet Recruiting
Guadajalara, Mexico
Clinica de Investigacion en Reumatologia y Obesidad S. C.Not Yet Recruiting
Guadalajara, Mexico
Centro de Investigación y Gastroenterología - S.C.Not Yet Recruiting
Mexico City, Mexico
Centro de Investigación Clinica ChapultepecNot Yet Recruiting
Mexico City, Mexico
Instituto Nacional de Ciencias Medicas y Nutricion Salvador ZubiranNot Yet Recruiting
Mexico City, Mexico
Servicios de Oncología Médica Integral - MonterreyNot Yet Recruiting
San Pedro Garza García, Mexico
Scientia Investigacion Clinica S.C.Not Yet Recruiting
Tijuana, Mexico
Clinical Research Institute S.C.Not Yet Recruiting
Tlalnepantla, Mexico
Medimanage ResearchNot Yet Recruiting
Tlalpan, Mexico
FAICIC S. de R.L. de C.V.Not Yet Recruiting
Veracruz, Mexico
RadboudumcNot Yet Recruiting
Nijmegen, Netherlands
Elisabeth-TweeSteden ZiekenhuisNot Yet Recruiting
Tilburg, Netherlands
Gyncentrum sp. z o.o. NZOZ Holsamed - oddział LiberoNot Yet Recruiting
Katowice, Poland
IRMEDNot Yet Recruiting
Piotrkow Trybunalski, Poland
Pratia PoznańNot Yet Recruiting
Poznan, Poland
Uniwersyteckie Centrum Stomatologii i Medycyny SpecjalistycznejNot Yet Recruiting
Poznan, Poland
Twoja Przychodnia SCMNot Yet Recruiting
Szczecin, Poland
Sonomed Sp. z o. o.Not Yet Recruiting
Szczecin, Poland
WSD MEDINot Yet Recruiting
Warsaw, Poland
Medical Network Spółka z o.o. WIP Warsaw IBD Point Profesor KierkuśNot Yet Recruiting
Warsaw, Poland
ETG ZamośćNot Yet Recruiting
Zamość, Poland
Spitalul de Oncologie MonzaNot Yet Recruiting
Bucharest, Romania
Delta Health CareRecruiting
Bucharest, Romania
Spitalul Clinic ColentinaNot Yet Recruiting
Bucharest, Romania
Constanta County Emergency Clinical Hospital Sf.Ap.AndreiNot Yet Recruiting
Constanța, Romania
Spital Judetean de UrgentaRecruiting
Satu Mare, Romania
S.C Centrul de Gastroenterologie Dr. Goldis S.R.LRecruiting
Timișoara, Romania
Centro Médico TeknonNot Yet Recruiting
Barcelona, Spain
Hospital Universitario de FuenlabradaNot Yet Recruiting
Fuenlabrada, Spain
Hospital de CabueñesNot Yet Recruiting
Gijón, Spain
Hospital Universitario La PazNot Yet Recruiting
Madrid, Spain
Hospital Universitario Nuestra Señora de CandelariaNot Yet Recruiting
Santa Cruz de Tenerife, Spain
Adana City HospitalNot Yet Recruiting
Adana, Turkey (Türkiye)
Gazi University Health Research and Application Center Gazi HospitalNot Yet Recruiting
Ankara, Turkey (Türkiye)
Antalya Egitim ve Arastırma HastanesiNot Yet Recruiting
Antalya, Turkey (Türkiye)
Eskisehir Osmangazi UniversityNot Yet Recruiting
Eskişehir, Turkey (Türkiye)
Mustafa Kemal UniversitesiNot Yet Recruiting
Hatay, Turkey (Türkiye)
Kocaeli University Medical Faculty HospitalNot Yet Recruiting
İzmit, Turkey (Türkiye)
İnönü Üniversitesi Turgut Özal Tıp Merkezi Eğitim ve Araştırma HastanesiNot Yet Recruiting
Malatya, Turkey (Türkiye)
Mersin UniversityNot Yet Recruiting
Mersin, Turkey (Türkiye)
Dicle ÜniversitesiNot Yet Recruiting
Sur, Turkey (Türkiye)
LY4268989 (MORF-057) Co-Administered With Mirikizumab in Adults With Moderately to Severely Active Ulcerative Colitis: · TrialPath