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

Status: Recruiting
Location: See all (149) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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 118 weeks, including 104 weeks of treatment and may include up to 21 visits.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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 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

Locations
United States
Arizona
Mayo Clinic in Arizona - Scottsdale
NOT_YET_RECRUITING
Scottsdale
California
Clinnova Research - Anaheim
NOT_YET_RECRUITING
Anaheim
Om Research LLC
NOT_YET_RECRUITING
Lancaster
Biopharma Informatic, LLC
RECRUITING
Los Angeles
Colorado
Peak Gastroenterology Associates
NOT_YET_RECRUITING
Colorado Springs
Florida
NeoClinical Research
RECRUITING
Hialeah
Encore Borland-Groover Clinical Research
NOT_YET_RECRUITING
Jacksonville
Clinical Research of Osceola
RECRUITING
Kissimmee
Florida Research Institute
NOT_YET_RECRUITING
Lakewood Rch
Alliance Medical Research
RECRUITING
Lighthouse Pt
Atlantic Medical Research
NOT_YET_RECRUITING
Margate
Digestive and Liver Center of Florida
RECRUITING
Orlando
Illinois
Center for Gastrointestinal Health - Fairview Heights
NOT_YET_RECRUITING
Belleville
Lakeshore Gastroenterology and Liver Disease Institute
NOT_YET_RECRUITING
Des Plaines
GI Alliance - Glenview
RECRUITING
Glenview
Gi Alliance - Gurnee
RECRUITING
Gurnee
Indiana
Gastroenterology Health Partners
RECRUITING
New Albany
Kentucky
Gastroenterology Health Partners
RECRUITING
Louisville
Massachusetts
Brigham and Women's Hospital
NOT_YET_RECRUITING
Boston
Michigan
Clinical Research Institute of Michigan, LLC
NOT_YET_RECRUITING
Clinton Township
Mississippi
GI Associates - GIA and Endoscopy Center - Flowood
RECRUITING
Flowood
New York
Columbia University Irving Medical Center
NOT_YET_RECRUITING
New York
Digestive Disease Medicine of Central New York
NOT_YET_RECRUITING
Utica
Ohio
Gastroenterology & Hepatology Specialists
NOT_YET_RECRUITING
Canton
Dayton Gastroenterology, LLC
NOT_YET_RECRUITING
Dayton
Rhode Island
University Gastroenterology - Providence - West River Street
RECRUITING
Providence
South Carolina
Gastroenterology Associates, P.A. of Greenville
NOT_YET_RECRUITING
Greenville
Tennessee
Gastro One - Walnut Run Road
RECRUITING
Cordova
Texas
Texas Digestive Disease Consultants - Cedar Park
NOT_YET_RECRUITING
Cedar Park
GI Alliance - Dallas - Gaston Avenue
NOT_YET_RECRUITING
Dallas
GI Alliance - Fort Worth
NOT_YET_RECRUITING
Fort Worth
GI Alliance - Garland
RECRUITING
Garland
GI Alliance - Lubbock
RECRUITING
Lubbock
Southern Star Research Institute
RECRUITING
San Antonio
Tyler Research Institute
RECRUITING
Tyler
GI Alliance-Webster
RECRUITING
Webster
Utah
Care Access - Ogden
RECRUITING
Ogden
Virginia
Clinical Research Partners, LLC
RECRUITING
Richmond
GI Alliance - Richmond
NOT_YET_RECRUITING
Richmond
Washington
Washington Gastroenterology - Bellevue
RECRUITING
Bellevue
Other Locations
Austria
Uniklinikum Salzburg
NOT_YET_RECRUITING
Salzburg
Medizinische Universität Wien
NOT_YET_RECRUITING
Vienna
Brazil
Chronos Pesquisa Clínica
NOT_YET_RECRUITING
Brasília
CAEP - Synvia Labs
NOT_YET_RECRUITING
Campinas
Fundação Universidade de Caxias do Sul (FUCS)
NOT_YET_RECRUITING
Caxias Do Sul
Centro Digestivo de Curitiba
NOT_YET_RECRUITING
Curitiba
Galileo Medical Research
NOT_YET_RECRUITING
Juiz De Fora
NewData Clinical Research - Maceió
NOT_YET_RECRUITING
Maceió
Hospital Ernesto Dornelles
NOT_YET_RECRUITING
Porto Alegre
Centro Internacional de Pesquisa Clínica (CIPES)
NOT_YET_RECRUITING
São José Dos Campos
Clínica Hepatogastro JK
NOT_YET_RECRUITING
São Paulo
CPQuali Pesquisa Clínica
NOT_YET_RECRUITING
São Paulo
Hospital Santa Catarina - Paulista
NOT_YET_RECRUITING
São Paulo
Solare Trials
NOT_YET_RECRUITING
São Paulo
Universidade Federal Do Piaui - Campos Universitario
NOT_YET_RECRUITING
Teresina
Canada
Charlton Digestive Disease Centre
NOT_YET_RECRUITING
Hamilton
London Digestive Disease Institute
NOT_YET_RECRUITING
London
Victoria Hospital & Children's Hospital - London Health Sciences Centre
NOT_YET_RECRUITING
London
West GTA Research Inc.
NOT_YET_RECRUITING
Mississauga
C.I.C. Mauricie inc.
NOT_YET_RECRUITING
Trois-rivières
China
Changzhou Second People's Hospital
NOT_YET_RECRUITING
Changzhou
Chongqing General Hospital
NOT_YET_RECRUITING
Chongqing
The First Affiliated Hospital Of Fujian Medical University
NOT_YET_RECRUITING
Fuzhou
Sir Run Run Shaw Hospital of Zhejiang University School of Medicine
NOT_YET_RECRUITING
Hangzhou
First Affiliated Hospital of Kunming Medical University
NOT_YET_RECRUITING
Kunming
Jiangsu Province Hospital
NOT_YET_RECRUITING
Nanjing
The Affiliated Hospital of Qingdao University
NOT_YET_RECRUITING
Qingdao
Shengjing Hospital of China Medical University
NOT_YET_RECRUITING
Shenyang
The Second Afilliated Hospital of Hebei Medical University
NOT_YET_RECRUITING
Shijiazhuang
Taian City Central Hospital
NOT_YET_RECRUITING
Taian
Wuhan Union Hospital
NOT_YET_RECRUITING
Wuhan
Wuxi People's Hospital
NOT_YET_RECRUITING
Wuxi
Denmark
Aalborg Universitetshospital, Syd
NOT_YET_RECRUITING
Aalborg
Aarhus Universitetshospital, Skejby
NOT_YET_RECRUITING
Aarhus
Herlev and Gentofte Hospital
NOT_YET_RECRUITING
Copenhagen
Odense Universitetshospital
NOT_YET_RECRUITING
Odense
Germany
Charité Universitaetsmedizin Berlin - Campus Mitte
NOT_YET_RECRUITING
Berlin
Studienzentrum MVZ Dachau
NOT_YET_RECRUITING
Dachau
Universitätsklinikum Regensburg
NOT_YET_RECRUITING
Regensburg
Universitaetsklinikum Ulm
NOT_YET_RECRUITING
Ulm
Hungary
Békés Megyei Központi Kórház Dr. Réthy Pál Tagkórház
NOT_YET_RECRUITING
Békéscsaba
Óbudai Egészségügyi Centrum
NOT_YET_RECRUITING
Budapest
Pannónia Magánorvosi Centrum
NOT_YET_RECRUITING
Budapest
Semmelweis Egyetem
NOT_YET_RECRUITING
Budapest
Clinexpert Gyöngyös
NOT_YET_RECRUITING
Gyöngyös
Komarom-Esztergom Varmegyei Szent Borbala Korhaz
NOT_YET_RECRUITING
Tatabánya
Jávorszky Ödön Kórház
NOT_YET_RECRUITING
Vác
India
Sardar Vallabhbhai Patel Institute of Medical Sciences and Research
NOT_YET_RECRUITING
Ahmedabad
Rajiv Gandhi Government General Hospital
NOT_YET_RECRUITING
Chennai
Ashwin Hospital
NOT_YET_RECRUITING
Coimbatore
Sushruta Multispeciality Hospital & Research Centre
NOT_YET_RECRUITING
Hubli
Mahavir Hospital & Research Centre - Hyderabad
NOT_YET_RECRUITING
Hyderabad
All India Institute of Medical Sciences
NOT_YET_RECRUITING
New Delhi
Medipoint Hospitals Pvt. Ltd.
NOT_YET_RECRUITING
Pune
Shree Giriraj Multispeciality Hospital
NOT_YET_RECRUITING
Rajkot
Italy
ASST Grande Ospedale Metropolitano Niguarda
NOT_YET_RECRUITING
Milan
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
NOT_YET_RECRUITING
Milan
Ospedale San Raffaele
NOT_YET_RECRUITING
Milan
Fondazione Policlinico Universitario Agostino Gemelli
NOT_YET_RECRUITING
Roma
Humanitas
NOT_YET_RECRUITING
Rozzano
Japan
Fukuoka University Hospital
NOT_YET_RECRUITING
Fukuoka
Gokeikai Ofuna Chuo Hospital
NOT_YET_RECRUITING
Kamakura
Tsujinaka Hospital - Kashiwanoha
NOT_YET_RECRUITING
Kashiwa
National Hospital Organization Osaka National Hospital
NOT_YET_RECRUITING
Osaka
Toho University Sakura Medical Center
NOT_YET_RECRUITING
Sakura
Sapporo Tokushukai Hospital
NOT_YET_RECRUITING
Sapporo
Mexico
Scientia Investigacion Clinica S.C.
NOT_YET_RECRUITING
Chihuahua City
Instituto de Investigaciones Aplicadas a la Neurociencia A.C.
NOT_YET_RECRUITING
Durango
Boca Clinical Trials Mexico S.C.
NOT_YET_RECRUITING
Guadajalara
Clinica de Investigacion en Reumatologia y Obesidad S. C.
NOT_YET_RECRUITING
Guadalajara
Centro de Investigación Clinica Chapultepec
NOT_YET_RECRUITING
Mexico City
Centro de Investigación y Gastroenterología - S.C.
NOT_YET_RECRUITING
Mexico City
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
NOT_YET_RECRUITING
Mexico City
Servicios de Oncología Médica Integral - Monterrey
NOT_YET_RECRUITING
San Pedro Garza García
Scientia Investigacion Clinica S.C.
NOT_YET_RECRUITING
Tijuana
Clinical Research Institute S.C.
NOT_YET_RECRUITING
Tlalnepantla
Medimanage Research
NOT_YET_RECRUITING
Tlalpan
FAICIC S. de R.L. de C.V.
NOT_YET_RECRUITING
Veracruz
Netherlands
Radboudumc
NOT_YET_RECRUITING
Nijmegen
Elisabeth-TweeSteden Ziekenhuis
NOT_YET_RECRUITING
Tilburg
Poland
Gyncentrum sp. z o.o. NZOZ Holsamed - oddział Libero
NOT_YET_RECRUITING
Katowice
IRMED
NOT_YET_RECRUITING
Piotrkow Trybunalski
Pratia Poznań
NOT_YET_RECRUITING
Poznan
Uniwersyteckie Centrum Stomatologii i Medycyny Specjalistycznej
NOT_YET_RECRUITING
Poznan
Sonomed Sp. z o. o.
NOT_YET_RECRUITING
Szczecin
Twoja Przychodnia SCM
NOT_YET_RECRUITING
Szczecin
Medical Network Spółka z o.o. WIP Warsaw IBD Point Profesor Kierkuś
NOT_YET_RECRUITING
Warsaw
WSD MEDI
NOT_YET_RECRUITING
Warsaw
ETG Zamość
NOT_YET_RECRUITING
Zamość
Romania
Delta Health Care
NOT_YET_RECRUITING
Bucharest
Spitalul Clinic Colentina
NOT_YET_RECRUITING
Bucharest
Spitalul de Oncologie Monza
NOT_YET_RECRUITING
Bucharest
Constanta County Emergency Clinical Hospital Sf.Ap.Andrei
NOT_YET_RECRUITING
Constanța
Spital Judetean de Urgenta
NOT_YET_RECRUITING
Satu Mare
S.C Centrul de Gastroenterologie Dr. Goldis S.R.L
NOT_YET_RECRUITING
Timișoara
Spain
Centro Médico Teknon
NOT_YET_RECRUITING
Barcelona
Hospital Universitario de Fuenlabrada
NOT_YET_RECRUITING
Fuenlabrada
Hospital de Cabueñes
NOT_YET_RECRUITING
Gijón
Hospital Universitario La Paz
NOT_YET_RECRUITING
Madrid
Hospital Universitario Nuestra Señora de Candelaria
NOT_YET_RECRUITING
Santa Cruz De Tenerife
Turkey
Adana City Hospital
NOT_YET_RECRUITING
Adana
Gazi University Health Research and Application Center Gazi Hospital
NOT_YET_RECRUITING
Ankara
Antalya Egitim ve Arastırma Hastanesi
NOT_YET_RECRUITING
Antalya
Eskisehir Osmangazi University
NOT_YET_RECRUITING
Eskişehir
Mustafa Kemal Universitesi
NOT_YET_RECRUITING
Hatay
Kocaeli University Medical Faculty Hospital
NOT_YET_RECRUITING
İzmit
İnönü Üniversitesi Turgut Özal Tıp Merkezi Eğitim ve Araştırma Hastanesi
NOT_YET_RECRUITING
Malatya
Mersin University
NOT_YET_RECRUITING
Mersin
Dicle Üniversitesi
NOT_YET_RECRUITING
Sur
Contact Information
Primary
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
LillyTrials@Lilly.com
1-317-615-4559
Backup
Physicians interested in becoming principal investigators please contact
clinical_inquiry_hub@lilly.com
Time Frame
Start Date: 2025-11-11
Estimated Completion Date: 2029-03
Participants
Target number of participants: 252
Treatments
Experimental: LY4268989 + Mirikizumab
LY4268989 administered orally (PO) + Mirikizumab administered intravenously (IV), then subcutaneously (SC). Responders will be re-randomized for Study Period 2.
Experimental: Mirikizumab + LY4268989 Placebo
Mirikizumab administered IV, then SC + LY4268989 placebo administered PO. Responders and Non-responders will re-randomized for Study Period 2.
Sponsors
Leads: Eli Lilly and Company

This content was sourced from clinicaltrials.gov

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