Actively Recruiting
LY4268989 (MORF-057) Co-Administered With Mirikizumab in Adults With Moderately to Severely Active Ulcerative Colitis:
Led by Eli Lilly and Company · Updated on 2026-05-13
252
Participants Needed
148
Research Sites
172 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
LY4268989 (MORF-057) Co-Administered With Mirikizumab in Adults With Moderately to Severely Active Ulcerative Colitis:
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 80 years
- Established diagnosis of ulcerative colitis for at least 3 months with endoscopic and histopathology confirmation
- Moderately to severely active ulcerative colitis defined by Modified Mayo Score 5 to 9 with endoscopic score 2 or higher and rectal bleeding score 1 or higher
- Endoscopy performed within 21 days before baseline
- Participants with more than 8 years of UC symptoms have recent surveillance colonoscopy within 1 year or per local guidelines
- Up-to-date on colorectal cancer surveillance per local guidelines
- Inadequate response, loss of response, or intolerance to at least one medication including corticosteroids, immunomodulators, biologics (except mirikizumab), Janus kinase inhibitors, or sphingosine 1-phosphate receptor 1 inhibitors
You will not qualify if you...
- Current diagnosis of Crohn's disease, unclassified inflammatory bowel disease, or primary sclerosing cholangitis
- History of or need for bowel resection or intestinal/intra-abdominal surgery
- Evidence of toxic megacolon, intra-abdominal abscess, or bowel strictures not traversable by colonoscope or symptomatic
- Presence of adenomatous polyps in colon areas not affected by colitis unless completely removed with only low-grade dysplasia
- Current or recent acute active infection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 148 locations
1
Mayo Clinic in Arizona - Scottsdale
Scottsdale, Arizona, United States, 85259
Not Yet Recruiting
2
Clinnova Research - Anaheim
Anaheim, California, United States, 92805
Actively Recruiting
3
Om Research LLC
Lancaster, California, United States, 93534
Actively Recruiting
4
Biopharma Informatic, LLC
Los Angeles, California, United States, 90035
Actively Recruiting
5
Peak Gastroenterology Associates
Colorado Springs, Colorado, United States, 80907
Actively Recruiting
6
NeoClinical Research
Hialeah, Florida, United States, 33016
Actively Recruiting
7
Encore Borland-Groover Clinical Research
Jacksonville, Florida, United States, 32256
Actively Recruiting
8
Clinical Research of Osceola
Kissimmee, Florida, United States, 34741
Actively Recruiting
9
Florida Research Institute
Lakewood Rch, Florida, United States, 34211
Actively Recruiting
10
Alliance Medical Research
Lighthouse PT, Florida, United States, 33064
Actively Recruiting
11
Atlantic Medical Research
Margate, Florida, United States, 33063
Actively Recruiting
12
Digestive and Liver Center of Florida
Orlando, Florida, United States, 32825
Actively Recruiting
13
Center for Gastrointestinal Health - Fairview Heights
Belleville, Illinois, United States, 62223
Not Yet Recruiting
14
Northwestern University
Chicago, Illinois, United States, 60611
Not Yet Recruiting
15
Midtown Gastroenterology and Liver Disease
Des Plaines, Illinois, United States, 60016
Actively Recruiting
16
GI Alliance - Glenview
Glenview, Illinois, United States, 60026
Actively Recruiting
17
Gi Alliance - Gurnee
Gurnee, Illinois, United States, 60031
Actively Recruiting
18
Gastroenterology Health Partners
New Albany, Indiana, United States, 47150
Actively Recruiting
19
Gastroenterology Health Partners
Louisville, Kentucky, United States, 40218
Actively Recruiting
20
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02215
Actively Recruiting
21
Clinical Research Institute of Michigan, LLC
Clinton Township, Michigan, United States, 48038
Actively Recruiting
22
GI Associates - GIA and Endoscopy Center - Flowood
Flowood, Mississippi, United States, 39232
Actively Recruiting
23
Digestive Disease Medicine of Central New York
Utica, New York, United States, 13502
Actively Recruiting
24
Gastroenterology & Hepatology Specialists
Canton, Ohio, United States, 44718
Actively Recruiting
25
Dayton Gastroenterology, LLC
Dayton, Ohio, United States, 45415
Actively Recruiting
26
University Gastroenterology - Providence - West River Street
Providence, Rhode Island, United States, 02904
Actively Recruiting
27
Gastroenterology Associates, P.A. of Greenville
Greenville, South Carolina, United States, 29607
Actively Recruiting
28
Gastro One - Walnut Run Road
Cordova, Tennessee, United States, 38018
Actively Recruiting
29
Texas Digestive Disease Consultants - Cedar Park
Cedar Park, Texas, United States, 78613
Actively Recruiting
30
GI Alliance - Dallas - Gaston Avenue
Dallas, Texas, United States, 75246
Suspended
31
GI Alliance - Fort Worth
Fort Worth, Texas, United States, 76104
Actively Recruiting
32
GI Alliance - Garland
Garland, Texas, United States, 75044
Actively Recruiting
33
GI Alliance - Lubbock
Lubbock, Texas, United States, 79410
Actively Recruiting
34
Southern Star Research Institute
San Antonio, Texas, United States, 78229
Actively Recruiting
35
Tyler Research Institute
Tyler, Texas, United States, 75701
Actively Recruiting
36
GI Alliance-Webster
Webster, Texas, United States, 77598
Actively Recruiting
37
Care Access - Ogden
Ogden, Utah, United States, 84403
Actively Recruiting
38
Clinical Research Partners, LLC
Richmond, Virginia, United States, 23226
Actively Recruiting
39
GI Alliance - Richmond
Richmond, Virginia, United States, 23229
Actively Recruiting
40
Carilion Clinic
Roanoke, Virginia, United States, 24014
Not Yet Recruiting
41
Washington Gastroenterology - Bellevue
Bellevue, Washington, United States, 98004
Actively Recruiting
42
Uniklinikum Salzburg
Salzburg, Austria, 5020
Suspended
43
Medizinische Universität Wien
Vienna, Austria, 1090
Not Yet Recruiting
44
Chronos Pesquisa Clínica
Brasília, Brazil, 72145-450
Not Yet Recruiting
45
CAEP - Synvia Labs
Campinas, Brazil, 13087-567
Actively Recruiting
46
Fundação Universidade de Caxias do Sul (FUCS)
Caxias do Sul, Brazil, 95070-560
Actively Recruiting
47
Centro Digestivo de Curitiba
Curitiba, Brazil, 80430-180
Actively Recruiting
48
Galileo Medical Research
Juiz de Fora, Brazil, 36033-318
Not Yet Recruiting
49
NewData Clinical Research - Maceió
Maceió, Brazil, 57020-360
Not Yet Recruiting
50
Hospital Ernesto Dornelles
Porto Alegre, Brazil, 90160-092
Not Yet Recruiting
51
Centro Internacional de Pesquisa Clínica (CIPES)
São José dos Campos, Brazil, 12230-001
Not Yet Recruiting
52
CPQuali Pesquisa Clínica
São Paulo, Brazil, 01228-000
Actively Recruiting
53
Solare Trials
São Paulo, Brazil, 01307-002
Suspended
54
Hospital Santa Catarina - Paulista
São Paulo, Brazil, 01310-000
Not Yet Recruiting
55
Clínica Hepatogastro JK
São Paulo, Brazil, 04543-011
Actively Recruiting
56
Universidade Federal Do Piaui - Campos Universitario
Teresina, Brazil, 64049-550
Actively Recruiting
57
Charlton Digestive Disease Centre
Hamilton, Canada, L8N 1Y2
Actively Recruiting
58
Victoria Hospital & Children's Hospital - London Health Sciences Centre
London, Canada, N6A 5W9
Not Yet Recruiting
59
London Digestive Disease Institute
London, Canada, N6K 1M6
Actively Recruiting
60
West GTA Research Inc.
Mississauga, Canada, L5M 2S4
Not Yet Recruiting
61
C.I.C. Mauricie inc.
Trois-Rivières, Canada, G8T 7A1
Actively Recruiting
62
Changzhou Second People's Hospital
Changzhou, China, 213000
Actively Recruiting
63
Chongqing General Hospital
Chongqing, China, 401147
Actively Recruiting
64
The First Affiliated Hospital Of Fujian Medical University
Fuzhou, China, 350005
Actively Recruiting
65
Sir Run Run Shaw Hospital of Zhejiang University School of Medicine
Hangzhou, China, 310018
Actively Recruiting
66
First Affiliated Hospital of Kunming Medical University
Kunming, China, 650032
Actively Recruiting
67
Jiangsu Province Hospital
Nanjing, China, 210029
Actively Recruiting
68
The Affiliated Hospital of Qingdao University
Qingdao, China, 266003
Actively Recruiting
69
Shengjing Hospital of China Medical University
Shenyang, China, 110004
Actively Recruiting
70
The Second Afilliated Hospital of Hebei Medical University
Shijiazhuang, China, 050000
Actively Recruiting
71
Taian City Central Hospital
Taian, China, 271000
Actively Recruiting
72
Wuhan Union Hospital
Wuhan, China, 430022
Actively Recruiting
73
Wuxi People's Hospital
Wuxi, China, 214023
Actively Recruiting
74
Herlev and Gentofte Hospital
Copenhagen, Denmark, 2730
Actively Recruiting
75
Aalborg Universitetshospital, Syd
Gistrup, Denmark, 9260
Actively Recruiting
76
Odense Universitetshospital
Odense, Denmark, 5000
Actively Recruiting
77
Charité Universitaetsmedizin Berlin - Campus Mitte
Berlin, Germany, 10117
Not Yet Recruiting
78
Studienzentrum MVZ Dachau
Dachau, Germany, 85221
Actively Recruiting
79
Universitätsklinikum Regensburg
Regensburg, Germany, 93053
Not Yet Recruiting
80
Universitaetsklinikum Ulm
Ulm, Germany, 89081
Not Yet Recruiting
81
Békés Megyei Központi Kórház Dr. Réthy Pál Tagkórház
Békéscsaba, Hungary, 5600
Not Yet Recruiting
82
Óbudai Egészségügyi Centrum
Budapest, Hungary, 1036
Actively Recruiting
83
Semmelweis Egyetem
Budapest, Hungary, 1088
Actively Recruiting
84
Pannónia Magánorvosi Centrum
Budapest, Hungary, 1136
Actively Recruiting
85
Clinexpert Gyöngyös
Gyöngyös, Hungary, 3200
Actively Recruiting
86
Komarom-Esztergom Varmegyei Szent Borbala Korhaz
Tatabánya, Hungary, 2800
Actively Recruiting
87
Jávorszky Ödön Kórház
Vác, Hungary, 2600
Actively Recruiting
88
Sardar Vallabhbhai Patel Institute of Medical Sciences and Research
Ahmedabad, India, 380006
Not Yet Recruiting
89
Rajiv Gandhi Government General Hospital
Chennai, India, 600003
Not Yet Recruiting
90
Ashwin Hospital
Coimbatore, India, 641012
Not Yet Recruiting
91
Sushruta Multispeciality Hospital & Research Centre
Hubli, India, 580021
Not Yet Recruiting
92
Mahavir Hospital & Research Centre - Hyderabad
Hyderabad, India, 500004
Not Yet Recruiting
93
All India Institute of Medical Sciences
New Delhi, India, 110029
Not Yet Recruiting
94
Medipoint Hospitals Pvt. Ltd.
Pune, India, 411007
Not Yet Recruiting
95
Shree Giriraj Multispeciality Hospital
Rajkot, India, 360005
Not Yet Recruiting
96
ASST Grande Ospedale Metropolitano Niguarda
Milan, Italy, 20162
Not Yet Recruiting
97
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Milan, Italy, 20122
Actively Recruiting
98
Ospedale San Raffaele
Milan, Italy, 20132
Not Yet Recruiting
99
Fondazione Policlinico Universitario Agostino Gemelli
Roma, Italy, 00168
Not Yet Recruiting
100
Humanitas
Rozzano, Italy, 20089
Not Yet Recruiting
101
Fukuoka University Hospital
Fukuoka, Japan, 814-0180
Actively Recruiting
102
Gokeikai Ofuna Chuo Hospital
Kamakura, Japan, 247-0056
Actively Recruiting
103
Tsujinaka Hospital - Kashiwanoha
Kashiwa, Japan, 277-0871
Actively Recruiting
104
National Hospital Organization Osaka National Hospital
Osaka, Japan, 540-0006
Actively Recruiting
105
Toho University Sakura Medical Center
Sakura, Japan, 285-8741
Actively Recruiting
106
Sapporo Tokushukai Hospital
Sapporo, Japan, 004-0041
Actively Recruiting
107
Scientia Investigacion Clinica S.C.
Chihuahua City, Mexico, 31207
Not Yet Recruiting
108
Instituto de Investigaciones Aplicadas a la Neurociencia A.C.
Durango, Mexico, 34000
Not Yet Recruiting
109
Boca Clinical Trials Mexico S.C.
Guadajalara, Mexico, 44600
Not Yet Recruiting
110
Clinica de Investigacion en Reumatologia y Obesidad S. C.
Guadalajara, Mexico, 44650
Not Yet Recruiting
111
Centro de Investigación y Gastroenterología - S.C.
Mexico City, Mexico, 03330
Not Yet Recruiting
112
Centro de Investigación Clinica Chapultepec
Mexico City, Mexico, 04100
Not Yet Recruiting
113
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Mexico City, Mexico, 14080
Not Yet Recruiting
114
Servicios de Oncología Médica Integral - Monterrey
San Pedro Garza García, Mexico, 66220
Not Yet Recruiting
115
Scientia Investigacion Clinica S.C.
Tijuana, Mexico, 22105
Not Yet Recruiting
116
Clinical Research Institute S.C.
Tlalnepantla, Mexico, 54055
Not Yet Recruiting
117
Medimanage Research
Tlalpan, Mexico, 14050
Not Yet Recruiting
118
FAICIC S. de R.L. de C.V.
Veracruz, Mexico, 91900
Not Yet Recruiting
119
Radboudumc
Nijmegen, Netherlands, 6525 GA
Not Yet Recruiting
120
Elisabeth-TweeSteden Ziekenhuis
Tilburg, Netherlands, 5022 GC
Not Yet Recruiting
121
Gyncentrum sp. z o.o. NZOZ Holsamed - oddział Libero
Katowice, Poland, 40-600
Not Yet Recruiting
122
IRMED
Piotrkow Trybunalski, Poland, 97-300
Not Yet Recruiting
123
Pratia Poznań
Poznan, Poland, 60-192
Not Yet Recruiting
124
Uniwersyteckie Centrum Stomatologii i Medycyny Specjalistycznej
Poznan, Poland, 60-354
Not Yet Recruiting
125
Twoja Przychodnia SCM
Szczecin, Poland, 71-434
Not Yet Recruiting
126
Sonomed Sp. z o. o.
Szczecin, Poland, 71-685
Not Yet Recruiting
127
WSD MEDI
Warsaw, Poland, 02-786
Not Yet Recruiting
128
Medical Network Spółka z o.o. WIP Warsaw IBD Point Profesor Kierkuś
Warsaw, Poland, 04-501
Not Yet Recruiting
129
ETG Zamość
Zamość, Poland, 22-400
Not Yet Recruiting
130
Spitalul de Oncologie Monza
Bucharest, Romania, 013823
Not Yet Recruiting
131
Delta Health Care
Bucharest, Romania, 014142
Actively Recruiting
132
Spitalul Clinic Colentina
Bucharest, Romania, 020125
Actively Recruiting
133
Constanta County Emergency Clinical Hospital Sf.Ap.Andrei
Constanța, Romania, 900591
Actively Recruiting
134
Spital Judetean de Urgenta
Satu Mare, Romania, 440055
Actively Recruiting
135
S.C Centrul de Gastroenterologie Dr. Goldis S.R.L
Timișoara, Romania, 300002
Actively Recruiting
136
Centro Médico Teknon
Barcelona, Spain, 08022
Actively Recruiting
137
Hospital Universitario de Fuenlabrada
Fuenlabrada, Spain, 28942
Not Yet Recruiting
138
Hospital de Cabueñes
Gijón, Spain, 33394
Not Yet Recruiting
139
Hospital Universitario La Paz
Madrid, Spain, 28046
Actively Recruiting
140
Adana City Hospital
Adana, Turkey (Türkiye)
Not Yet Recruiting
141
Gazi University Health Research and Application Center Gazi Hospital
Ankara, Turkey (Türkiye), 06560
Not Yet Recruiting
142
Antalya Egitim ve Arastırma Hastanesi
Antalya, Turkey (Türkiye), 07100
Not Yet Recruiting
143
Eskisehir Osmangazi University
Eskişehir, Turkey (Türkiye), 26480
Not Yet Recruiting
144
Mustafa Kemal Universitesi
Hatay, Turkey (Türkiye), 31030
Not Yet Recruiting
145
Kocaeli University Medical Faculty Hospital
İzmit, Turkey (Türkiye), 41380
Not Yet Recruiting
146
İnönü Üniversitesi Turgut Özal Tıp Merkezi Eğitim ve Araştırma Hastanesi
Malatya, Turkey (Türkiye), 44280
Not Yet Recruiting
147
Mersin University
Mersin, Turkey (Türkiye), 33110
Not Yet Recruiting
148
Dicle Üniversitesi
Sur, Turkey (Türkiye), 21200
Not Yet Recruiting
Research Team
T
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACT
P
Physicians interested in becoming principal investigators please contact
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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