Actively Recruiting
A Master Protocol for Phase 2, Randomized, Controlled Studies of Multiple Treatments for Adults With Moderately to Severely Active Ulcerative Colitis or Crohn's Disease
Led by Eli Lilly and Company · Updated on 2026-06-04
60
Participants Needed
72
Research Sites
39 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating new treatments for adults with moderately to severely active ulcerative colitis or Crohn's disease through a master protocol called IIBD. This protocol supports multiple individual sub-studies with shared design features, aiming to assess the effectiveness and safety of these treatments over at least 62 weeks. Participants are assigned to the appropriate study before being randomly placed into treatment groups. The study includes two main treatment periods. In one group, participants receive mirikizumab intravenously during the first period, and responders then receive mirikizumab subcutaneously in the second period. Another group receives a combination of oral LY4395089 and intravenous mirikizumab initially, with responders later stopping LY4395089 and continuing with mirikizumab subcutaneously. These treatments are being compared to understand their effects better. Participants will undergo assessments including clinical evaluations, endoscopic examinations, and laboratory tests to confirm disease activity and monitor response. The primary measurement is the number of participants allocated to each treatment appendix during the first 42 days. The study also tracks safety and treatment response over the course of at least 62 weeks, with ongoing evaluations to gather comprehensive data on these interventions.
CONDITIONS
Brief Title
A Master Protocol (IIBD): A Study of Multiple Drugs in Adults With Ulcerative Colitis or Crohn's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 80 years
- Established diagnosis of ulcerative colitis or Crohn's disease for at least 3 months
- For ulcerative colitis: Moderately to severely active disease with a modified Mayo score of 5-9 and endoscopic subscore 2; 2, with rectal bleeding of at least 1
- For Crohn's disease: Moderately to severely active disease with a Crohn's disease activity index score between 220 and 450 and specific endoscopic scores confirmed within 21 days before randomization
- Inadequate response, loss of response, or intolerance to corticosteroids, immunomodulators, or advanced therapy for ulcerative colitis or Crohn's disease
- Screening laboratory tests within protocol-specified parameters
You will not qualify if you...
- Current diagnosis of inflammatory bowel disease-unclassified or primary sclerosing cholangitis
- For ulcerative colitis participants: Current diagnosis of Crohn's disease
- For Crohn's disease participants: Current diagnosis of ulcerative colitis
- History of or need for bowel resection or intestinal or intra-abdominal surgery as specified in the protocol
- Complications such as stricture, stenosis (with some exceptions for Crohn's disease), or short bowel syndrome
- Significant uncontrolled illness that may affect safety or data interpretation
- Failure of more than 5 approved advanced treatments with different mechanisms of action
- Failure of anti-interleukin-23p19 antibody treatment
- Use of prohibited medications for ulcerative colitis or Crohn's disease as specified in the protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 weeks (Study Period 1) followed by continuation with subcutaneous treatment in Study Period 2
Participants receive study drugs including mirikizumab administered intravenously initially, and responders transition to subcutaneous injections. Some participants also receive oral LY4395089 during the first study period before switching to mirikizumab subcutaneous only.
Multiple visits for drug administration and assessments during treatment periods
Trial Site Locations
Total: 72 locations
1
Mayo Clinic in Arizona - Scottsdale
Scottsdale, Arizona, United States, 85259
Not Yet Recruiting
2
Biopharma Informatic, LLC
Los Angeles, California, United States, 90035
Actively Recruiting
3
Om Research LLC
Oxnard, California, United States, 93030
Not Yet Recruiting
4
South Denver Gastroenterology
Englewood, Colorado, United States, 80113
Not Yet Recruiting
5
Gastro Health Research - Miami
Miami, Florida, United States, 33176
Not Yet Recruiting
6
Ezy Medical Research
Miami Lakes, Florida, United States, 33015
Actively Recruiting
7
Atlanta Gastroenterology Associates - Peachtree Dunwoody
Atlanta, Georgia, United States, 30342
Actively Recruiting
8
Rush University Medical Center
Chicago, Illinois, United States, 60612
Not Yet Recruiting
9
Cotton O'Neil Digestive Health Center
Topeka, Kansas, United States, 66606
Actively Recruiting
10
Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinical Research Center
Wyoming, Michigan, United States, 49519
Actively Recruiting
11
KAD Clinical Research
St Louis, Missouri, United States, 63123
Not Yet Recruiting
12
Vector Clinical Trials
Las Vegas, Nevada, United States, 89128
Actively Recruiting
13
Innovo Research - Wilmington Gastroenterology Associates
Wilmington, North Carolina, United States, 28403
Not Yet Recruiting
14
One of a Kind Clinical Research Center - Kingwood
Kingwood, Texas, United States, 77339
Not Yet Recruiting
15
Southern Star Research Institute
San Antonio, Texas, United States, 78229
Actively Recruiting
16
AZ Maria Middelares
Ghent, Belgium, 9000
Not Yet Recruiting
17
UZ Gent
Ghent, Belgium, 9000
Not Yet Recruiting
18
UZ Leuven
Leuven, Belgium, 3000
Not Yet Recruiting
19
AZ Delta vzw
Roeselare, Belgium, 8800
Not Yet Recruiting
20
Loema Instituto de Pesquisa Clinica
Campinas, Brazil, 13092-133
Not Yet Recruiting
21
Fundação Universidade de Caxias do Sul (FUCS)
Caxias do Sul, Brazil, 95070-560
Not Yet Recruiting
22
Centro Digestivo de Curitiba
Curitiba, Brazil, 80430-180
Not Yet Recruiting
23
Centro de Pesquisa Clínica de Marília - CPCLIM
Marília, Brazil, 17504-072
Not Yet Recruiting
24
CPHosp Medicina, Ensino e Pesquisa (CPQuali)
São Paulo, Brazil, 01228-000
Not Yet Recruiting
25
CPCLIN
São Paulo, Brazil, 01228-200
Not Yet Recruiting
26
BR Trials - Ensaios Clinicos e Consultoria
São Paulo, Brazil, 01236030
Not Yet Recruiting
27
Solare Trials
São Paulo, Brazil, 01307-002
Not Yet Recruiting
28
Clínica Hepatogastro JK
São Paulo, Brazil, 04077-020
Not Yet Recruiting
29
CEDOES
Vitória, Brazil, 29055450
Not Yet Recruiting
30
Prairie Institute of Liver and Luminal Advanced Research Ltd (PILLAR)
Lethbridge, Canada, T1J 4G9
Not Yet Recruiting
31
London Digestive Disease Institute
London, Canada, N6K 1M6
Not Yet Recruiting
32
Tdda Inc.
Vaughan, Canada, L4L 4Y7
Not Yet Recruiting
33
The Second Xiangya Hospital of Central South University
Changsha, China, 410011
Not Yet Recruiting
34
Changzhou Second People's Hospital
Changzhou, China, 213000
Not Yet Recruiting
35
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, China, 510080
Not Yet Recruiting
36
The Second Affiliated hospital of Zhejiang University school of medicine
Hangzhou, China, 310052
Not Yet Recruiting
37
Huizhou Central People's Hospital
Huizhou, China, 516001
Not Yet Recruiting
38
The Second Affiliated Hospital of Soochow University
Suzhou, China, 215004
Not Yet Recruiting
39
The Second Affiliated Hospital YuYing Childens Hospital of Wenzhou Medical university
Wenzhou, China, 325000
Not Yet Recruiting
40
Zhongshan Hospital Affiliated to Xiamen University
Xiamen, China, 361000
Not Yet Recruiting
41
Affiliated Hospital of Jiangsu University
Zhenjiang, China, 212000
Not Yet Recruiting
42
Charité Universitaetsmedizin Berlin - Campus Mitte
Berlin, Germany, 10117
Not Yet Recruiting
43
Studienzentrum MVZ Dachau
Dachau, Germany, 85221
Not Yet Recruiting
44
Studiengesellschaft BSF Unternehmergesellschaft
Halle, Germany, 06108
Not Yet Recruiting
45
St. Marien- und St. Annastiftskrankenhaus
Ludwigshafen, Germany, 67067
Not Yet Recruiting
46
Universitaetsklinikum Ulm
Ulm, Germany, 89081
Not Yet Recruiting
47
Geomedical Egészségügyi Központ
Budapest, Hungary, 1066
Not Yet Recruiting
48
Semmelweis Egyetem
Budapest, Hungary, 1082
Not Yet Recruiting
49
Komarom-Esztergom Varmegyei Szent Borbala Korhaz
Tatabánya, Hungary, 2800
Not Yet Recruiting
50
Assuta Ashdod Medical Center
Ashdod, Israel, 7747629
Not Yet Recruiting
51
Rambam Health Care Campus
Haifa, Israel, 3109601
Not Yet Recruiting
52
Shaare Zedek Medical Center
Jerusalem, Israel, 9103102
Not Yet Recruiting
53
Hadassah Medical Center
Jerusalem, Israel, 9112001
Not Yet Recruiting
54
Rabin Medical Center
Petah Tikva, Israel, 4941492
Not Yet Recruiting
55
Sheba Medical Center
Ramat Gan, Israel, 5262100
Not Yet Recruiting
56
Yitzhak Shamir Medical Center
Ẕerifin, Israel, 7033001
Not Yet Recruiting
57
Azienda Ospedaliera Universitaria Careggi
Florence, Italy, 50134
Not Yet Recruiting
58
Ospedale San Raffaele
Milan, Italy, 20132
Not Yet Recruiting
59
Fondazione IRCCS San Gerardo dei Tintori
Monza, Italy, 20900
Not Yet Recruiting
60
Ospedale Sacro Cuore Don G. Calabria
Negrar, Italy, 37024
Not Yet Recruiting
61
Fondazione Policlinico Universitario Agostino Gemelli
Roma, Italy, 00168
Not Yet Recruiting
62
Humanitas
Rozzano, Italy, 20089
Not Yet Recruiting
63
Gyncentrum sp. z o.o. NZOZ Holsamed - oddział Libero
Katowice, Poland, 40-600
Not Yet Recruiting
64
Oslomed Centrum Medyczne
Krakow, Poland, 31-228
Not Yet Recruiting
65
Medrise Sp. z o.o.
Lublin, Poland, 20-582
Not Yet Recruiting
66
Twoja Przychodnia PCM
Poznan, Poland, 60-324
Not Yet Recruiting
67
ETG Siedlce
Siedlce, Poland, 08-110
Not Yet Recruiting
68
Twoja Przychodnia SCM
Szczecin, Poland, 71-434
Not Yet Recruiting
69
Sonomed Sp. z o. o.
Szczecin, Poland, 71-685
Not Yet Recruiting
70
WSD MEDI
Warsaw, Poland, 02-786
Not Yet Recruiting
71
Medical Network Spółka z o.o. WIP Warsaw IBD Point Profesor Kierkuś
Warsaw, Poland, 04-501
Not Yet Recruiting
72
ETG Zamość
Zamość, Poland, 22-400
Not Yet Recruiting
Research Team
T
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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