Colitis, UlcerativePhase 2NCT07483073
A Master Protocol (IIBD): A Study of Multiple Drugs in Adults With Ulcerative Colitis or Crohn's Disease
A Phase 2 study testing Mirikizumab - Intravenous (IV), Mirikizumab - Subcutaneous (SC) and LY4395089 in people with Colitis, Ulcerative and Crohn Disease, run by Eli Lilly and Company at 70 sites in 10 countries.
Trial summary
Study IIBD is a master protocol that will support a collection of individual sub studies that share key design components. Participants will be assigned to the appropriate study prior to randomization to a treatment group. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colitis, Ulcerative, Crohn Disease
- What is being tested?
- Mirikizumab - Intravenous (IV), Mirikizumab - Subcutaneous (SC) and LY4395089
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 70 sitesin 10 countries
- Study dates
- 4 May 2026to Mar 2028
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must have an established diagnosis of Ulcerative Colitis (UC) or Crohn's Disease (CD) for at least 3 month duration, which includes clinical and endoscopic evidence of UC or CD and a histopathology report that supports a diagnosis of UC or CD.
- For UC:
- Have moderately to severely active UC as defined by a modified Mayo score (mMS) of 5-9 points and Endoscopic Subscore (ES) greater than or equal to (≥) 2, confirmed by the central reader and rectal bleeding (RB)≥1.
- For CD:
- Have moderately to severely active CD as defined by a Crohn's disease activity index (CDAI) score ≥ 220 and less than or equal to (≤) 450. Have a centrally read Simple Endoscopic Score for Crohn's Disease (SES-CD) score ≥6 for participants with ileal-colonic or ≥4 for participants with isolated ileal disease.
- Must have demonstrated an inadequate response, loss of response, or intolerance to at least one of the following: corticosteroids, immunomodulators, or an advanced therapy for UC or CD
- Have screening laboratory test results within the protocol specified parameters.
Who cannot join
- Must not have a current diagnosis of inflammatory bowel disease (IBD)-unclassified or primary sclerosing cholangitis
- For UC - must not have a current diagnosis of CD
- For CD - must not have a current diagnosis of UC
- Must not have had or will need bowel resection or intestinal or intra-abdominal surgery as specified in the protocol
- Must not have complications of UC or CD, including but not limited to stricture or stenosis (some exceptions allowed for CD) or short bowel syndrome
- Must not have a significant uncontrolled illness that in the opinion of the investigator may compromise the participant's safety or interfere with interpretation of data
Show all 9Show fewer
- Must not have failed more than 5 approved advanced treatments for UC or CD with different mechanisms of action
- Must not have failed an anti-interleukin-23p19 (anti-IL-23p19) antibody treatment
- Must not have received or will need any prohibited medications for UC or CD as specified in the protocol
Trial locations and contacts
70 sites in 10 countries. Contact the study team or a site near you to ask about taking part.
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or contact
70 sites in 10 countries
United States14 sites, 13 recruiting
- Recruiting
Atlanta Gastroenterology Associates - Peachtree Dunwoody
Atlanta, Georgia, 30342
Nitin Gupta
- Not yet recruiting
Rush University Medical Center
Chicago, Illinois, 60612
Atsushi Sakuraba
- Recruiting
South Denver Gastroenterology
Englewood, Colorado, 80113
Marcelo Kugelmas
- Recruiting
One of a Kind Clinical Research Center - Kingwood
Kingwood, Texas, 77339
Sushovan Guha
- Recruiting
Vector Clinical Trials
Las Vegas, Nevada, 89128
7027500000
Christian Stone
- Recruiting
Biopharma Informatic, LLC
Los Angeles, California, 90035
(281) 944-3610
Morris Silver, MD
- Recruiting
Gastro Health Research - Miami
Miami, Florida, 33176
Lukasz Kwapisz
- Recruiting
Ezy Medical Research
Miami Lakes, Florida, 33015
7864838162
Hendry Perez-Pascual
- Recruiting
Om Research LLC
Oxnard, California, 93030
661.388.2239
Karen Simon
- Recruiting
Southern Star Research Institute
San Antonio, Texas, 78229
210-581-2812
Jeff Bullock
- Suspended
Mayo Clinic in Arizona - Scottsdale
Scottsdale, Arizona, 85259
- Recruiting
KAD Clinical Research
St Louis, Missouri, 63123
1-314-254-3168
Adrian Di Bisceglie
- Recruiting
Cotton O'Neil Digestive Health Center
Topeka, Kansas, 66606
785-368-0477
Curtis Baum
- Recruiting
Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinical Research Center
Wyoming, Michigan, 49519
Allan Coates
Poland10 sites, 10 recruiting
- Not yet recruiting
Gyncentrum sp. z o.o. NZOZ Holsamed - oddział Libero
Katowice, 40-600
Marek Olakowski
- Recruiting
Centrum Medyczne Oslomed
Krakow, 31-228
Anna Drozdz
- Not yet recruiting
Medrise Sp. z o.o.
Lublin, 20-582
+48 795 404 502
Wit Danilkiewicz
- Recruiting
Twoja Przychodnia PCM
Poznan, 60-324
+48 724 444 299
Ewa Furmanowska-Ladorska
- Recruiting
ETG Siedlce
Siedlce, 08-110
Anna Lewandowska
- Recruiting
Twoja Przychodnia SCM
Szczecin, 71-434
48 91 433 29 19
Beata Gawdis-Wojnarska
- Not yet recruiting
Sonomed Sp. z o. o.
Szczecin, 71-685
Anna Wiechowska-Kozlowska
- Not yet recruiting
WSD MEDI
Warsaw, 02-786
+48 504 440 092
Michal Krogulecki
- Not yet recruiting
Medical Network Spółka z o.o. WIP Warsaw IBD Point Profesor Kierkuś
Warsaw, 04-501
500111648
Jaroslaw Kierkus
- Recruiting
ETG Zamość
Zamość, 22-400
48606930022
Katarzyna Wojcik
Brazil9 sites, 9 recruiting
- Not yet recruiting
Loema Instituto de Pesquisa Clinica
Campinas, 13092-133
19 3252-5611
Joaquim Simoes Neto
- Recruiting
Fundação Universidade de Caxias do Sul (FUCS)
Caxias do Sul, 95070-560
Eduardo Brambilla
- Not yet recruiting
Centro Digestivo de Curitiba
Curitiba, 80430-180
+55 41 3322-1115
Odery Ramos Júnior
- Recruiting
Centro de Pesquisa Clínica de Marília - CPCLIM
Marília, 17504-072
FABIO TEIXEIRA
- Recruiting
CPHosp Medicina, Ensino e Pesquisa (CPQuali)
São Paulo, 01228-000
+55 (11) 2776-6801
Rafael Lages
- Not yet recruiting
CPCLIN
São Paulo, 01228-200
Adolpho Alexander da Silva
- Recruiting
BR Trials - Ensaios Clinicos e Consultoria
São Paulo, 01236030
Roberto da Silva
- Recruiting
Clínica Hepatogastro JK
São Paulo, 04077-020
5511999158070
Rodrigo Andrey Rocco
- Recruiting
CEDOES
Vitória, 29055450
5527988393435
Felipe Ferreira
China9 sites, 9 recruiting
- Recruiting
The Second Xiangya Hospital of Central South University
Changsha, 410011
Xuehong Wang
- Recruiting
Changzhou Second People's Hospital
Changzhou, 213000
Wenjia LIU
- Recruiting
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, 510080
Baili Chen
- Recruiting
The Second Affiliated hospital of Zhejiang University school of medicine
Hangzhou, 310052
Yan Chen
- Recruiting
Huizhou Central People's Hospital
Huizhou, 516001
Huixin Chen
- Recruiting
The Second Affiliated Hospital of Soochow University
Suzhou, 215004
Wen Tang
- Recruiting
The Second Affiliated Hospital YuYing Childens Hospital of Wenzhou Medical university
Wenzhou, 325000
yi Jiang
- Recruiting
Zhongshan Hospital Affiliated to Xiamen University
Xiamen, 361000
Yanyun Fan
- Recruiting
Affiliated Hospital of Jiangsu University
Zhenjiang, 212000
Min Xu
Israel7 sites, 7 recruiting
- Recruiting
Assuta Ashdod Medical Center
Ashdod, 7747629
+9720723398277
Adi Lahat-Zok
- Recruiting
Rambam Health Care Campus
Haifa, 3109601
972-4-7772850
Roni Weisshof
- Recruiting
Shaare Zedek Medical Center
Jerusalem, 9103102
+972 26666916
Benjamin Koslowsky
- Recruiting
Hadassah Medical Center
Jerusalem, 9112001
+97225842111
ADAR ZINGER
- Recruiting
Rabin Medical Center
Petah Tikva, 4941492
+97239377241 (5)
Irit Avni-Biron
- Recruiting
Sheba Medical Center
Ramat Gan, 5262100
0523894508
Asaf Levartovsky
- Recruiting
Yitzhak Shamir Medical Center
Ẕerifin, 7033001
972-8-9779066
Vered Richter
Italy6 sites, 6 recruiting
- Not yet recruiting
Azienda Ospedaliera Universitaria Careggi
Florence, 50134
+393331247273
Gabriele Dragoni
- Not yet recruiting
Ospedale San Raffaele
Milan, 20132
Silvio Danese
- Not yet recruiting
Fondazione IRCCS San Gerardo dei Tintori
Monza, 20900
Chiara Viganò
- Not yet recruiting
Ospedale Sacro Cuore Don G. Calabria
Negrar, 37024
Angela Variola
- Not yet recruiting
Fondazione Policlinico Universitario Agostino Gemelli
Roma, 00168
0630154678
Franco Scaldaferri
- Not yet recruiting
Humanitas
Rozzano, 20089
0282243263
Alessandro Armuzzi
Germany5 sites, 4 recruiting
- Not yet recruiting
Charité Universitaetsmedizin Berlin - Campus Mitte
Berlin, 10117
004930450614031
Christoph Jochum
- Suspended
Studienzentrum MVZ Dachau
Dachau, 85221
- Recruiting
Studiengesellschaft Mitteldeutschland GmbH
Halle, 06108
00493452997626
Lars Fechner
- Recruiting
St. Marien- und St. Annastiftskrankenhaus
Ludwigshafen, 67067
+49 (621) 5501-2224
Tanja Kuehbacher
- Not yet recruiting
Universitaetsklinikum Ulm
Ulm, 89081
0497315000
Jochen Klaus
Belgium4 sites, 4 recruiting
- Not yet recruiting
AZ Maria Middelares
Ghent, 9000
+3292467100
Didier Baert
- Not yet recruiting
UZ Gent
Ghent, 9000
09 332 51 66
Jeroen Geldof
- Not yet recruiting
UZ Leuven
Leuven, 3000
+3216348856
Bram Verstockt
- Not yet recruiting
AZ Delta vzw
Roeselare, 8800
+3251237215
Filip Baert
Canada3 sites, 3 recruiting
- Not yet recruiting
Prairie Institute of Liver and Luminal Advanced Research Ltd (PILLAR)
Lethbridge, T1J 4G9
Kaleb Marr
- Not yet recruiting
London Digestive Disease Institute
London, N6K 1M6
Vipul Jairath
- Recruiting
Tdda Inc.
Vaughan, L4L 4Y7
14166500017
David Ford
Hungary3 sites, 3 recruiting
- Recruiting
Geomedical Egészségügyi Központ
Budapest, 1066
Gabor Hegede
- Not yet recruiting
Semmelweis Egyetem
Budapest, 1082
0036208250460
Pal Miheller
- Recruiting
Komarom-Esztergom Varmegyei Szent Borbala Korhaz
Tatabánya, 2800
Samer Francis
About this study
Official title: A Master Protocol for Phase 2, Randomized, Controlled Studies of Multiple Interventions for the Treatment of Adults With Moderately to Severely Active Ulcerative Colitis or Crohn's Disease
Study IIBD is a master protocol that will support a collection of individual sub studies that share key design components. Participants will be assigned to the appropriate study prior to randomization to a treatment group. The studies aim to evaluate the efficacy and safety of new treatments in adults with moderately to severely active ulcerative colitis or Crohn's disease and will last at least 62 weeks.
- Conditions
- Colitis, Ulcerative, Crohn Disease
- Being tested
- Mirikizumab - Intravenous (IV), Mirikizumab - Subcutaneous (SC), LY4395089
- Medical subject headings
- Colitis, Ulcerative, Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mirikizumab - Intravenous (IV)Drug
Also called LY3074828
Administered IV
Mirikizumab - Subcutaneous (SC)Drug
Also called LY3074828
Administered SC
LY4395089Drug
Administered orally
| Study group | Role | What they receive |
|---|---|---|
| Mirikizumab | Active comparator | Study Period 1: mirikizumab administered via IV. Study Period 2: Responders will receive mirikizumab SC. Receives: Drug: Mirikizumab - Intravenous (IV); Drug: Mirikizumab - Subcutaneous (SC) |
| LY4395089 and Mirikizumab Co-Administration | Experimental | Study Period 1: Co-administration of LY4395089 administered orally and mirikizumab administered IV. Study Period 2: Responders will stop LY4395089 and receive mirikizumab SC. Receives: Drug: Mirikizumab - Intravenous (IV); Drug: Mirikizumab - Subcutaneous (SC); Drug: LY4395089 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Allocated to Each of the Intervention-Specific Appendices (ISA)
Measured: Baseline, Up to Day 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2026
- Study start4 May 2026
- Primary completionJun 2027 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colitis, UlcerativeStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Contact Lilly at 1-877-CTLILLY (1-877-285-4559) or, Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07483073
- Sponsor's protocol ID
- 27807
- Other IDs
- 2025-524112-11-00, J6Z-MC-IIBD, J6Z-MC-CD01, 2025
- Status last verified
- Oct 2026
- First submitted
- 16 Mar 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.