Ulcerative ColitisPhase 2TOPAZ-UCNCT07186101
LY4268989 (MORF-057) Co-Administered With Mirikizumab in Adults With Moderately to Severely Active Ulcerative Colitis:
A Phase 2 study testing LY4268989 and Mirikizumab in people with Ulcerative Colitis, run by Eli Lilly and Company at 147 sites in 17 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- LY4268989 and Mirikizumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 252 participants
- Where
- 147 sitesin 17 countries
- Study dates
- 10 Nov 2025to Mar 2029
- 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
- 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 at screening endoscopy and RB ≥1.
- 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)
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
147 sites in 17 countries. Contact the study team or a site near you to ask about taking part.
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or contact
Physicians interested in becoming principal investigators please contact contact
147 sites in 17 countries
United States40 sites, 40 recruiting
- Recruiting
Clinnova Research - Anaheim
Anaheim, California, 92805
Amit Bhanvadia
- Not yet recruiting
Center for Gastrointestinal Health - Fairview Heights
Belleville, Illinois, 62223
SHAKEEL AHMED
- Recruiting
Washington Gastroenterology - Bellevue
Bellevue, Washington, 98004
425-454-4768
Nicholas Procaccini
- Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02115
617-732-6389
Jessica Allegretti
- Recruiting
Texas Digestive Disease Consultants - Cedar Park
Cedar Park, Texas, 78613
512-341-0900
Junaid Siddiqui
- Not yet recruiting
Northwestern University
Chicago, Illinois, 60611
312-695-4077
Keith Summa
- Recruiting
Clinical Research Institute of Michigan, LLC
Clinton Township, Michigan, 48038
586-598-3329
Mohanad Suede
- Recruiting
Peak Gastroenterology Associates
Colorado Springs, Colorado, 80907
719-310-6719
Bhaktasharan Patel
- Recruiting
Gastro One - Walnut Run Road
Cordova, Tennessee, 38018
Ziad Younes
- Not yet recruiting
GI Alliance - Dallas - Gaston Avenue
Dallas, Texas, 75246
214-323-8500
Ben Kahn
- Recruiting
Dayton Gastroenterology, LLC
Dayton, Ohio, 45415
937-320-5050
Drew Triplett
- Recruiting
Midtown Gastroenterology and Liver Disease
Des Plaines, Illinois, 60016
262-925-1280
John Agaiby
- Recruiting
GI Associates - GIA and Endoscopy Center - Flowood
Flowood, Mississippi, 39232
601-863-0395
Ralph Vance
- Recruiting
GI Alliance - Fort Worth
Fort Worth, Texas, 76104
817-612-5575
Kumar Gutta
- Recruiting
GI Alliance - Garland
Garland, Texas, 75044
972-265-8201
Harry Sarles
- Recruiting
GI Alliance - Glenview
Glenview, Illinois, 60026
Nina Merel
- Recruiting
Gastroenterology Associates, P.A. of Greenville
Greenville, South Carolina, 29607
864-451-5026
Matthew Barnes
- Recruiting
Gi Alliance - Gurnee
Gurnee, Illinois, 60031
Jonathan A. Rosenberg
- Recruiting
NeoClinical Research
Hialeah, Florida, 33016
305-456-9062
Isaac Bassan
- Recruiting
Encore Borland-Groover Clinical Research
Jacksonville, Florida, 32256
904-680-0871
Kyle Etzkorn
- Recruiting
Clinical Research of Osceola
Kissimmee, Florida, 34741
407-954-4016
Basher Atiquzzaman
- Recruiting
Florida Research Institute
Lakewood Rch, Florida, 34211
941-727-7772
Manuel Rodriguez
- Recruiting
Om Research LLC
Lancaster, California, 93534
661-388-2239
Jatinder Pruthi
- Recruiting
Alliance Medical Research
Lighthouse PT, Florida, 33064
954-428-2480
Vipin Gupta
- Recruiting
Biopharma Informatic, LLC
Los Angeles, California, 90035
281-944-3610
Morris Silver, MD
- Recruiting
Gastroenterology Health Partners
Louisville, Kentucky, 40218
502-888-1988
Michael Krease
- Recruiting
GI Alliance - Lubbock
Lubbock, Texas, 79410
806-793-3141
Adam Hughston
- Recruiting
Atlantic Medical Research
Margate, Florida, 33063
954-850-0589
Peter Gach
- Recruiting
Gastroenterology Health Partners
New Albany, Indiana, 47150
812-206-1702
Robert Luckett
- Recruiting
Care Access - Ogden
Ogden, Utah, 84403
801-614-0010
Chad Gonzales
- Recruiting
Digestive and Liver Center of Florida
Orlando, Florida, 32825
407-384-7388
Harinath Sheela
- Recruiting
University Gastroenterology - Providence - West River Street
Providence, Rhode Island, 02904
401-227-8393
Jason Ferreira
- Recruiting
Clinical Research Partners, LLC
Richmond, Virginia, 23226
Kara Foster-Weiss
- Recruiting
GI Alliance - Richmond
Richmond, Virginia, 23229
804-362-0954
Omer Khalid
- Recruiting
Carilion Clinic
Roanoke, Virginia, 24014
Lana Wahid
- Recruiting
Southern Star Research Institute
San Antonio, Texas, 78229
210-581-2812
Jeff Bullock
- Recruiting
Mayo Clinic in Arizona - Scottsdale
Scottsdale, Arizona, 85259
480-301-8000
Manreet Kaur
- Recruiting
Tyler Research Institute
Tyler, Texas, 75701
903-630-6211
George DuVall
- Recruiting
Digestive Disease Medicine of Central New York
Utica, New York, 13502
Harvey Allen
- Recruiting
GI Alliance-Webster
Webster, Texas, 77598
281-626-7035
Ravi Mani
Brazil14 sites, 13 recruiting
- Recruiting
Chronos Pesquisa Clínica
Brasília, 72145-450
61999780700
Cintia Mendes Clemente
- Recruiting
CAEP - Synvia Labs
Campinas, 13087-567
Leandro Negreiros
- Recruiting
Fundação Universidade de Caxias do Sul (FUCS)
Caxias do Sul, 95070-560
Eduardo Brambilla
- Recruiting
Centro Digestivo de Curitiba
Curitiba, 80430-180
+55 41 3322-1115
Odery Ramos Júnior
- Recruiting
Galileo Medical Research
Juiz de Fora, 36033-318
Julio Chebli
- Recruiting
NewData Clinical Research - Maceió
Maceió, 57020-360
+55 79 98825-9395
Alex Callado França
- Recruiting
Hospital Ernesto Dornelles
Porto Alegre, 90160-092
+5551999624012
Cristina Flores
- Recruiting
Centro Internacional de Pesquisa Clínica (CIPES)
São José dos Campos, 12230-001
Anderson Silva
- Recruiting
CPQuali Pesquisa Clínica
São Paulo, 01228-000
+55 11 2776-6801
Alexandre de Sousa Carlos
- Suspended
Solare Trials
São Paulo, 01307-002
- Recruiting
Hospital Santa Catarina - Paulista
São Paulo, 01310-000
Daniel da Silva
- Recruiting
Clínica Hepatogastro JK
São Paulo, 04543-011
5511999158070
Rodrigo Andrey Rocco
- Recruiting
BRA - Clínica Médica e Terapia Assistida
Tajaí, 88301-220
Munique Kurtz de Mello
- Recruiting
Universidade Federal Do Piaui - Campos Universitario
Teresina, 64049-550
+55 86 999813603
José Miguel Parente
China12 sites, 12 recruiting
- Recruiting
Changzhou Second People's Hospital
Changzhou, 213000
Wenjia LIU
- Recruiting
Chongqing General Hospital
Chongqing, 401147
86-13508389768
Hong Guo
- Recruiting
The First Affiliated Hospital Of Fujian Medical University
Fuzhou, 350005
86 13178111141
Chengdang Wang
- Recruiting
Sir Run Run Shaw Hospital of Zhejiang University School of Medicine
Hangzhou, 310018
Qian Cao
- Recruiting
First Affiliated Hospital of Kunming Medical University
Kunming, 650032
Juan Luo
- Recruiting
Jiangsu Province Hospital
Nanjing, 210029
Hongjie ZHANG
- Recruiting
The Affiliated Hospital of Qingdao University
Qingdao, 266003
Xueli Ding
- Recruiting
Shengjing Hospital of China Medical University
Shenyang, 110004
Lixuan Sang
- Recruiting
The Second Afilliated Hospital of Hebei Medical University
Shijiazhuang, 050000
Xiaolan Zhang
- Recruiting
Taian City Central Hospital
Taian, 271000
13375387610
Haipeng Yuan
- Recruiting
Wuhan Union Hospital
Wuhan, 430022
Rong LIN
- Recruiting
Wuxi People's Hospital
Wuxi, 214023
Qunyan Zhou
Mexico12 sites, 12 recruiting
- Recruiting
Scientia Investigacion Clinica S.C.
Chihuahua City, 31207
Karina Ramirez
- Recruiting
Instituto de Investigaciones Aplicadas a la Neurociencia A.C.
Durango, 34000
LUIS CARLOS DIAZ HERRERA
- Recruiting
Boca Clinical Trials Mexico S.C.
Guadajalara, 44600
3338306672
Christian Jaramillo Buendía
- Not yet recruiting
Clinica de Investigacion en Reumatologia y Obesidad S. C.
Guadalajara, 44650
Hector Martinez Torres
- Recruiting
Centro de Investigación y Gastroenterología - S.C.
Mexico City, 03330
5510546591
Alma Ladron de Guevara Cetina
- Not yet recruiting
Centro de Investigación Clinica Chapultepec
Mexico City, 04100
Elda Rodriguez Negrete
- Not yet recruiting
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Mexico City, 14080
JESUS YAMAMOTO-FURUSHO
- Recruiting
Servicios de Oncología Médica Integral - Monterrey
San Pedro Garza García, 66220
Manuel Martinez Vazquez
- Recruiting
Scientia Investigacion Clinica S.C.
Tijuana, 22105
Luis Lopez
- Recruiting
Clinical Research Institute S.C.
Tlalnepantla, 54055
52 55 53627780
Leticia Marin
- Recruiting
Medimanage Research
Tlalpan, 14050
Enrique Coss Adame
- Recruiting
FAICIC S. de R.L. de C.V.
Veracruz, 91900
2299327808
Aracely Cruz Palacios
Poland9 sites, 9 recruiting
- Recruiting
Gyncentrum sp. z o.o. NZOZ Holsamed - oddział Libero
Katowice, 40-600
Marek Olakowski
- Recruiting
IRMED
Piotrkow Trybunalski, 97-300
Katarzyna Ostrowska
- Recruiting
Pratia Poznań
Poznan, 60-192
Magdalena Andrzejewska
- Recruiting
Uniwersyteckie Centrum Stomatologii i Medycyny Specjalistycznej
Poznan, 60-354
618547552
Piotr Eder
- Recruiting
Twoja Przychodnia SCM
Szczecin, 71-434
48 91 433 29 19
Beata Gawdis-Wojnarska
- Recruiting
Sonomed Sp. z o. o.
Szczecin, 71-685
Anna Wiechowska-Kozlowska
- Recruiting
WSD MEDI
Warsaw, 02-786
+48 504 440 092
Michal Krogulecki
- 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
Turkey (Türkiye)9 sites, 9 recruiting
- Recruiting
Adana City Hospital
Adana
BANU KARA
- Recruiting
Gazi University Health Research and Application Center Gazi Hospital
Ankara, 06560
0 505 319 22 57
Tarkan Karakan
- Not yet recruiting
Antalya Egitim ve Arastırma Hastanesi
Antalya, 07100
Ayhan Hilmi Cekin
- Recruiting
Eskisehir Osmangazi University
Eskişehir, 26480
Tuncer Temel
- Recruiting
Mustafa Kemal Universitesi
Hatay, 31030
Mehmet Demir
- Recruiting
Kocaeli University Medical Faculty Hospital
İzmit, 41380
0090 505 877 48 21
Hasan Yilmaz
- Recruiting
İnönü Üniversitesi Turgut Özal Tıp Merkezi Eğitim ve Araştırma Hastanesi
Malatya, 44280
Yasir Cagin
- Recruiting
Mersin University
Mersin, 33110
905326145276
Engin Altintas
- Recruiting
Dicle Üniversitesi
Sur, 21200
05323724782
Kendal Yalcin
India8 sites, 8 recruiting
- Recruiting
Sardar Vallabhbhai Patel Institute of Medical Sciences and Research
Ahmedabad, 380006
09825005167
Kaushal Vyas
- Recruiting
Rajiv Gandhi Government General Hospital
Chennai, 600003
Senthil Ponnaiah
- Recruiting
Ashwin Hospital
Coimbatore, 641012
Ganesh Muniappan
- Recruiting
Sushruta Multispeciality Hospital & Research Centre
Hubli, 580021
09448804251
LAXMIKANT DESAI
- Recruiting
Mahavir Hospital & Research Centre - Hyderabad
Hyderabad, 500004
Sameer Kumar
- Not yet recruiting
All India Institute of Medical Sciences
New Delhi, 110029
09867932836
Vineet Ahuja
- Recruiting
Medipoint Hospitals Pvt. Ltd.
Pune, 411007
Pankaj Nemade
- Recruiting
Shree Giriraj Multispeciality Hospital
Rajkot, 360005
Chetan Mehta
Hungary7 sites, 7 recruiting
- Recruiting
Békés Megyei Központi Kórház Dr. Réthy Pál Tagkórház
Békéscsaba, 5600
003666555582
Marta Varga
- Recruiting
Óbudai Egészségügyi Centrum
Budapest, 1036
06309399575
Tamás Toth
- Recruiting
Semmelweis Egyetem
Budapest, 1088
3612664616
Zsolt Tulassay
- Recruiting
Pannónia Magánorvosi Centrum
Budapest, 1136
003613301143
Robert Schnabel
- Recruiting
Clinexpert Gyöngyös
Gyöngyös, 3200
+36209650290
Gyula Horvat
- Recruiting
Komarom-Esztergom Varmegyei Szent Borbala Korhaz
Tatabánya, 2800
36309578269
András Káfony
- Recruiting
Jávorszky Ödön Kórház
Vác, 2600
+36302001489
Tibor Szaloki
Japan6 sites, 6 recruiting
- Recruiting
Fukuoka University Hospital
Fukuoka, 814-0180
81120023812
Fumihito Hirai
- Recruiting
Gokeikai Ofuna Chuo Hospital
Kamakura, 247-0056
81120023812
Atsushi Yoshida
- Recruiting
Tsujinaka Hospital - Kashiwanoha
Kashiwa, 277-0871
81120023812
Ken Takeuchi
- Recruiting
National Hospital Organization Osaka National Hospital
Osaka, 540-0006
81120023812
Yuko Sakakibara
- Recruiting
Toho University Sakura Medical Center
Sakura, 285-8741
81120023812
Katsuyoshi Matsuoka
- Recruiting
Sapporo Tokushukai Hospital
Sapporo, 004-0041
81120023812
Toshifumi Ashida
Canada5 sites, 5 recruiting
- Recruiting
Charlton Digestive Disease Centre
Hamilton, L8N 1Y2
905-526-7002 x 3123
Neeraj Narula
- Not yet recruiting
London Health Sciences Centre
London, N6A 5W9
519-685-8500
Terry Ponich
- Recruiting
London Digestive Disease Institute
London, N6K 1M6
Vipul Jairath
- Recruiting
West GTA Research Inc.
Mississauga, L5M 2S4
Arif Yusuf
- Recruiting
C.I.C. Mauricie inc.
Trois-Rivières, G8T 7A1
Madeleine Bonneviot
Germany5 sites, 5 recruiting
- Recruiting
Charité Universitaetsmedizin Berlin - Campus Mitte
Berlin, 10117
004930450614031
Christoph Jochum
- Recruiting
Studienzentrum MVZ Dachau
Dachau, 85221
004981316119311
Wilfred Landry
- Not yet recruiting
Universitaetsklinikum Erlangen
Erlangen, 91054
Sebastian Zundler
- Not yet recruiting
Universitätsklinikum Regensburg
Regensburg, 93053
+499419447010
Arne Kandulski
- Recruiting
Universitaetsklinikum Ulm
Ulm, 89081
0497315000
Jochen Klaus
Italy5 sites, 5 recruiting
- Recruiting
ASST Grande Ospedale Metropolitano Niguarda
Milan, 20162
Marcello Vangeli
- Recruiting
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Milan, 20122
0255032141
Flavio Caprioli
- Recruiting
Ospedale San Raffaele
Milan, 20132
Silvio Danese
- Recruiting
Fondazione Policlinico Universitario Agostino Gemelli
Roma, 00168
0630154678
Franco Scaldaferri
- Not yet recruiting
Humanitas
Rozzano, 20089
0282243263
Alessandro Armuzzi
Romania5 sites, 5 recruiting
- Recruiting
Delta Health Care
Bucharest, 014142
40745086735
Camelia Chioncel
- Recruiting
Spitalul Clinic Colentina
Bucharest, 020125
0213152590
Bogdan Mateescu
- Recruiting
Constanta County Emergency Clinical Hospital Sf.Ap.Andrei
Constanța, 900591
+40744761454
Eugen Dumitru
- Recruiting
Spital Judetean de Urgenta
Satu Mare, 440055
+40747 170 170
Bogdan Pintea
- Recruiting
S.C Centrul de Gastroenterologie Dr. Goldis S.R.L
Timișoara, 300002
0040722410712
Adrian Goldis
Spain4 sites, 4 recruiting
- Recruiting
Centro Médico Teknon
Barcelona, 08022
Miquel Sans Cuffi
- Recruiting
Hospital Universitario de Fuenlabrada
Fuenlabrada, 28942
34916006175
Fernando Bermejo San José
- Recruiting
Hospital de Cabueñes
Gijón, 33394
Pilar Varela Trastoy
- Recruiting
Hospital Universitario La Paz
Madrid, 28046
MARIA DOLORES MARTIN ARRANZ
Denmark3 sites, 3 recruiting
- Recruiting
Herlev and Gentofte Hospital
Copenhagen, 2730
Jakob Seidelin
- Recruiting
Aalborg Universitetshospital, Syd
Gistrup, 9260
Henrik Jacobsen
- Recruiting
Odense Universitetshospital
Odense, 5000
Mark Ainsworth
Netherlands2 sites, 2 recruiting
- Recruiting
Radboudumc
Nijmegen, 6525 GA
+31 24 3619190
Marjolijn Duijvestein
- Recruiting
Elisabeth-TweeSteden Ziekenhuis
Tilburg, 5022 GC
0031(0)132218466
Robert Laheij
Austria1 site, 1 recruiting
- Recruiting
Medizinische Universität Wien
Vienna, 1090
004314040062450
Walter Reinisch
About this study
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
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
- Ulcerative Colitis
- Being tested
- LY4268989, Mirikizumab, LY4268989 Placebo
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY4268989Drug
Also called MORF-057, zotemtegrast
Administered PO
MirikizumabDrug
Also called LY3074828
Administered IV then SC
LY4268989 PlaceboDrug
Administered PO
| Study group | Role | What they receive |
|---|---|---|
| LY4268989 + Mirikizumab | Experimental | LY4268989 administered orally (PO) + Mirikizumab administered intravenously (IV), then subcutaneously (SC). Responders will be re-randomized for Study Period 2. Receives: Drug: LY4268989; Drug: Mirikizumab |
| Mirikizumab + LY4268989 Placebo | Experimental | Mirikizumab administered IV, then SC + LY4268989 placebo administered PO. Responders and Non-responders will re-randomized for Study Period 2. Receives: Drug: Mirikizumab; Drug: LY4268989 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Who Achieve Clinical Remission with Modified Mayo Score (mMS)
The mMS is a composite score reported by participants and physician and is comprised of the following 3 subscores: Stool Frequency (SF); Rectal Bleeding (RB), and Endoscopic Subscore (ES).
Clinical remission (mMS) is defined as:
- SF subscore = 0 or 1 and no greater than baseline
- RB subscore = 0
- Centrally read ES = 0 or 1; score of 1 modified to exclude friability
Measured: Week 12
Secondary outcomes (9)
Percentage of Participants Who Achieve Clinical Response with mMS
Measured: Week 12
Percentage of Participants Who Achieve Endoscopic Improvement
Measured: Week 12
Percentage of Participants Who Achieve Symptomatic Remission
Measured: Week 12
Percentage of Participants Who Achieve Clinical Remission with mMS
Measured: Week 24
Percentage of Participants Who Achieve Clinical Response with mMS
Measured: Week 24
Percentage of Participants Who Achieve Clinical Remission with mMS
Measured: Week 48
Percentage of Participants Who Achieve Clinical Response with mMS
Measured: Week 48
Percentage of Participants Who Achieve Clinical Remission with mMS + Physician's Global Assessment (PGA)
Measured: Week 48
Percentage of Participants Who Achieve Clinical Response with mMS + PGA
Measured: Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2025
- Study start10 Nov 2025
- Primary completionMay 2027 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 252 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Call 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07186101
- Sponsor's protocol ID
- 27704
- Other IDs
- J6E-MC-KWAN, MORF-057
- Acronym
- TOPAZ-UC
- Status last verified
- Oct 2026
- First submitted
- 16 Sep 2025
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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.