Inflammatory Bowel DiseasesPhase 2GARNETNCT06226883
A Phase 2 Study to Evaluate MORF-057 in Adults With Moderately to Severely Active Crohn's Disease
A Phase 2 study testing MORF-057 in people with Inflammatory Bowel Diseases and Crohn's Disease, run by Morphic Therapeutic, Inc. (A Wholly Owned Subsidiary of Eli Lilly and Company) at 225 sites in 28 countries.
Trial summary
This is a Phase 2, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of 3 active dose regimens of MORF-057 in adult study participants with moderately to severely active Crohn's disease (CD). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Inflammatory Bowel Diseases, Crohn's Disease
- What is being tested?
- MORF-057
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 385 participants
- Where
- 225 sitesin 28 countries
- Study dates
- 18 Jul 2024to Jun 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Has signs/symptoms of CD for at least 90 days prior to screening
- Has a CDAI score of 220 to 450, with an average daily stool subscore ≥4 points and/or an average daily abdominal pain subscore of ≥2 points
- Has an SES-CD score of ≥6 (or an SES-CD score of ≥4 if CD is isolated to the ileum)
- Demonstrated an inadequate response, loss of response, or intolerance to at least one of the following treatments: Corticosteroids, Immunosuppressants (eg, azathioprine, 6-mercaptopurine, methotrexate) and/or advanced therapies for CD (eg, biologic agents, Janus kinase [JAK] inhibitors, applicable investigational products)
Who cannot join
- Diagnosed with indeterminate colitis, microscopic colitis, ischemic colitis, radiation colitis, or UC, or has clinical findings suggestive of UC
- Has CD that is isolated to the oral cavity, stomach, duodenum, jejunum, or perianal region, without colonic or ileal involvement
- Has had extensive bowel resection (>100 cm), and/or more than 3 resections, and/or has a known diagnosis of short bowel syndrome
- Is currently receiving total parenteral nutrition, tube feeding, or a formula diet
- Has positive findings on a subjective neurological screening questionnaire
- Has a concurrent, clinically significant, serious, unstable comorbidity
Show all 11Show fewer
- Previous treatment with vedolizumab or other licensed or investigational integrin inhibitors
- Is currently participating in any other interventional study or has received any investigational therapy within 30 days
- Previous exposure to MORF-057 and/or a known hypersensitivity to drugs with a similar mechanism to MORF-057
- Unable to attend study visits or comply with study procedures
- Has a history of any major neurological disorders, including: stroke, multiple sclerosis, brain tumor, demyelinating, or neurodegenerative disease
Trial locations and contacts
225 sites in 28 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
225 sites in 28 countries
Poland26 sites, 24 recruiting
- Recruiting
"MEDIS" Medical Center
Bydgoszcz, 85-229
+48 () 601667497
Maria Klopocka
- Recruiting
Non-public Health Care Center KERmed Medical Centre
Bydgoszcz, 85-231
+48 () 533 550 245
Patryk Korga
- Recruiting
CLINSANTE Clinical Research Centre Ewa Galczak-Nowak, Malgorzata Trzaska
Bydgoszcz, 85-794
+48 () 609 183 911
Michal Wiatr
- Recruiting
Synexus Polska Sp. Z o.o. Branch in Czestochowa
Częstochowa, 42-202
+0 (48) 538 935 600
Jaroslaw Ziemba
- Completed
St. John Paul 2nd Municipal Hospital in Elblag
Elblag, 82-300
- Recruiting
AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Gdansku
Gdansk, 80-382
+48 (58) 712 9970
Marek Cesarz
- Recruiting
Synexus Polska - Katowicach
Katowice, 40-040
+48 () 604 586 316
Magdalena Olszanecka-Glinianowicz
- Recruiting
"Vita Longa" Non-Public Healthcare Facility, Limited Liability Company
Katowice, 40-748
+48 () 797 947 052
Przemyslaw Ramos
- Not yet recruiting
GLOBE Clinical Research Sp. z o.o.
Kłodzko, 57-300
+48 (661) 160 410
Miroslaw Wojcik
- Recruiting
PLEJADY Medical Centre
Krakow, 30-363
+48 (12) 422 3271
Monika Augustyn
- Recruiting
"Landa" Specialist Doctor's Offices
Krakow, 31-156
+48 () 504 042 403
Katarzyna Landa
- Recruiting
Oslomed Medical Center
Krakow, 31-228
Anna Drozdz
- Recruiting
Twoja Przychodnia Medical Centre of Opole
Opole, 45-819
+48 () 690 548 825
Marzena Kwinto
- Recruiting
EMC Medical Institute Joint Stock Company, "Certus" Private Healthcare Facility Hospital No. 1
Poznan, 60-309
+48 () 698120205
Piotr Szablowski
- Recruiting
Twoja Przychodnia Medical Centre of Poznan
Poznan, 60-324
Ewa Furmanowska-Ladorska
- Recruiting
Synexus Polska Sp. z o.o. Branch in Poznan
Poznan, 81-537
+48 (61) 880 2994
Magdalena Andrzejewska
- Recruiting
Endoskopia Sp. z.o.o.
Sopot, 81-756
+48 () 501011879
Marek Horynski
- Recruiting
Twoja Przychodnia-Szczecinskie Centrum Medyczne
Szczecin, 71-434
+48 (91) 433 2919
Beata Gawdis-Wojnarska
- Recruiting
H-T. Medical Center
Tychy, 43-100
+48 (501) 464 891
Tomasz Romanczyk
- Completed
MDM Healthcare Centre
Warsaw, 00-189
- Recruiting
Synexus Polska Sp. z o.o. Oddzial w Warszawie
Warsaw, 02-672
+48 (22) 644 4161
Katarzyna Wierzbicka
- Not yet recruiting
ETG Warszawa
Warsaw, 02-677
+ (48) 575 000 489
Marek Bugajski
- Recruiting
WSD Medi
Warsaw, 02-786
+48 (60) 443 5392
Michal Krogulecki
- Recruiting
WIP Warsaw IBD Point Profesor Kierkus
Warsaw, 04-501
+48 (22) 815 7384
Jaroslaw Kierkus
- Recruiting
Synexus Polska Sp. z o.o.
Wroclaw, 50-381
+48 (71) 772 6000
Agnieszka Ciesiolkiewicz-Wojcik
- Recruiting
Medical Centre Oporow
Wroclaw, 52-416
+ (48) 604 911 743
Radoslaw Kempinski
United States25 sites, 25 recruiting
- Recruiting
Atlanta Gastroenterology Specialists, PC
Atlanta, Georgia, 30024
Steven Thalvinder (Thali) Sangha
- Recruiting
Atlanta Gastroenterology Associates (Part of United Digestive)
Atlanta, Georgia, 30342
404-257-9000
Nitin Gupta
- Recruiting
SSM Health DePaul Hospital- St. Louis
Bridgeton, Missouri, 063044
918-880-0676
Yezaz Ghouri
- Recruiting
GI Alliance - Cedar Park
Cedar Park, Texas, 78613
Junaid Siddiqui
- Recruiting
Peak Gastroenterology Associates - Colorado Springs
Colorado Springs, Colorado, 80921
719-362-2266
Prashant Krishnan
- Not yet recruiting
North Texas Gastroenterology
Denton, Texas, 76210
Vijaya Dasari
- Recruiting
Cross Creek Medical Clinic
Fayetteville, North Carolina, 28304
920-437-5130
Nitinchandra Desai
- Recruiting
Peters Medical Research
High Point, North Carolina, 27260
336-883-9773
Roy Peters
- Recruiting
Tandem Clinical Research
Houma, Louisiana, 70360
Conar Fitton
- Recruiting
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
Tugrul Purnak
- Recruiting
Gastrointestinal Associates of Northeast Tennessee
Johnson City, Tennessee, 44060
423-208-9073
Chakradhar Reddy
- Recruiting
Clinical Research of Osceola
Kissimmee, Florida, 34741
407-846-6331
Basher Atiquzzaman
- Recruiting
Gastro Care Institute
Lancaster, California, 93534
661-529-7550
Kumaravel Perumalsamy
- Recruiting
Prime Clinical Research - Lewisville
Lewisville, Texas, 75067
817-907-7330
Ayodele Osowo
- Recruiting
Gastroenterology Associates of Central Virginia
Lynchburg, Virginia, 24502
Larry Clark, Jr.
- Recruiting
Prime Clinical Research
Mansfield, Texas, 76063
Olufemi Abiodun
- Recruiting
Bioresearch Partner-Kendale Lakes
Miami, Florida, 33155
833-489-4968
Keila Hoover
- Recruiting
Las Vegas Clinical Trials
North Las Vegas, Nevada, 89030
Christian Stone
- Recruiting
Care Access Research - Ogden
Ogden, Utah, 84403
Chad Gonzales
- Recruiting
Endoscopic Research Inc
Orlando, Florida, 32803
407-241-1726
Marlon Ilagan
- Recruiting
Tropical Clinical Trials
Palmetto Bay, Florida, 33176
754-946-4172
MIchael Feldman
- Not yet recruiting
Wake Research Associates
Raleigh, North Carolina, 27612
336-613-6908
Lisa Cohen
- Recruiting
Infinity Clinical Research
San Diego, California, 92108
Tommy Yen
- Recruiting
Palmetto Gastroenterology Clinical Research
Summerville, South Carolina, 29486
843-376-0670
Brett Van Leer-Greenberg
- Recruiting
Tyler Research Institute, LLC
Tyler, Texas, 75701
903-630-6211
George DuVall
India16 sites, 16 recruiting
- Recruiting
Navneet Memorial Hospital SUSHRUSHA
Ahmedabad, 380009
91 Q83298336) 22 433
Kaivan Shah
- Not yet recruiting
Institute of Medical Sciences & SUM Hospital, Siksha 'O' Anusandhan, Department of Gastroenterology & Hepatology
Bhubaneswar, 751003
+91 (6372) 900-010
Ayaskanta Singh
- Recruiting
Apollo Cancer Centre
Chennai, 600035
Ganesh Subramanian
- Not yet recruiting
VGM Hospital
Coimbatore, 641005
+91 (4222) 327-17
Mohanprasad Virukalapatti Gopalratnam
- Recruiting
SMS Medical College Hospital
Jaipur, 302004
Gaurav Kumar Gupta
- Recruiting
S R Kalla Memorial Gastro and General Hospital
Jaipur, 302006
+91 (9829) 050 622
Mukesh Kalla
- Recruiting
Lisie Hospital
Kochi, 682017
Mathew Philip
- Recruiting
Amrita Institute of Medical Sciences and Research Centre
Kochi, 682041
9497556339
Shine Sadasivan
- Not yet recruiting
Dayanand Medical College and Hospital
Ludhiana, 141001
+91 (9891) 552 828
Vandana Midha
- Recruiting
Max Super Speciality Hospital
New Delhi, 110 017
K Madan
- Recruiting
Noble Hospital Pvt Ltd
Pune, 411013
+91 (9766) 968 987
Pramod Katare
- Recruiting
Prime Institute of Digestive Sciences
Rajkot, 360001
+91 (98242) 12 169
Krishnkant Rawal
- Recruiting
Shree Giriraj Multispeciality Hospital
Rajkot, 360005
+91 (9825) 077-472
Chetan Mehta
- Recruiting
Yashoda Hospital
Secunderabad, 500003
B. Ravi Shankar
- Recruiting
SIDS Hospital and Research Centre
Surat, 395002
Mayank Kabrawala
- Recruiting
Samvedna Hospital
Varanasi, 221005
+91 (939) 107 5600
Hemant Kumar Gupta
Japan15 sites, 15 recruiting
- Recruiting
Asahikawa Medical College Hospital
Asahikawa, 078-8510
81120023812
Mikihiro Fujiya
- Recruiting
Institute of Science Tokyo Hospital
Bunkyō, 113-8519
81120023812
Ryuichi Okamoto
- Recruiting
Fukuoka University Chikushi Hospital
Chikushino-shi, 818-8502
81120023812
Takashi Hisabe
- Recruiting
Kokikai Tsujinaka Hospital Kashiwanoha
Kashiwa-shi, 277-0871
81120023812
Ken Takeuchi
- Recruiting
Kobe University Hospital
Kobe, 650-0017
81120023812
Daisuke Watanabe
- Recruiting
Yamanashi Prefectural Central Hospital
Kofu, 400-0027
81120023812
Yuichiro Kojima
- Recruiting
Nagasaki University Hospital
Nagasaki, 852-8501
81120023812
Kayoko Matsushima
- Recruiting
Nara Prefecture General Medical Center
Nara, 630-8054
81120023812
Kei Moriya
- Recruiting
Osaka Metropolitan University Hospital
Osaka, 5450051
81120023812
Shuhei Hosomi
- Recruiting
Saga University Hospital
Saga, 849-8501
81120023812
Nanae Tsuruoka
- Recruiting
Tokitokai Tokito Clinic
Saitama, 336-0963
81120023812
Satoki Tokito
- Recruiting
Saitama Medical Center
Saitama-Ken, 350 8550
81120023812
Kato Shingo MD
- Recruiting
Toho University Sakura Medical Center
Sakura, 285-8741
81120023812
Katsuyoshi Matsuoka
- Recruiting
Sapporo Higashi Tokushukai Hospital
Sapporo, 065-0033
81120023812
Atsuo Maemoto
- Recruiting
Tokyo Yamate Medical Center
Tokyo, 169-0073
81120023812
Masayuki Fukata
Germany13 sites, 13 recruiting
- Recruiting
Charite - University Hospital Berlin
Berlin, 10117
+49 (30) 450 514102
Christoph Jochum
- Recruiting
DRK Clinic Berlin-Koepenick
Berlin, 12559
49 (152) 0157 3335
Benjamin Moser
- Recruiting
Medical Care Unit Dachau
Dachau, 85221
+49 (08131) 61 190
Wilfred Landry
- Recruiting
Sana Hospital Duisburg
Duisburg, 53119
+49 (203) 733 2385
Wolfgang Nitz
- Not yet recruiting
Agaplesion Markus Hospital
Frankfurt am Main, 60431
+49 (069) 95332201
Axel Dignass
- Recruiting
University Hospital Halle (Saale)
Halle, 06120
+49 (345) 557 2665
Jens Walldorf
- Recruiting
Universitätsklinikum Heidelberg
Heidelberg, 69120
+49 (6221) 563 8865
Annika Gauss
- Recruiting
University Hospital Schleswig-Holstein
Kiel, 24105
+49 (431) 500 22202
Stefan Schreiber
- Not yet recruiting
University of Leipzig Medical Cent
Leipzig, 04103
+49 (341) 712 226
Babett Holler
- Not yet recruiting
GastroPraxis Magdeburg
Magdeburg, 110 39104
Lars Zimmermann
- Not yet recruiting
Hospital Ludwig-Maximilians-University Munich, Campus Grosshadern
Munich, 81377
Benjamin Misselwitz
- Recruiting
Group Practice Jakobeit
Wipperfürth, 51688
+49 (2267) 9201
Christian Jakobeit
- Not yet recruiting
Wolfsburg Hospital Department of internal Medicine
Wolfsburg, 38440
Nils Homann
Canada12 sites, 12 recruiting
- Not yet recruiting
CaRe Clinic
Alberta, T4P 1K4
Josias Badenhorst
- Not yet recruiting
Integrated University Health and Social Services Center of Saguenay-Lac-Saint-Jean
Chicoutimi, G7H 5H6
Alban Michaud-Herbst
- Recruiting
Nova Scotia Health Authority
Halifax, B3H 1V7
+902 (473) 1499
Jennifer Jones
- Not yet recruiting
Prairie Institute of Liver and Luminal Advanced Research
Lethbridge, T1J 4G9
Kaleb Marr
- Recruiting
London Health Sciences Centre
London, N6A 4L6
Terry Ponich
- Not yet recruiting
London Digestive Disease Institute
London, N6K 1M6
+519 (685) 8500
Vipul Jairath
- Not yet recruiting
Clinique IMD
Montreal, H3H 1E8
Waqqas Afif
- Recruiting
Diex Recherche Quebec Inc.
Québec, G1V 4T3
Pascale Chouinard
- Recruiting
Scarborough Center for Inflammatory Bowel Disease
Scarborough, M1B 3V4
Jason Reinglas
- Recruiting
Mount Sinai Hospital
Toronto, M5G 1X5
Hillary Steinhart
- Recruiting
St Joseph'S Health Centre Toronto
Toronto, M6R 1B5
Ian Bookman
- Recruiting
Toronto Digestive Disease Associates, Inc.
Vaughan, L4L 4Y7
David Ford
Italy12 sites, 12 recruiting
- Recruiting
Policlinico S. Orsola-Malpighi
Bologna, 40138
Fernando Rizzello
- Not yet recruiting
Poliambulanza Hospital
Brescia, 25124
Paola Cesaro
- Not yet recruiting
Universita Degli Studi-Magna Graecia-de Catanzaro
Catanzaro, 88100
+39 (0961) 364 7111
Francesco Luzza
- Recruiting
Big Metropolitan Hospital Niguarda Regional Health Authority
Milan, 20162
+39 (026) 444 4454
Marcello Vangeli
- Recruiting
IRCCS San Raffaele
Milan, 20132
+39 (02) 2643 2069
Silvio Danese
- Recruiting
Ospedale Sacro Cuore Don G. Calabria
Negrar, 37024
+39 (045) 601 4838
Angela Variola
- Not yet recruiting
Hospital of Padova
Padova, 35128
+39 () 0498215656
Fabiana Zingone
- Recruiting
Azienda Ospedaliera San Camillo Forlanini
Roma, 00152
Rocco Cosintino
- Recruiting
IRCCS Istituto Clinico Humanitas- Centro Malattie Infiammatorie Intestinali
Rozzano, 20089
+39 (338) 736 7765
Alessandro Armuzzi
- Recruiting
IRCCS Policlinico San Donato
San Donato Milanese, 20097
Vito Annese
- Recruiting
IRCCS Ospedale Casa Sollievo della Sofferenza
San Giovanni Rotondo, 71013
+39 (0882) 410 815
Fabrizio Bossa
- Not yet recruiting
University Hospital City of Health and Science of Turin - Hospital Molinette
Turin, 10126
+00393476861126
Davide Giuseppe Ribaldone
Taiwan12 sites, 12 recruiting
- Not yet recruiting
Ditmanson Medical Foundation Chia-Yi Christian Hospital
Chiayi City, 60002
+886 (5) 276 5041
Chu-Kuang Chou
- Not yet recruiting
National Taiwan University Hospital
Hsinchu, 302
Meng-Tzu Weng
- Not yet recruiting
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 807377
886 7 312 1101
Wen-Hung Hsu
- Not yet recruiting
Kaohsiung Veterans General Hospital
Kaohsiung City, 81362
+886 (7) 342 2121
Tzung-Jiun Tsai
- Not yet recruiting
Far Eastern Memorial Hospital
New Taipei City, 22060
+886 (2) 77281704
Chen-Shuan Chung
- Not yet recruiting
China Medical University Hospital
Taichung, 404327
+886 (4) 22052121
Tsung-Yu Tsai
- Not yet recruiting
Taichung Veterans General Hospital
Taichung, 407219
+886 (423) 592 525
Chung-Hsin Chang
- Not yet recruiting
Chi Mei Medical Center
Tainan, 71004
+886 (6) 243 3407
I CHE FENG
- Not yet recruiting
National Taiwan University Hospital
Taipei, 100225
+886 (2) 23123456 +886 (9) 726
Chia-Hung Tu
- Not yet recruiting
Mackay Memorial Hospital
Taipei, 10449
+886 (6) 6655-1256
Horng-Yuan Wang
- Not yet recruiting
Taipei Veterans General Hospital
Taipei, 11217
Jiing-Chyuan Luo
- Not yet recruiting
Chang Gung Memorial Hospital - Linkou
Taoyuan City, 333
+886 (03) 328 1200
Puo-Hsien Le
Australia8 sites, 8 recruiting
- Not yet recruiting
Southern Adelaide Local Health Network
Bedford Park, 5042
+61 (8) 8204 4964
Reme Mountifield
- Not yet recruiting
Royal Brisbane and Women's Hospital
Herston, 4029
+61 (7) 3646 4273
Anthony Croft
- Not yet recruiting
IBD SA SA Group of Specialists
Kurralta Park, 5037
Paul Spizzo
- Not yet recruiting
The Alfred Hospital
Melbourne, 3004
+61 (03) 9076 8838
Miles Sparrow
- Not yet recruiting
St. Vincent's Hospital
Melbourne, 3065
+61 (3) 92313580
John Nik Sheng Ding
- Not yet recruiting
Royal Perth Hospital
Perth, 6000
Kenji So
- Not yet recruiting
Sir Charles Gairdner Hospital
Perth, 6009
+61 (0) -8645-7367
Nabil Siddique
- Not yet recruiting
Princess Alexandra Hospital, Metro South Health
Woolloongabba, QLD, 4102
61731767792
Gerald Holtmann
Mexico8 sites, 8 recruiting
- Recruiting
Applied Neuroscience Research Institute A.C.
Durango, 34000
+52 (618) 197 3882
Raquel Morones Esquivel
- Recruiting
Proactive CR México SA de CV
Irapuato, 36520
Andrés Mendoza Sanchez
- Recruiting
Medical Clinical Surgical Center Specialized in Research
Jalisco, 45640
Roberto Cruz Neri
- Recruiting
Medical Care and Research SA de CV
Mérida, 97070
AXEL MENA QUINTERO
- Recruiting
Key Stone Clinical Trials
Mexico City, Distrito Federal, 06100
Karina Olvera Obregon
- Recruiting
Centro de Investigacion Clinica Chapultepec S.A. de C.V.
Morelia, 58260
Victor Sevilla Lizcano
- Recruiting
Oaxaca Site Management Organization
Oaxaca City, 68000
Ana Vera Heredia
- Recruiting
Centro de Estudios Clínicos de Querétaro (CECLIQ)
Querétaro, 76000
Raul Chavez Ayala
Kazakhstan7 sites, 7 recruiting
- Recruiting
Scientific Research Institute of Cardiology and Internal Disease of the Ministry of Health of the Republic of Kazakhstan
Almaty, 050000
+7 (747) 105-11-95
Jamilya Kaibullayeva
- Recruiting
National Research Medical Center
Astana, Z00P6K6
+7 (701) 884 4994
Ainur Doszhan
- Recruiting
Sana Clinic
Astana, Z00P6K6
7 (701) 800 8621
Assyltay Nauryzbayeva
- Recruiting
Karaganda Medical University
Karaganda, 100000
+7 (701) 227-80-60
Yelena Laryushina
- Recruiting
Semey Medical University
Semey, 071400
7 (778) 177-53-81
Aizhan Shakhanova
- Recruiting
"Gastromed" Medical Center
Shymkent, 160005
7 (701) 732-43-67
Assem Kurmangaliyeva
- Recruiting
Diagnostic Center of Shymkent
Shymkent, 160021
+7 (777) 502-99-55
Ainur Chalabayeva
Brazil6 sites, 6 recruiting
- Recruiting
NewData FBHC, NewData Clinical Research
Aracaju, 49075-000
Alex Callado França
- Not yet recruiting
Faculdade de Medicina da UNESP
Botucatu, 18618-687
Ligia Yukie Sassaki
- Recruiting
Chronos Pesquisa Clínica
Brasília, 72145-450
Cintia Mendes Clemente
- Not yet recruiting
Loema Clinical Research Institute and Consultants SS Ltda- i9 Clinical Research
Campinas, 13093-133
+55 (19) 98122-4244
Joaquim Simoes Neto
- Recruiting
Pesquisare
Santo André, 09080-110
+55 (11) 99245-2102
ALEXANDER DE SA ROLIM
- Recruiting
Clínica Hepatogastro JK
São Paulo, 04543-011
Rodrigo Andrey Rocco
Colombia6 sites, 6 recruiting
- Recruiting
Cardiomet Cequin S.A.S., Research Unit
Armenia, 630004
+57 (6) 731 3737
Juan Guillermo Lopez Valencia
- Recruiting
Fundación Valle del Lili
Cali, 760032
Carlos Rojas Rodriguez
- Recruiting
Cardiovascular Foundation of Colombia
Floridablanca, 681017
+57 (7) 639 9658
Mario Gabriel Figueredo Meneses
- Recruiting
Corporation for Health Studies "CES"
Medellín, 050012
+57 (604) 576 7272
Veronica Posada Velez
- Recruiting
Hospital Pablo Tobon Uribe
Medellín, 050034
57 (4) 445 9963
Gabriel Mosquera Klinger
- Recruiting
Northern University Foundation Hospital
Soledad, 083001
+57 (575) 371 5510
Hugo Macareno
Georgia6 sites, 6 recruiting
- Recruiting
High Technology Hospital Medcenter LLC
Batumi, 6010
+995 (593) 646 438
Nana Bolkvadze
- Recruiting
Emergency Cardiology Center by Academician G. Chapidze LLC
Tbilisi, 0159
+995 (595) 527 222
Lela Chankvetadze
- Recruiting
LTD Institute of Clinical Cardiology
Tbilisi, 0159
+995 (577) 415 937
Irina Jashi
- Recruiting
LTD Aversi Clinic
Tbilisi, 0160
+995 (599) 585 864
Nino Kiknadze
- Recruiting
LEPL The First University Clinic of Tbilisi State Medical University
Tbilisi, 0178
+995 (593) 338 379
Tamara Megrelishvili
- Recruiting
LTD The First Medical Center
Tbilisi, 0180
+995 (593) 283 528
Ekaterine Labadze
Hungary6 sites, 6 recruiting
- Recruiting
Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaz IV. Belgyogyaszat
Békéscsaba, 5600
+36 (66) 441 411
Marta Varga
- Recruiting
Semmelweis Medical University
Budapest, 1083
+36 (1) 459 1500
Akos Ilias
- Recruiting
Markhot Ferenc Oktatókórház
Eger, 3300
+36 (36) 411 444
Zoltan Sallo
- Recruiting
Bugat Pal Hospital Gyongyos
Gyöngyös, 3200
+36 (37) 312 491
Gabor Makai
- Recruiting
Fejer County St. Gyorgy University Teaching Hospital
Székesfehérvár, H-8000
+36 (22) 535 732
Roland Fejes
- Recruiting
CLINFAN Szolgáltató Kft
Szekszárd, 7100
+36 (74) 501 872
Agnes Salamon
Serbia6 sites, 6 recruiting
- Recruiting
Zvezdara University Medical Center
Belgrade, 11 000
+381 (11) 381 0390
Srdjan Markovic
- Recruiting
Clinical Center " Dr Dragisa Misovic Dedinje"
Belgrade, 11000
+0 (381) 637700043
Aleksandra Pavlovic
- Recruiting
Clinical Hospital Center Bezanijska Kosa
Belgrade, 11000
+381 (64) 015 0022
Marija Brankovic
- Recruiting
General Hospital Leskovac
Leskovac, 16000
+381 (64) 21023733
Tomislav Tasic
- Recruiting
General Hospital Uzice
Užice, 31000
381 (60) 513 5299
Danijela Savic
- Recruiting
General Hospital "Djordje Joanovic"
Zrenjanin, 23000
+381 (060) 607 6527
Tatjana Latinovic Radakovic
Spain6 sites, 6 recruiting
- Recruiting
Complejo Hospitalario Universitario de Ferrol (CHUF)- Hospital Naval
Ferrol, 15405
Ana Isabel Echarri Piudo
- Recruiting
Hospital Universitario Arnau de Vilanova de Lleida
Lleida, 25198
Francesc Xavier Molero Richard
- Recruiting
Hospital Universitario La Paz
Madrid, 28046
+34 (91) 727 7264
MARIA DOLORES MARTIN ARRANZ
- Recruiting
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, 28222
+34 () 911916453
Irene Gonzalez Partida
- Recruiting
Hospital Universitario Virgen Macarena
Seville, 41009
+34 (95) 500 8801
Federico Argüelles-Arias
- Recruiting
University and Polytechnic Hospital La Fe
Valencia, 46026
+34 (961) 973 118
Marisa Iborra Colomino
Austria4 sites, 4 recruiting
- Recruiting
Medical University Hematology
Innsbruck, 6020
+43 (512) 504 23539
Robert Koch
- Recruiting
Salzburg Regional Hospital
Salzburg, 5020
Sonja Heeren
- Recruiting
University Hospital St. Poelten
Sankt Pölten, 3100
+43 (2742) 9004 12311
Andreas Maieron
- Recruiting
Medical University of Vienna
Vienna, 1090
+43 (1) 40400 62450
Walter Reinisch
Czechia4 sites, 4 recruiting
- Recruiting
SurGal Clinic s.r.o.
Brno, 602 00
+ (420) 724 101 038
Jan Ulbrych
- Recruiting
Military Hospital Brno,
Brno, 615 00
+ (420) 973 445 520
Peter Hegyi
- Recruiting
Clinoxus s.r.o., Outpatient Clinic Budejovicka
Prague, 140 00
+420 () 222 962 476
Petr Hrabak
- Recruiting
Axon Clinical, s.r.o.
Prague, 14000
+ (420) 776767590
Jan Matous
Moldova4 sites, 4 recruiting
- Not yet recruiting
PMSI "Timofei Mosneaga" Republican Clinical Hospital, Outpatient Department
Chisinau, MD-2025
+373 (692) 63 789
Victoria Babitchi
- Not yet recruiting
PMSI "Timofei Mosneaga" Republican Clinical Hospital, Therapy Department, Division of Gastroenterology
Chisinau, MD-2025
+373 (79) 436 554
Svetlana Turcan
- Not yet recruiting
"Sfanta Treime" Municipal Clinical Hospital
Chisinau, MD-2068
+373 (69) 010 553
Gheorghe Lupu
- Not yet recruiting
Rtl Sm Srl
Chisinau, MD2072
78855508
Minodora Mazur
Romania4 sites, 4 recruiting
- Recruiting
"Sfanta Vineri" Medical Center
Bucharest, 011273
+40 (732) 806 599
Marieta-Madalina Florescu
- Recruiting
Monza Oncology Hospital SRL
Bucharest, 013823
Ion-Eugeniu Craciun
- Recruiting
Colentina Clinical Hospital
Bucharest, 020125
+40 (2) 1315 2590
Radu Bogdan Mateescu
- Recruiting
Oncohelp Association
Timișoara, 300239
+40 (767) 152 254
Razvan Diaconescu
Slovakia4 sites, 4 recruiting
- Recruiting
Cliniq s.r.o.
Bratislava, 811 09
+421 () 917 752 297
Tibor Hlavaty
- Recruiting
ENDOMED s.r.o.
Košice, 04013
+421 () 905 271 215
Miroslav Fedurco
- Recruiting
GASTRO I., s.r.o.
Prešov, 08001
+421 () 903 607 349
Bohus Bunganic
- Recruiting
Gastro LM s.r.o.
Prešov, 08001
+421 () 905 794 001
Lubomir Mihalkanin
Bosnia and Herzegovina3 sites, 3 recruiting
- Not yet recruiting
University Clinical Centre of the Republic of Srpska
Banja Luka, 78000
+387 (51) 342 100
Renata Tamburic
- Not yet recruiting
Hospital Plava Medical Group
Tuzla, 75000
Admir Kurtcehajic
- Not yet recruiting
Cantonal Hospital Zenica, Department of Internal Medicine
Zenica, 72000
Lejla Saranovic Ceco
Croatia3 sites, 3 recruiting
- Recruiting
Poliklinika Borzan
Osijek, 31000
Vladimir Borzan
- Recruiting
Specialty hospital Medico Rijeka
Rijeka, 51000
+385 (99) 834 3552
Davor Stimac
- Recruiting
Poliklinika Solmed
Zagreb, 10000
+ (385) 915881571
Dominik Kralj
Estonia3 sites, 3 recruiting
- Recruiting
East Tallinn Central Hospital
Tallinn, 10138
+372 () 5326 9290
Peeter Koiva
- Recruiting
West Tallinn Central Hospital
Tallinn, 10617
+372 () 651 1471
Kulliki Suurmaa
- Not yet recruiting
Tartu University Hospital, Department of Gastroenterology
Tartu, 50406
+372 () 731 8634
Karin Kull
Bulgaria2 sites, 2 recruiting
- Recruiting
"Medical Center Kanev" EOOD
Rousse, 7002
+359 (89) 980 5965
Ruslan Kulinski
- Recruiting
Diagnostic Consultative Center XX - Sofia
Sofia, 1618
+359 (878) 304 281
Dimitar Dimitrov
France2 sites, 2 recruiting
- Recruiting
Hospices Civils de Lyon - Lyon Sud
Pierre-Bénite, 69310
+33 () 4 78 86 12 89
Stephane Nancey
- Recruiting
CHRU Nancy Brabois - Hôpital d'Enfants
Vandœuvre-lès-Nancy, 54500
+33 (3) 83153 631
Marine Ferry
Latvia2 sites, 2 recruiting
- Recruiting
Liepaja Regional Hospital
Liepāja, LV-3414
Linda Erne
- Recruiting
Pauls Stradins Clinical Univeristy Hospital
Riga, LV-1002
+371 () 2925 3394
Aldis Pukitis
About this study
Official title: A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of 3 Active Dose Regimens of MORF-057 in Adults With Moderately to Severely Active Crohn's Disease (GARNET)
This is a Phase 2, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of 3 active dose regimens of MORF-057 in adult study participants with moderately to severely active Crohn's disease (CD).
Read the detailed description
This is a Phase 2, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of induction therapy with 3 active dose regimens of MORF-057 versus matching placebo in adult study participants with moderately to severely active CD. After completion of the 14-week Induction Period, all participants will receive open-label MORF-057 during the 38-week Maintenance Period. All participants who complete the full 52-week Treatment Period will also have the opportunity to continue treatment in a 52-week Long-Term Extension.
- Conditions
- Inflammatory Bowel Diseases, Crohn's Disease
- Being tested
- Placebo, MORF-057
- Keywords
- Crohn's disease (CD), Inflammatory bowel disease (IBD), a4b7, Moderate-to-severe, Integrin, GARNET
- Medical subject headings
- Inflammatory Bowel Diseases, Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Matching placebo (identical appearance to MORF-057) administered orally.
MORF-057Drug
Also called zotemtegrast
MORF-057 is a small molecule that is designed to selectively inhibit integrin α4β7 and is administered orally.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (Part A) | Experimental | Blinded MORF-057 Dosing Regimen 1 for Induction Period and open-label MORF-057 for Maintenance Period Receives: Drug: MORF-057 |
| Group 2 (Part A) | Experimental | Blinded MORF-057 Dosing Regimen 2 for Induction Period and open-label MORF-057 for Maintenance Period Receives: Drug: MORF-057 |
| Group 3 (Part A) | Placebo comparator | Blinded matching placebo for Induction Period and open-label MORF-057 for Maintenance Period Receives: Drug: Placebo; Drug: MORF-057 |
| Group 4 (Part B) | Experimental | Blinded MORF-057 Dosing Regimen 1 for Induction Period and open-label MORF-057 for Maintenance Period Receives: Drug: MORF-057 |
| Group 5 (Part B) | Experimental | Blinded MORF-057 Dosing Regimen 2 for Induction Period and open-label MORF-057 for Maintenance Period Receives: Drug: MORF-057 |
| Group 6 (Part B) | Placebo comparator | Blinded matching placebo for Induction Period and open-label MORF-057 for Maintenance Period Receives: Drug: Placebo; Drug: MORF-057 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants with endoscopic response at Week 14 as determined using the Simple Endoscopic Score-CD (SES-CD)
The SES-CD is an endoscopic scoring system for evaluating CD activity. Endoscopic response is defined as an SES-CD decrease from baseline of ≥50%
Measured: Baseline to Week 14
Secondary outcomes (2)
Proportion of participants with clinical response at Week 14 as determined using the Crohn's Disease Activity Index (CDAI)
The CDAI is a composite of subscores for clinical and laboratory findings, and patient-reported CD symptoms. Clinical response is defined as a reduction from baseline CDAI score by ≥100 points or a CDAI score of <150 points.
Measured: Baseline to Week 14
Proportion of participants with clinical remission at Week 14 as determined using the CDAI.
The CDAI is a composite of subscores for clinical and laboratory findings, and patient-reported CD symptoms. Clinical remission is defined as a CDAI score of <150 points.
Measured: Baseline to Week 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2024
- Study start18 Jul 2024
- Primary completionSep 2028 (estimated)
- Study completionJun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 385 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Morphic Therapeutic, Inc. (A Wholly Owned Subsidiary of 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
- NCT06226883
- Sponsor's protocol ID
- 27383
- Other IDs
- J6E-MC-KWAB, MORF-057-203, U1111-1297-7265, 2023-508158-24, 2023
- Acronym
- GARNET
- Status last verified
- Oct 2026
- First submitted
- 16 Jan 2024
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of 3 Active Dose Regimens of MORF-057 in Adults With Moderately to Severely Active Crohn's Disease (GARNET)
- ClinicalTrials.gov ID
- NCT06226883
- Acronym / sponsor ID
- GARNET / 27383
- Conditions
- Inflammatory Bowel Diseases, Crohn's Disease
- Keywords
- Crohn's disease (CD), Inflammatory bowel disease (IBD), a4b7, Moderate-to-severe, Integrin, GARNET
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 385 participants (estimated)
- Lead sponsor
- Morphic Therapeutic, Inc. (A Wholly Owned Subsidiary of Eli Lilly and Company)Industry (pharma, biotech, devices)
- Study start
- 18 Jul 2024 (actual)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Jun 2030 (estimated)
- First posted
- 26 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 2, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of 3 active dose regimens of MORF-057 in adult study participants with moderately to severely active Crohn's disease (CD).
Detailed description
This is a Phase 2, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of induction therapy with 3 active dose regimens of MORF-057 versus matching placebo in adult study participants with moderately to severely active CD. After completion of the 14-week Induction Period, all participants will receive open-label MORF-057 during the 38-week Maintenance Period. All participants who complete the full 52-week Treatment Period will also have the opportunity to continue treatment in a 52-week Long-Term Extension.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Group 1 (Part A) | Experimental | Drug: MORF-057Blinded MORF-057 Dosing Regimen 1 for Induction Period and open-label MORF-057 for Maintenance Period |
| Group 2 (Part A) | Experimental | Drug: MORF-057Blinded MORF-057 Dosing Regimen 2 for Induction Period and open-label MORF-057 for Maintenance Period |
| Group 3 (Part A) | Placebo comparator | Drug: Placebo, Drug: MORF-057Blinded matching placebo for Induction Period and open-label MORF-057 for Maintenance Period |
| Group 4 (Part B) | Experimental | Drug: MORF-057Blinded MORF-057 Dosing Regimen 1 for Induction Period and open-label MORF-057 for Maintenance Period |
| Group 5 (Part B) | Experimental | Drug: MORF-057Blinded MORF-057 Dosing Regimen 2 for Induction Period and open-label MORF-057 for Maintenance Period |
| Group 6 (Part B) | Placebo comparator | Drug: Placebo, Drug: MORF-057Blinded matching placebo for Induction Period and open-label MORF-057 for Maintenance Period |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Has signs/symptoms of CD for at least 90 days prior to screening
- Has a CDAI score of 220 to 450, with an average daily stool subscore ≥4 points and/or an average daily abdominal pain subscore of ≥2 points
- Has an SES-CD score of ≥6 (or an SES-CD score of ≥4 if CD is isolated to the ileum)
- Demonstrated an inadequate response, loss of response, or intolerance to at least one of the following treatments: Corticosteroids, Immunosuppressants (eg, azathioprine, 6-mercaptopurine, methotrexate) and/or advanced therapies for CD (eg, biologic agents, Janus kinase [JAK] inhibitors, applicable investigational products)
Key exclusion criteria (11 listed)
- Diagnosed with indeterminate colitis, microscopic colitis, ischemic colitis, radiation colitis, or UC, or has clinical findings suggestive of UC
- Has CD that is isolated to the oral cavity, stomach, duodenum, jejunum, or perianal region, without colonic or ileal involvement
- Has had extensive bowel resection (>100 cm), and/or more than 3 resections, and/or has a known diagnosis of short bowel syndrome
- Is currently receiving total parenteral nutrition, tube feeding, or a formula diet
- Has positive findings on a subjective neurological screening questionnaire
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboMatching placebo (identical appearance to MORF-057) administered orally. | Drug | Group 3 (Part A), Group 6 (Part B) |
| MORF-057Also: zotemtegrastMORF-057 is a small molecule that is designed to selectively inhibit integrin α4β7 and is administered orally. | Drug | Group 1 (Part A), Group 2 (Part A), Group 3 (Part A), Group 4 (Part B), Group 5 (Part B), Group 6 (Part B) |
Primary outcome
Proportion of participants with endoscopic response at Week 14 as determined using the Simple Endoscopic Score-CD (SES-CD)
Time frame: Baseline to Week 14
The SES-CD is an endoscopic scoring system for evaluating CD activity. Endoscopic response is defined as an SES-CD decrease from baseline of ≥50%
2 secondary outcomes
Proportion of participants with clinical response at Week 14 as determined using the Crohn's Disease Activity Index (CDAI)
Time frame: Baseline to Week 14
Proportion of participants with clinical remission at Week 14 as determined using the CDAI.
Time frame: Baseline to Week 14
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or contact
Physicians interested in becoming principal investigators please contact contact
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
225 sites in 28 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MORF-057 in people with Inflammatory Bowel Diseases and Crohn's Disease, run by Morphic Therapeutic, Inc. (A Wholly Owned Subsidiary of Eli Lilly and Company) at 225 sites in 28 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 225 sites in Poland, United States, India, Japan, Germany and 23 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or (1-317-615-4559, LillyTrials@Lilly.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants with endoscopic response at Week 14 as determined using the Simple Endoscopic Score-CD (SES-CD) (time frame: Baseline to Week 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.