A Phase 2 Study to Evaluate MORF-057 in Adults With Moderately to Severely Active Crohn's Disease
GARNET
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)
5 other identifiers
interventional
385
26 countries
215
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2024
Longer than P75 for phase_2
215 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 16, 2024
CompletedFirst Posted
Study publicly available on registry
January 26, 2024
CompletedStudy Start
First participant enrolled
July 18, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2030
June 4, 2026
June 1, 2026
4.1 years
January 16, 2024
June 3, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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%
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)
Baseline to Week 14
Proportion of participants with clinical remission at Week 14 as determined using the CDAI.
Baseline to Week 14
Study Arms (6)
Group 1 (Part A)
EXPERIMENTALBlinded MORF-057 Dosing Regimen 1 for Induction Period and open-label MORF-057 for Maintenance Period
Group 2 (Part A)
EXPERIMENTALBlinded MORF-057 Dosing Regimen 2 for Induction Period and open-label MORF-057 for Maintenance Period
Group 3 (Part A)
PLACEBO COMPARATORBlinded matching placebo for Induction Period and open-label MORF-057 for Maintenance Period
Group 4 (Part B)
EXPERIMENTALBlinded MORF-057 Dosing Regimen 1 for Induction Period and open-label MORF-057 for Maintenance Period
Group 5 (Part B)
EXPERIMENTALBlinded MORF-057 Dosing Regimen 2 for Induction Period and open-label MORF-057 for Maintenance Period
Group 6 (Part B)
PLACEBO COMPARATORBlinded matching placebo for Induction Period and open-label MORF-057 for Maintenance Period
Interventions
Matching placebo (identical appearance to MORF-057) administered orally.
MORF-057 is a small molecule that is designed to selectively inhibit integrin α4β7 and is administered orally.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (226)
Gastro Care Institute
Lancaster, California, 93534, United States
Infinity Clinical Research
San Diego, California, 92108, United States
Peak Gastroenterology Associates - Colorado Springs
Colorado Springs, Colorado, 80921, United States
Clinical Research of Osceola
Kissimmee, Florida, 34741, United States
Bioresearch Partner-Kendale Lakes
Miami, Florida, 33155, United States
Endoscopic Research Inc
Orlando, Florida, 32803, United States
Tropical Clinical Trials
Palmetto Bay, Florida, 33176, United States
Atlanta Gastroenterology Specialists, PC
Atlanta, Georgia, 30024, United States
Atlanta Gastroenterology Associates (Part of United Digestive)
Atlanta, Georgia, 30342, United States
Tandem Clinical Research
Houma, Louisiana, 70360, United States
SSM Health DePaul Hospital- St. Louis
Bridgeton, Missouri, 063044, United States
Las Vegas Clinical Trials
North Las Vegas, Nevada, 89030, United States
Cross Creek Medical Clinic
Fayetteville, North Carolina, 28304, United States
Peters Medical Research
High Point, North Carolina, 27260, United States
Wake Research Associates
Raleigh, North Carolina, 27612, United States
Palmetto Gastroenterology Clinical Research
Summerville, South Carolina, 29486, United States
Gastrointestinal Associates of Northeast Tennessee
Johnson City, Tennessee, 44060, United States
GI Alliance - Cedar Park
Cedar Park, Texas, 78613, United States
North Texas Gastroenterology
Denton, Texas, 76210, United States
The University of Texas Health Science Center at Houston
Houston, Texas, 77030, United States
Prime Clinical Research - Lewisville
Lewisville, Texas, 75067, United States
Prime Clinical Research
Mansfield, Texas, 76063, United States
Tyler Research Institute, LLC
Tyler, Texas, 75701, United States
Care Access Research - Ogden
Ogden, Utah, 84403, United States
Gastroenterology Associates of Central Virginia
Lynchburg, Virginia, 24502, United States
Southern Adelaide Local Health Network
Bedford Park, 5042, Australia
Royal Brisbane and Women's Hospital
Herston, 4029, Australia
IBD SA SA Group of Specialists
Kurralta Park, 5037, Australia
The Alfred Hospital
Melbourne, 3004, Australia
St. Vincent's Hospital
Melbourne, 3065, Australia
Royal Perth Hospital
Perth, 6000, Australia
Sir Charles Gairdner Hospital
Perth, 6009, Australia
Princess Alexandra Hospital, Metro South Health
Woolloongabba, QLD, 4102, Australia
Medical University Hematology
Innsbruck, 6020, Austria
Salzburg Regional Hospital
Salzburg, 5020, Austria
University Hospital St. Poelten
Sankt Pölten, 3100, Austria
Medical University of Vienna
Vienna, 1090, Austria
University Clinical Centre of the Republic of Srpska
Banja Luka, 78000, Bosnia and Herzegovina
Hospital Plava Medical Group
Tuzla, 75000, Bosnia and Herzegovina
Cantonal Hospital Zenica, Department of Internal Medicine
Zenica, 72000, Bosnia and Herzegovina
NewData FBHC, NewData Clinical Research
Aracaju, 49075-000, Brazil
Faculdade de Medicina da UNESP
Botucatu, 18618-687, Brazil
Chronos Pesquisa Clínica
Brasília, 72145-450, Brazil
Loema Clinical Research Institute and Consultants SS Ltda- i9 Clinical Research
Campinas, 13093-133, Brazil
Pesquisare
Santo André, 09080-110, Brazil
Clínica Hepatogastro JK
São Paulo, 04543-011, Brazil
"Medical Center Kanev" EOOD
Rousse, 7002, Bulgaria
Diagnostic Consultative Center XX - Sofia
Sofia, 1618, Bulgaria
CaRe Clinic
Alberta, T4P 1K4, Canada
Integrated University Health and Social Services Center of Saguenay-Lac-Saint-Jean
Chicoutimi, G7H 5H6, Canada
Nova Scotia Health Authority
Halifax, B3H 1V7, Canada
Prairie Institute of Liver and Luminal Advanced Research
Lethbridge, T1J 4G9, Canada
London Health Sciences Centre
London, N6A 4L6, Canada
London Digestive Disease Institute
London, N6K 1M6, Canada
Clinique IMD
Montreal, H3H 1E8, Canada
Diex Recherche Quebec Inc.
Québec, G1V 4T3, Canada
Scarborough Center for Inflammatory Bowel Disease
Scarborough, M1B 3V4, Canada
Mount Sinai Hospital
Toronto, M5G 1X5, Canada
St Joseph'S Health Centre Toronto
Toronto, M6R 1B5, Canada
Toronto Digestive Disease Associates, Inc.
Vaughan, L4L 4Y7, Canada
Cardiomet Cequin S.A.S., Research Unit
Armenia, 630004, Colombia
Fundación Valle del Lili
Cali, 760032, Colombia
Cardiovascular Foundation of Colombia
Floridablanca, 681017, Colombia
Corporation for Health Studies "CES"
Medellín, 050012, Colombia
Hospital Pablo Tobon Uribe
Medellín, 050034, Colombia
Northern University Foundation Hospital
Soledad, 083001, Colombia
Poliklinika Borzan
Osijek, 31000, Croatia
Specialty hospital Medico Rijeka
Rijeka, 51000, Croatia
General Hospital Zadar
Zadar, 23000, Croatia
Poliklinika Solmed
Zagreb, 10000, Croatia
SurGal Clinic s.r.o.
Brno, 602 00, Czechia
Military Hospital Brno,
Brno, 615 00, Czechia
Clinoxus s.r.o., Outpatient Clinic Budejovicka
Prague, 140 00, Czechia
Axon Clinical, s.r.o.
Prague, 14000, Czechia
East Tallinn Central Hospital
Tallinn, 10138, Estonia
West Tallinn Central Hospital
Tallinn, 10617, Estonia
Tartu University Hospital, Department of Gastroenterology
Tartu, 50406, Estonia
Hospices Civils de Lyon - Lyon Sud
Pierre-Bénite, 69310, France
CHRU Nancy Brabois - Hôpital d'Enfants
Vandœuvre-lès-Nancy, 54500, France
High Technology Hospital Medcenter LLC
Batumi, 6010, Georgia
Emergency Cardiology Center by Academician G. Chapidze LLC
Tbilisi, 0159, Georgia
LTD Institute of Clinical Cardiology
Tbilisi, 0159, Georgia
LTD Aversi Clinic
Tbilisi, 0160, Georgia
LEPL The First University Clinic of Tbilisi State Medical University
Tbilisi, 0178, Georgia
LTD The First Medical Center
Tbilisi, 0180, Georgia
Charite - University Hospital Berlin
Berlin, 10117, Germany
DRK Clinic Berlin-Koepenick
Berlin, 12559, Germany
Medical Care Unit Dachau
Dachau, 85221, Germany
Sana Hospital Duisburg
Duisburg, 53119, Germany
Agaplesion Markus Hospital
Frankfurt am Main, 60431, Germany
University Hospital Halle (Saale)
Halle, 06120, Germany
Universitätsklinikum Heidelberg
Heidelberg, 69120, Germany
University Hospital Schleswig-Holstein
Kiel, 24105, Germany
University of Leipzig Medical Cent
Leipzig, 04103, Germany
GastroPraxis Magdeburg
Magdeburg, 110 39104, Germany
Hospital Ludwig-Maximilians-University Munich, Campus Grosshadern
Munich, 81377, Germany
Group Practice Jakobeit
Wipperfürth, 51688, Germany
Wolfsburg Hospital Department of internal Medicine
Wolfsburg, 38440, Germany
Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaz IV. Belgyogyaszat
Békéscsaba, 5600, Hungary
Semmelweis Medical University
Budapest, 1083, Hungary
Markhot Ferenc Oktatókórház
Eger, 3300, Hungary
Bugat Pal Hospital Gyongyos
Gyöngyös, 3200, Hungary
CLINFAN Szolgáltató Kft
Szekszárd, 7100, Hungary
Fejer County St. Gyorgy University Teaching Hospital
Székesfehérvár, H-8000, Hungary
Navneet Memorial Hospital SUSHRUSHA
Ahmedabad, 380009, India
Institute of Medical Sciences & SUM Hospital, Siksha 'O' Anusandhan, Department of Gastroenterology & Hepatology
Bhubaneswar, 751003, India
Apollo Cancer Centre
Chennai, 600035, India
VGM Hospital
Coimbatore, 641005, India
SMS Medical College Hospital
Jaipur, 302004, India
S R Kalla Memorial Gastro and General Hospital
Jaipur, 302006, India
Lisie Hospital
Kochi, 682017, India
Amrita Institute of Medical Sciences and Research Centre
Kochi, 682041, India
Dayanand Medical College and Hospital
Ludhiana, 141001, India
Max Super Speciality Hospital
New Delhi, 110 017, India
Noble Hospital Pvt Ltd
Pune, 411013, India
Prime Institute of Digestive Sciences
Rajkot, 360001, India
Shree Giriraj Multispeciality Hospital
Rajkot, 360005, India
Yashoda Hospital
Secunderabad, 500003, India
SIDS Hospital and Research Centre
Surat, 395002, India
Samvedna Hospital
Varanasi, 221005, India
Policlinico S. Orsola-Malpighi
Bologna, 40138, Italy
Poliambulanza Hospital
Brescia, 25124, Italy
Universita Degli Studi-Magna Graecia-de Catanzaro
Catanzaro, 88100, Italy
Big Metropolitan Hospital Niguarda Regional Health Authority
Milan, 20162, Italy
IRCCS San Raffaele
Milan, 20132, Italy
Ospedale Sacro Cuore Don G. Calabria
Negrar, 37024, Italy
Hospital of Padova
Padova, 35128, Italy
Azienda Ospedaliera San Camillo Forlanini
Roma, 00152, Italy
IRCCS Istituto Clinico Humanitas- Centro Malattie Infiammatorie Intestinali
Rozzano, 20089, Italy
IRCCS Policlinico San Donato
San Donato Milanese, 20097, Italy
IRCCS Ospedale Casa Sollievo della Sofferenza
San Giovanni Rotondo, 71013, Italy
University Hospital City of Health and Science of Turin - Hospital Molinette
Turin, 10126, Italy
Asahikawa Medical College Hospital
Asahikawa, 078-8510, Japan
Institute of Science Tokyo Hospital
Bunkyō, 113-8519, Japan
Fukuoka University Chikushi Hospital
Chikushino-shi, 818-8502, Japan
Kokikai Tsujinaka Hospital Kashiwanoha
Kashiwa-shi, 277-0871, Japan
Kobe University Hospital
Kobe, 650-0017, Japan
Yamanashi Prefectural Central Hospital
Kofu, 400-0027, Japan
Nagasaki University Hospital
Nagasaki, 852-8501, Japan
Nara Prefecture General Medical Center
Nara, 630-8054, Japan
Osaka Metropolitan University Hospital
Osaka, 5450051, Japan
Saga University Hospital
Saga, 849-8501, Japan
Tokitokai Tokito Clinic
Saitama, 336-0963, Japan
Saitama Medical Center
Saitama-Ken, 350 8550, Japan
Toho University Sakura Medical Center
Sakura, 285-8741, Japan
Sapporo Higashi Tokushukai Hospital
Sapporo, 065-0033, Japan
Tokyo Yamate Medical Center
Tokyo, 169-0073, Japan
Scientific Research Institute of Cardiology and Internal Disease of the Ministry of Health of the Republic of Kazakhstan
Almaty, 050000, Kazakhstan
National Research Medical Center
Astana, Z00P6K6, Kazakhstan
Sana Clinic
Astana, Z00P6K6, Kazakhstan
Karaganda Medical University
Karaganda, 100000, Kazakhstan
Semey Medical University
Semey, 071400, Kazakhstan
"Gastromed" Medical Center
Shymkent, 160005, Kazakhstan
Diagnostic Center of Shymkent
Shymkent, 160021, Kazakhstan
Liepaja Regional Hospital
Liepāja, LV-3414, Latvia
Pauls Stradins Clinical Univeristy Hospital
Riga, LV-1002, Latvia
Applied Neuroscience Research Institute A.C.
Durango, 34000, Mexico
Proactive CR México SA de CV
Irapuato, 36520, Mexico
Medical Clinical Surgical Center Specialized in Research
Jalisco, 45640, Mexico
Key Stone Clinical Trials
Mexico City, Distrito Federal, 06100, Mexico
Medical Care and Research SA de CV
Mérida, 97070, Mexico
Centro de Investigacion Clinica Chapultepec S.A. de C.V.
Morelia, 58260, Mexico
Oaxaca Site Management Organization
Oaxaca City, 68000, Mexico
Centro de Estudios Clínicos de Querétaro (CECLIQ)
Querétaro, 76000, Mexico
PMSI "Timofei Mosneaga" Republican Clinical Hospital, Outpatient Department
Chisinau, MD-2025, Moldova
PMSI "Timofei Mosneaga" Republican Clinical Hospital, Therapy Department, Division of Gastroenterology
Chisinau, MD-2025, Moldova
"Sfanta Treime" Municipal Clinical Hospital
Chisinau, MD-2068, Moldova
Rtl Sm Srl
Chisinau, MD2072, Moldova
"MEDIS" Medical Center
Bydgoszcz, 85-229, Poland
Non-public Health Care Center KERmed Medical Centre
Bydgoszcz, 85-231, Poland
CLINSANTE Clinical Research Centre Ewa Galczak-Nowak, Malgorzata Trzaska
Bydgoszcz, 85-794, Poland
Synexus Polska Sp. Z o.o. Branch in Czestochowa
Częstochowa, 42-202, Poland
St. John Paul 2nd Municipal Hospital in Elblag
Elblag, 82-300, Poland
AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Gdansku
Gdansk, 80-382, Poland
Synexus Polska - Katowicach
Katowice, 40-040, Poland
"Vita Longa" Non-Public Healthcare Facility, Limited Liability Company
Katowice, 40-748, Poland
PLEJADY Medical Centre
Krakow, 30-363, Poland
"Landa" Specialist Doctor's Offices
Krakow, 31-156, Poland
Oslomed Medical Center
Krakow, 31-228, Poland
GLOBE Clinical Research Sp. z o.o.
Kłodzko, 57-300, Poland
Twoja Przychodnia Medical Centre of Opole
Opole, 45-819, Poland
EMC Medical Institute Joint Stock Company, "Certus" Private Healthcare Facility Hospital No. 1
Poznan, 60-309, Poland
Twoja Przychodnia Medical Centre of Poznan
Poznan, 60-324, Poland
Synexus Polska Sp. z o.o. Branch in Poznan
Poznan, 81-537, Poland
Endoskopia Sp. z.o.o.
Sopot, 81-756, Poland
Twoja Przychodnia-Szczecinskie Centrum Medyczne
Szczecin, 71-434, Poland
H-T. Medical Center
Tychy, 43-100, Poland
MDM Healthcare Centre
Warsaw, 00-189, Poland
Synexus Polska Sp. z o.o. Oddzial w Warszawie
Warsaw, 02-672, Poland
ETG Warszawa
Warsaw, 02-677, Poland
WSD Medi
Warsaw, 02-786, Poland
WIP Warsaw IBD Point Profesor Kierkus
Warsaw, 04-501, Poland
Synexus Polska Sp. z o.o.
Wroclaw, 50-381, Poland
Medical Centre Oporow
Wroclaw, 52-416, Poland
"Sfanta Vineri" Medical Center
Bucharest, 011273, Romania
Monza Oncology Hospital SRL
Bucharest, 013823, Romania
Colentina Clinical Hospital
Bucharest, 020125, Romania
Oncohelp Association
Timișoara, 300239, Romania
Zvezdara University Medical Center
Belgrade, 11 000, Serbia
Clinical Center " Dr Dragisa Misovic Dedinje"
Belgrade, 11000, Serbia
Clinical Hospital Center Bezanijska Kosa
Belgrade, 11000, Serbia
General Hospital Leskovac
Leskovac, 16000, Serbia
General Hospital Uzice
Užice, 31000, Serbia
General Hospital "Djordje Joanovic"
Zrenjanin, 23000, Serbia
Cliniq s.r.o.
Bratislava, 811 09, Slovakia
ENDOMED s.r.o.
Košice, 04013, Slovakia
GASTRO I., s.r.o.
Prešov, 08001, Slovakia
Gastro LM s.r.o.
Prešov, 08001, Slovakia
Complejo Hospitalario Universitario de Ferrol (CHUF)- Hospital Naval
Ferrol, 15405, Spain
Hospital Universitario Arnau de Vilanova de Lleida
Lleida, 25198, Spain
Hospital Universitario La Paz
Madrid, 28046, Spain
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, 28222, Spain
Hospital Universitario Virgen Macarena
Seville, 41009, Spain
University and Polytechnic Hospital La Fe
Valencia, 46026, Spain
Ditmanson Medical Foundation Chia-Yi Christian Hospital
Chiayi City, 60002, Taiwan
National Taiwan University Hospital
Hsinchu, 302, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 807377, Taiwan
Kaohsiung Veterans General Hospital
Kaohsiung City, 81362, Taiwan
Far Eastern Memorial Hospital
New Taipei City, 22060, Taiwan
China Medical University Hospital
Taichung, 404327, Taiwan
Taichung Veterans General Hospital
Taichung, 407219, Taiwan
Chi Mei Medical Center
Tainan, 71004, Taiwan
National Taiwan University Hospital
Taipei, 100225, Taiwan
Mackay Memorial Hospital
Taipei, 10449, Taiwan
Taipei Veterans General Hospital
Taipei, 11217, Taiwan
Chang Gung Memorial Hospital - Linkou
Taoyuan City, 333, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
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)
Eli Lilly and Company
Central Study Contacts
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACT
Physicians interested in becoming principal investigators please contact
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 16, 2024
First Posted
January 26, 2024
Study Start
July 18, 2024
Primary Completion (Estimated)
September 1, 2028
Study Completion (Estimated)
June 1, 2030
Last Updated
June 4, 2026
Record last verified: 2026-06