A Phase 2 Study to Evaluate MORF-057 in Adults With Moderately to Severely Active Crohn's Disease
NCT ID: NCT06226883
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
210 participants
INTERVENTIONAL
2024-07-18
2028-08-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Group 1
Blinded MORF-057 Dosing Regimen 1 for Induction Period and open-label MORF-057 for Maintenance Period
MORF-057
MORF-057 is a small molecule that is designed to selectively inhibit integrin α4β7 and is administered orally.
Group 2
Blinded MORF-057 Dosing Regimen 2 for Induction Period and open-label MORF-057 for Maintenance Period
MORF-057
MORF-057 is a small molecule that is designed to selectively inhibit integrin α4β7 and is administered orally.
Group 3
Blinded matching placebo for Induction Period and open-label MORF-057 for Maintenance Period
Placebo
Matching placebo (identical appearance to MORF-057) administered orally.
MORF-057
MORF-057 is a small molecule that is designed to selectively inhibit integrin α4β7 and is administered orally.
Interventions
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Placebo
Matching placebo (identical appearance to MORF-057) administered orally.
MORF-057
MORF-057 is a small molecule that is designed to selectively inhibit integrin α4β7 and is administered orally.
Eligibility Criteria
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Inclusion Criteria
* 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)
* Agrees to abide by the study guidelines and requirements
* Capable of giving signed informed consent
Exclusion Criteria
* 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
18 Years
85 Years
ALL
No
Sponsors
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Morphic Therapeutic, Inc. (A Wholly Owned Subsidiary of Eli Lilly and Company)
INDUSTRY
Responsible Party
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Principal Investigators
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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)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Gastro Care Institute
Lancaster, California, United States
Wake Research Associates
Raleigh, North Carolina, United States
Palmetto Gastroenterology Clinical Research
Summerville, South Carolina, United States
Gastrointestinal Associates of Northeast Tennessee
Johnson City, Tennessee, United States
GI Alliance - Cedar Park
Cedar Park, Texas, United States
The University of Texas Health Science Center at Houston
Houston, Texas, United States
Texas Digestive Disease Consultants
San Marcos, Texas, United States
Tyler Research Institute, LLC
Tyler, Texas, United States
Care Access Research - Ogden
Ogden, Utah, United States
Gastroenterology Associates of Central Virginia
Lynchburg, Virginia, United States
Medical University Hematology
Innsbruck, , Austria
Salzburg Regional Hospital
Salzburg, , Austria
University Hospital St. Poelten
Sankt Pölten, , Austria
Medical University of Vienna
Vienna, , Austria
Chronos Pesquisa Clínica
Brasília, , Brazil
Pesquisare
Santo André, , Brazil
Pesquisare
Santo André, , Brazil
Clínica Hepatogastro JK
São Paulo, , Brazil
Nova Scotia Health Authority
Halifax, , Canada
London Health Sciences Centre
London, , Canada
Hopital Maisonneuve-Rosemont
Montreal, , Canada
Diex Recherche Quebec Inc.
Québec, , Canada
Mount Sinai Hospital
Toronto, , Canada
St Joseph'S Health Centre Toronto
Toronto, , Canada
Toronto Digestive Disease Associates, Inc.
Vaughan, , Canada
Cardiomet Cequin S.A.S., Research Unit
Armenia, , Colombia
Fundación Valle del Lili
Cali, , Colombia
Cardiovascular Foundation of Colombia
Floridablanca, , Colombia
Corporation for Health Studies "CES"
Medellín, , Colombia
Hospital Pablo Tobon Uribe
Medellín, , Colombia
Northern University Foundation Hospital
Soledad, , Colombia
Poliklinika Borzan
Osijek, , Croatia
Specialty hospital Medico Rijeka
Rijeka, , Croatia
Virovitica General Hospital
Virovitica, , Croatia
General Hospital Zadar
Zadar, , Croatia
Poliklinika Solmed
Zagreb, , Croatia
SurGal Clinic s.r.o.
Brno, , Czechia
Military Hospital Brno,
Brno, , Czechia
Clinoxus s.r.o., Outpatient Clinic Budejovicka
Prague, , Czechia
Axon Clinical, s.r.o.
Prague, , Czechia
Hospices Civils de Lyon - Lyon Sud
Pierre-Bénite, , France
CHU de Saint-Etienne
Saint-Etienne, , France
CHRU Nancy Brabois - Hôpital d'Enfants
Vandœuvre-lès-Nancy, , France
High Technology Hospital Medcenter LLC
Batumi, , Georgia
Emergency Cardiology Center by Academician G. Chapidze LLC
Tbilisi, , Georgia
LTD Institute of Clinical Cardiology
Tbilisi, , Georgia
LTD Aversi Clinic
Tbilisi, , Georgia
LEPL The First University Clinic of Tbilisi State Medical University
Tbilisi, , Georgia
LTD The First Medical Center
Tbilisi, , Georgia
Charite - University Hospital Berlin
Berlin, , Germany
emovis GmbH - Futuremeds
Berlin, , Germany
DRK Clinic Berlin-Koepenick
Berlin, , Germany
Medical Care Unit Dachau
Dachau, , Germany
Sana Hospital Duisburg
Duisburg, , Germany
University Hospital Halle (Saale)
Halle, , Germany
Universitätsklinikum Heidelberg
Heidelberg, , Germany
University Hospital Schleswig-Holstein
Kiel, , Germany
University Hospital Ulm
Ulm, , Germany
Group Practice Jakobeit
Wipperfürth, , Germany
Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaz IV. Belgyogyaszat
Békéscsaba, , Hungary
Semmelweis Medical University
Budapest, , Hungary
Markhot Ferenc Oktatókórház
Eger, , Hungary
Bugat Pal Hospital Gyongyos
Gyöngyös, , Hungary
CLINFAN Szolgáltató Kft
Szekszárd, , Hungary
Fejer County St. Gyorgy University Teaching Hospital
Székesfehérvár, , Hungary
Navneet Memorial Hospital SUSHRUSHA
Ahmedabad, , India
Apollo Cancer Centre
Chennai, , India
SMS Medical College Hospital
Jaipur, , India
S R Kalla Memorial Gastro and General Hospital
Jaipur, , India
Amrita Institute of Medical Sciences and Research Centre
Kochi, , India
Max Super Speciality Hospital
New Delhi, , India
Noble Hospital Pvt Ltd
Pune, , India
Prime Institute of Digestive Sciences
Rajkot, , India
Shree Giriraj Multispeciality Hospital
Rajkot, , India
Yashoda Hospital
Secunderabad, , India
SIDS Hospital and Research Centre
Surat, , India
Samvedna Hospital
Varanasi, , India
Policlinico S. Orsola-Malpighi
Bologna, , Italy
Big Metropolitan Hospital Niguarda Regional Health Authority
Milan, , Italy
IRCCS San Raffaele
Milan, , Italy
Ospedale Sacro Cuore Don G. Calabria
Negrar, , Italy
Azienda Ospedaliera San Camillo Forlanini
Roma, , Italy
IRCCS Istituto Clinico Humanitas- Centro Malattie Infiammatorie Intestinali
Rozzano, , Italy
IRCCS Policlinico San Donato
San Donato Milanese, , Italy
IRCCS Ospedale Casa Sollievo della Sofferenza
San Giovanni Rotondo, , Italy
Ospedale Santa Maria della Misericordia, Clinica Ematologica ASUFC (Azienda Sanitaria Universitaria Friuli Centrale)
Udine, , Italy
Asahikawa Medical College Hospital
Asahikawa, , Japan
Institute of Science Tokyo Hospital
Bunkyō, , Japan
Fukuoka University Chikushi Hospital
Chikushino-shi, , Japan
Kokikai Tsujinaka Hospital Kashiwanoha
Kashiwa-shi, , Japan
Yamanashi Prefectural Central Hospital
Kofu, , Japan
Nagasaki University Hospital
Nagasaki, , Japan
Nara Prefecture General Medical Center
Nara, , Japan
Osaka Metropolitan University Hospital
Osaka, , Japan
Tokitokai Tokito Clinic
Saitama, , Japan
Toho University Sakura Medical Center
Sakura, , Japan
Sapporo Higashi Tokushukai Hospital
Sapporo, , Japan
Tokyo Yamate Medical Center
Tokyo, , Japan
Scientific Research Institute of Cardiology and Internal Disease of the Ministry of Health of the Republic of Kazakhstan
Almaty, , Kazakhstan
National Research Medical Center
Astana, , Kazakhstan
Sana Clinic
Astana, , Kazakhstan
Karaganda Medical University
Karaganda, , Kazakhstan
Semey Medical University
Semey, , Kazakhstan
"Gastromed" Medical Center
Shymkent, , Kazakhstan
Diagnostic Center of Shymkent
Shymkent, , Kazakhstan
Liepaja Regional Hospital
Liepāja, , Latvia
Pauls Stradins Clinical Univeristy Hospital
Riga, , Latvia
Applied Neuroscience Research Institute A.C.
Durango, , Mexico
Medical Clinical Surgical Center Specialized in Research
Jalisco, , Mexico
Key Stone Clinical Trials
Mexico City, Distrito Federal, , Mexico
Centro de Investigacion Clinica Chapultepec S.A. de C.V.
Morelia, , Mexico
Centro de Estudios Clínicos de Querétaro (CECLIQ)
Querétaro, , Mexico
"MEDIS" Medical Center
Bydgoszcz, , Poland
Non-public Health Care Center KERmed Medical Centre
Bydgoszcz, , Poland
CLINSANTE Clinical Research Centre Ewa Galczak-Nowak, Malgorzata Trzaska
Bydgoszcz, , Poland
Synexus Polska Sp. Z o.o. Branch in Czestochowa
Częstochowa, , Poland
St. John Paul 2nd Municipal Hospital in Elblag
Elblag, , Poland
AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Gdansku
Gdansk, , Poland
Synexus Polska - Katowicach
Katowice, , Poland
"Vita Longa" Non-Public Healthcare Facility, Limited Liability Company
Katowice, , Poland
PLEJADY Medical Centre
Krakow, , Poland
"Landa" Specialist Doctor's Offices
Krakow, , Poland
Twoja Przychodnia Medical Centre of Opole
Opole, , Poland
EMC Medical Institute Joint Stock Company, "Certus" Private Healthcare Facility Hospital No. 1
Poznan, , Poland
Twoja Przychodnia Medical Centre of Poznan
Poznan, , Poland
Synexus Polska Sp. z o.o. Branch in Poznan
Poznan, , Poland
Endoskopia Sp. z.o.o.
Sopot, , Poland
Twoja Przychodnia-Szczecinskie Centrum Medyczne
Szczecin, , Poland
H-T. Medical Center
Tychy, , Poland
MDM Healthcare Centre
Warsaw, , Poland
Synexus Polska Sp. z o.o. Oddzial w Warszawie
Warsaw, , Poland
WSD Medi
Warsaw, , Poland
WIP Warsaw IBD Point Profesor Kierkus
Warsaw, , Poland
Synexus Polska Sp. z o.o.
Wroclaw, , Poland
Medical Centre Oporow
Wroclaw, , Poland
"Sfanta Vineri" Medical Center
Bucharest, , Romania
Monza Oncology Hospital SRL
Bucharest, , Romania
Colentina Clinical Hospital
Bucharest, , Romania
Gastromed S.R.L.
Constanța, , Romania
Oncohelp Association
Timișoara, , Romania
Zvezdara University Medical Center
Belgrade, , Serbia
Clinical Center " Dr Dragisa Misovic Dedinje"
Belgrade, , Serbia
Clinical Hospital Center Bezanijska Kosa
Belgrade, , Serbia
Clinical Center Kragujevac
Kragujevac, , Serbia
General Hospital Leskovac
Leskovac, , Serbia
Clinical Center of Vojvodina
Novi Sad, , Serbia
General Hospital Uzice
Užice, , Serbia
General Hospital "Djordje Joanovic"
Zrenjanin, , Serbia
Cliniq s.r.o.
Bratislava, , Slovakia
ENDOMED s.r.o.
Košice, , Slovakia
GASTRO I., s.r.o.
Prešov, , Slovakia
Gastro LM s.r.o.
Prešov, , Slovakia
Complejo Hospitalario Universitario de Ferrol (CHUF)- Hospital Naval
Ferrol, , Spain
Hospital Universitario Arnau de Vilanova de Lleida
Lleida, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, , Spain
Hospital Universitario Virgen Macarena
Seville, , Spain
University and Polytechnic Hospital La Fe
Valencia, , Spain
Countries
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Central Contacts
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Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
Role: CONTACT
Phone: 1-317-615-4559
Email: [email protected]
Physicians interested in becoming principal investigators please contact
Role: CONTACT
Email: [email protected]
Facility Contacts
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Other Identifiers
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27383
Identifier Type: -
Identifier Source: org_study_id
J6E-MC-KWAB
Identifier Type: OTHER
Identifier Source: secondary_id
MORF-057-203
Identifier Type: OTHER
Identifier Source: secondary_id