A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of 2 Active Dose Regimens of MORF-057 in Adults With Moderately to Severely Active Crohn's Disease (GARNET)
Status: Recruiting
Location: See all (156) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
This is a Phase 2, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of 2 active dose regimens of MORF-057 in adult study participants with moderately to severely active Crohn's disease (CD).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:
• Has signs/symptoms of CD for at least 3 months 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)
• Agrees to abide by the study guidelines and requirements
• Capable of giving signed informed consent
Locations
United States
California
Gastro Care Institute
RECRUITING
Lancaster
Florida
IHS Health Research
NOT_YET_RECRUITING
Kissimmee
North Carolina
Wake Research Associates
RECRUITING
Raleigh
South Carolina
Palmetto Gastroenterology Clinical Research
RECRUITING
Summerville
Tennessee
Gastrointestinal Associates of Northeast Tennessee
RECRUITING
Johnson City
Texas
GI Alliance - Cedar Park
RECRUITING
Cedar Park
The University of Texas Health Science Center at Houston
NOT_YET_RECRUITING
Houston
Texas Digestive Disease Consultants
NOT_YET_RECRUITING
San Marcos
Tyler Research Institute, LLC
RECRUITING
Tyler
Utah
Care Access Research - Ogden
RECRUITING
Ogden
Virginia
Gastroenterology Associates of Central Virginia
RECRUITING
Lynchburg
Other Locations
Austria
Medical University Hematology
NOT_YET_RECRUITING
Innsbruck
Salzburg Regional Hospital
RECRUITING
Salzburg
University Hospital St. Poelten
NOT_YET_RECRUITING
Sankt Pölten
Medical University of Vienna
RECRUITING
Vienna
Brazil
Chronos Pesquisa Clínica
RECRUITING
Brasília
Pesquisare
NOT_YET_RECRUITING
Santo André
Pesquisare
RECRUITING
Santo André
Clínica Hepatogastro JK
RECRUITING
São Paulo
Canada
University of Calgary
NOT_YET_RECRUITING
Calgary
Nova Scotia Health Authority
RECRUITING
Halifax
London Health Sciences Centre
RECRUITING
London
Hopital Maisonneuve-Rosemont
NOT_YET_RECRUITING
Montreal
Diex Recherche Quebec Inc.
RECRUITING
Québec
Mount Sinai Hospital
NOT_YET_RECRUITING
Toronto
St Joseph'S Health Centre Toronto
RECRUITING
Toronto
Toronto Digestive Disease Associates, Inc.
RECRUITING
Vaughan
Colombia
Cardiomet Cequin S.A.S., Research Unit
RECRUITING
Armenia
Fundación Valle del Lili
RECRUITING
Cali
Cardiovascular Foundation of Colombia
NOT_YET_RECRUITING
Floridablanca
Corporation for Health Studies CES
RECRUITING
Medellín
Hospital Pablo Tobon Uribe
RECRUITING
Medellín
Northern University Foundation Hospital
NOT_YET_RECRUITING
Soledad
Croatia
Poliklinika Borzan
RECRUITING
Osijek
Specialty hospital Medico Rijeka
RECRUITING
Rijeka
Virovitica General Hospital
NOT_YET_RECRUITING
Virovitica
General Hospital Zadar
NOT_YET_RECRUITING
Zadar
Poliklinika Solmed
RECRUITING
Zagreb
France
Hospices Civils de Lyon - Lyon Sud
RECRUITING
Pierre-bénite
CHU de Saint-Etienne
NOT_YET_RECRUITING
Saint-etienne
CHRU Nancy Brabois - Hôpital d'Enfants
RECRUITING
Vandœuvre-lès-nancy
Georgia
High Technology Hospital Medcenter LLC
RECRUITING
Batumi
Emergency Cardiology Center by Academician G. Chapidze LLC
RECRUITING
Tbilisi
LEPL The First University Clinic of Tbilisi State Medical University
RECRUITING
Tbilisi
LTD Aversi Clinic
RECRUITING
Tbilisi
LTD Institute of Clinical Cardiology
RECRUITING
Tbilisi
LTD The First Medical Center
RECRUITING
Tbilisi
Germany
Charite - University Hospital Berlin
NOT_YET_RECRUITING
Berlin
DRK Clinic Berlin-Koepenick
NOT_YET_RECRUITING
Berlin
emovis GmbH - Futuremeds
NOT_YET_RECRUITING
Berlin
Medical Care Unit Dachau
RECRUITING
Dachau
Sana Hospital Duisburg
RECRUITING
Duisburg
University Hospital Halle (Saale)
RECRUITING
Halle
Universitätsklinikum Heidelberg
RECRUITING
Heidelberg
University Hospital Schleswig-Holstein
NOT_YET_RECRUITING
Kiel
University Hospital Ulm
NOT_YET_RECRUITING
Ulm
Group Practice Jakobeit
RECRUITING
Wipperfürth
Hungary
Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaz IV. Belgyogyaszat
RECRUITING
Békéscsaba
Semmelweis Medical University
RECRUITING
Budapest
Markhot Ferenc Oktatókórház
RECRUITING
Eger
Bugat Pal Hospital Gyongyos
RECRUITING
Gyöngyös
Fejer County St. Gyorgy University Teaching Hospital
RECRUITING
Székesfehérvár
CLINFAN Szolgáltató Kft
RECRUITING
Szekszárd
India
Navneet Memorial Hospital SUSHRUSHA
RECRUITING
Ahmedabad
Apollo Cancer Centre
NOT_YET_RECRUITING
Chennai
S R Kalla Memorial Gastro and General Hospital
RECRUITING
Jaipur
SMS Medical College Hospital
RECRUITING
Jaipur
Amrita Institute of Medical Sciences and Research Centre
RECRUITING
Kochi
Max Super Speciality Hospital
RECRUITING
New Delhi
Noble Hospital Pvt Ltd
NOT_YET_RECRUITING
Pune
Prime Institute of Digestive Sciences
RECRUITING
Rajkot
Shree Giriraj Multispeciality Hospital
RECRUITING
Rajkot
Yashoda Hospital
RECRUITING
Secunderabad
SIDS Hospital and Research Centre
RECRUITING
Surat
Samvedna Hospital
RECRUITING
Varanasi
Italy
Policlinico S. Orsola-Malpighi
RECRUITING
Bologna
Big Metropolitan Hospital Niguarda Regional Health Authority
RECRUITING
Milan
IRCCS San Raffaele
RECRUITING
Milan
Ospedale Sacro Cuore Don G. Calabria
NOT_YET_RECRUITING
Negrar
Azienda Ospedaliera San Camillo Forlanini
RECRUITING
Roma
IRCCS Istituto Clinico Humanitas- Centro Malattie Infiammatorie Intestinali
RECRUITING
Rozzano
IRCCS Policlinico San Donato
RECRUITING
San Donato Milanese
IRCCS Ospedale Casa Sollievo della Sofferenza
RECRUITING
San Giovanni Rotondo
Ospedale Santa Maria della Misericordia, Clinica Ematologica ASUFC (Azienda Sanitaria Universitaria Friuli Centrale)
NOT_YET_RECRUITING
Udine
Japan
Asahikawa Medical College Hospital
NOT_YET_RECRUITING
Asahikawa
Institute of Science Tokyo Hospital
NOT_YET_RECRUITING
Bunkyō
Fukuoka University Chikushi Hospital
NOT_YET_RECRUITING
Chikushino-shi
Kokikai Tsujinaka Hospital Kashiwanoha
NOT_YET_RECRUITING
Kashiwa-shi
Yamanashi Prefectural Central Hospital
NOT_YET_RECRUITING
Kofu
Nagasaki University Hospital
NOT_YET_RECRUITING
Nagasaki
Nara Prefecture General Medical Center
NOT_YET_RECRUITING
Nara
Osaka Metropolitan University Hospital
NOT_YET_RECRUITING
Osaka
Tokitokai Tokito Clinic
NOT_YET_RECRUITING
Saitama
Toho University Sakura Medical Center
NOT_YET_RECRUITING
Sakura
Sapporo Higashi Tokushukai Hospital
NOT_YET_RECRUITING
Sapporo
Tokyo Yamate Medical Center
NOT_YET_RECRUITING
Tokyo
Kazakhstan
Scientific Research Institute of Cardiology and Internal Disease of the Ministry of Health of the Republic of Kazakhstan
RECRUITING
Almaty
National Research Medical Center
RECRUITING
Astana
Sana Clinic
RECRUITING
Astana
Karaganda Medical University
RECRUITING
Karaganda
Semey Medical University
NOT_YET_RECRUITING
Semey
Diagnostic Center of Shymkent
RECRUITING
Shymkent
Gastromed Medical Center
RECRUITING
Shymkent
Latvia
Liepaja Regional Hospital
NOT_YET_RECRUITING
Liepāja
Pauls Stradins Clinical Univeristy Hospital
RECRUITING
Riga
Mexico
Applied Neuroscience Research Institute A.C.
RECRUITING
Durango
Medical Clinical Surgical Center Specialized in Research
RECRUITING
Jalisco
Key Stone Clinical Trials
RECRUITING
Mexico City, Distrito Federal
Centro de Investigacion Clinica Chapultepec S.A. de C.V.
RECRUITING
Morelia
Centro de Estudios Clínicos de Querétaro (CECLIQ)
RECRUITING
Querétaro
Poland
CLINSANTE Clinical Research Centre Ewa Galczak-Nowak, Malgorzata Trzaska
RECRUITING
Bydgoszcz
MEDIS Medical Center
RECRUITING
Bydgoszcz
Non-public Health Care Center KERmed Medical Centre
RECRUITING
Bydgoszcz
Synexus Polska Sp. Z o.o. Branch in Czestochowa
RECRUITING
Częstochowa
St. John Paul 2nd Municipal Hospital in Elblag
RECRUITING
Elblag
AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Gdansku
RECRUITING
Gdansk
Synexus Polska - Katowicach
RECRUITING
Katowice
Vita Longa Non-Public Healthcare Facility, Limited Liability Company
RECRUITING
Katowice
Landa Specialist Doctor's Offices
RECRUITING
Krakow
PLEJADY Medical Centre
NOT_YET_RECRUITING
Krakow
Twoja Przychodnia Medical Centre of Opole
RECRUITING
Opole
EMC Medical Institute Joint Stock Company, Certus Private Healthcare Facility Hospital No. 1
RECRUITING
Poznan
Synexus Polska Sp. z o.o. Branch in Poznan
RECRUITING
Poznan
Twoja Przychodnia Medical Centre of Poznan
RECRUITING
Poznan
Endoskopia Sp. z.o.o.
RECRUITING
Sopot
Twoja Przychodnia-Szczecinskie Centrum Medyczne
RECRUITING
Szczecin
H-T. Medical Center
RECRUITING
Tychy
MDM Healthcare Centre
RECRUITING
Warsaw
Synexus Polska Sp. z o.o. Oddzial w Warszawie
RECRUITING
Warsaw
WIP Warsaw IBD Point Profesor Kierkus
RECRUITING
Warsaw
WSD Medi
RECRUITING
Warsaw
Medical Centre Oporow
RECRUITING
Wroclaw
Synexus Polska Sp. z o.o.
RECRUITING
Wroclaw
Romania
Colentina Clinical Hospital
RECRUITING
Bucharest
Monza Oncology Hospital SRL
RECRUITING
Bucharest
Sfanta Vineri Medical Center
RECRUITING
Bucharest
Gastromed S.R.L.
NOT_YET_RECRUITING
Constanța
Oncohelp Association
RECRUITING
Timișoara
Serbia
Clinical Center Dr Dragisa Misovic Dedinje
RECRUITING
Belgrade
Clinical Hospital Center Bezanijska Kosa
RECRUITING
Belgrade
Zvezdara University Medical Center
RECRUITING
Belgrade
Clinical Center Kragujevac
NOT_YET_RECRUITING
Kragujevac
General Hospital Leskovac
RECRUITING
Leskovac
Clinical Center of Vojvodina
NOT_YET_RECRUITING
Novi Sad
General Hospital Uzice
RECRUITING
Užice
General Hospital Djordje Joanovic
RECRUITING
Zrenjanin
Slovakia
Cliniq s.r.o.
RECRUITING
Bratislava
ENDOMED s.r.o.
RECRUITING
Košice
GASTRO I., s.r.o.
RECRUITING
Prešov
Gastro LM s.r.o.
RECRUITING
Prešov
Spain
Complejo Hospitalario Universitario de Ferrol (CHUF)- Hospital Naval
RECRUITING
Ferrol
Hospital Universitario Arnau de Vilanova de Lleida
RECRUITING
Lleida
Hospital Universitario La Paz
NOT_YET_RECRUITING
Madrid
Hospital Universitario Puerta de Hierro Majadahonda
RECRUITING
Majadahonda
Hospital Universitario Virgen Macarena
RECRUITING
Seville
University and Polytechnic Hospital La Fe
RECRUITING
Valencia
Contact Information
Primary
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
LillyTrials@Lilly.com
1-317-615-4559
Backup
Physicians interested in becoming principal investigators please contact
clinical_inquiry_hub@lilly.com
Time Frame
Start Date: 2024-07-18
Estimated Completion Date: 2028-08
Participants
Target number of participants: 210
Treatments
Experimental: Group 1
Blinded MORF-057 Dosing Regimen 1 for Induction Period and open-label MORF-057 for Maintenance Period
Experimental: Group 2
Blinded MORF-057 Dosing Regimen 2 for Induction Period and open-label MORF-057 for Maintenance Period
Placebo_comparator: Group 3
Blinded matching placebo for Induction Period and open-label MORF-057 for Maintenance Period
Related Therapeutic Areas
Sponsors
Leads: Morphic Therapeutic, Inc. (A Wholly Owned Subsidiary of Eli Lilly and Company)