- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT06226883
En fase 2-studie for å evaluere MORF-057 hos voksne med moderat til alvorlig aktiv Crohns sykdom (GARNET)
En fase 2, randomisert, dobbeltblind, placebokontrollert studie for å evaluere sikkerheten og effekten av 2 aktive doseregimer av MORF-057 hos voksne med moderat til alvorlig aktiv Crohns sykdom (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).
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Antatt)
Fase
- Fase 2
Kontakter og plasseringer
Studiekontakt
- Navn: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
- Telefonnummer: 1-317-615-4559
- E-post: LillyTrials@Lilly.com
Studer Kontakt Backup
- Navn: Physicians interested in becoming principal investigators please contact
- E-post: clinical_inquiry_hub@lilly.com
Studiesteder
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Bedford Park, Australia, 5042
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Herston, Australia, 4029
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- Royal Brisbane and Women's Hospital
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Kurralta Park, Australia, 5037
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Melbourne, Australia, 3004
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Melbourne, Australia, 3065
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Perth, Australia, 6000
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Perth, Australia, 6009
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Woolloongabba, QLD, Australia, 4102
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Banja Luka, Bosnia og Herzegovina, 78000
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Tuzla, Bosnia og Herzegovina, 75000
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Zenica, Bosnia og Herzegovina, 72000
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Aracaju, Brasil, 49075-000
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Botucatu, Brasil, 18618-687
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Brasília, Brasil, 72145-450
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Campinas, Brasil, 13093-133
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Santo André, Brasil, 09080-110
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São Paulo, Brasil, 04543-011
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Rousse, Bulgaria, 7002
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Sofia, Bulgaria, 1618
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Alberta, Canada, T4P 1K4
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Chicoutimi, Canada, G7H 5H6
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Halifax, Canada, B3H 1V7
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Lethbridge, Canada, T1J 4G9
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London, Canada, N6A 4L6
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London, Canada, N6K 1M6
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Montreal, Canada, H3H 1E8
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Québec, Canada, G1V 4T3
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Scarborough, Canada, M1B 3V4
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Toronto, Canada, M5G 1X5
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Toronto, Canada, M6R 1B5
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Vaughan, Canada, L4L 4Y7
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Armenia, Colombia, 630004
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Cali, Colombia, 760032
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Floridablanca, Colombia, 681017
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Medellín, Colombia, 050034
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Medellín, Colombia, 050012
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Soledad, Colombia, 083001
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Tallinn, Estland, 10617
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Tallinn, Estland, 10138
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Tartu, Estland, 50406
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California
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Lancaster, California, Forente stater, 93534
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San Diego, California, Forente stater, 92108
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Colorado
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Colorado Springs, Colorado, Forente stater, 80921
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Florida
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Kissimmee, Florida, Forente stater, 34741
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Miami, Florida, Forente stater, 33155
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Orlando, Florida, Forente stater, 32803
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Palmetto Bay, Florida, Forente stater, 33176
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Georgia
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Atlanta, Georgia, Forente stater, 30024
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Atlanta, Georgia, Forente stater, 30342
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Louisiana
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Houma, Louisiana, Forente stater, 70360
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Missouri
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Bridgeton, Missouri, Forente stater, 063044
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Nevada
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North Las Vegas, Nevada, Forente stater, 89030
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North Carolina
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Fayetteville, North Carolina, Forente stater, 28304
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High Point, North Carolina, Forente stater, 27260
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Raleigh, North Carolina, Forente stater, 27612
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South Carolina
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Summerville, South Carolina, Forente stater, 29486
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Tennessee
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Johnson City, Tennessee, Forente stater, 44060
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Texas
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Cedar Park, Texas, Forente stater, 78613
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Denton, Texas, Forente stater, 76210
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Houston, Texas, Forente stater, 77030
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Lewisville, Texas, Forente stater, 75067
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Mansfield, Texas, Forente stater, 76063
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Tyler, Texas, Forente stater, 75701
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Utah
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Ogden, Utah, Forente stater, 84403
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Virginia
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Lynchburg, Virginia, Forente stater, 24502
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Pierre-Bénite, Frankrike, 69310
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Vandœuvre-lès-Nancy, Frankrike, 54500
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Batumi, Georgia, 6010
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Tbilisi, Georgia, 0159
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Tbilisi, Georgia, 0160
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Tbilisi, Georgia, 0159
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Tbilisi, Georgia, 0180
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Tbilisi, Georgia, 0178
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Ahmedabad, India, 380009
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Bhubaneswar, India, 751003
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Chennai, India, 600035
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Coimbatore, India, 641005
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Jaipur, India, 302004
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Jaipur, India, 302006
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Kochi, India, 682041
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Kochi, India, 682017
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Ludhiana, India, 141001
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New Delhi, India, 110 017
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Pune, India, 411013
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Rajkot, India, 360005
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Rajkot, India, 360001
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Secunderabad, India, 500003
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Surat, India, 395002
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Varanasi, India, 221005
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Bologna, Italia, 40138
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Brescia, Italia, 25124
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Catanzaro, Italia, 88100
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Milan, Italia, 20132
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Milan, Italia, 20162
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Negrar, Italia, 37024
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Padova, Italia, 35128
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Roma, Italia, 00152
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Rozzano, Italia, 20089
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San Donato Milanese, Italia, 20097
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San Giovanni Rotondo, Italia, 71013
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Turin, Italia, 10126
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Asahikawa, Japan, 078-8510
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Bunkyō, Japan, 113-8519
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Chikushino-shi, Japan, 818-8502
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Kashiwa-shi, Japan, 277-0871
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Kobe, Japan, 650-0017
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-
Hovedetterforsker:
- Daisuke Watanabe
-
Kofu, Japan, 400-0027
- Rekruttering
- Yamanashi Prefectural Central Hospital
-
Ta kontakt med:
- Telefonnummer: 81120023812
-
Hovedetterforsker:
- Yuichiro Kojima
-
Nagasaki, Japan, 852-8501
- Rekruttering
- Nagasaki University Hospital
-
Ta kontakt med:
- Telefonnummer: 81120023812
-
Hovedetterforsker:
- Kayoko Matsushima
-
Nara, Japan, 630-8054
- Rekruttering
- Nara Prefecture General Medical Center
-
Ta kontakt med:
- Telefonnummer: 81120023812
-
Hovedetterforsker:
- Kei Moriya
-
Osaka, Japan, 5450051
- Rekruttering
- Osaka Metropolitan University Hospital
-
Ta kontakt med:
- Telefonnummer: 81120023812
-
Hovedetterforsker:
- Shuhei Hosomi
-
Saga, Japan, 849-8501
- Rekruttering
- Saga University Hospital
-
Ta kontakt med:
- Telefonnummer: 81120023812
-
Hovedetterforsker:
- Nanae Tsuruoka
-
Saitama, Japan, 336-0963
- Rekruttering
- Tokitokai Tokito Clinic
-
Hovedetterforsker:
- Satoki Tokito
-
Ta kontakt med:
- Telefonnummer: 81120023812
-
Saitama-Ken, Japan, 350 8550
- Rekruttering
- Saitama Medical Center
-
Ta kontakt med:
- Telefonnummer: 81120023812
-
Hovedetterforsker:
- Kato Shingo MD
-
Sakura, Japan, 285-8741
- Rekruttering
- Toho University Sakura Medical Center
-
Hovedetterforsker:
- Katsuyoshi Matsuoka
-
Ta kontakt med:
- Telefonnummer: 81120023812
-
Sapporo, Japan, 065-0033
- Rekruttering
- Sapporo Higashi Tokushukai Hospital
-
Hovedetterforsker:
- Atsuo Maemoto
-
Ta kontakt med:
- Telefonnummer: 81120023812
-
Tokyo, Japan, 169-0073
- Rekruttering
- Tokyo Yamate Medical Center
-
Hovedetterforsker:
- Masayuki Fukata
-
Ta kontakt med:
- Telefonnummer: 81120023812
-
-
-
-
-
Almaty, Kasakhstan, 050000
- Rekruttering
- Scientific Research Institute of Cardiology and Internal Disease of the Ministry of Health of the Republic of Kazakhstan
-
Ta kontakt med:
- Telefonnummer: +7 (747) 105-11-95
-
Hovedetterforsker:
- Jamilya Kaibullayeva
-
Astana, Kasakhstan, Z00P6K6
- Rekruttering
- National Research Medical Center
-
Ta kontakt med:
- Telefonnummer: +7 (701) 884 4994
-
Hovedetterforsker:
- Ainur Doszhan
-
Astana, Kasakhstan, Z00P6K6
- Rekruttering
- Sana Clinic
-
Ta kontakt med:
- Telefonnummer: 7 (701) 800 8621
-
Hovedetterforsker:
- Assyltay Nauryzbayeva
-
Karaganda, Kasakhstan, 100000
- Rekruttering
- Karaganda Medical University
-
Ta kontakt med:
- Telefonnummer: +7 (701) 227-80-60
-
Hovedetterforsker:
- Yelena Laryushina
-
Semey, Kasakhstan, 071400
- Rekruttering
- Semey Medical University
-
Ta kontakt med:
- Telefonnummer: 7 (778) 177-53-81
-
Hovedetterforsker:
- Aizhan Shakhanova
-
Shymkent, Kasakhstan, 160005
- Rekruttering
- "Gastromed" Medical Center
-
Ta kontakt med:
- Telefonnummer: 7 (701) 732-43-67
-
Hovedetterforsker:
- Assem Kurmangaliyeva
-
Shymkent, Kasakhstan, 160021
- Rekruttering
- Diagnostic Center of Shymkent
-
Ta kontakt med:
- Telefonnummer: +7 (777) 502-99-55
-
Hovedetterforsker:
- Ainur Chalabayeva
-
-
-
-
-
Osijek, Kroatia, 31000
- Rekruttering
- Poliklinika Borzan
-
Hovedetterforsker:
- Vladimir Borzan
-
Rijeka, Kroatia, 51000
- Rekruttering
- Specialty hospital Medico Rijeka
-
Ta kontakt med:
- Telefonnummer: +385 (99) 834 3552
-
Hovedetterforsker:
- Davor Stimac
-
Zagreb, Kroatia, 10000
- Rekruttering
- Poliklinika Solmed
-
Hovedetterforsker:
- Dominik Kralj
-
Ta kontakt med:
- Telefonnummer: + (385) 915881571
-
-
-
-
-
Liepāja, Latvia, LV-3414
- Rekruttering
- Liepaja Regional Hospital
-
Hovedetterforsker:
- Linda Erne
-
Riga, Latvia, LV-1002
- Rekruttering
- Pauls Stradins Clinical Univeristy Hospital
-
Hovedetterforsker:
- Aldis Pukitis
-
Ta kontakt med:
- Telefonnummer: +371 () 2925 3394
-
-
-
-
-
Durango, Mexico, 34000
- Rekruttering
- Applied Neuroscience Research Institute A.C.
-
Ta kontakt med:
- Telefonnummer: +52 (618) 197 3882
-
Hovedetterforsker:
- Raquel Morones Esquivel
-
Irapuato, Mexico, 36520
- Rekruttering
- Proactive CR México SA de CV
-
Hovedetterforsker:
- Andrés Mendoza Sanchez
-
Jalisco, Mexico, 45640
- Rekruttering
- Medical Clinical Surgical Center Specialized in Research
-
Hovedetterforsker:
- Roberto Cruz Neri
-
Mexico City, Distrito Federal, Mexico, 06100
- Rekruttering
- Key Stone Clinical Trials
-
Hovedetterforsker:
- Karina Olvera Obregon
-
Morelia, Mexico, 58260
- Rekruttering
- Centro de Investigacion Clinica Chapultepec S.A. de C.V.
-
Hovedetterforsker:
- Victor Sevilla Lizcano
-
Mérida, Mexico, 97070
- Rekruttering
- Medical Care and Research SA de CV
-
Hovedetterforsker:
- AXEL MENA QUINTERO
-
Oaxaca City, Mexico, 68000
- Rekruttering
- Oaxaca Site Management Organization
-
Hovedetterforsker:
- Ana Vera Heredia
-
Querétaro, Mexico, 76000
- Rekruttering
- Centro de Estudios Clínicos de Querétaro (CECLIQ)
-
Hovedetterforsker:
- Raul Chavez Ayala
-
-
-
-
-
Chisinau, Moldova, MD-2025
- Har ikke rekruttert ennå
- PMSI "Timofei Mosneaga" Republican Clinical Hospital, Outpatient Department
-
Ta kontakt med:
- Telefonnummer: +373 (692) 63 789
-
Hovedetterforsker:
- Victoria Babitchi
-
Chisinau, Moldova, MD-2025
- Har ikke rekruttert ennå
- PMSI "Timofei Mosneaga" Republican Clinical Hospital, Therapy Department, Division of Gastroenterology
-
Ta kontakt med:
- Telefonnummer: +373 (79) 436 554
-
Hovedetterforsker:
- Svetlana Turcan
-
Chisinau, Moldova, MD-2068
- Har ikke rekruttert ennå
- "Sfanta Treime" Municipal Clinical Hospital
-
Ta kontakt med:
- Telefonnummer: +373 (69) 010 553
-
Hovedetterforsker:
- Gheorghe Lupu
-
Chisinau, Moldova, MD2072
- Har ikke rekruttert ennå
- Rtl Sm Srl
-
Ta kontakt med:
- Telefonnummer: 78855508
-
Hovedetterforsker:
- Minodora Mazur
-
-
-
-
-
Bydgoszcz, Polen, 85-229
- Rekruttering
- "MEDIS" Medical Center
-
Hovedetterforsker:
- Maria Klopocka
-
Ta kontakt med:
- Telefonnummer: +48 () 601667497
-
Bydgoszcz, Polen, 85-231
- Rekruttering
- Non-public Health Care Center KERmed Medical Centre
-
Hovedetterforsker:
- Patryk Korga
-
Ta kontakt med:
- Telefonnummer: +48 () 533 550 245
-
Bydgoszcz, Polen, 85-794
- Rekruttering
- CLINSANTE Clinical Research Centre Ewa Galczak-Nowak, Malgorzata Trzaska
-
Ta kontakt med:
- Telefonnummer: +48 () 609 183 911
-
Hovedetterforsker:
- Michal Wiatr
-
Częstochowa, Polen, 42-202
- Rekruttering
- Synexus Polska Sp. Z o.o. Branch in Czestochowa
-
Ta kontakt med:
- Telefonnummer: +0 (48) 538 935 600
-
Hovedetterforsker:
- Jaroslaw Ziemba
-
Elblag, Polen, 82-300
- Fullført
- St. John Paul 2nd Municipal Hospital in Elblag
-
Gdansk, Polen, 80-382
- Rekruttering
- AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Gdansku
-
Hovedetterforsker:
- Marek Cesarz
-
Ta kontakt med:
- Telefonnummer: +48 (58) 712 9970
-
Katowice, Polen, 40-748
- Rekruttering
- "Vita Longa" Non-Public Healthcare Facility, Limited Liability Company
-
Hovedetterforsker:
- Przemyslaw Ramos
-
Ta kontakt med:
- Telefonnummer: +48 () 797 947 052
-
Katowice, Polen, 40-040
- Rekruttering
- Synexus Polska - Katowicach
-
Hovedetterforsker:
- Magdalena Olszanecka-Glinianowicz
-
Ta kontakt med:
- Telefonnummer: +48 () 604 586 316
-
Krakow, Polen, 31-156
- Rekruttering
- "Landa" Specialist Doctor's Offices
-
Ta kontakt med:
- Telefonnummer: +48 () 504 042 403
-
Hovedetterforsker:
- Katarzyna Landa
-
Krakow, Polen, 30-363
- Rekruttering
- PLEJADY Medical Centre
-
Hovedetterforsker:
- Monika Augustyn
-
Ta kontakt med:
- Telefonnummer: +48 (12) 422 3271
-
Krakow, Polen, 31-228
- Rekruttering
- Oslomed Medical Center
-
Hovedetterforsker:
- Anna Drozdz
-
Kłodzko, Polen, 57-300
- Har ikke rekruttert ennå
- GLOBE Clinical Research Sp. z o.o.
-
Ta kontakt med:
- Telefonnummer: +48 (661) 160 410
-
Hovedetterforsker:
- Miroslaw Wojcik
-
Opole, Polen, 45-819
- Rekruttering
- Twoja Przychodnia Medical Centre of Opole
-
Hovedetterforsker:
- Marzena Kwinto
-
Ta kontakt med:
- Telefonnummer: +48 () 690 548 825
-
Poznan, Polen, 60-309
- Rekruttering
- EMC Medical Institute Joint Stock Company, "Certus" Private Healthcare Facility Hospital No. 1
-
Ta kontakt med:
- Telefonnummer: +48 () 698120205
-
Hovedetterforsker:
- Piotr Szablowski
-
Poznan, Polen, 81-537
- Rekruttering
- Synexus Polska Sp. z o.o. Branch in Poznan
-
Hovedetterforsker:
- Magdalena Andrzejewska
-
Ta kontakt med:
- Telefonnummer: +48 (61) 880 2994
-
Poznan, Polen, 60-324
- Rekruttering
- Twoja Przychodnia Medical Centre of Poznan
-
Hovedetterforsker:
- Ewa Furmanowska-Ladorska
-
Sopot, Polen, 81-756
- Rekruttering
- Endoskopia Sp. z.o.o.
-
Hovedetterforsker:
- Marek Horynski
-
Ta kontakt med:
- Telefonnummer: +48 () 501011879
-
Szczecin, Polen, 71-434
- Rekruttering
- Twoja Przychodnia-Szczecinskie Centrum Medyczne
-
Hovedetterforsker:
- Beata Gawdis-Wojnarska
-
Ta kontakt med:
- Telefonnummer: +48 (91) 433 2919
-
Tychy, Polen, 43-100
- Rekruttering
- H-T. Medical Center
-
Hovedetterforsker:
- Tomasz Romanczyk
-
Ta kontakt med:
- Telefonnummer: +48 (501) 464 891
-
Warsaw, Polen, 04-501
- Rekruttering
- WIP Warsaw IBD Point Profesor Kierkus
-
Hovedetterforsker:
- Jaroslaw Kierkus
-
Ta kontakt med:
- Telefonnummer: +48 (22) 815 7384
-
Warsaw, Polen, 02-677
- Har ikke rekruttert ennå
- ETG Warszawa
-
Ta kontakt med:
- Telefonnummer: + (48) 575 000 489
-
Hovedetterforsker:
- Marek Bugajski
-
Warsaw, Polen, 02-672
- Rekruttering
- Synexus Polska Sp. z o.o. Oddzial w Warszawie
-
Ta kontakt med:
- Telefonnummer: +48 (22) 644 4161
-
Hovedetterforsker:
- Katarzyna Wierzbicka
-
Warsaw, Polen, 00-189
- Fullført
- MDM Healthcare Centre
-
Warsaw, Polen, 02-786
- Rekruttering
- WSD Medi
-
Ta kontakt med:
- Telefonnummer: +48 (60) 443 5392
-
Hovedetterforsker:
- Michal Krogulecki
-
Wroclaw, Polen, 52-416
- Rekruttering
- Medical Centre Oporow
-
Hovedetterforsker:
- Radoslaw Kempinski
-
Ta kontakt med:
- Telefonnummer: + (48) 604 911 743
-
Wroclaw, Polen, 50-381
- Rekruttering
- Synexus Polska Sp. z o.o.
-
Hovedetterforsker:
- Agnieszka Ciesiolkiewicz-Wojcik
-
Ta kontakt med:
- Telefonnummer: +48 (71) 772 6000
-
-
-
-
-
Bucharest, Romania, 020125
- Rekruttering
- Colentina Clinical Hospital
-
Hovedetterforsker:
- Radu Bogdan Mateescu
-
Ta kontakt med:
- Telefonnummer: +40 (2) 1315 2590
-
Bucharest, Romania, 011273
- Rekruttering
- "Sfanta Vineri" Medical Center
-
Ta kontakt med:
- Telefonnummer: +40 (732) 806 599
-
Hovedetterforsker:
- Marieta-Madalina Florescu
-
Bucharest, Romania, 013823
- Rekruttering
- Monza Oncology Hospital SRL
-
Hovedetterforsker:
- Ion-Eugeniu Craciun
-
Timișoara, Romania, 300239
- Rekruttering
- Oncohelp Association
-
Ta kontakt med:
- Telefonnummer: +40 (767) 152 254
-
Hovedetterforsker:
- Razvan Diaconescu
-
-
-
-
-
Belgrade, Serbia, 11000
- Rekruttering
- Clinical Center " Dr Dragisa Misovic Dedinje"
-
Ta kontakt med:
- Telefonnummer: +0 (381) 637700043
-
Hovedetterforsker:
- Aleksandra Pavlovic
-
Belgrade, Serbia, 11 000
- Rekruttering
- Zvezdara University Medical Center
-
Hovedetterforsker:
- Srdjan Markovic
-
Ta kontakt med:
- Telefonnummer: +381 (11) 381 0390
-
Belgrade, Serbia, 11000
- Rekruttering
- Clinical Hospital Center Bezanijska Kosa
-
Hovedetterforsker:
- Marija Brankovic
-
Ta kontakt med:
- Telefonnummer: +381 (64) 015 0022
-
Leskovac, Serbia, 16000
- Rekruttering
- General Hospital Leskovac
-
Ta kontakt med:
- Telefonnummer: +381 (64) 21023733
-
Hovedetterforsker:
- Tomislav Tasic
-
Užice, Serbia, 31000
- Rekruttering
- General Hospital Uzice
-
Ta kontakt med:
- Telefonnummer: 381 (60) 513 5299
-
Hovedetterforsker:
- Danijela Savic
-
Zrenjanin, Serbia, 23000
- Rekruttering
- General Hospital "Djordje Joanovic"
-
Hovedetterforsker:
- Tatjana Latinovic Radakovic
-
Ta kontakt med:
- Telefonnummer: +381 (060) 607 6527
-
-
-
-
-
Bratislava, Slovakia, 811 09
- Rekruttering
- Cliniq s.r.o.
-
Hovedetterforsker:
- Tibor Hlavaty
-
Ta kontakt med:
- Telefonnummer: +421 () 917 752 297
-
Košice, Slovakia, 04013
- Rekruttering
- ENDOMED s.r.o.
-
Hovedetterforsker:
- Miroslav Fedurco
-
Ta kontakt med:
- Telefonnummer: +421 () 905 271 215
-
Prešov, Slovakia, 08001
- Rekruttering
- Gastro LM s.r.o.
-
Hovedetterforsker:
- Lubomir Mihalkanin
-
Ta kontakt med:
- Telefonnummer: +421 () 905 794 001
-
Prešov, Slovakia, 08001
- Rekruttering
- GASTRO I., s.r.o.
-
Ta kontakt med:
- Telefonnummer: +421 () 903 607 349
-
Hovedetterforsker:
- Bohus Bunganic
-
-
-
-
-
Ferrol, Spania, 15405
- Rekruttering
- Complejo Hospitalario Universitario de Ferrol (CHUF)- Hospital Naval
-
Hovedetterforsker:
- Ana Isabel Echarri Piudo
-
Lleida, Spania, 25198
- Rekruttering
- Hospital Universitario Arnau de Vilanova de Lleida
-
Hovedetterforsker:
- Francesc Xavier Molero Richard
-
Madrid, Spania, 28046
- Rekruttering
- Hospital Universitario La Paz
-
Hovedetterforsker:
- MARIA DOLORES MARTIN ARRANZ
-
Ta kontakt med:
- Telefonnummer: +34 (91) 727 7264
-
Majadahonda, Spania, 28222
- Rekruttering
- Hospital Universitario Puerta de Hierro Majadahonda
-
Ta kontakt med:
- Telefonnummer: +34 () 911916453
-
Hovedetterforsker:
- Irene Gonzalez Partida
-
Seville, Spania, 41009
- Rekruttering
- Hospital Universitario Virgen Macarena
-
Hovedetterforsker:
- Federico Argüelles-Arias
-
Ta kontakt med:
- Telefonnummer: +34 (95) 500 8801
-
Valencia, Spania, 46026
- Rekruttering
- University and Polytechnic Hospital La Fe
-
Hovedetterforsker:
- Marisa Iborra Colomino
-
Ta kontakt med:
- Telefonnummer: +34 (961) 973 118
-
-
-
-
-
Chiayi City, Taiwan, 60002
- Har ikke rekruttert ennå
- Ditmanson Medical Foundation Chia-Yi Christian Hospital
-
Hovedetterforsker:
- Chu-Kuang Chou
-
Ta kontakt med:
- Telefonnummer: +886 (5) 276 5041
-
Hsinchu, Taiwan, 302
- Har ikke rekruttert ennå
- National Taiwan University Hospital
-
Hovedetterforsker:
- Meng-Tzu Weng
-
Kaohsiung City, Taiwan, 81362
- Har ikke rekruttert ennå
- Kaohsiung Veterans General Hospital
-
Ta kontakt med:
- Telefonnummer: +886 (7) 342 2121
-
Hovedetterforsker:
- Tzung-Jiun Tsai
-
Kaohsiung City, Taiwan, 807377
- Har ikke rekruttert ennå
- Kaohsiung Medical University Chung-Ho Memorial Hospital
-
Ta kontakt med:
- Telefonnummer: 886 7 312 1101
-
Hovedetterforsker:
- Wen-Hung Hsu
-
New Taipei City, Taiwan, 22060
- Har ikke rekruttert ennå
- Far Eastern Memorial Hospital
-
Ta kontakt med:
- Telefonnummer: +886 (2) 77281704
-
Hovedetterforsker:
- Chen-Shuan Chung
-
Taichung, Taiwan, 407219
- Har ikke rekruttert ennå
- Taichung Veterans General Hospital
-
Hovedetterforsker:
- Chung-Hsin Chang
-
Ta kontakt med:
- Telefonnummer: +886 (423) 592 525
-
Taichung, Taiwan, 404327
- Har ikke rekruttert ennå
- China Medical University Hospital
-
Ta kontakt med:
- Telefonnummer: +886 (4) 22052121
-
Hovedetterforsker:
- Tsung-Yu Tsai
-
Tainan, Taiwan, 71004
- Har ikke rekruttert ennå
- Chi Mei Medical Center
-
Ta kontakt med:
- Telefonnummer: +886 (6) 243 3407
-
Hovedetterforsker:
- I CHE FENG
-
Taipei, Taiwan, 11217
- Har ikke rekruttert ennå
- Taipei Veterans General Hospital
-
Hovedetterforsker:
- Jiing-Chyuan Luo
-
Taipei, Taiwan, 10449
- Har ikke rekruttert ennå
- Mackay Memorial Hospital
-
Ta kontakt med:
- Telefonnummer: +886 (6) 6655-1256
-
Hovedetterforsker:
- Horng-Yuan Wang
-
Taipei, Taiwan, 100225
- Har ikke rekruttert ennå
- National Taiwan University Hospital
-
Hovedetterforsker:
- Chia-Hung Tu
-
Ta kontakt med:
- Telefonnummer: +886 (2) 23123456 +886 (9) 726
-
Taoyuan City, Taiwan, 333
- Har ikke rekruttert ennå
- Chang Gung Memorial Hospital - Linkou
-
Ta kontakt med:
- Telefonnummer: +886 (03) 328 1200
-
Hovedetterforsker:
- Puo-Hsien Le
-
-
-
-
-
Brno, Tsjekkia, 602 00
- Rekruttering
- SurGal Clinic s.r.o.
-
Hovedetterforsker:
- Jan Ulbrych
-
Ta kontakt med:
- Telefonnummer: + (420) 724 101 038
-
Brno, Tsjekkia, 615 00
- Rekruttering
- Military Hospital Brno,
-
Ta kontakt med:
- Telefonnummer: + (420) 973 445 520
-
Hovedetterforsker:
- Peter Hegyi
-
Prague, Tsjekkia, 140 00
- Rekruttering
- Clinoxus s.r.o., Outpatient Clinic Budejovicka
-
Ta kontakt med:
- Telefonnummer: +420 () 222 962 476
-
Hovedetterforsker:
- Petr Hrabak
-
Prague, Tsjekkia, 14000
- Rekruttering
- Axon Clinical, s.r.o.
-
Hovedetterforsker:
- Jan Matous
-
Ta kontakt med:
- Telefonnummer: + (420) 776767590
-
-
-
-
-
Berlin, Tyskland, 10117
- Rekruttering
- Charite - University Hospital Berlin
-
Ta kontakt med:
- Telefonnummer: +49 (30) 450 514102
-
Hovedetterforsker:
- Christoph Jochum
-
Berlin, Tyskland, 12559
- Rekruttering
- DRK Clinic Berlin-Koepenick
-
Ta kontakt med:
- Telefonnummer: 49 (152) 0157 3335
-
Hovedetterforsker:
- Benjamin Moser
-
Dachau, Tyskland, 85221
- Rekruttering
- Medical Care Unit Dachau
-
Ta kontakt med:
- Telefonnummer: +49 (08131) 61 190
-
Hovedetterforsker:
- Wilfred Landry
-
Duisburg, Tyskland, 53119
- Rekruttering
- Sana Hospital Duisburg
-
Ta kontakt med:
- Telefonnummer: +49 (203) 733 2385
-
Hovedetterforsker:
- Wolfgang Nitz
-
Frankfurt am Main, Tyskland, 60431
- Har ikke rekruttert ennå
- Agaplesion Markus Hospital
-
Hovedetterforsker:
- Axel Dignass
-
Ta kontakt med:
- Telefonnummer: +49 (069) 95332201
-
Halle, Tyskland, 06120
- Rekruttering
- University Hospital Halle (Saale)
-
Hovedetterforsker:
- Jens Walldorf
-
Ta kontakt med:
- Telefonnummer: +49 (345) 557 2665
-
Heidelberg, Tyskland, 69120
- Rekruttering
- Universitätsklinikum Heidelberg
-
Ta kontakt med:
- Telefonnummer: +49 (6221) 563 8865
-
Hovedetterforsker:
- Annika Gauss
-
Kiel, Tyskland, 24105
- Rekruttering
- University Hospital Schleswig-Holstein
-
Hovedetterforsker:
- Stefan Schreiber
-
Ta kontakt med:
- Telefonnummer: +49 (431) 500 22202
-
Leipzig, Tyskland, 04103
- Har ikke rekruttert ennå
- University of Leipzig Medical Cent
-
Hovedetterforsker:
- Babett Holler
-
Ta kontakt med:
- Telefonnummer: +49 (341) 712 226
-
Magdeburg, Tyskland, 110 39104
- Har ikke rekruttert ennå
- GastroPraxis Magdeburg
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Hovedetterforsker:
- Lars Zimmermann
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Munich, Tyskland, 81377
- Har ikke rekruttert ennå
- Hospital Ludwig-Maximilians-University Munich, Campus Grosshadern
-
Hovedetterforsker:
- Benjamin Misselwitz
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Wipperfürth, Tyskland, 51688
- Rekruttering
- Group Practice Jakobeit
-
Hovedetterforsker:
- Christian Jakobeit
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Ta kontakt med:
- Telefonnummer: +49 (2267) 9201
-
Wolfsburg, Tyskland, 38440
- Har ikke rekruttert ennå
- Wolfsburg Hospital Department of internal Medicine
-
Hovedetterforsker:
- Nils Homann
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-
-
-
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Budapest, Ungarn, 1083
- Rekruttering
- Semmelweis Medical University
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Ta kontakt med:
- Telefonnummer: +36 (1) 459 1500
-
Hovedetterforsker:
- Akos Ilias
-
Békéscsaba, Ungarn, 5600
- Rekruttering
- Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaz IV. Belgyogyaszat
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Hovedetterforsker:
- Marta Varga
-
Ta kontakt med:
- Telefonnummer: +36 (66) 441 411
-
Eger, Ungarn, 3300
- Rekruttering
- Markhot Ferenc Oktatókórház
-
Ta kontakt med:
- Telefonnummer: +36 (36) 411 444
-
Hovedetterforsker:
- Zoltan Sallo
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Gyöngyös, Ungarn, 3200
- Rekruttering
- Bugat Pal Hospital Gyongyos
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Ta kontakt med:
- Telefonnummer: +36 (37) 312 491
-
Hovedetterforsker:
- Gabor Makai
-
Szekszárd, Ungarn, 7100
- Rekruttering
- CLINFAN Szolgáltató Kft
-
Hovedetterforsker:
- Agnes Salamon
-
Ta kontakt med:
- Telefonnummer: +36 (74) 501 872
-
Székesfehérvár, Ungarn, H-8000
- Rekruttering
- Fejer County St. Gyorgy University Teaching Hospital
-
Hovedetterforsker:
- Roland Fejes
-
Ta kontakt med:
- Telefonnummer: +36 (22) 535 732
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Innsbruck, Østerrike, 6020
- Rekruttering
- Medical University Hematology
-
Hovedetterforsker:
- Robert Koch
-
Ta kontakt med:
- Telefonnummer: +43 (512) 504 23539
-
Salzburg, Østerrike, 5020
- Rekruttering
- Salzburg Regional Hospital
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Hovedetterforsker:
- Sonja Heeren
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Sankt Pölten, Østerrike, 3100
- Rekruttering
- University Hospital St. Poelten
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Ta kontakt med:
- Telefonnummer: +43 (2742) 9004 12311
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Hovedetterforsker:
- Andreas Maieron
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Vienna, Østerrike, 1090
- Rekruttering
- Medical University of Vienna
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Hovedetterforsker:
- Walter Reinisch
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Ta kontakt med:
- Telefonnummer: +43 (1) 40400 62450
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Key Inclusion Criteria:
- 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:
- 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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Group 1 (Part A)
Blinded MORF-057 Dosing Regimen 1 for Induction Period and open-label MORF-057 for Maintenance Period |
MORF-057 is a small molecule that is designed to selectively inhibit integrin α4β7 and is administered orally.
Andre navn:
|
|
Eksperimentell: Group 2 (Part A)
Blinded MORF-057 Dosing Regimen 2 for Induction Period and open-label MORF-057 for Maintenance Period |
MORF-057 is a small molecule that is designed to selectively inhibit integrin α4β7 and is administered orally.
Andre navn:
|
|
Placebo komparator: Group 3 (Part A)
Blinded matching placebo for Induction Period and open-label MORF-057 for Maintenance Period |
MORF-057 is a small molecule that is designed to selectively inhibit integrin α4β7 and is administered orally.
Andre navn:
Matching placebo (identical appearance to MORF-057) administered orally. |
|
Eksperimentell: Group 4 (Part B)
Blinded MORF-057 Dosing Regimen 1 for Induction Period and open-label MORF-057 for Maintenance Period |
MORF-057 is a small molecule that is designed to selectively inhibit integrin α4β7 and is administered orally.
Andre navn:
|
|
Eksperimentell: Group 5 (Part B)
Blinded MORF-057 Dosing Regimen 2 for Induction Period and open-label MORF-057 for Maintenance Period |
MORF-057 is a small molecule that is designed to selectively inhibit integrin α4β7 and is administered orally.
Andre navn:
|
|
Placebo komparator: Group 6 (Part B)
Blinded matching placebo for Induction Period and open-label MORF-057 for Maintenance Period |
MORF-057 is a small molecule that is designed to selectively inhibit integrin α4β7 and is administered orally.
Andre navn:
Matching placebo (identical appearance to MORF-057) administered orally. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Proportion of participants with endoscopic response at Week 14 as determined using the Simple Endoscopic Score-CD (SES-CD)
Tidsramme: 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% |
Baseline to Week 14
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Proportion of participants with clinical response at Week 14 as determined using the Crohn's Disease Activity Index (CDAI)
Tidsramme: Baseline to Week 14
|
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. |
Baseline to Week 14
|
|
Proportion of participants with clinical remission at Week 14 as determined using the CDAI.
Tidsramme: Baseline to Week 14
|
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. |
Baseline to Week 14
|
Samarbeidspartnere og etterforskere
Etterforskere
- Studieleder: 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
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 27383
- MORF-057-203 (Annen identifikator: Morphic Therapeutic, Inc)
- J6E-MC-KWAB (Annen identifikator: Eli Lilly and Company)
- U1111-1297-7265 (Annen identifikator: UTN)
- 2023-508158-24 (Annen identifikator: EU Trial (CTIS))
- 2023 (U.S. NIH-stipend/kontrakt)
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
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