A Phase 2 Study to Evaluate MORF-057 in Adults With Moderately to Severely Active Crohn's Disease
Start Date
7/18/2024
Completion Date
6/1/2030
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).
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.
Eligibility Criteria
Age Range: 18 years to 85 years
Interventions
Placebo
MORF-057
Conditions
Locations
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