중간 정도의 활성 크론 병을 가진 참가자에서 RO7790121을 사용한 유도 요법의 효능 및 안전성을 평가하는 연구 (SIBERITE-2)
중간 정도에서 중증의 크론 병 환자에서 RO7790121을 사용한 유도 요법의 효능 및 안전성을 평가하기위한 III 상, 다기관, 이중 맹검, 위약 대조 연구.
This Phase III, multicenter, double-blind, placebo-controlled study will evaluate the efficacy and safety of induction therapy with Afimkibart (also known as RO7790121) in participants with moderately to severely active Crohn's disease (CD).
연구 개요
연구 유형
등록 (추정된)
단계
- 3단계
연락처 및 위치
연구 연락처
- 이름: Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
연구 연락처 백업
- 이름: Reference Study ID Number: GA45332 https://forpatients.roche.com/ No attachments to email below.
- 전화번호: 888-662-6728 (U.S. and Canada)
- 이메일: global-roche-genentech-trials@gene.com
연구 장소
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Daegu, 대한민국, 42415
- 모병
- Yeungnam University Medical Center
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Gwangju, 대한민국, 61453
- 모병
- Chosun University Hospital
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Seoul, 대한민국, 04763
- 모병
- Hanyang University Seoul Hospital
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Seoul, 대한민국, 03312
- 모병
- The Catholic University of Korea Eunpyeong St. Mary's Hospital
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Gyeonggi-do
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Ansan-si, Gyeonggi-do, 대한민국, 15355
- 모병
- Korea University Ansan Hospital
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-
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Heidelberg, 독일, 69120
- 모병
- Universitätsklinikum Heidelberg
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Potsdam, 독일, 14467
- 모병
- Klinikum Ernst von Bergmann
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-
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Cluj-Napoca, 루마니아
- 모병
- Spital Digenio - Centrul de Excelen?? în Afec?iuni Digestive
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-
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Alabama
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Dothan, Alabama, 미국, 36305
- 모병
- Digestive Health Specialists of the Southeast
-
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Arizona
-
Glendale, Arizona, 미국, 85304
- 모병
- Sun City Clinical Research
-
-
California
-
Lancaster, California, 미국, 93534
- 모병
- Om Research LLC
-
Newport Beach, California, 미국, 92663
- 모병
- Hoag Memorial Hospital Presbyterian;Hoag Center for Research and Education
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Pomona, California, 미국, 91767
- 빼는
- Empire Clinical Research
-
Redwood City, California, 미국, 94063
- 모병
- Stanford Medicine Outpatient Center
-
San Diego, California, 미국, 92103
- 모병
- Clinical Applications Laboratories, Inc.
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Santa Clarita, California, 미국, 91355
- 모병
- Amicis Research Center
-
-
Colorado
-
Colorado Springs, Colorado, 미국, 80907
- 모병
- Peak Gastroenterology Associates
-
-
Florida
-
Doral, Florida, 미국, 33126
- 모병
- J&A Clinical Research
-
Lakeland, Florida, 미국, 33813
- 모병
- Auzmer Research
-
Lehigh Acres, Florida, 미국, 33936
- 모병
- Galenus Group Inc
-
Miami, Florida, 미국, 33155
- 모병
- Rejuvaline Medical Research
-
Miami, Florida, 미국, 33155
- 모병
- Allied Biomedical Research Institute, Inc
-
Miami, Florida, 미국, 33033
- 모병
- Homestead Associates in Research, Inc.
-
Miami Beach, Florida, 미국, 33141
- 모병
- Miami Beach Clinical Research Center
-
Miramar, Florida, 미국, 33027
- 모병
- Eminat Research Group
-
Orlando, Florida, 미국, 32825
- 모병
- Digestive and Liver Center of Florida
-
Port Orange, Florida, 미국, 32127
- 모병
- Advanced Medical Research Center
-
Tampa, Florida, 미국, 33615
- 모병
- Santos Research Center, CORP
-
Weston, Florida, 미국, 33331
- 모병
- Cleveland Clinic Florida
-
-
Georgia
-
Atlanta, Georgia, 미국, 30310-1495
- 모병
- Morehouse School Of Medicine
-
-
Illinois
-
Chicago, Illinois, 미국, 60637
- 모병
- The University of Chicago
-
-
Kansas
-
Kansas City, Kansas, 미국, 66160
- 모병
- University of Kansas Medical Center
-
-
Kentucky
-
Louisville, Kentucky, 미국, 40206
- 모병
- Robley Rex VA Medical Center
-
Louisville, Kentucky, 미국, 40218
- 모병
- One GI: GHP - Gastroenterology Health Partners Louisville
-
-
Louisiana
-
Baton Rouge, Louisiana, 미국, 70809
- 모병
- Baton Rouge General Medical Center
-
Shreveport, Louisiana, 미국, 71105
- 모병
- Louisiana Research Center - GastroIntestinal Associates
-
-
Maryland
-
Baltimore, Maryland, 미국, 21202
- 모병
- Mercy Medical Center
-
Chevy Chase, Maryland, 미국, 20815
- 모병
- FOMAT Medical Research - Chevy Chase Clinical Research
-
-
Massachusetts
-
North Worcester, Massachusetts, 미국, 01655
- 모병
- University of Massachusetts Memorial Medical Center
-
-
Michigan
-
Wyoming, Michigan, 미국, 49519
- 모병
- Gastroenterology Associates of Western Michigan, P.L.C.
-
-
Mississippi
-
Flowood, Mississippi, 미국, 39232
- 모병
- Gastrointestinal Associates Research
-
-
Missouri
-
Columbia, Missouri, 미국, 65201-5275
- 모병
- Va Heartland Network - Harry S. Truman Memorial Veterans' Hospital
-
St Louis, Missouri, 미국, 63141
- 모병
- Specialists in Gastroenterology
-
-
New Hampshire
-
Lebanon, New Hampshire, 미국, 03756
- 모병
- Dartmouth-Hitchcock Medical Center-Norris Cotton Cancer Center
-
-
New Jersey
-
Moorestown, New Jersey, 미국, 08057
- 모병
- Virtua Crohns and Colitis Center
-
New Brunswick, New Jersey, 미국, 08901
- 모병
- Robert Wood Johnson University Hospital
-
-
New York
-
Brooklyn, New York, 미국, 11215
- 모병
- Ellipsis Research Group
-
Fresh Meadows, New York, 미국, 11366
- 모병
- Intercity Gastroenterology
-
Lake Success, New York, 미국, 11042
- 모병
- NYU Langone Long Island Clinical Research Associates
-
The Bronx, New York, 미국, 10468
- 모병
- James J Peters Veterans Affairs Medical Center
-
Utica, New York, 미국, 13502
- 모병
- Digestive Disease Medicine of Central New York
-
-
North Carolina
-
Charlotte, North Carolina, 미국, 28207
- 모병
- Charlotte Gastroenterology and Hepatology, P.L.L.C
-
High Point, North Carolina, 미국, 27260
- 모병
- Peters Medical Research (PMR), LLC
-
-
Ohio
-
Beavercreek, Ohio, 미국, 45431
- 모병
- Clinical Inquest Center
-
Cleveland, Ohio, 미국, 44195
- 모병
- Cleveland Clinic Foundation
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, 미국, 19104
- 모병
- University of Pennsylvania
-
-
Rhode Island
-
Providence, Rhode Island, 미국, 02904
- 모병
- University Gastroenterology
-
-
Tennessee
-
Cordova, Tennessee, 미국, 38018
- 모병
- Gastro One
-
Nashville, Tennessee, 미국, 37212-1375
- 모병
- Vanderbilt University Medical Center
-
-
Texas
-
Dallas, Texas, 미국, 75390-8565
- 모병
- University of Texas Southwestern Medical Center - Multidisciplinary Spine Clinic - James W. Aston Ambulatory Care Center
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Fort Worth, Texas, 미국, 76104
- 모병
- GI Alliance - Fort Worth
-
Garland, Texas, 미국, 75044
- 모병
- GI Alliance
-
Houston, Texas, 미국, 77090
- 모병
- Integrity Advanced Therapeutics PLLC
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Lubbock, Texas, 미국, 79410
- 모병
- Texas Digestive Disease Consultants-Lubbock powered by GI Alliance
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San Antonio, Texas, 미국, 78212
- 모병
- Carta - Clinical Associates In Research Therapeutics Of America;LLC
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Tyler, Texas, 미국, 75701
- 모병
- Tyler Research Institute, LLC
-
Tyler, Texas, 미국, 75708
- 모병
- University of Texas Health Center at Tyler
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Webster, Texas, 미국, 77598
- 모병
- TDDC GI Alliance research Webster
-
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Virginia
-
Richmond, Virginia, 미국, 23229
- 모병
- GI Alliance-Richmond
-
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Washington
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Seattle, Washington, 미국, 98101
- 모병
- Virginia Mason Medical Center
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Tacoma, Washington, 미국, 98405
- 모병
- Washington Gastroenterology
-
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West Virginia
-
Huntington, West Virginia, 미국, 25701
- 빼는
- University Physicians and Surgeons Inc, dba Marshall Health
-
-
-
-
-
Brussels, 벨기에, 1090
- 모병
- UZ Brussel
-
Brussels, 벨기에, 1200
- 모병
- Cliniques Universitaires St-Luc
-
Brussels, 벨기에, 1000
- 모병
- CHU St Pierre (St Pierre)
-
-
-
-
-
Panagyurishte, 불가리아, 4500
- 모병
- Multiprofile Hospital for Active Treatment Uni Hospital;Department of Gastroenterology.
-
Plovdiv, 불가리아, 4003
- 모병
- MC " Sveti Ivan Rilski Chudotvorets- 2010
-
-
-
-
Rio Grande do Sul
-
Porto Alegre, Rio Grande do Sul, 브라질, 90035-000
- 모병
- Hospital Moinhos de Vento
-
-
Rio de Janeiro
-
Volta Redonda, Rio de Janeiro, 브라질, 27258-000
- 모병
- Instituto Lobus Unimed Volta Redonda
-
-
Sergipe
-
Aracaju, Sergipe, 브라질, 49055-000
- 모병
- Newdata Clinical Trials
-
-
São Paulo
-
Jaú, São Paulo, 브라질, 17210-190
- 모병
- CECIP - Centro de Estudos Clínicos do Interior Paulista
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São José do Rio Preto, São Paulo, 브라질, 15090-000
- 모병
- Hospital de Base de Sao Jose do Rio Preto
-
São Paulo, São Paulo, 브라질, 01308-050
- 빼는
- Hospital Sírio-Libanês
-
-
-
-
-
Madrid, 스페인, 28040
- 모병
- Hospital General Universitario Gregorio Maranon
-
Zaragoza, 스페인, 50009
- 모병
- Hospital Clinico Univ. Lozano Blesa
-
-
Madrid
-
Alcorcón, Madrid, 스페인, 28922
- 모병
- Fundacion Hospital de Alcorcon
-
Majadahonda, Madrid, 스페인, 28222
- 모병
- Hospital Universitario Puerta de Hierro
-
-
-
-
-
Bratislava, 슬로바키아, 821 07
- 모병
- ABAWI spol. s r.o.
-
Nitra, 슬로바키아, 949 01
- 모병
- KM Management spol. s r.o.
-
-
-
-
-
Quilmes, 아르헨티나, B1878DVB
- 모병
- Instituto Medico CER
-
San Miguel de Tucumán, 아르헨티나, T4000DPK
- 모병
- CICE 9 de Julio
-
-
-
-
-
Bristol, 영국, BS10 5NB
- 모병
- Southmead Hospital
-
Bury, 영국, BL9 7TD
- 모병
- Fairfield General Hospital
-
Llanrhystud, 영국, SY23 1ER
- 모병
- Bronglais General Hospital
-
London, 영국, E1 1FR
- 모병
- Royal London Hospital
-
Newcastle upon Tyne, 영국, NE1 4LP
- 모병
- Royal Victoria Infirmary
-
Stockport, 영국, SK2 7JE
- 모집하지 않고 적극적으로
- Stepping Hill Hospital
-
-
-
-
-
Linz, 오스트리아, 4010
- 모병
- Ordensklinikum Linz Barmherzige Schwestern
-
Wels, 오스트리아, 4600
- 모병
- Klinikum Wels-Grieskirchen
-
-
-
-
-
Jerusalem, 이스라엘, 9103102
- 모병
- Shaare Zedek Medical Center
-
Jerusalem, 이스라엘, 9112001
- 모병
- Hadassah Medical Center
-
-
-
-
Basilicate
-
Matera, Basilicate, 이탈리아, 75100
- 모병
- Ospedale Madonna delle Grazie
-
-
Emilia-Romagna
-
Bologna, Emilia-Romagna, 이탈리아, 40138
- 모병
- Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi-Via Massarenti
-
-
Lazio
-
Rome, Lazio, 이탈리아, 00168
- 모병
- Policlinico Universitario Agostino Gemelli
-
Rome, Lazio, 이탈리아, 00128
- 모병
- Policlinico Universitario Campus Biomedico Di Roma
-
-
Lombardy
-
Brescia, Lombardy, 이탈리아, 25123
- 모병
- Asst Degli Spedali Civili Di Brescia
-
Milan, Lombardy, 이탈리아, 20132
- 모병
- IRCCS Ospedale San Raffaele
-
San Donato Milanese (MI), Lombardy, 이탈리아, 20097
- 모병
- I.R.C.C.S Policlinico San Donato
-
-
Veneto
-
Negrar, Veneto, 이탈리아, 37024
- 모병
- IRCCS Ospedale Sacro Cuore Don Calabria
-
-
-
-
Andhra Pradesh
-
Kurnool, Andhra Pradesh, 인도, 518002
- 모병
- Kurnool Medical College
-
-
Gujarat
-
Rajkot, Gujarat, 인도, 360005
- 빼는
- Shree Giriraj Multispeciality Hospital
-
Surat, Gujarat, 인도, 395002
- 모병
- Surat Institute of Digestive Sciences Hospitals
-
Surat, Gujarat, 인도, 395009
- 모병
- Gujarat Gastro and Vascular Hospital
-
-
Kerala
-
Kochi, Kerala, 인도, 682041
- 모병
- Amrita Institute of Medical Sciences
-
-
Maharashtra
-
Nagpur (urban), Maharashtra, 인도, 440018
- 모병
- MIDAS Multispeciality Hospital
-
-
National Capital Territory of Delhi
-
New Delhi, National Capital Territory of Delhi, 인도, 110029
- 모병
- All India Institute Of Medical Sciences (AIIMS)
-
-
Rajasthan
-
Jaipur, Rajasthan, 인도, 302006
- 모병
- SR Kalla Memorial Gastro & General Hospital
-
Jaipur, Rajasthan, 인도, 302007
- 모병
- SMS Superspeciality Hospital
-
-
Telangana
-
Gachibowli, Telangana, 인도, 500032
- 모병
- AIG Hospitals
-
Secunderabad, Telangana, 인도, 500003
- 모병
- Yashoda Hospitals
-
Secunderabad, Telangana, 인도, 500003
- 모병
- Gandhi Hospital
-
-
West Bengal
-
Kolkata, West Bengal, 인도, 700020
- 모병
- Institute of Post Graduate Medical Education and Research (IPGMER) and SSKM Hospital
-
-
-
-
-
Beijing, 중국, 100730
- 모병
- Beijing Union Hospital
-
Chengdu, 중국, 610072
- 모병
- Sichuan Provincial People's Hospital
-
Guangzhou, 중국, 510280
- 모병
- Zhujiang Hospital, Southern Medical University
-
Guangzhou, 중국, 510180
- 모병
- Guangzhou First People's Hospital
-
Haikou, 중국, 570311
- 모병
- Hainan General Hospital
-
Huai'an, 중국
- 모병
- Huai'an First People's Hospital
-
Huizhou, 중국
- 모병
- Huizhou First Hospital
-
Kunming, 중국, 650032
- 모병
- The First Affilliated Hospital of Kunming Medical University
-
Nanchang, 중국, 330008
- 모병
- The Second Affiliated Hospital of Nanchang University
-
Shanghai, 중국, 200092
- 모병
- Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
-
Shanghai, 중국, 200127
- 모병
- Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
-
Shenyang, 중국, 110004
- 모병
- Shengjing Hospital of China Medical University
-
Shijiazhuang, 중국, 050004
- 모병
- Hebei Medical University - The Second Hospital
-
Suzhou, 중국, 215004
- 모병
- The Second Affiliated Hospital of Soochow University
-
Xi'an, 중국, 710004
- 모병
- The Second Affiliated Hospital of Xi'an Jiao Tong University
-
Xiamen, 중국, 361003
- 모병
- The First Affiliated Hospital of Xiamen University
-
Zhenjiang, 중국, 212001
- 모병
- Affiliated Hospital of Jiangsu University
-
-
Jiangxi
-
Ganzhou, Jiangxi, 중국, 341000
- 모병
- First Affiliated Hospital of Gannan Medical University
-
-
Zhejiang
-
Jinhua, Zhejiang, 중국, 321013
- 모병
- Jinhua municipal central hospital
-
-
-
-
-
Hradec Králové, 체코, 500 12
- 모병
- Hepato-Gastroenterologie HK, s.r.o.
-
Ostrava - Poruba, 체코, 708 52
- 모병
- Fakultni nemocnice Ostrava
-
Prague, 체코, 170 04
- 모병
- ISCARE a.s.
-
Prague, 체코, 140 21
- 모병
- Institutu Klinicke a Experimentaini Mediciny (IKEM);Klinika hepatogastroenterologie
-
Ústí nad Labem, 체코, 401 13
- 모병
- Krajska zdravotni, a.s. ? Masarykova nemocnice v Usti nad Labem, o.z., Ocni oddeleni
-
-
-
-
-
Las Condes, 칠레, 7560908
- 모병
- Medicina de Precisión - Celerity
-
Santiago, 칠레, 8330034
- 모병
- Centro de Investigación Clínica UC-CICUC
-
Santiago, 칠레, 7500000
- 모병
- Medwal
-
-
-
-
Ontario
-
Barrie, Ontario, 캐나다, L4M 7G1
- 모병
- Barrie GI Associates
-
Brampton, Ontario, 캐나다, L6S 0E2
- 모병
- GNRR Digestive Clinics and Research Center Inc.
-
London, Ontario, 캐나다, N6K 1M6
- 모병
- LDDI Clinical Trials Inc.
-
London, Ontario, 캐나다, N6A 5A5
- 빼는
- London Health Sciences Centre Uni Campus
-
North YORK, Ontario, 캐나다, M6A 3B4
- 모병
- Toronto Immune and Digestive Health Institute
-
-
Quebec
-
Montreal, Quebec, 캐나다, H1T 2M4
- 모병
- CIUSSS de l Est de l Ile de Montreal - Hopital Maisonneuve Rosemont
-
-
-
-
-
Bogotá, 콜롬비아, 000472
- 모병
- Hospital Universitario San Ignacio
-
Bogotá, 콜롬비아, 111071
- 모병
- Clinica Colsanitas S.A. - Sede Clinica Reina Sofia
-
Bogotá, 콜롬비아, 110221
- 빼는
- Clínica de la Mujer
-
Montería, 콜롬비아, 230002
- 모병
- Oncomedica S.A.
-
-
Santander Department
-
Piedecuesta, Santander Department, 콜롬비아, 681004
- 모병
- Fundacion Cardiovascular de Colombia - KM 7 Autopista
-
-
-
-
-
Osijek, 크로아티아, 31000
- 모병
- Borzan Polyclinic
-
Zagreb, 크로아티아, 10000
- 모병
- Clinical Hospital Centre Zagreb
-
-
-
-
-
Braga, 포르투갈, 4710-243
- 모병
- Hospital de Braga
-
Lisbon, 포르투갈, 1649-035
- 모병
- Hospital de Santa Maria
-
Porto, 포르투갈, 4202-451
- 모병
- Hospital de Sao Joao
-
Santa Maria da Feira, 포르투갈, 4520-211
- 모병
- Centro Hospitalar de Entre Douro e Vouga - H. São Sebastião
-
Viseu, 포르투갈, 3504-509
- 모병
- Hospital Sao Teotonio
-
-
-
-
-
Bia?ystok, 폴란드, 15-322
- 모병
- Gastromed Kralisz, Romatowski, Stachurska sp.j.
-
Bydgoszcz, 폴란드, 85-231
- 모병
- Medical Center Kermed
-
Elblag, 폴란드, 82-300
- 모병
- Szpital Miejski sw. Jana Paw?a II w Elblagu
-
I?awa, 폴란드, 14-200
- 모병
- Osrodek Badan Klinicznych Bd Research
-
Knurów, 폴란드, 44-190
- 모병
- MZ Badania Slowik Zymla Sp.j.
-
Krakow, 폴란드, 31-513
- 모병
- Centrum Medyczne Promed
-
Lodz, 폴란드, 91-495
- 모병
- Amicare Sp. z o.o. S.K.
-
Lublin, 폴란드, 20-582
- 모병
- Medrise sp z o.o
-
Poznan, 폴란드, 61-731
- 모병
- Clinical Research Center Sp. z o.o. MEDIC-R Spó?ka Komandytowa
-
Późna, 폴란드, 60-309
- 모병
- EMC Instytut Medyczny SA
-
Późna, 폴란드, 61-441
- 모병
- Gabinety Lekarskie Rivermed
-
Sopot, 폴란드, 81-756
- 모병
- Endoskopia Sp. z o.o.
-
Staszów, 폴란드, 20-200
- 모병
- Nowe Zdrowie-CK Kieltucki I Wspolnicy Sp. j.
-
Szczecin, 폴란드, 71-685
- 모병
- Sonomed Sp. z o.o.
-
Warsaw, 폴란드, 00-189
- 모병
- Centrum Zdrowia-MDM
-
Warsaw, 폴란드, 02-679
- 모병
- Medon Clinical Research sp. z o.o
-
Warsaw, 폴란드, 03-580
- 모병
- Vivamed Spolka Z Ograniczona Odpowiedzialnoscia
-
Wroc?aw, 폴란드, 52-210
- 모병
- PlanetMed sp. z o.o.
-
-
-
-
-
Manati, 푸에르토 리코, 00674
- 모병
- Galenus Group Of Puerto Rica Inc
-
-
-
-
-
Chambray-lès-Tours, 프랑스, 37170
- 모병
- CHU Tours - Hôpital Trousseau
-
Clermont-Ferrand, 프랑스, 63000
- 모병
- CHU Clermont Ferrand - Hôpital d'Estaing
-
Créteil, 프랑스, 94000
- 모병
- Hôpital Henri Mondor
-
La Roche-sur-Yon, 프랑스, 85925
- 모병
- CH Dptal Les Oudairies
-
Lille, 프랑스, 59037
- 모병
- CHRU de Lille - Hopital Claude Huriez
-
Limoges, 프랑스, 87042
- 모병
- Hopital Dupuytren
-
Montpellier, 프랑스, 34295
- 모병
- Hopital Saint-Eloi
-
Neuilly-sur-Seine, 프랑스, 92200
- 모집하지 않고 적극적으로
- Institut des MICI, Clinique Ambroise Paré
-
Paris, 프랑스, 75475
- 모병
- Hôpital Saint-Louis
-
Vandœuvre-lès-Nancy, 프랑스, 54511
- 모병
- Hôpital de Brabois Adultes
-
-
Rhône
-
Pierre-Bénite, Rhône, 프랑스, 69310
- 모집하지 않고 적극적으로
- Centre hospitalier Lyon Sud
-
-
-
-
-
Budapest, 헝가리, 1082
- 모병
- Semmelweis Egyetem
-
Budapest, 헝가리, 1062
- 모병
- Észak-Pesti Centrumkórház-Honvédkórház
-
Budapest, 헝가리, 1066
- 모병
- Geomedical Orvosi Kft
-
Budapest, 헝가리, 1139
- 모병
- Endomedix Kft.
-
Szombathely, 헝가리, 9700
- 모병
- Vas-Oxy Egeszsegugyi Kft
-
-
-
-
New South Wales
-
Macquarie Park, New South Wales, 호주, 2109
- 모병
- Macquarie University Hospital
-
Wahroonga, New South Wales, 호주, 2076
- 모병
- Sydney Adventist Hospital
-
-
Queensland
-
Mackay, Queensland, 호주, 4740
- 빼는
- Coral Sea Clinical Research Institute
-
-
South Australia
-
Adelaide, South Australia, 호주, 5112
- 모병
- Lyell McEwin Hospital
-
-
Victoria
-
Footscray, Victoria, 호주, 3011
- 모병
- Footscray Hospital
-
Parkville, Victoria, 호주, 3050
- 모병
- Royal Melbourne Hospital
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Confirmed diagnosis of CD
- Moderately to severely active CD
- Bodyweight >= 40 kilogram (kg)
- Demonstrated inadequate response, loss of response and/or intolerance to at least one protocol-specified conventional or advanced CD therapy
- Males and females of childbearing potential must meet protocol criteria for contraception requirements
Exclusion Criteria:
- Current diagnosis of ulcerative colitis (UC) or indeterminate colitis, ischemic colitis, infectious colitis, radiation colitis, microscopic colitis
- Participant with a history of >= 3 bowel resections (> 2 missing segments of the 5 following segments: terminal ilelium, right colon, transverse colon, sigmoid and left colon, and rectum)
- Diagnosis of short gut or short bowel syndrome
- Presence of an ileostomy, colostomy or ileoanal pouch
- Participants with symptomatic bowel strictures, fulminant colitis, or toxic megacolon
- Presence of abdominal or perianal abscess
- Presence of rectovaginal, enterovaginal, high output enterocutaneous fistula, enterovesical fistulas or perianal fistulas with >3 openings
- Participants with symptomatic bowel strictures, fulminant colitis, or toxic megacolon
- Current diagnosis or suspicion of primary sclerosing cholangitis
- Pregnancy or breastfeeding, or intention of becoming pregnant during the study
- Any past or current evidence of cancer of gastrointestinal tract, high-grade colonic dysplasia and participants with low-grade dysplasia are eligible if lesions have been completely removed
- History of non-gastrointestinal cancer, with the exception of adequately treated non-metastatic basal cell or squamous cell skin cancer or in situ cervical cancer
- Evidence of infection with Clostridioides difficile (C. difficile; formerly known as Clostridium difficile), cytomegalovirus (CMV), human immunodeficiency virus (HIV), Hepatitis B (HBV), Hepatitis C (HCV) during screening
- Has evidence of active tuberculosis (TB), latent TB not successfully treated (per local guidance) or inadequately treated TB
- Has received protocol-specified prohibited medicines, including known exposure to any type of anti-TL1A therapy
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Afimkibart
Participants will receive afimkibart intravenously (IV) followed by afimkibart subcutaneous (SC) injection. |
Afimkibart will be administered as IV infusion. Afimkibart will be administered as SC injection.
다른 이름들:
|
|
위약 비교기: Placebo
Participants will receive placebo IV followed by afimkibart SC injection. |
Placebo matching IV afimkibart. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Percentage of Participants with Clinical Remission per Crohn's Disease Activity Index (CDAI) Score
기간: At Week 12
|
Percentage of participants achieving a CDAI score of <150. The index is a weighted sum of scores on eight components: number of liquid or soft stools (stool frequency), abdominal pain, general well-being, number of complications, use of anti-diarrheal medication, presence of an abdominal mass, hematocrit, and percentage deviation from standard body weight. CDAI generally ranges from 0 to roughly 600, with higher values indicating greater activity. |
At Week 12
|
|
Percentage of Participants with Endoscopic Response
기간: At Week 12
|
Percentage of participants achieving a decrease in Simple Endoscopic Score for Crohn's Disease (SES-CD) of >50% from baseline. The SES-CD is a composite of four features of endoscopic activity (presence and size of ulcers, extent of ulcerated surface, extent of affected and presence and type of narrowings or stenosis) in up to five ileocolonic segments (terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum). Each feature is scored on a scale from 0 to 3, giving segment subscores of 0 to 12 points and a total SES-CD range of 0-60, with a higher value indicating greater severity. |
At Week 12
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Incidence and Severity of Adverse Events (AEs)
기간: Up to 30 Weeks after Baseline
|
Incidence and severity of AEs, including serious AEs, AEs leading to treatment discontinuation and AEs of special interest. |
Up to 30 Weeks after Baseline
|
|
Percentage of Participants with Symptomatic Remission
기간: At Week 12
|
Percentage of participants with the daily number of liquid or very soft stools <=2.8 and the average of daily abdominal pain scores in the past week <=1, with neither being greater than baseline. |
At Week 12
|
|
Percentage of Participants with Endoscopic Remission
기간: At Week 12
|
Percentage of participants with an SES-CD of 0 to 4 with a decrease from baseline >=2 and no subscore >1. |
At Week 12
|
|
Percentage of Participants with Ulcer-free Endoscopy
기간: At Week 12
|
Percentage of participants with an SES-CD ulcerated surface subscore of 0. |
At Week 12
|
|
Average of Daily Number of Liquid or Very Soft Stools in the Past Week (SF)
기간: Baseline through Week 12
|
Daily average number of liquid or very soft stools over 7 days. |
Baseline through Week 12
|
|
Average of Daily Abdominal Pain Scores in the Past Week (APS)
기간: Baseline through Week 12
|
The average daily rating of abdominal pain in the past 7 days. The pain is assessed on a scale of 0-3 with 0 indicating no pain and 3 indicating severe pain. |
Baseline through Week 12
|
|
Bowel Urgency
기간: Baseline to Week 12
|
Bowel urgency from baseline through week 12 and. Bowel urgency is a single-item self-reported assessment of sudden or immediate need to have a bowel movement in the past 24 hours. The item response is reported on a 4-point Likert scale, from "None" to "Severe." |
Baseline to Week 12
|
|
Fatigue
기간: Baseline to Week 12
|
Fatigue, as measured by the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), from baseline to Week 12. FACIT-F is a 13-item self-reported assessment of fatigue. Each item response option indicates the degree to which a given statement describing the level or impact of fatigue applies in the past 7 days. Response options are graded on a 5-point Likert-type scale, from "Not at all" to "Very much." |
Baseline to Week 12
|
|
Inflammatory Bowel Disease Questionnaire (IBDQ) Score
기간: Baseline to Week 12
|
Change in IBDQ score from baseline to week 12. The IBDQ is a 32-item questionnaire that measures four domains: bowel symptoms (10 questions); systemic symptoms (5 questions); emotional function (12 questions); and social function (5 questions). The total score ranges from 32-224, with a higher score indicating a better quality of life. |
Baseline to Week 12
|
|
Percentage of Participants with Clinical Remission: Among Biomarker-Defined Subgroups of Participants
기간: At Week 12
|
Percentage of participants achieving a CDAI score of <150 at Week 12 in biomarker-defined subgroups. The index is a weighted sum of scores on eight components: number of liquid or soft stools (stool frequency), abdominal pain, general well-being, number of complications, use of anti-diarrheal medication, presence of an abdominal mass, hematocrit, and percentage deviation from standard body weight. CDAI generally ranges from 0 to roughly 600, with higher values indicating greater activity. |
At Week 12
|
|
Percentage of Participants with Endoscopic Response: Among Biomarker-Defined Subgroups of Participants
기간: At Week 12
|
Percentage of participants achieving a decrease in SES-CD of >50% from baseline. The SES-CD is a composite of four features of endoscopic activity (presence and size of ulcers, extent of ulcerated surface, extent of affected and presence and type of narrowings or stenosis) in up to five ileocolonic segments (terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum). Each feature is scored on a scale from 0 to 3, giving segment subscores of 0 to 12 points and a total SES-CD range of 0-60, with a higher value indicating greater severity. |
At Week 12
|
|
Percentage of Participants with Clinical Response
기간: At Week 12
|
Percentage of participants with a decrease >=100 in CDAI from baseline. |
At Week 12
|
|
Percentage of Participants with Symptomatic Response
기간: At Week 12
|
Percentage of participants with a decrease >=30% in both SF and APS, with neither being greater than baseline. |
At Week 12
|
|
Overall Change in CD Symptoms
기간: Baseline to Weeks 2, 6 and 12
|
Overall change in CD symptoms, as measured by the Patient Global Impression of Change (PGIC) from baseline to Weeks 2, 6 and 12. PGIC measures overall change in Crohn's disease symptoms from "Much better" to "Much worse". |
Baseline to Weeks 2, 6 and 12
|
|
Overall Severity in CD Symptoms
기간: Baseline to Weeks 2, 6 and 12
|
Overall severity in CD symptoms, as measured by the Patient Global Impression of Severity (PGIS) from baseline to Weeks 2, 6 and 12. PGIS measures severity of Crohn's disease symptoms from "None" to "Very severe". |
Baseline to Weeks 2, 6 and 12
|
|
Change in General Well-being
기간: Baseline through Week 12
|
The average daily rating of general well-being in the past 7 days. Well-being is assessed on a scale of 0-4 with 0 indicating generally well and 4 indicating terrible. |
Baseline through Week 12
|
|
Presence of Draining Fistulas
기간: Baseline through Week 12
|
Fistulas will be assessed for draining or closed status, where closed fistulas will be assessed by the investigator as no longer draining. |
Baseline through Week 12
|
공동 작업자 및 조사자
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- GA45332
- 2024-513054-30-00 (씨티스)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .