A Study to Assess the Efficacy and Safety of Induction and Maintenance Therapy With Afimkibart (RO7790121) in Participants With Moderately to Severely Active Crohn's Disease (SIBERITE-1)
June 1, 2026 updated by: Hoffmann-La Roche
A Phase III, Multicenter, Double-Blind, Placebo-Controlled, Treat-Through Study to Assess the Efficacy and Safety of Induction and Maintenance Therapy With RO7790121 in Patients With Moderately to Severely Active Crohn's Disease
This Phase III, multicenter, double-blind, placebo-controlled treat-through study will evaluate the efficacy and safety of induction and maintenance therapy with Afimkibart (also known as RO7790121) in participants with moderately to severely active Crohn's disease (CD).
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
600
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Reference Study ID Number: GA45331 https://forpatients.roche.com/
- Phone Number: 888-662-6728 (U.S. and Canada)
- Email: global-roche-genentech-trials@gene.com
Study Contact Backup
- Name: Fastest response: use the inquiry form. No email attachments. https://www.gene.com/contact-us/submit-medical-inquiry
Study Locations
-
-
-
Ciudad Autonoma Bs As, Argentina, C1280AEB
- Recruiting
- Hospital Britanico
-
Rosario, Argentina, S2002KDS
- Recruiting
- Hospital Provincial del Centenario
-
-
-
-
Australian Capital Territory
-
Garran, Australian Capital Territory, Australia, 2605
- Recruiting
- The Canberra Hospital
-
-
New South Wales
-
Sydney, New South Wales, Australia, 2050
- Recruiting
- Royal Prince Alfred Hospital
-
-
Queensland
-
Herston, Queensland, Australia, 4029
- Recruiting
- Royal Brisbane and Women's Hospital
-
South Brisbane, Queensland, Australia, 4101
- Recruiting
- Mater Misericordiae Limited
-
Woolloongabba, Queensland, Australia, 4102
- Recruiting
- Princess Alexandra Hospital
-
-
South Australia
-
Adelaide, South Australia, Australia, 5042
- Recruiting
- Flinders Medical Center
-
Adelaide, South Australia, Australia, 5112
- Recruiting
- Lyell McEwin Hospital
-
-
Victoria
-
Epping, Victoria, Australia, 3076
- Recruiting
- Northern Hospital
-
-
Western Australia
-
Murdoch, Western Australia, Australia, 6150
- Recruiting
- Fiona Stanley Hospital
-
Perth, Western Australia, Australia, 6000
- Recruiting
- Royal Perth Hospital
-
-
-
-
-
Innsbruck, Austria, 6020
- Recruiting
- Medizinische Universität Innsbruck
-
Sankt Pölten, Austria, 3100
- Recruiting
- Universitätsklinikum St. Pölten
-
Vienna, Austria, 1090
- Recruiting
- Medizinische Universität Wien
-
Vienna, Austria, 1020
- Recruiting
- Barmherzige Brüder Wien
-
-
-
-
-
Aalst, Belgium, 9300
- Recruiting
- AZORG Campus Aalst-Moorselbaan
-
Brussels, Belgium, 1200
- Recruiting
- Cliniques Universitaires St-Luc
-
Edegem, Belgium, 2650
- Recruiting
- UZ Antwerpen
-
Ghent, Belgium, 9000
- Recruiting
- AZ Maria Middelares
-
Ghent, Belgium, 9000
- Recruiting
- AZ Sint Lucas (Sint Lucas)
-
Hasselt, Belgium, 3500
- Withdrawn
- Jessa Zkh (Campus Virga Jesse)
-
Liège, Belgium, 4000
- Recruiting
- CHC MontLegia
-
Liège, Belgium, 4000
- Recruiting
- CHU de Liège (Sart Tilman)
-
Mons, Belgium, 7000
- Recruiting
- CHU HELORA - Hôpital de Mons - Site Kennedy
-
Sint-Niklaas, Belgium, 9100
- Recruiting
- VITAZ
-
-
-
-
Estado de Bahia
-
Salvador, Estado de Bahia, Brazil, 41500-300
- Recruiting
- CLIAGEN - Clinica de Atenção em Gastroenterologia, Especialidades e Nutrição
-
-
Federal District
-
Brasília, Federal District, Brazil, 70200-730
- Recruiting
- L2 Ip Instituto de Pesquisas Clinicas Ltda ME
-
-
Paraná
-
Curitiba, Paraná, Brazil, 80430-160
- Recruiting
- Centro Digestivo de Curitiba
-
-
Rio Grande do Sul
-
Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
- Recruiting
- Hospital de Clinicas de Porto Alegre X
-
-
São Paulo
-
Botucatu, São Paulo, Brazil, 18618-970
- Recruiting
- UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu
-
Campinas, São Paulo, Brazil, 13060-904
- Recruiting
- Centro de Pesquisa Sao Lucas
-
São Paulo, São Paulo, Brazil, 01228-000
- Recruiting
- CPQuali Pesquisa Clínica Ltda
-
São Paulo, São Paulo, Brazil, 03325-050
- Recruiting
- BR Trials - Pesquisa Clínica
-
-
-
-
-
Burgas, Bulgaria, 8011
- Recruiting
- MBAL Burgasmed
-
Gorna Oryahovitsa, Bulgaria, 5100
- Recruiting
- MHAT St. Ivan Rilski
-
Plovdiv, Bulgaria, 4000
- Recruiting
- MHAT Saint Karidad EAD
-
Plovdiv, Bulgaria, 4000
- Recruiting
- Futuremeds Medical Center
-
-
-
-
Alberta
-
Edmonton, Alberta, Canada, T6K 4B2
- Recruiting
- South Edmonton Gastroenterology
-
-
Ontario
-
Vaughan, Ontario, Canada, L4L 4Y7
- Recruiting
- TDDA Specialty Research
-
-
Quebec
-
Trois-Rivières, Quebec, Canada, G8T 7A1
- Recruiting
- C.I.C. Mauricie
-
-
-
-
-
Concepción, Chile, 4030000
- Recruiting
- Hospital Guillermo Grant Benavente
-
Santiago, Chile
- Recruiting
- Clínica Universidad de Los Andes
-
Santiago, Chile, 7500000
- Recruiting
- Medwal
-
-
-
-
-
Beijing, China, 100191
- Recruiting
- Peking University Third Hospital
-
Changchun, China, 130021
- Recruiting
- The First Hospital of Jilin University
-
Changsha, China, 410013
- Recruiting
- Third Xiangya Hospital Centrel South University
-
Chengdu, China, 610041
- Recruiting
- West China Hospital of Sichuan University
-
Chongqing, China, 401147
- Recruiting
- Chongqing General Hospital
-
Fuzhou, China, 350005
- Recruiting
- The First Affiliated Hospital of Fujian Medical University
-
Guangzhou, China, 510655
- Recruiting
- the sixth affiliated hospital of Sun Yat-sen University
-
Guangzhou, China, 510260
- Recruiting
- The Second Affiliated Hospital of Guangzhou Medical University
-
Hangzhou, China, 310016
- Recruiting
- Sir Run Run Shaw Hospital Zhejiang University
-
Hangzhou, China, 310006
- Recruiting
- Zhejiang Province Traditional Chinese Medical Hospital
-
Hefei, China, 230001
- Recruiting
- Anhui Provincial Hospital
-
Hefei, China, 230022
- Recruiting
- The First Affiliated Hospital of Anhui Medical University
-
Huizhou, China, 516001
- Recruiting
- Huizhou Central People's Hospital
-
Nanchang, China, 330006
- Recruiting
- The 1st Affiliated Hospital of Nanchang Unversity
-
Nanning, China, 530021
- Recruiting
- The First Affiliate Hospital of Guangxi Medical University
-
Ningbo, China, 315000
- Recruiting
- The first affiliated Hospital of Ningbo University
-
Shanghai, China, 200126
- Recruiting
- Shanghai East Hospital
-
Shenzhen, China, 518036
- Recruiting
- Peking University Shenzhen Hospital
-
Taizhou, China, 318050
- Recruiting
- Taizhou Hospital of Zhejiang Province
-
Wuhan, China, 430014
- Recruiting
- The Central Hospital of Wuhan
-
Wuhan, China, 430060
- Recruiting
- Ren Min Hospital Affiliated Wu Han University
-
Wuxi, China, 214023
- Recruiting
- Wuxi People's Hospital
-
Xiamen, China, 361004
- Recruiting
- Zhongshan Hospital Xiamen University
-
Zhengzhou, China
- Recruiting
- The Second Affiliated Hospital of Zhengzhou University
-
Zhuzhou, China, 412007
- Recruiting
- ZhuZhou Central Hospital
-
-
-
-
-
Bogota, D.C., Colombia, 111321
- Recruiting
- Clinica Colsanitas S.A. sede Clinica Universitaria Colombia
-
Bogotá, Colombia, 11001
- Recruiting
- Clínica del Country
-
Medellín, Colombia, 050034
- Recruiting
- Hospital Pablo Tobon Uribe
-
-
-
-
-
Osijek, Croatia, 31000
- Recruiting
- Borzan Polyclinic
-
Zagreb, Croatia, 10000
- Recruiting
- Clinical Hospital Centre Zagreb
-
-
-
-
-
Brno, Czechia, 602 00
- Recruiting
- SurGal clinic s.r.o.
-
Hradec Králové, Czechia, 500 05
- Recruiting
- Fakultni nemocnice Hradec Kralove
-
Hradec Králové, Czechia, 500 02
- Recruiting
- Gastroenterologie s.r.o.
-
České Budějovice, Czechia, 370 01
- Recruiting
- Nemocnice Ceske Budejovice a.s.
-
-
-
-
-
Herlev, Denmark, 2730
- Recruiting
- Herlev Hospital
-
-
-
-
-
Santo Domingo, Dominican Republic, 10134
- Recruiting
- CEMDOE (Centro Médico de Diabetes, Obesidad y Especialidades)
-
-
-
-
-
Amiens, France, 80054
- Recruiting
- CHU Amiens - Hopital Sud
-
Marseille, France, 13015
- Recruiting
- Hôpital Nord
-
Nice, France, 06202
- Recruiting
- CHU Nice - Hopital de l'Archet 2
-
Pessac, France, 33604
- Recruiting
- Chu Bordeaux - Hôpital Haut-Lévêque
-
Reims, France, 51092
- Recruiting
- Hopital Robert Debre
-
Rennes, France, 35033
- Recruiting
- CHU de Rennes - Hopital de Pontchaillo
-
Saint-Etienne, France, 42055
- Recruiting
- CHU Saint Etienne - Hôpital Nord
-
-
-
-
-
Berlin, Germany, 12203
- Recruiting
- Charite - Campus Benjamin Franklin
-
Frankfurt, Germany, 60431
- Recruiting
- AGAPLESION Markus-Krankenhaus
-
Frankfurt, Germany, 60590
- Recruiting
- Klinik Johann Wolfgang von Goethe Uni
-
Halle, Germany, 06120
- Recruiting
- Universitaetsklinikum Halle (Saale)
-
Hanover, Germany, 30625
- Recruiting
- Med. Hochschule Hannover
-
Jena, Germany, 77430
- Recruiting
- Universitaetsklinikum Jena
-
Mannheim, Germany, 68167
- Withdrawn
- Klinikum Mannheim GmbH Universitätsklinikum
-
Ulm, Germany, 89081
- Recruiting
- Universitätsklinikum Ulm
-
-
-
-
-
Guatemala City, Guatemala, 01010
- Recruiting
- Celan S.A.
-
Guatemala City, Guatemala, 01016
- Recruiting
- Medi-k
-
-
-
-
-
Budapest, Hungary, 1088
- Recruiting
- Semmelweis Egyetem
-
Budapest, Hungary, 1036
- Recruiting
- Obudai Egeszsegugyi Centrum Kft.
-
Budapest, Hungary, 1136
- Recruiting
- Pannónia Magánorvosi Centrum
-
Békéscsaba, Hungary, 5600
- Recruiting
- Bekes Varmegyei Kozponti Korhaz, dr Rethy Pal Tagkorhaz
-
Gyöngyös, Hungary, 3200
- Recruiting
- Clinexpert Gyongyos Kft
-
Szekszárd, Hungary, 7100
- Recruiting
- Clinfan Szolgaltato Kft.
-
Székesfehérvár, Hungary, 8000
- Recruiting
- Fejer Varmegyei Szent Gyorgy Egyetemi Oktatokorhaz
-
-
-
-
Gujarat
-
Rajkot, Gujarat, India, 360005
- Recruiting
- Shree Giriraj Multispeciality Hospital
-
Surat, Gujarat, India, 395002
- Recruiting
- Surat Institute of Digestive Sciences Hospitals
-
Surat, Gujarat, India, 395009
- Recruiting
- Gujarat Gastro and Vascular Hospital
-
-
Kerala
-
Kochi, Kerala, India, 682041
- Recruiting
- Amrita Institute of Medical Sciences
-
-
Maharashtra
-
Nagpur (urban), Maharashtra, India, 440018
- Recruiting
- Midas Multispeciality Hospital
-
-
National Capital Territory of Delhi
-
New Delhi, National Capital Territory of Delhi, India, 110029
- Recruiting
- All India Institute of Medical Sciences (AIIMS)
-
-
Rajasthan
-
Jaipur, Rajasthan, India, 302006
- Recruiting
- SR Kalla Memorial Gastro & General Hospital
-
-
Telangana
-
Gachibowli, Telangana, India, 500032
- Recruiting
- AIG Hospitals
-
Secunderabad, Telangana, India, 500003
- Recruiting
- Yashoda Hospitals
-
Secunderabad, Telangana, India, 500003
- Recruiting
- Gandhi Hospital
-
-
-
-
-
Haifa, Israel, 3109601
- Recruiting
- Rambam Health Care Campus
-
Jerusalem, Israel, 9112001
- Recruiting
- Hadassah Medical Center
-
Ramat Gan, Israel, 5265601
- Recruiting
- Chaim Sheba Medical Center
-
-
Negev
-
Beersheba, Negev, Israel, 84101
- Recruiting
- Soroka University Medical Centre
-
-
-
-
Apulia
-
Bari, Apulia, Italy, 70124
- Recruiting
- A.O. Universitaria Ospedale Consorziale Policlinico Di Bari
-
-
Calabria
-
Catanzaro, Calabria, Italy, 88100
- Recruiting
- Azienda Ospedaliero-Universitaria "Renato Dulbecco" Catanzaro
-
-
Campania
-
Naples, Campania, Italy, 80131
- Recruiting
- Universita'degli Studi di Napoli Federico II
-
-
Lazio
-
Rome, Lazio, Italy, 00151
- Recruiting
- Azienda Ospedaliera San Camillo Forlanini
-
Rome, Lazio, Italy, 00186
- Recruiting
- Ospedale Isola Tiberina Gemelli
-
-
Lombardy
-
Milan, Lombardy, Italy, 20142
- Recruiting
- Asst Santi Paolo E Carlo
-
Milan, Lombardy, Italy, 20121
- Recruiting
- ASST Fatebenefratelli-Sacco, Polo "Ospedale Fatebenefratelli ed oftalmico"
-
Monza MI, Lombardy, Italy, 20900
- Recruiting
- Azienda Ospedaliera San Gerardo di Monza
-
Pavia, Lombardy, Italy, 27100
- Recruiting
- Fondazione IRCCS Policlinico San Matteo di Pavia
-
Rho, Lombardy, Italy, 20017
- Recruiting
- Asst Rhodense - Ospedale Di Rho
-
Rozzano (MI), Lombardy, Italy, 20089
- Recruiting
- Istituto Clinico Humanitas
-
San Giovanni Rotondo, Lombardy, Italy, 71013
- Recruiting
- IRCCS Ospedale Casa Sollievo della Soffenza
-
-
Piedmont
-
Turin, Piedmont, Italy, 10128
- Recruiting
- Ospedale Mauriziano Umberto I
-
-
Sardinia
-
Monserrato, Sardinia, Italy, 09042
- Recruiting
- Azienda Ospedaliero - Universitaria di Cagliari
-
-
Tuscany
-
Florence, Tuscany, Italy, 50124
- Recruiting
- A.O.U Careggi
-
-
Veneto
-
Padova, Veneto, Italy, 35128
- Recruiting
- Azienda Ospedaliera di Padova
-
-
-
-
-
Aichi, Japan, 467-8602
- Recruiting
- Nagoya City University Hospital
-
Aichi, Japan, 443-8501
- Recruiting
- Gamagori City Hospital
-
Aomori, Japan, 036-8545
- Recruiting
- National Hospital Organization Hirosaki General Medical Center
-
Asahikawa-shi, Japan, 070-8610
- Recruiting
- Asahikawa City Hospital
-
Chiba, Japan, 277-0871
- Recruiting
- Tsujinaka Hospital Kashiwanoha
-
Chikushino-shi, Japan, 818-8502
- Recruiting
- Fukuoka University Chikushi Hospital
-
Ehime, Japan, 790-0024
- Recruiting
- Ehime Prefectural Central Hospital
-
Fukui, Japan, 910-8526
- Recruiting
- Fukui Prefectural Hospital
-
Fukuoka, Japan, 812-8582
- Recruiting
- Kyushu University Hospital
-
Fukuoka, Japan, 810-8563
- Recruiting
- National Hospital Organization Kyushu Medical Center
-
Fukuoka, Japan, 830-0011
- Recruiting
- Kurume University Hospital
-
Fukuoka, Japan, 814-0180
- Recruiting
- Fukuoka University Hospital
-
Fukuoka, Japan, 802-8561
- Recruiting
- Kitakyushu Municipal Medical Center
-
Hiroshima, Japan, 734-8551
- Recruiting
- Hiroshima University Hospital
-
Hiroshima, Japan, 734-8530
- Recruiting
- Hiroshima Prefectural Hospital
-
Hokkaido, Japan, 060-8543
- Recruiting
- Sapporo Medical University Hospital
-
Hokkaido, Japan, 060-0033
- Recruiting
- Sapporo Kosei General Hospital
-
Hokkaido, Japan, 064-0919
- Recruiting
- Medical Corporation Sapporo IBD Clinic
-
Hyōgo, Japan, 663-8501
- Recruiting
- Hyogo Medical University Hospital
-
Ishikawa, Japan, 920-8530
- Recruiting
- Ishikawa Prefectural Central Hospital
-
Kagawa, Japan, 760-8557
- Recruiting
- Kagawa Prefectural Central Hospital
-
Kagoshima, Japan, 892-0846
- Recruiting
- Sameshima Hospital
-
Kanagawa, Japan, 232-0024
- Recruiting
- Yokohama City University Medical Center
-
Kanagawa, Japan, 247-0056
- Recruiting
- Gokeikai Ofuna Chuo Hospital
-
Kumamoto, Japan, 861-8520
- Recruiting
- Japanese Red Cross Kumamoto Hospital
-
Miyagi, Japan, 981-0914
- Recruiting
- Sendai Kousei Hospital
-
Miyagi, Japan, 983-8520
- Recruiting
- Sendai Medical Center
-
Nagasaki, Japan, 852-8501
- Recruiting
- Nagasaki University Hospital
-
Okayama, Japan, 700-8558
- Recruiting
- Okayama University Hospital
-
Osaka, Japan, 540-0006
- Recruiting
- National Hospital Organization Osaka National Hospital
-
Osaka, Japan, 530-0011
- Withdrawn
- Kinshukai Infusion Clinic
-
Saga, Japan, 849-8501
- Recruiting
- Saga University Hospital
-
Saga, Japan, 840-8571
- Recruiting
- Saga-Ken Medical Centre Koseikan
-
Shizuoka, Japan, 432-8061
- Recruiting
- Matsuda Hospital
-
Shizuoka, Japan, 431-3192
- Recruiting
- Hamamatsu University Hospital
-
Shizuoka, Japan, 411-8611
- Recruiting
- National Hospital Organization Shizuoka Medical Center
-
Tokyo, Japan, 160-8582
- Recruiting
- Keio University Hospital
-
Tokyo, Japan, 130-8575
- Recruiting
- Tokyo Metropolitan Bokutoh Hospital
-
Tokyo, Japan, 181-8611
- Recruiting
- Kyorin University Hospital
-
Tokyo, Japan, 113-8519
- Recruiting
- Institute of Science Tokyo Hospital
-
Tokyo, Japan, 169-0073
- Recruiting
- JCHO Tokyo Yamate Medical Center
-
Tokyo, Japan, 162-0052
- Recruiting
- National Center for Global Health and Medicine
-
Toyama, Japan, 930-0194
- Recruiting
- Toyama University Hospital
-
Wakayama, Japan, 640-8558
- Recruiting
- Japanese Red Cross Wakayama Medical Center
-
Yamagata, Japan, 990-9585
- Recruiting
- Yamagata University Hospital
-
Yamanashi, Japan, 400-8506
- Recruiting
- Yamanashi Prefectural Central Hospital
-
-
Hokkaido
-
Asahikawa-shi, Hokkaido, Japan, 078-8510
- Recruiting
- Asahikawa Medical University Hospital
-
-
Kagawa-ken
-
Takamatsu, Kagawa-ken, Japan, 760-0017
- Recruiting
- Takamatsu Red Cross Hospital
-
-
Miyagi
-
Sendai, Miyagi, Japan, 981-3213
- Recruiting
- Takagi Clinic
-
-
-
-
Jalisco
-
Guadalajara, Jalisco, Mexico, 44600
- Recruiting
- Boca Clinical Trials Mexico S.C. (Guadalajara)
-
-
Tlaxcala
-
Mexico, Tlaxcala, Mexico, 06726
- Recruiting
- Hospital General de Mexico
-
-
Yucatán
-
Mérida, Yucatán, Mexico, 97000
- Recruiting
- Medical Care & Research SA de CV
-
-
-
-
-
Arnhem, Netherlands, 6815 AD
- Recruiting
- Ziekenhuis Rijnstate
-
Sittard-Geleen, Netherlands, 6162 BG
- Recruiting
- Zuyderland Medisch Centrum - Sittard Geleen
-
Tilburg, Netherlands, 5022 GC
- Recruiting
- ETZ Elisabeth
-
Utrecht, Netherlands, 3584 CX
- Recruiting
- Universitair Medisch Centrum Utrecht
-
-
-
-
-
Panama City, Panama, 07192
- Recruiting
- Gastroenterólogos y Asociados
-
Panama City, Panama, 0801
- Recruiting
- Instituto de Investigación e Innovación y Gestión del Conocimiento (III-GC)
-
-
-
-
-
??czna, Poland, 21-010
- Recruiting
- SPZOZ w ??cznej
-
?ód?, Poland, 92-213
- Recruiting
- Clinical Trials UMED Sp. z o. o.
-
Bia?ystok, Poland, 15-276
- Recruiting
- Uniwersytecki Szpital Kliniczny W Bia?Ymstoku
-
Bydgoszcz, Poland, 85-229
- Recruiting
- Centrum Medyczne "Medis"
-
Chojnice, Poland, 89-600
- Recruiting
- Centrum Medyczne Lukamed Joanna Luka-Wendrowska
-
Karczew, Poland
- Recruiting
- Endo-Med Sp. z o.o.
-
Krakow, Poland, 30-363
- Recruiting
- Centrum Medyczne Plejady
-
Krakow, Poland, 31-501
- Recruiting
- Krakowskie Centrum Medyczne - Part of Futuremeds
-
Nowy Targ, Poland, 34-400
- Recruiting
- Allmedica Badania Kliniczne Sp z o.o. Sp K.
-
Olsztyn, Poland, 10-561
- Recruiting
- Wojewodzki Specjalistyczny Szpital w Olsztynie
-
Pabianice, Poland, 95-200
- Recruiting
- NZOZ Eskulap Pabianice
-
Piotrkow Trybunalski, Poland, 97-300
- Recruiting
- Trialmed CRS
-
Późna, Poland, 60-529
- Recruiting
- Solumed Centrum Medyczne
-
Rzeszów, Poland, 35-326
- Recruiting
- Centrum Medyczne "MEDYK"
-
Staszów, Poland, 20-200
- Recruiting
- Nowe Zdrowie-CK Kieltucki I Wspolnicy Sp. j.
-
Toru?, Poland, 87-100
- Recruiting
- GASTROMED Sp. z o.o.
-
Warsaw, Poland, 02-507
- Recruiting
- Centralny Szpital Kliniczny MSW w Warszawie
-
Warsaw, Poland, 00-728
- Recruiting
- WIP Warsaw IBD Point Profesor Kierkus
-
Wroc?aw, Poland, 53-149
- Recruiting
- Vistamed & Vertigo Spó?Ka Z Ograniczon? Odpowiedzialno?Ci?
-
Wroc?aw, Poland, 50-449
- Recruiting
- Melita Medical
-
Wroc?aw, Poland, 54-239
- Recruiting
- Penta Hospitals Przychodnie, Wroclaw Wejherowska
-
Wroclaw, Poland, 52-416
- Recruiting
- Centrum Medyczne Oporow
-
Zamość, Poland, 22-400
- Recruiting
- ETG Zamość
-
-
-
-
-
Braga, Portugal, 4710-243
- Recruiting
- Hospital de Braga
-
Lisbon, Portugal, 1649-035
- Recruiting
- Hospital de Santa Maria
-
Porto, Portugal, 4202-451
- Recruiting
- Hospital de Sao Joao
-
Santa Maria da Feira, Portugal, 4520-211
- Recruiting
- Centro Hospitalar de Entre Douro e Vouga - H. São Sebastião
-
Viseu, Portugal, 3504-509
- Recruiting
- Hospital Sao Teotonio
-
-
-
-
-
San Juan, Puerto Rico, 00936-5067
- Recruiting
- University of Puerto Rico Medical Sciences Campus
-
San Juan, Puerto Rico, 00909
- Recruiting
- Klinical Investigations Group LLC
-
-
-
-
-
Bucharest, Romania, 020125
- Recruiting
- Colentina Clinical Hospital
-
Bucharest, Romania, 020475
- Recruiting
- Cantacuzino Clinical Hospital
-
-
-
-
-
Belgrade, Serbia, 11080
- Recruiting
- University Hospital Medical Center Bezanijska kosa
-
Belgrade, Serbia, 11080
- Recruiting
- Clinical Hospital Center Zemun
-
Belgrade, Serbia, 11120
- Recruiting
- University Hospital Medical Center Zvezdara
-
Belgrade, Serbia, 11040
- Recruiting
- University Hospital Center Dr Dragisa Misovic - Dedinje
-
Novi Sad, Serbia, 21137
- Recruiting
- Clinical Center of Vojvodina
-
Zrenjanin, Serbia, 23000
- Recruiting
- General Hospital "Djordje Joanovic"
-
-
-
-
-
Bratislava, Slovakia, 811 09
- Recruiting
- Cliniq s.r.o.
-
Bratislava, Slovakia, 841 03
- Recruiting
- Nemocnica Bory -Penta Hospitals
-
Košice, Slovakia, 040 01
- Recruiting
- Endomed, s.r.o.
-
Ružomberok, Slovakia, 034 26
- Recruiting
- Ustredna vojenska nemocnica SNP Ruzomberok ? FN
-
-
-
-
-
Busan, South Korea, 48108
- Recruiting
- Inje University Haeundae Paik Hospital
-
Busan, South Korea, 49201
- Recruiting
- Dong-A University Hospital
-
Daegu, South Korea, 41944
- Recruiting
- Kyungpook National University Hospital
-
Daejeon, South Korea, 34943
- Recruiting
- The Catholic University of Korea Daejeon ST. Mary?s Hospital
-
Gangwon-do, South Korea, 26426
- Recruiting
- Yonsei University Wonju Severance Christian Hospital
-
Guri-si, South Korea, 11923
- Recruiting
- Hanyang University Guri Hospital
-
Seoul, South Korea, 03080
- Recruiting
- Seoul National University Hospital
-
Seoul, South Korea, 06351
- Recruiting
- Samsung Medical Center
-
Seoul, South Korea, 03181
- Recruiting
- Kangbuk Samsung Hospital
-
Seoul, South Korea, 06973
- Recruiting
- Chung-Ang University Hospital
-
Seoul, South Korea, 07804
- Recruiting
- Ewha Womans University Hospital (Seoul)
-
-
-
-
-
Madrid, Spain, 28046
- Recruiting
- Hospital Universitario La Paz
-
Murcia, Spain, 30003
- Recruiting
- Hospital Universitario Reina Sofia
-
Valencia, Spain, 46026
- Recruiting
- Hospital Universitari i Politecnic La Fe de Valencia
-
Valladolid, Spain, 47012
- Recruiting
- Hospital Universitario Rio Hortega
-
-
Cantabria
-
Santander, Cantabria, Spain, 39008
- Recruiting
- Hospital Universitario Marqués de Valdecilla
-
-
Vizcaya
-
Galdacao, Vizcaya, Spain, 48960
- Recruiting
- Hospital de Galdakao
-
-
-
-
-
Kaohsiung City, Taiwan, 82445
- Recruiting
- E-DA Hospital
-
Taichung, Taiwan, 40201
- Recruiting
- Chung Shan Medical University Hospital
-
Taichung, Taiwan, 40447
- Recruiting
- China Medical University Hospital
-
-
Zhongzheng District
-
Taipei, Zhongzheng District, Taiwan, 100
- Recruiting
- National Taiwan University Hospital
-
-
-
-
-
Bangkok, Thailand, 10330
- Recruiting
- Division of Gastroenterology, Depart of Medicine, Fac of Med., Chulalongkorn University
-
Bangkok, Thailand, 10700
- Recruiting
- Division of Gastroenterology, Depart of Internal Med, Siriraj H, Mahidol Uni
-
Khon Kaen, Thailand, 40002
- Recruiting
- Khon Kaen Uni
-
Pathum Thani, Thailand, 12120
- Recruiting
- Thammasat University Hospital
-
Songkhla, Thailand, 90110
- Recruiting
- Division of Gastroenterology, Depart of Medicine, Fac. of Med, Songklanagarind University
-
-
-
-
-
Abu Dhabi, United Arab Emirates, 11001
- Recruiting
- Sheikh Shakhbout Medical City
-
Abu Dhabi, United Arab Emirates, 7400
- Recruiting
- Burjeel Hopital
-
Abu Dhabi, United Arab Emirates, 51900
- Recruiting
- Sheikh Khalifa Medical City (SKMC)
-
Dubai, United Arab Emirates, 4545
- Recruiting
- Rashid Hospital
-
-
-
-
-
Cambridge, United Kingdom, CB2 0QQ
- Recruiting
- Addenbrookes Hospital
-
Harrow, United Kingdom, HA1 3UJ
- Recruiting
- St Mark's Hospital & Imperial College
-
Liverpool, United Kingdom, L7 8XP
- Recruiting
- Royal Liverpool University Hospital
-
London, United Kingdom, SE5 9RS
- Recruiting
- King College Hospital NHS Foundation Trust
-
London, United Kingdom, W1T 6AH
- Withdrawn
- Queen Anne Street Medical Centre
-
Newcastle upon Tyne, United Kingdom, NE1 4LP
- Recruiting
- Royal Victoria Infirmary
-
North Shields, United Kingdom, NE29 8NH
- Recruiting
- North Tyneside General Hospital
-
Nottingham, United Kingdom, NG7 2UH
- Recruiting
- Nottingham University Hospitals Queen's Medical Centre
-
-
-
-
Alabama
-
Dothan, Alabama, United States, 36305
- Recruiting
- Digestive Health Specialists of the Southeast (Gastroenterology Associates of Dothan) - Dothan
-
-
Arizona
-
Phoenix, Arizona, United States, 85054
- Recruiting
- Mayo Clinic Hospital
-
Sun City, Arizona, United States, 85351
- Recruiting
- Arizona Digestive Health, P.C (ADH)
-
Tucson, Arizona, United States, 85724
- Recruiting
- University of Arizona-CATS Research Center
-
-
California
-
Garden Grove, California, United States, 92845-2006
- Recruiting
- Valley View Internal Medicine
-
Inglewood, California, United States, 90301
- Recruiting
- 310 Clinical Research
-
La Jolla, California, United States, 92037-0897
- Recruiting
- UCSD Medical Center
-
Lancaster, California, United States, 93534
- Recruiting
- OM Research LLC
-
Lancaster, California, United States, 93534
- Recruiting
- Gastro Care Associates
-
Los Alamitos, California, United States, 90720
- Recruiting
- United Gastroenterologists
-
San Diego, California, United States, 92120
- Recruiting
- Acclaim Clinical Research, Inc.
-
San Francisco, California, United States, 94115
- Recruiting
- Kaiser Permanente
-
San Francisco, California, United States, 94115
- Recruiting
- UCSF/Medical Center at Mount Zion
-
-
Colorado
-
Littleton, Colorado, United States, 80120
- Recruiting
- Rocky Mountain Gastroenterology
-
Lone Tree, Colorado, United States, 80124
- Recruiting
- Peak Gastroenterology Surgery Center
-
-
Florida
-
Brooksville, Florida, United States, 34613
- Recruiting
- Access Research Institute
-
Clearwater, Florida, United States, 33756
- Recruiting
- Gastro Florida
-
Coral Gables, Florida, United States, 33134
- Recruiting
- Hi Tech and Global Research, LLC
-
Coral Gables, Florida, United States, 33134
- Recruiting
- HealthMed Clinical Center Inc.
-
Hialeah, Florida, United States, 33016
- Recruiting
- NeoClinical Research
-
Hialeah, Florida, United States, 33013
- Recruiting
- The Sister Life Research
-
Kissimmee, Florida, United States, 34741
- Recruiting
- Clinical Research of Osceola, LLC
-
Lakewood Rch, Florida, United States, 34211
- Recruiting
- Florida Research Institute - Lakewood
-
Miami, Florida, United States, 33126
- Recruiting
- LCC Medical Research Institute, LLC
-
Miami, Florida, United States, 33176
- Withdrawn
- Ambert Medical Research
-
Orlando, Florida, United States, 32806
- Recruiting
- Orlando Regional Healthcare
-
Tampa, Florida, United States, 33614
- Recruiting
- Guardian Angel Research Center, LLC
-
Tampa, Florida, United States, 33607
- Recruiting
- Nodal Medical Center Research - NMC
-
Tampa, Florida, United States, 33612
- Recruiting
- University of South Florida School of Medicine Morsani Center for Advanced Health Care
-
Temple Terrace, Florida, United States, 33617
- Recruiting
- Theia Clinical Research Centers, LLC
-
Weston, Florida, United States, 33331
- Recruiting
- Cleveland Clinic Florida
-
Zephyrhills, Florida, United States, 33542
- Recruiting
- Florida Medical Clinic - Orlando Health
-
-
Georgia
-
Atlanta, Georgia, United States, 30342
- Recruiting
- Atlanta Gastroenterology Associates
-
Atlanta, Georgia, United States, 30327
- Recruiting
- Digestive Healthcare of Georgia
-
Macon, Georgia, United States, 31201
- Recruiting
- Gastroenterology Associates of Central Georgia
-
-
Idaho
-
Idaho Falls, Idaho, United States, 83404
- Recruiting
- Grand Teton Research Group, PLLC
-
-
Illinois
-
Chicago, Illinois, United States, 60611
- Recruiting
- Northwestern Memorial Hospital
-
Glenview, Illinois, United States, 60026
- Recruiting
- Illinois Gastroenterology Group-Glenview powered by GI Alliance
-
Gurnee, Illinois, United States, 60031
- Recruiting
- Gi Alliance - Gurnee
-
-
Indiana
-
Indianapolis, Indiana, United States, 46202
- Recruiting
- Indiana University Health University Hospital
-
New Albany, Indiana, United States, 47150
- Recruiting
- Gastroenterology Health Partners, PLLC
-
-
Kansas
-
Wichita, Kansas, United States, 67226
- Recruiting
- Kansas Gastroenterology, LLC under Clinical Trials Network
-
-
Kentucky
-
Crestview Hills, Kentucky, United States, 41017-3409
- Recruiting
- Tri-State Gastroenterology Associates
-
Louisville, Kentucky, United States, 40218
- Recruiting
- Gastroenterology Health Partners, PLLC
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02115
- Recruiting
- Brigham and Women's Hospital
-
Boston, Massachusetts, United States, 02118
- Recruiting
- Boston University
-
-
Michigan
-
Farmington Hills, Michigan, United States, 48334
- Recruiting
- Michigan Center of Medical Research
-
-
Mississippi
-
Oxford, Mississippi, United States, 38655
- Recruiting
- Gastroenterology Associates and Endoscopy Center of North Mississippi
-
Southaven, Mississippi, United States, 38671
- Recruiting
- Delta Gastroenterology & Endoscopy Center
-
-
Nevada
-
North Las Vegas, Nevada, United States, 89030
- Recruiting
- Las Vegas Clinical Trials, LLC
-
-
New York
-
New York, New York, United States, 10075
- Recruiting
- Lenox Hill Hospital
-
New York, New York, United States, 10029
- Recruiting
- Mount Sinai Hospital - IBD Clinical Center
-
North Massapequa, New York, United States, 11758
- Recruiting
- DiGiovanna Inst for Med Ed&Res
-
Queens Village, New York, United States, 11428
- Recruiting
- Queens Village Medical Care
-
Richmond Hill, New York, United States, 11418
- Recruiting
- Mainstreet - Richmond Hill Clinic
-
Rochester, New York, United States, 14642
- Recruiting
- University of Rochester Medical Center
-
Rochester, New York, United States, 14618
- Recruiting
- Gastroenterology Group Of Rochester, LLP
-
-
North Carolina
-
Charlotte, North Carolina, United States, 28204
- Recruiting
- Atrium Health, Carolinas Healthcare System
-
Fuquay-Varina, North Carolina, United States, 27526
- Recruiting
- Omega Research North Carolina, LLC
-
Monroe, North Carolina, United States, 28112
- Recruiting
- Monroe Biomedical Research
-
-
Ohio
-
Beavercreek, Ohio, United States, 45440
- Recruiting
- Dayton Gastroenterology, Inc.
-
Brunswick, Ohio, United States, 44212
- Recruiting
- Digestive Disease Consultants
-
Cincinnati, Ohio, United States, 45267
- Recruiting
- University of Cincinnati Hospital
-
Cleveland, Ohio, United States, 44195
- Recruiting
- Cleveland Clinic Foundation
-
Columbus, Ohio, United States, 43210
- Recruiting
- The Ohio State University Wexner Medical Center
-
Columbus, Ohio, United States, 43202
- Recruiting
- Ohio Gastroenterology Group
-
Liberty Township, Ohio, United States, 45044
- Recruiting
- Gastro Health- Liberty
-
Westlake, Ohio, United States, 44145
- Recruiting
- Gastro Intestinal Research Institute of Northern Ohio
-
-
Oklahoma
-
Norman, Oklahoma, United States, 73071
- Recruiting
- Central Sooner Research
-
-
Pennsylvania
-
Hershey, Pennsylvania, United States, 17033
- Recruiting
- Penn State Milton S. Hershey Medical Center
-
Uniontown, Pennsylvania, United States, 15401-9069
- Recruiting
- Frontier Clinical Re search, LLC
-
-
Rhode Island
-
Providence, Rhode Island, United States, 02904
- Recruiting
- University Gastroenterology
-
-
South Carolina
-
Charleston, South Carolina, United States, 29425
- Recruiting
- Medical University of South Carolina
-
Greenville, South Carolina, United States, 29607
- Recruiting
- Gastroenterology Associates
-
-
Tennessee
-
Germantown, Tennessee, United States, 38138
- Recruiting
- Gastro One
-
Nashville, Tennessee, United States, 37211
- Recruiting
- Quality Medical Research
-
-
Texas
-
Arlington, Texas, United States, 76012
- Recruiting
- Texas Clinical Research Institute, LLC
-
El Paso, Texas, United States, 79902
- Recruiting
- Proactive El Paso,LLC
-
Georgetown, Texas, United States, 78628
- Recruiting
- Amel Med LLC
-
Harlingen, Texas, United States, 78550
- Recruiting
- Cano Medical Center
-
Mansfield, Texas, United States, 76063
- Recruiting
- TDDC dba GI Alliance Research
-
Mesquite, Texas, United States, 75149
- Recruiting
- SMS Clinical Research, LLC
-
San Antonio, Texas, United States, 78229
- Recruiting
- Gastroenterology Research of America, LLC
-
Southlake, Texas, United States, 76092
- Recruiting
- GI Alliance - Southlake
-
Temple, Texas, United States, 76508
- Recruiting
- Baylor Scott and White Medical Center
-
Tyler, Texas, United States, 75701
- Recruiting
- Tyler Research Institute, LLC
-
-
Virginia
-
Chesapeake, Virginia, United States, 23320
- Recruiting
- Tidewater Gastroenterology Pllc T/A Gastro. Assoc. of Tidewater
-
Lansdowne Town Center, Virginia, United States, 20176
- Recruiting
- Emeritas Research Group
-
Lynchburg, Virginia, United States, 24502
- Recruiting
- Blue Ridge Medical Research - Gastroenterology Associates of Central Virginia
-
Roanoke, Virginia, United States, 24014
- Recruiting
- Gastroenterology Consultants and Endoscopy Center of Southwest Virginia
-
Williamsburg, Virginia, United States, 23188
- Recruiting
- Tidewater Physicians Multispecialty Group (TPMG) - Clinical Research Division - Williamsburg
-
-
Washington
-
Vancouver, Washington, United States, 98664
- Recruiting
- The Vancouver Clinic
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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
- 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, definite low-grade or high-grade colonic dysplasia
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Arm 3: Placebo
Participants will receive placebo IV followed by placebo SC.
|
Placebo matching IV afimkibart.
Placebo matching SC afimkibart.
|
|
Experimental: Arm 1: 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.
Other Names:
|
|
Experimental: Arm 2: Afimkibart
Participants will receive afimkibart IV followed by afimkibart SC injection.
|
Afimkibart will be administered as IV infusion.
Afimkibart will be administered as SC injection.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percentage of Participants with Clinical Remission per Crohn's Disease Activity Index (CDAI) Score
Time Frame: At Week 52
|
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 52
|
|
Percentage of Participants with Endoscopic Response
Time Frame: At Week 52
|
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 52
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence and Severity of Adverse Events (AEs)
Time Frame: Up to 70 Weeks after Baseline
|
Incidence and severity of AEs, including serious AEs, AEs leading to treatment discontinuation and AEs of special interest.
|
Up to 70 Weeks after Baseline
|
|
Percentage of Participants with Symptomatic Remission
Time Frame: 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
Time Frame: 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
Time Frame: 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)
Time Frame: 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)
Time Frame: 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
|
|
Percentage of Participants with Clinical Remission: Among Biomarker-Defined Subgroups of Participants
Time Frame: 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
Time Frame: 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
Time Frame: At Week 12
|
Percentage of participants with a decrease >=100 in CDAI from baseline.
|
At Week 12
|
|
Percentage of Participants with Symptomatic Response
Time Frame: At Week 12
|
Percentage of participants with a decrease >=30% in both SF and APS, with neither being greater than baseline.
|
At Week 12
|
|
Percentage of Participants with Clinical Remission
Time Frame: 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
Time Frame: 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 Endoscopic Remission
Time Frame: At Week 52
|
Percentage of participants with SES-CD=0 to 4 with decrease from baseline >=2 and no subscore >1 .
|
At Week 52
|
|
Percentage of Participants with Symptomatic Remission
Time Frame: At Week 52
|
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 52
|
|
Percentage of Participants with Corticosteroid-free Clinical Remission
Time Frame: At Week 52
|
Percentage of participants with clinical remission at Week 52 and no use of corticosteroids for CD at least 8 weeks prior to Week 52.
|
At Week 52
|
|
Maintenance of Clinical Remission
Time Frame: At Weeks 12 and 52
|
Percentage of participants with clinical remission at both Weeks 12 and 52.
|
At Weeks 12 and 52
|
|
Maintenance of Endoscopic Response
Time Frame: At Weeks 12 and 52
|
Percentage of participants with endoscopic response at both Weeks 12 and 52.
|
At Weeks 12 and 52
|
|
Percentage of Participants with Clinical Remission and Endoscopic Remission at Week 52
Time Frame: At Week 52
|
Percentage of participants achieving a CDAI score of <150 and SES-CD of 0 to 4 with a decrease from baseline >=2 and no subscore >1 at Week 52.
|
At Week 52
|
|
Percentage of Participants with Ulcer-free Endoscopy
Time Frame: At Week 52
|
Percentage of participants with an SES-CD ulcerated surface subscore of 0.
|
At Week 52
|
|
Bowel Urgency
Time Frame: Baseline through Week 12 and Week 52
|
Bowel urgency from baseline through week 12 and week 52.
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 through Week 12 and Week 52
|
|
Fatigue
Time Frame: Baseline to Week 12 and Week 52
|
Fatigue, as measured by the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), from baseline to Week 12 and Week 52.
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 and Week 52
|
|
Inflammatory Bowel Disease Questionnaire (IBDQ) Score
Time Frame: Baseline to Week 12 and Week 52
|
Change in IBDQ score from baseline to week 12 and 52.
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 and Week 52
|
|
Percentage of Participants with Clinical Remission: Among Biomarker-Defined Subgroups of Participants
Time Frame: At Week 52
|
Percentage of participants achieving a CDAI score of <150 at Week 52 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 52
|
|
Percentage of Participants with Endoscopic Response: Among Biomarker-Defined Subgroups of Participants
Time Frame: At Week 52
|
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 52
|
|
Overall Change in CD Symptoms
Time Frame: Baseline to Weeks 2, 6, 12 and 52
|
Overall change in CD symptoms, as measured by the Patient Global Impression of Change (PGIC) from baseline to Weeks 2, 6, 12 and 52.
PGIC measures overall change in Crohn's disease symptoms from "Much better" to "Much worse".
|
Baseline to Weeks 2, 6, 12 and 52
|
|
Overall Severity in CD Symptoms
Time Frame: Baseline to Weeks 2, 6, 12 and 52
|
Overall severity in CD symptoms, as measured by the Patient Global Impression of Severity (PGIS) from baseline to Weeks 2, 6, 12 and 52.
PGIS measures severity of Crohn's disease symptoms from "None" to "Very severe".
|
Baseline to Weeks 2, 6, 12 and 52
|
|
Change in General Well-being
Time Frame: Baseline through Week 52
|
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 52
|
|
Percentage of Participants with a Presence of Draining Fistulas
Time Frame: Baseline through Week 12 and Week 52
|
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 and Week 52
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Clinical Trials, Hoffmann-La Roche
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 17, 2025
Primary Completion (Estimated)
December 31, 2028
Study Completion (Estimated)
December 31, 2033
Study Registration Dates
First Submitted
February 6, 2025
First Submitted That Met QC Criteria
February 6, 2025
First Posted (Actual)
February 11, 2025
Study Record Updates
Last Update Posted (Actual)
June 3, 2026
Last Update Submitted That Met QC Criteria
June 1, 2026
Last Verified
June 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GA45331
- 2024-513053-69-00 (Ctis: EU CT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
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
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Moderately to Severely Active Crohns Disease
-
Hoffmann-La RocheRecruitingModerately to Severely Active Crohns DiseaseTaiwan, Australia, Thailand
-
Hoffmann-La RocheChugai PharmaceuticalRecruitingModerately to Severely Active Crohns DiseaseUnited States, Israel, China, Poland, Germany, Croatia, Spain, France, Czechia, Australia, Portugal, Belgium, United Kingdom, Canada, Hungary, Italy, Austria, Slovakia, India, Brazil, Chile, Argentina, Bulgaria, Colombia, South Korea, Rom...
-
Hoffmann-La RocheRecruitingModerately to Severely Active Ulcerative ColitisUnited States, Taiwan, Thailand, United Kingdom, Australia, China
-
Nanjing Immunophage Biotech Co., LtdPeking Union Medical CollegeNot yet recruitingModerately to Severely Active Ulcerative Colitis (UC)China
-
Shandong Suncadia Medicine Co., Ltd.RecruitingAdult Patients With Moderately to Severely Active Ulcerative ColitisChina
-
Guangdong Hengrui Pharmaceutical Co., LtdActive, not recruitingAdult Patients With Moderately to Severely Active Ulcerative ColitisChina
-
Abivax S.A.RecruitingModerately to Severely Active Crohn DiseaseNetherlands, France, United States, Belgium, Italy, Spain, Germany, Hungary, Poland, Romania, Slovakia, Czechia
-
Alimentiv Inc.TakedaRecruitingCrohn Disease | Moderately to Severely Active Crohn's Disease | Disease CrohnUnited States, Canada, Australia, Belgium, United Kingdom, Netherlands, Denmark, Germany, Czechia, Italy, Poland, Portugal, France
-
CelltrionCompletedModerately to Severely Active Rheumatoid ArthritisPoland
-
Shanghai Henlius BiotechCompletedModerately to Severely Active Rheumatoid ArthritisChina
Clinical Trials on Afimkibart
-
Hoffmann-La RocheRecruitingModerately to Severely Active Crohns DiseaseTaiwan, Australia, Thailand
-
Hoffmann-La RocheRecruitingAtopic DermatitisUnited States, Brazil, Canada, Poland, Germany
-
Hoffmann-La RocheNot yet recruiting
-
Hoffmann-La RocheActive, not recruitingCrohns DiseaseUnited States, France, Belgium, Poland
-
Hoffmann-La RocheRecruitingModerately to Severely Active Ulcerative ColitisUnited States, Taiwan, Thailand, United Kingdom, Australia, China
-
Hoffmann-La RocheActive, not recruitingAtopic DermatitisSpain, United States, Canada, Poland, Brazil, Germany, Italy, France
-
Hoffmann-La RocheRecruitingModerately to Severely Active Ulcerative ColitisUnited States, China, Poland, Taiwan, United Kingdom, Portugal, Argentina, France, Canada, Hungary, Australia, Italy, Spain, Israel, Croatia, Germany, Austria, Serbia, Chile, India, Mexico, Thailand, Puerto Rico, Bulgaria, Brazil, Czechia, ... and more
-
Hoffmann-La RocheChugai PharmaceuticalRecruitingModerately to Severely Active Crohns DiseaseUnited States, Israel, China, Poland, Germany, Croatia, Spain, France, Czechia, Australia, Portugal, Belgium, United Kingdom, Canada, Hungary, Italy, Austria, Slovakia, India, Brazil, Chile, Argentina, Bulgaria, Colombia, South Korea, Rom...
-
Hoffmann-La RocheChugai PharmaceuticalActive, not recruitingModerately to Severely Active Ulcerative ColitisUnited States, United Kingdom, Austria, Denmark, France, Spain, Australia, Japan, Portugal, Serbia, China, Hungary, India, Romania, Bulgaria, Thailand, Argentina, Poland, Mexico, Belgium, Slovakia, Czechia, Chile, Taiwan, Canada, Brazil, Italy and more
-
Hoffmann-La RocheRecruitingRheumatoid ArthritisBelgium, United States, Poland, Spain, Argentina, United Kingdom, Italy, Denmark, Brazil, France, Germany