A Study to Assess the Efficacy and Safety of Induction Therapy With Afimkibart (RO7790121) in Participants With Moderately to Severely Active Crohn's Disease (SIBERITE-2)
August 28, 2026 updated by: Hoffmann-La Roche
A Phase III, Multicenter, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Induction Therapy With RO7790121 in Patients With Moderately to Severely Active Crohn's Disease
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).
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
425
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: Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
Study Contact Backup
- Name: Reference Study ID Number: GA45332 https://forpatients.roche.com/ No attachments to email below.
- Phone Number: 888-662-6728 (U.S. and Canada)
- Email: global-roche-genentech-trials@gene.com
Study Locations
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Quilmes, Argentina, B1878DVB
- Recruiting
- Instituto Medico CER
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San Miguel de Tucumán, Argentina, T4000DPK
- Recruiting
- CICE 9 de Julio
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New South Wales
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Macquarie Park, New South Wales, Australia, 2109
- Recruiting
- Macquarie University Hospital
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Wahroonga, New South Wales, Australia, 2076
- Recruiting
- Sydney Adventist Hospital
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Queensland
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Mackay, Queensland, Australia, 4740
- Withdrawn
- Coral Sea Clinical Research Institute
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Victoria
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Footscray, Victoria, Australia, 3011
- Recruiting
- Footscray Hospital
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Parkville, Victoria, Australia, 3050
- Recruiting
- Royal Melbourne Hospital
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Linz, Austria, 4010
- Recruiting
- Ordensklinikum Linz Barmherzige Schwestern
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Wels, Austria, 4600
- Recruiting
- Klinikum Wels-Grieskirchen
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Brussels, Belgium, 1090
- Recruiting
- UZ Brussel
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Brussels, Belgium, 1200
- Recruiting
- Cliniques Universitaires St-Luc
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Brussels, Belgium, 1000
- Recruiting
- CHU St Pierre (St Pierre)
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Rio Grande do Sul
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Porto Alegre, Rio Grande do Sul, Brazil, 90035-000
- Recruiting
- Hospital Moinhos de Vento
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Rio de Janeiro
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Volta Redonda, Rio de Janeiro, Brazil, 27258-000
- Recruiting
- Instituto Lobus Unimed Volta Redonda
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Sergipe
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Aracaju, Sergipe, Brazil, 49055-000
- Recruiting
- Newdata Clinical Trials
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São Paulo
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Jaú, São Paulo, Brazil, 17210-190
- Recruiting
- CECIP - Centro de Estudos Clínicos do Interior Paulista
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São José do Rio Preto, São Paulo, Brazil, 15090-000
- Recruiting
- Hospital de Base de Sao Jose do Rio Preto
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São Paulo, São Paulo, Brazil, 01308-050
- Recruiting
- Hospital Sírio-Libanês
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Panagyurishte, Bulgaria, 4500
- Recruiting
- Multiprofile Hospital for Active Treatment Uni Hospital;Department of Gastroenterology.
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Plovdiv, Bulgaria, 4003
- Recruiting
- MC " Sveti Ivan Rilski Chudotvorets- 2010
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Ontario
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Barrie, Ontario, Canada, L4M 7G1
- Recruiting
- Barrie GI Associates
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Brampton, Ontario, Canada, L6S 0E2
- Recruiting
- GNRR Digestive Clinics and Research Center Inc.
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London, Ontario, Canada, N6K 1M6
- Recruiting
- LDDI Clinical Trials Inc.
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London, Ontario, Canada, N6A 5A5
- Withdrawn
- London Health Sciences Centre Uni Campus
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North YORK, Ontario, Canada, M6A 3B4
- Recruiting
- Toronto Immune and Digestive Health Institute
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Quebec
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Montreal, Quebec, Canada, H1T 2M4
- Recruiting
- CIUSSS de l Est de l Ile de Montreal - Hopital Maisonneuve Rosemont
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Las Condes, Chile, 7560908
- Recruiting
- Medicina de Precisión - Celerity
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Santiago, Chile, 8330034
- Recruiting
- Centro de Investigación Clínica UC-CICUC
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Santiago, Chile, 7500000
- Recruiting
- Medwal
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Beijing, China, 100730
- Recruiting
- Beijing Union Hospital
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Chengdu, China, 610072
- Recruiting
- Sichuan Provincial People's Hospital
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Guangzhou, China, 510280
- Recruiting
- Zhujiang Hospital, Southern Medical University
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Guangzhou, China, 510180
- Recruiting
- Guangzhou First People's Hospital
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Haikou, China, 570311
- Recruiting
- Hainan General Hospital
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Huizhou, China
- Recruiting
- Huizhou First Hospital
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Nanchang, China, 330008
- Recruiting
- The Second Affiliated Hospital of Nanchang University
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Shanghai, China, 200092
- Recruiting
- Xinhua Hospital Affiliated To Shanghai Jiao Tong University School Of Medicine
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Shanghai, China, 200127
- Recruiting
- Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
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Shenyang, China, 110004
- Recruiting
- Shengjing Hospital Of China Medical University
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Shijiazhuang, China, 050004
- Recruiting
- Hebei Medical University - The Second Hospital
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Suzhou, China, 215004
- Recruiting
- The Second Affiliated Hospital of Soochow University
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Xi'an, China, 710004
- Recruiting
- The Second Affiliated Hospital of Xi'an Jiao Tong University
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Xiamen, China, 361003
- Recruiting
- The First Affiliated Hospital of Xiamen University
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Zhenjiang, China, 212001
- Recruiting
- Affiliated Hospital of Jiangsu University
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Jiangxi
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Ganzhou, Jiangxi, China, 341000
- Recruiting
- First Affiliated Hospital of Gannan Medical University
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Yunnan
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Kunming, Yunnan, China, 650032
- Recruiting
- The First Affilliated Hospital of Kunming Medical University
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Zhejiang
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Jinhua, Zhejiang, China, 321013
- Recruiting
- Jinhua municipal central hospital
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Bogotá, Colombia, 110221
- Recruiting
- Clinica de la Mujer
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Bogotá, Colombia, 000472
- Recruiting
- Hospital Universitario San Ignacio
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Bogotá, Colombia, 111071
- Recruiting
- Clinica Colsanitas S.A. - Sede Clinica Reina Sofia
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Montería, Colombia, 230002
- Recruiting
- Oncomedica S.A.
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Osijek, Croatia, 31000
- Recruiting
- Borzan Polyclinic
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Zagreb, Croatia, 10000
- Recruiting
- Clinical Hospital Centre Zagreb
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Hradec Králové, Czechia, 500 12
- Recruiting
- Hepato-gastroenterologie HK, s.r.o.
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Ostrava - Poruba, Czechia, 708 52
- Recruiting
- Fakultni Nemocnice Ostrava
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Prague, Czechia, 170 04
- Recruiting
- ISCARE a.s.
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Prague, Czechia, 140 21
- Recruiting
- Institutu Klinicke a Experimentaini Mediciny (IKEM);Klinika hepatogastroenterologie
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Ústí nad Labem, Czechia, 401 13
- Recruiting
- Krajska zdravotni, a.s. ? Masarykova nemocnice v Usti nad Labem, o.z., Ocni oddeleni
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Chambray-lès-Tours, France, 37170
- Recruiting
- CHU Tours - Hôpital Trousseau
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Clermont-Ferrand, France, 63000
- Recruiting
- CHU Clermont Ferrand - Hôpital d'Estaing
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Créteil, France, 94000
- Recruiting
- Hôpital Henri Mondor
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La Roche-sur-Yon, France, 85925
- Recruiting
- CH Dptal Les Oudairies
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Lille, France, 59037
- Recruiting
- CHRU de Lille - Hopital Claude Huriez
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Limoges, France, 87042
- Recruiting
- Hopital Dupuytren
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Montpellier, France, 34295
- Recruiting
- Hopital Saint-Eloi
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Neuilly-sur-Seine, France, 92200
- Active, not recruiting
- Institut des MICI, Clinique Ambroise Paré
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Paris, France, 75475
- Recruiting
- Hôpital Saint-Louis
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Vandœuvre-lès-Nancy, France, 54511
- Recruiting
- Hôpital de Brabois Adultes
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Rhône
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Pierre-Bénite, Rhône, France, 69310
- Active, not recruiting
- Centre Hospitalier Lyon Sud
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Heidelberg, Germany, 69120
- Recruiting
- Universitätsklinikum Heidelberg
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Potsdam, Germany, 14467
- Recruiting
- Klinikum Ernst von Bergmann
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Budapest, Hungary, 1082
- Recruiting
- Semmelweis Egyetem
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Budapest, Hungary, 1062
- Recruiting
- Észak-Pesti Centrumkórház-Honvédkórház
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Budapest, Hungary, 1066
- Recruiting
- Geomedical Orvosi Kft
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Budapest, Hungary, 1139
- Recruiting
- Endomedix Kft.
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Szombathely, Hungary, 9700
- Recruiting
- Vas-Oxy Egeszsegugyi Kft
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Andhra Pradesh
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Kurnool, Andhra Pradesh, India, 518002
- Recruiting
- Kurnool Medical College
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Gujarat
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Rajkot, Gujarat, India, 360005
- Recruiting
- Shree Giriraj Multispeciality Hospital
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Surat, Gujarat, India, 395002
- Recruiting
- Surat Institute of Digestive Sciences Hospitals
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Surat, Gujarat, India, 395009
- Recruiting
- Gujarat Gastro and Vascular Hospital
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Kerala
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Kochi, Kerala, India, 682041
- Recruiting
- Amrita Institute of Medical Sciences
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Maharashtra
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Nagpur (urban), Maharashtra, India, 440018
- Recruiting
- MIDAS Multispeciality Hospital
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National Capital Territory of Delhi
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New Delhi, National Capital Territory of Delhi, India, 110029
- Recruiting
- All India Institute of Medical Sciences (AIIMS)
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Rajasthan
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Jaipur, Rajasthan, India, 302006
- Recruiting
- SR Kalla Memorial Gastro & General Hospital
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Jaipur, Rajasthan, India, 302007
- Recruiting
- SMS Superspeciality Hospital
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Telangana
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Gachibowli, Telangana, India, 500032
- Recruiting
- AIG Hospitals
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Secunderabad, Telangana, India, 500003
- Recruiting
- Yashoda Hospitals
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Secunderabad, Telangana, India, 500003
- Recruiting
- Gandhi Hospital
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West Bengal
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Kolkata, West Bengal, India, 700020
- Recruiting
- Institute of Post Graduate Medical Education and Research (IPGMER) and SSKM Hospital
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Jerusalem, Israel, 9103102
- Recruiting
- Shaare Zedek Medical Center
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Jerusalem, Israel, 9112001
- Recruiting
- Hadassah Medical Center
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Basilicate
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Matera, Basilicate, Italy, 75100
- Recruiting
- Ospedale Madonna delle Grazie
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Emilia-Romagna
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Bologna, Emilia-Romagna, Italy, 40138
- Recruiting
- Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi-Via Massarenti
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Lazio
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Rome, Lazio, Italy, 00168
- Recruiting
- Policlinico Universitario Agostino Gemelli
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Rome, Lazio, Italy, 00128
- Recruiting
- Policlinico Universitario Campus Biomedico Di Roma
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Lombardy
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Brescia, Lombardy, Italy, 25123
- Recruiting
- ASST degli Spedali Civili di Brescia
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Milan, Lombardy, Italy, 20132
- Recruiting
- IRCCS Ospedale San Raffaele
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San Donato Milanese (MI), Lombardy, Italy, 20097
- Recruiting
- I.R.C.C.S Policlinico San Donato
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Veneto
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Negrar, Veneto, Italy, 37024
- Recruiting
- IRCCS Ospedale Sacro Cuore Don Calabria
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Bia?ystok, Poland, 15-322
- Recruiting
- Gastromed Kralisz, Romatowski, Stachurska sp.j.
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Bydgoszcz, Poland, 85-231
- Recruiting
- Medical Center Kermed
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Elblag, Poland, 82-300
- Recruiting
- Szpital Miejski sw. Jana Paw?a II w Elblagu
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I?awa, Poland, 14-200
- Recruiting
- Osrodek Badan Klinicznych Bd Research
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Knurów, Poland, 44-190
- Recruiting
- MZ Badania Slowik Zymla Sp.j.
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Krakow, Poland, 31-513
- Recruiting
- Centrum Medyczne Promed
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Lodz, Poland, 91-495
- Recruiting
- Amicare Sp. z o.o. S.K.
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Lublin, Poland, 20-582
- Recruiting
- Medrise sp z o.o
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Poznan, Poland, 61-731
- Recruiting
- Clinical Research Center Sp. z o.o. MEDIC-R Spó?ka Komandytowa
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Późna, Poland, 60-309
- Recruiting
- EMC Instytut Medyczny SA
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Późna, Poland, 61-441
- Recruiting
- Gabinety Lekarskie Rivermed
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Sopot, Poland, 81-756
- Recruiting
- Endoskopia Sp. z o.o.
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Szczecin, Poland, 71-685
- Recruiting
- Sonomed Sp. z o.o.
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Warsaw, Poland, 00-189
- Recruiting
- Centrum Zdrowia-MDM
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Warsaw, Poland, 02-679
- Recruiting
- Medon Clinical Research sp. z o.o
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Warsaw, Poland, 03-580
- Recruiting
- Vivamed Spolka Z Ograniczona Odpowiedzialnoscia
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Wroc?aw, Poland, 52-210
- Recruiting
- PlanetMed Sp. z o.o.
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Braga, Portugal, 4710-243
- Recruiting
- Hospital de Braga
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Lisbon, Portugal, 1649-035
- Recruiting
- Hospital de Santa Maria
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Porto, Portugal, 4202-451
- Recruiting
- Hospital de Sao Joao
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Santa Maria da Feira, Portugal, 4520-211
- Recruiting
- Centro Hospitalar de Entre Douro e Vouga - H. São Sebastião
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Viseu, Portugal, 3504-509
- Recruiting
- Hospital Sao Teotonio
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Manati, Puerto Rico, 00674
- Recruiting
- Galenus Group Of Puerto Rica Inc
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Cluj-Napoca, Romania, DUMMY_VALUE
- Recruiting
- Spital Digenio - Centrul de Excelen?? în Afec?iuni Digestive
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Bratislava, Slovakia, 821 07
- Recruiting
- ABAWI spol. s r.o.
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Nitra, Slovakia, 949 01
- Recruiting
- KM Management spol. s r.o.
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Daegu, South Korea, 42415
- Recruiting
- Yeungnam University Medical Center
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Gwangju, South Korea, 61453
- Recruiting
- Chosun university hospital
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Seoul, South Korea, 04763
- Recruiting
- Hanyang University Seoul Hospital
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Seoul, South Korea, 03312
- Recruiting
- The Catholic University of Korea Eunpyeong St. Mary's Hospital
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Gyeonggi-do
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Ansan-si, Gyeonggi-do, South Korea, 15355
- Recruiting
- Korea University Ansan Hospital
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Madrid, Spain, 28040
- Recruiting
- Hospital General Universitario Gregorio Marañon
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Zaragoza, Spain, 50009
- Recruiting
- Hospital Clinico Univ. Lozano Blesa
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Madrid
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Alcorcón, Madrid, Spain, 28922
- Recruiting
- Fundacion Hospital de Alcorcon
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Majadahonda, Madrid, Spain, 28222
- Recruiting
- Hospital Universitario Puerta de Hierro
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Bristol, United Kingdom, BS10 5NB
- Recruiting
- Southmead Hospital
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Bury, United Kingdom, BL9 7TD
- Recruiting
- Fairfield General Hospital
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Llanrhystud, United Kingdom, SY23 1ER
- Recruiting
- Bronglais General Hospital
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London, United Kingdom, E1 1FR
- Recruiting
- Royal London Hospital
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Stockport, United Kingdom, SK2 7JE
- Active, not recruiting
- Stepping Hill Hospital
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Alabama
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Dothan, Alabama, United States, 36305
- Recruiting
- Digestive Health Specialists of the Southeast
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Arizona
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Glendale, Arizona, United States, 85304
- Recruiting
- Sun City Clinical Research
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California
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Lancaster, California, United States, 93534
- Recruiting
- Om Research LLC
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Newport Beach, California, United States, 92663
- Recruiting
- Hoag Memorial Hospital Presbyterian;Hoag Center for Research and Education
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Pomona, California, United States, 91767
- Withdrawn
- Empire Clinical Research
-
Redwood City, California, United States, 94063
- Recruiting
- Stanford Medicine Outpatient Center
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San Diego, California, United States, 92103
- Recruiting
- Clinical Applications Laboratories, Inc.
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Santa Clarita, California, United States, 91355
- Recruiting
- Amicis Research Center
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Colorado
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Colorado Springs, Colorado, United States, 80907
- Recruiting
- Peak Gastroenterology Associates
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Florida
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Doral, Florida, United States, 33126
- Recruiting
- J&A Clinical Research
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Lakeland, Florida, United States, 33813
- Recruiting
- Auzmer Research
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Lehigh Acres, Florida, United States, 33936
- Recruiting
- Galenus Group Inc
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Miami, Florida, United States, 33155
- Recruiting
- Rejuvaline Medical Research
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Miami, Florida, United States, 33155
- Recruiting
- Allied Biomedical Research Institute, Inc
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Miami, Florida, United States, 33033
- Recruiting
- Homestead Associates in Research, Inc.
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Miami Beach, Florida, United States, 33141
- Recruiting
- Miami Beach Clinical Research Center
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Miramar, Florida, United States, 33027
- Recruiting
- Eminat Research Group
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Orlando, Florida, United States, 32825
- Recruiting
- Digestive and Liver Center of Florida
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Port Orange, Florida, United States, 32127
- Recruiting
- Advanced Medical Research Center
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Tampa, Florida, United States, 33615
- Recruiting
- Santos Research Center, CORP
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Weston, Florida, United States, 33331
- Recruiting
- Cleveland Clinic Florida
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Georgia
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Atlanta, Georgia, United States, 30310-1495
- Recruiting
- Morehouse School of Medicine
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Illinois
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Chicago, Illinois, United States, 60637
- Recruiting
- The University of Chicago
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Kansas
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Kansas City, Kansas, United States, 66160
- Recruiting
- University of Kansas Medical Center
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Kentucky
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Louisville, Kentucky, United States, 40206
- Recruiting
- Robley Rex VA Medical Center
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Louisville, Kentucky, United States, 40218
- Recruiting
- One GI: GHP - Gastroenterology Health Partners Louisville
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Louisiana
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Baton Rouge, Louisiana, United States, 70809
- Recruiting
- Baton Rouge General Medical Center
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Shreveport, Louisiana, United States, 71105
- Recruiting
- Louisiana Research Center - GastroIntestinal Associates
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Maryland
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Baltimore, Maryland, United States, 21202
- Recruiting
- Mercy Medical Center
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Chevy Chase, Maryland, United States, 20815
- Recruiting
- Chevy Chase Clinical Research
-
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Massachusetts
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North Worcester, Massachusetts, United States, 01655
- Recruiting
- University of Massachusetts Memorial Medical Center
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Michigan
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Wyoming, Michigan, United States, 49519
- Recruiting
- Gastroenterology Associates of Western Michigan, P.L.C.
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Mississippi
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Flowood, Mississippi, United States, 39232
- Recruiting
- Gastrointestinal Associates Research
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Missouri
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Columbia, Missouri, United States, 65201-5275
- Recruiting
- Va Heartland Network - Harry S. Truman Memorial Veterans' Hospital
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St Louis, Missouri, United States, 63141
- Recruiting
- Specialists in Gastroenterology
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New Hampshire
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Lebanon, New Hampshire, United States, 03756
- Recruiting
- Dartmouth-Hitchcock Medical Center-Norris Cotton Cancer Center
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New Jersey
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Moorestown, New Jersey, United States, 08057
- Recruiting
- Virtua Crohns and Colitis Center
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New Brunswick, New Jersey, United States, 08901
- Recruiting
- Robert Wood Johnson University Hospital
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New York
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Brooklyn, New York, United States, 11215
- Recruiting
- Ellipsis Research Group
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Fresh Meadows, New York, United States, 11366
- Recruiting
- Intercity Gastroenterology
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The Bronx, New York, United States, 10468
- Recruiting
- James J Peters Veterans Affairs Medical Center
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Utica, New York, United States, 13502
- Recruiting
- Digestive Disease Medicine of Central New York
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North Carolina
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Charlotte, North Carolina, United States, 28207
- Recruiting
- Charlotte Gastroenterology and Hepatology, P.L.L.C
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High Point, North Carolina, United States, 27260
- Recruiting
- Peters Medical Research (PMR), LLC
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Ohio
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Beavercreek, Ohio, United States, 45431
- Recruiting
- Clinical Inquest Center
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Cleveland, Ohio, United States, 44195
- Recruiting
- Cleveland Clinic Foundation
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Recruiting
- University of Pennsylvania
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Rhode Island
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Providence, Rhode Island, United States, 02904
- Recruiting
- University Gastroenterology
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Tennessee
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Cordova, Tennessee, United States, 38018
- Recruiting
- Gastro One
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Nashville, Tennessee, United States, 37212-1375
- Recruiting
- Vanderbilt University Medical Center
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Texas
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Dallas, Texas, United States, 75390-8565
- Recruiting
- University of Texas Southwestern Medical Center - Multidisciplinary Spine Clinic - James W. Aston Ambulatory Care Center
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Fort Worth, Texas, United States, 76104
- Recruiting
- GI Alliance - Fort Worth
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Garland, Texas, United States, 75044
- Recruiting
- GI Alliance
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Houston, Texas, United States, 77090
- Recruiting
- Integrity Advanced Therapeutics PLLC
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Lubbock, Texas, United States, 79410
- Recruiting
- Texas Digestive Disease Consultants-Lubbock powered by GI Alliance
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San Antonio, Texas, United States, 78212
- Recruiting
- Carta - Clinical Associates In Research Therapeutics Of America;LLC
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Tyler, Texas, United States, 75708
- Recruiting
- University of Texas Health Center at Tyler
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Webster, Texas, United States, 77598
- Recruiting
- TDDC GI Alliance research Webster
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Virginia
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Richmond, Virginia, United States, 23229
- Recruiting
- GI Alliance-Richmond
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West Virginia
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Huntington, West Virginia, United States, 25701
- Recruiting
- University Physicians and Surgeons Inc, dba Marshall Health
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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
- 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
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 |
|---|---|
|
Experimental: 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:
|
|
Placebo Comparator: Placebo
Participants will receive placebo IV followed by afimkibart SC injection.
|
Placebo matching IV afimkibart.
|
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 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 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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence and Severity of Adverse Events (AEs)
Time Frame: 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
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
|
|
Bowel Urgency
Time Frame: 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
Time Frame: 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
Time Frame: 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
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 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
|
|
Overall Change in CD Symptoms
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
|
|
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
|
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)
May 12, 2025
Primary Completion (Estimated)
December 31, 2028
Study Completion (Estimated)
April 30, 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)
August 31, 2026
Last Update Submitted That Met QC Criteria
August 28, 2026
Last Verified
August 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GA45332
- 2024-513054-30-00 (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
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