Actively Recruiting
A Phase III, Multicenter, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Induction Therapy With Afimkibart (RO7790121) in Patients With Moderately to Severely Active Crohn's Disease
Led by Hoffmann-La Roche · Updated on 2026-06-08
425
Participants Needed
178
Research Sites
225 weeks
Total Duration
On this page
Sponsors
H
Hoffmann-La Roche
Lead Sponsor
C
Chugai Pharmaceutical
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of induction therapy using Afimkibart (RO7790121) in people with moderately to severely active Crohn's disease. This Phase III, multicenter, double-blind, placebo-controlled trial aims to understand how well this treatment works compared to placebo during the induction phase. The study focuses on participants who have not responded adequately to other conventional or advanced therapies for Crohn's disease. Participants will be randomly assigned to receive either Afimkibart through an intravenous (IV) infusion followed by subcutaneous (SC) injections or a placebo IV infusion followed by Afimkibart SC injections. This treatment schedule is designed to assess the induction effectiveness of Afimkibart in reducing disease activity over a 12-week period. The study includes two treatment groups to compare outcomes between the active drug and placebo. During the study, participants will be monitored for clinical remission and endoscopic response at week 12, along with other measures such as symptomatic remission, bowel urgency, abdominal pain, stool consistency, fatigue, and quality of life questionnaires. Safety assessments will continue for up to 30 weeks after baseline to record any adverse events. Participants will attend scheduled visits for evaluations and laboratory tests to track progress and response to treatment throughout the trial.
CONDITIONS
Brief Title
A Study to Assess the Efficacy and Safety of Induction Therapy With Afimkibart (RO7790121) in Participants With Moderately to Severely Active Crohn's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed diagnosis of Crohn's disease
- Moderately to severely active Crohn's disease
- Bodyweight of at least 40 kilograms
- Inadequate response, loss of response, or intolerance to at least one specified conventional or advanced Crohn's disease therapy
- Males and females of childbearing potential must meet contraception requirements
You will not qualify if you...
- Current diagnosis of ulcerative colitis, indeterminate colitis, ischemic colitis, infectious colitis, radiation colitis, or microscopic colitis
- History of 3 or more bowel resections involving more than 2 missing segments of key bowel areas
- Diagnosis of short gut or short bowel syndrome
- Presence of ileostomy, colostomy, or ileoanal pouch
- Symptomatic bowel strictures, fulminant colitis, or toxic megacolon
- Presence of abdominal or perianal abscess
- Presence of certain complex fistulas including rectovaginal, enterovaginal, high output enterocutaneous, enterovesical, or perianal fistulas with more than 3 openings
- Current diagnosis or suspicion of primary sclerosing cholangitis
- Pregnancy, breastfeeding, or intention to become pregnant during the study
- Past or current gastrointestinal tract cancer or colonic dysplasia
- History of non-gastrointestinal cancer except treated non-metastatic skin or in situ cervical cancer
- Evidence of infection with C. difficile, cytomegalovirus, HIV, Hepatitis B or C during screening
- Active or inadequately treated tuberculosis
- Prior use of prohibited medicines including anti-TL1A therapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants receive induction therapy with Afimkibart or placebo to assess efficacy and safety in Crohn's disease.
Multiple visits during the 12-week treatment period
Trial Site Locations
Total: 178 locations
1
Sun City Clinical Research
Glendale, Arizona, United States, 85304
Actively Recruiting
2
Om Research LLC
Lancaster, California, United States, 93534
Actively Recruiting
3
Hoag Memorial Hospital Presbyterian;Hoag Center for Research and Education
Newport Beach, California, United States, 92663
Actively Recruiting
4
Empire Clinical Research
Pomona, California, United States, 91767
Withdrawn
5
Stanford Medicine Outpatient Center
Redwood City, California, United States, 94063
Actively Recruiting
6
Clinical Applications Laboratories, Inc.
San Diego, California, United States, 92103
Actively Recruiting
7
Amicis Research Center
Santa Clarita, California, United States, 91355
Actively Recruiting
8
Peak Gastroenterology Associates
Colorado Springs, Colorado, United States, 80907
Actively Recruiting
9
J&A Clinical Research
Doral, Florida, United States, 33126
Actively Recruiting
10
Auzmer Research
Lakeland, Florida, United States, 33813
Actively Recruiting
11
Galenus Group Inc
Lehigh Acres, Florida, United States, 33936
Actively Recruiting
12
Homestead Associates in Research, Inc.
Miami, Florida, United States, 33033
Actively Recruiting
13
Allied Biomedical Research Institute, Inc
Miami, Florida, United States, 33155
Actively Recruiting
14
Rejuvaline Medical Research
Miami, Florida, United States, 33155
Actively Recruiting
15
Miami Beach Clinical Research Center
Miami Beach, Florida, United States, 33141
Actively Recruiting
16
Eminat Research Group
Miramar, Florida, United States, 33027
Actively Recruiting
17
Digestive and Liver Center of Florida
Orlando, Florida, United States, 32825
Actively Recruiting
18
Advanced Medical Research Center
Port Orange, Florida, United States, 32127
Actively Recruiting
19
Santos Research Center, CORP
Tampa, Florida, United States, 33615
Actively Recruiting
20
Cleveland Clinic Florida
Weston, Florida, United States, 33331
Actively Recruiting
21
The University of Chicago
Chicago, Illinois, United States, 60637
Actively Recruiting
22
Robley Rex VA Medical Center
Louisville, Kentucky, United States, 40206
Actively Recruiting
23
Baton Rouge General Medical Center
Baton Rouge, Louisiana, United States, 70809
Actively Recruiting
24
Louisiana Research Center - GastroIntestinal Associates
Shreveport, Louisiana, United States, 71105
Actively Recruiting
25
Mercy Medical Center
Baltimore, Maryland, United States, 21202
Actively Recruiting
26
Chevy Chase Clinical Research
Chevy Chase, Maryland, United States, 20815
Actively Recruiting
27
University of Massachusetts Memorial Medical Center
North Worcester, Massachusetts, United States, 01655
Actively Recruiting
28
Gastroenterology Associates of Western Michigan, P.L.C.
Wyoming, Michigan, United States, 49519
Actively Recruiting
29
Gastrointestinal Associates Research
Flowood, Mississippi, United States, 39232
Actively Recruiting
30
Virtua Crohns and Colitis Center
Moorestown, New Jersey, United States, 08057
Actively Recruiting
31
Robert Wood Johnson University Hospital
New Brunswick, New Jersey, United States, 08901
Actively Recruiting
32
Ellipsis Research Group
Brooklyn, New York, United States, 11215
Actively Recruiting
33
Intercity Gastroenterology
Fresh Meadows, New York, United States, 11366
Actively Recruiting
34
James J Peters Veterans Affairs Medical Center
The Bronx, New York, United States, 10468
Actively Recruiting
35
Digestive Disease Medicine of Central New York
Utica, New York, United States, 13502
Actively Recruiting
36
Charlotte Gastroenterology and Hepatology, P.L.L.C
Charlotte, North Carolina, United States, 28207
Actively Recruiting
37
Peters Medical Research (PMR), LLC
High Point, North Carolina, United States, 27260
Actively Recruiting
38
Clinical Inquest Center
Beavercreek, Ohio, United States, 45431
Actively Recruiting
39
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Actively Recruiting
40
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
41
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37212-1375
Actively Recruiting
42
University of Texas Southwestern Medical Center - Multidisciplinary Spine Clinic - James W. Aston Ambulatory Care Center
Dallas, Texas, United States, 75390-8565
Actively Recruiting
43
GI Alliance - Fort Worth
Fort Worth, Texas, United States, 76104
Actively Recruiting
44
GI Alliance
Garland, Texas, United States, 75044
Actively Recruiting
45
Integrity Advanced Therapeutics PLLC
Houston, Texas, United States, 77090
Actively Recruiting
46
Texas Digestive Disease Consultants-Lubbock powered by GI Alliance
Lubbock, Texas, United States, 79410
Actively Recruiting
47
Carta - Clinical Associates In Research Therapeutics Of America;LLC
San Antonio, Texas, United States, 78212
Actively Recruiting
48
University of Texas Health Center at Tyler
Tyler, Texas, United States, 75708
Actively Recruiting
49
TDDC GI Alliance research Webster
Webster, Texas, United States, 77598
Actively Recruiting
50
University Physicians and Surgeons Inc, dba Marshall Health
Huntington, West Virginia, United States, 25701
Actively Recruiting
51
Instituto Medico CER
Quilmes, Argentina, B1878DVB
Actively Recruiting
52
CICE 9 de Julio
San Miguel de Tucumán, Argentina, T4000DPK
Actively Recruiting
53
Macquarie University Hospital
Macquarie Park, New South Wales, Australia, 2109
Actively Recruiting
54
Coral Sea Clinical Research Institute
Mackay, Queensland, Australia, 4740
Withdrawn
55
Footscray Hospital
Footscray, Victoria, Australia, 3011
Actively Recruiting
56
Royal Melbourne Hospital
Parkville, Victoria, Australia, 3050
Actively Recruiting
57
Ordensklinikum Linz Barmherzige Schwestern
Linz, Austria, 4010
Actively Recruiting
58
Klinikum Wels-Grieskirchen
Wels, Austria, 4600
Actively Recruiting
59
CHU St Pierre (St Pierre)
Brussels, Belgium, 1000
Actively Recruiting
60
UZ Brussel
Brussels, Belgium, 1090
Actively Recruiting
61
Cliniques Universitaires St-Luc
Brussels, Belgium, 1200
Actively Recruiting
62
Instituto Lobus Unimed Volta Redonda
Volta Redonda, Rio de Janeiro, Brazil, 27258-000
Actively Recruiting
63
Hospital Moinhos de Vento
Porto Alegre, Rio Grande do Sul, Brazil, 90035-000
Actively Recruiting
64
Newdata Clinical Trials
Aracaju, Sergipe, Brazil, 49055-000
Actively Recruiting
65
CECIP - Centro de Estudos Clínicos do Interior Paulista
Jaú, São Paulo, Brazil, 17210-190
Actively Recruiting
66
Hospital de Base de Sao Jose do Rio Preto
São José do Rio Preto, São Paulo, Brazil, 15090-000
Actively Recruiting
67
Hospital Sírio-Libanês
São Paulo, São Paulo, Brazil, 01308-050
Actively Recruiting
68
MC " Sveti Ivan Rilski Chudotvorets- 2010
Plovdiv, Bulgaria, 4003
Actively Recruiting
69
Barrie GI Associates
Barrie, Ontario, Canada, L4M 7G1
Actively Recruiting
70
GNRR Digestive Clinics and Research Center Inc.
Brampton, Ontario, Canada, L6S 0E2
Actively Recruiting
71
London Health Sciences Centre Uni Campus
London, Ontario, Canada, N6A 5A5
Actively Recruiting
72
LDDI Clinical Trials Inc.
London, Ontario, Canada, N6K 1M6
Actively Recruiting
73
Toronto Immune and Digestive Health Institute
North YORK, Ontario, Canada, M6A 3B4
Actively Recruiting
74
CIUSSS de l Est de l Ile de Montreal - Hopital Maisonneuve Rosemont
Montreal, Quebec, Canada, H1T 2M4
Actively Recruiting
75
Medicina de Precisión - Celerity
Las Condes, Chile, 7560908
Actively Recruiting
76
Centro de Investigación Clínica UC-CICUC
Santiago, Chile, 8330034
Actively Recruiting
77
First Affiliated Hospital of Gannan Medical University
Ganzhou, Jiangxi, China, 341000
Actively Recruiting
78
The First Affilliated Hospital of Kunming Medical University
Kunming, Yunnan, China, 650032
Actively Recruiting
79
Jinhua municipal central hospital
Jinhua, Zhejiang, China, 321013
Actively Recruiting
80
Beijing Union Hospital
Beijing, China, 100730
Actively Recruiting
81
Sichuan Provincial People's Hospital
Chengdu, China, 610072
Actively Recruiting
82
Guangzhou First People's Hospital
Guangzhou, China, 510180
Actively Recruiting
83
Zhujiang Hospital, Southern Medical University
Guangzhou, China, 510280
Actively Recruiting
84
Hainan General Hospital
Haikou, China, 570311
Actively Recruiting
85
Huizhou First Hospital
Huizhou, China
Actively Recruiting
86
The Second Affiliated Hospital of Nanchang University
Nanchang, China, 330008
Actively Recruiting
87
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, China, 200092
Actively Recruiting
88
Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, China, 200127
Actively Recruiting
89
Shengjing Hospital of China Medical University
Shenyang, China, 110004
Actively Recruiting
90
Hebei Medical University - The Second Hospital
Shijiazhuang, China, 050004
Actively Recruiting
91
The Second Affiliated Hospital of Soochow University
Suzhou, China, 215004
Actively Recruiting
92
The Second Affiliated Hospital of Xi'an Jiao Tong University
Xi'an, China, 710004
Actively Recruiting
93
The First Affiliated Hospital of Xiamen University
Xiamen, China, 361003
Actively Recruiting
94
Affiliated Hospital of Jiangsu University
Zhenjiang, China, 212001
Actively Recruiting
95
Hospital Universitario San Ignacio
Bogotá, Colombia, 000472
Actively Recruiting
96
Clínica de la Mujer
Bogotá, Colombia, 110221
Actively Recruiting
97
Clinica Colsanitas S.A. - Sede Clinica Reina Sofia
Bogotá, Colombia, 111071
Actively Recruiting
98
Oncomedica S.A.
Montería, Colombia, 230002
Actively Recruiting
99
Borzan Polyclinic
Osijek, Croatia, 31000
Actively Recruiting
100
Clinical Hospital Centre Zagreb
Zagreb, Croatia, 10000
Actively Recruiting
101
Hepato-Gastroenterologie HK, s.r.o.
Hradec Králové, Czechia, 500 12
Actively Recruiting
102
Fakultni nemocnice Ostrava
Ostrava - Poruba, Czechia, 708 52
Actively Recruiting
103
Institutu Klinicke a Experimentaini Mediciny (IKEM);Klinika hepatogastroenterologie
Prague, Czechia, 140 21
Actively Recruiting
104
ISCARE a.s.
Prague, Czechia, 170 04
Actively Recruiting
105
Krajska zdravotni, a.s. ? Masarykova nemocnice v Usti nad Labem, o.z., Ocni oddeleni
Ústí nad Labem, Czechia, 401 13
Actively Recruiting
106
Centre hospitalier Lyon Sud
Pierre-Bénite, Rhône, France, 69310
Active, Not Recruiting
107
CHU Tours - Hôpital Trousseau
Chambray-lès-Tours, France, 37170
Actively Recruiting
108
CHU Clermont Ferrand - Hôpital d'Estaing
Clermont-Ferrand, France, 63000
Actively Recruiting
109
Hôpital Henri Mondor
Créteil, France, 94000
Actively Recruiting
110
CH Dptal Les Oudairies
La Roche-sur-Yon, France, 85925
Actively Recruiting
111
CHRU de Lille - Hopital Claude Huriez
Lille, France, 59037
Actively Recruiting
112
Hopital Dupuytren
Limoges, France, 87042
Actively Recruiting
113
Hopital Saint-Eloi
Montpellier, France, 34295
Actively Recruiting
114
Institut des MICI, Clinique Ambroise Paré
Neuilly-sur-Seine, France, 92200
Actively Recruiting
115
Hôpital Saint-Louis
Paris, France, 75475
Actively Recruiting
116
Hôpital de Brabois Adultes
Vandœuvre-lès-Nancy, France, 54511
Actively Recruiting
117
Universitätsklinikum Heidelberg
Heidelberg, Germany, 69120
Actively Recruiting
118
Klinikum Ernst von Bergmann
Potsdam, Germany, 14467
Actively Recruiting
119
Észak-Pesti Centrumkórház-Honvédkórház
Budapest, Hungary, 1062
Actively Recruiting
120
Geomedical Orvosi Kft
Budapest, Hungary, 1066
Actively Recruiting
121
Semmelweis Egyetem
Budapest, Hungary, 1082
Actively Recruiting
122
Endomedix Kft.
Budapest, Hungary, 1139
Actively Recruiting
123
Vas-Oxy Egeszsegugyi Kft
Szombathely, Hungary, 9700
Actively Recruiting
124
Shree Giriraj Multispeciality Hospital
Rajkot, Gujarat, India, 360005
Actively Recruiting
125
Surat Institute of Digestive Sciences Hospitals
Surat, Gujarat, India, 395002
Actively Recruiting
126
Gujarat Gastro and Vascular Hospital
Surat, Gujarat, India, 395009
Actively Recruiting
127
Amrita Institute of Medical Sciences
Kochi, Kerala, India, 682041
Actively Recruiting
128
MIDAS Multispeciality Hospital
Nagpur (urban), Maharashtra, India, 440018
Actively Recruiting
129
All India Institute Of Medical Sciences (AIIMS)
New Delhi, National Capital Territory of Delhi, India, 110029
Actively Recruiting
130
SR Kalla Memorial Gastro & General Hospital
Jaipur, Rajasthan, India, 302006
Actively Recruiting
131
AIG Hospitals
Gachibowli, Telangana, India, 500032
Actively Recruiting
132
Gandhi Hospital
Secunderabad, Telangana, India, 500003
Actively Recruiting
133
Yashoda Hospitals
Secunderabad, Telangana, India, 500003
Actively Recruiting
134
Shaare Zedek Medical Center
Jerusalem, Israel, 9103102
Actively Recruiting
135
Hadassah Medical Center
Jerusalem, Israel, 9112001
Actively Recruiting
136
Ospedale Madonna delle Grazie
Matera, Basilicate, Italy, 75100
Actively Recruiting
137
Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi-Via Massarenti
Bologna, Emilia-Romagna, Italy, 40138
Actively Recruiting
138
Policlinico Universitario Campus Biomedico Di Roma
Rome, Lazio, Italy, 00128
Actively Recruiting
139
Policlinico Universitario Agostino Gemelli
Rome, Lazio, Italy, 00168
Actively Recruiting
140
Asst Degli Spedali Civili Di Brescia
Brescia, Lombardy, Italy, 25123
Actively Recruiting
141
IRCCS Ospedale San Raffaele
Milan, Lombardy, Italy, 20132
Actively Recruiting
142
I.R.C.C.S Policlinico San Donato
San Donato Milanese (MI), Lombardy, Italy, 20097
Actively Recruiting
143
IRCCS Ospedale Sacro Cuore Don Calabria
Negrar, Veneto, Italy, 37024
Actively Recruiting
144
Gastromed Kralisz, Romatowski, Stachurska sp.j.
Bia?ystok, Poland, 15-322
Actively Recruiting
145
Medical Center Kermed
Bydgoszcz, Poland, 85-231
Actively Recruiting
146
Szpital Miejski sw. Jana Paw?a II w Elblagu
Elblag, Poland, 82-300
Actively Recruiting
147
Osrodek Badan Klinicznych Bd Research
I?awa, Poland, 14-200
Actively Recruiting
148
MZ Badania Slowik Zymla Sp.j.
Knurów, Poland, 44-190
Actively Recruiting
149
Centrum Medyczne Promed
Krakow, Poland, 31-513
Actively Recruiting
150
Amicare Sp. z o.o. S.K.
Lodz, Poland, 91-495
Actively Recruiting
151
Medrise sp z o.o
Lublin, Poland, 20-582
Actively Recruiting
152
Clinical Research Center Sp. z o.o. MEDIC-R Spó?ka Komandytowa
Poznan, Poland, 61-731
Actively Recruiting
153
EMC Instytut Medyczny SA
Późna, Poland, 60-309
Actively Recruiting
154
Gabinety Lekarskie Rivermed
Późna, Poland, 61-441
Actively Recruiting
155
Endoskopia Sp. z o.o.
Sopot, Poland, 81-756
Actively Recruiting
156
Sonomed Sp. z o.o.
Szczecin, Poland, 71-685
Actively Recruiting
157
Centrum Zdrowia-MDM
Warsaw, Poland, 00-189
Actively Recruiting
158
Medon Clinical Research sp. z o.o
Warsaw, Poland, 02-679
Actively Recruiting
159
Vivamed Spolka Z Ograniczona Odpowiedzialnoscia
Warsaw, Poland, 03-580
Actively Recruiting
160
PlanetMed sp. z o.o.
Wroc?aw, Poland, 52-210
Actively Recruiting
161
Hospital de Braga
Braga, Portugal, 4710-243
Actively Recruiting
162
Hospital de Santa Maria
Lisbon, Portugal, 1649-035
Actively Recruiting
163
Hospital de Sao Joao
Porto, Portugal, 4202-451
Actively Recruiting
164
Centro Hospitalar de Entre Douro e Vouga - H. São Sebastião
Santa Maria da Feira, Portugal, 4520-211
Actively Recruiting
165
Hospital Sao Teotonio
Viseu, Portugal, 3504-509
Actively Recruiting
166
Spital Digenio - Centrul de Excelen?? în Afec?iuni Digestive
Cluj-Napoca, Romania
Actively Recruiting
167
ABAWI spol. s r.o.
Bratislava, Slovakia, 821 07
Actively Recruiting
168
KM Management spol. s r.o.
Nitra, Slovakia, 949 01
Actively Recruiting
169
Yeungnam University Medical Center
Daegu, South Korea, 42415
Actively Recruiting
170
Fundacion Hospital de Alcorcon
Alcorcón, Madrid, Spain, 28922
Actively Recruiting
171
Hospital Universitario Puerta de Hierro
Majadahonda, Madrid, Spain, 28222
Actively Recruiting
172
Hospital General Universitario Gregorio Maranon
Madrid, Spain, 28040
Actively Recruiting
173
Hospital Clinico Univ. Lozano Blesa
Zaragoza, Spain, 50009
Actively Recruiting
174
Southmead Hospital
Bristol, United Kingdom, BS10 5NB
Actively Recruiting
175
Fairfield General Hospital
Bury, United Kingdom, BL9 7TD
Actively Recruiting
176
Bronglais General Hospital
Llanrhystud, United Kingdom, SY23 1ER
Actively Recruiting
177
Royal London Hospital
London, United Kingdom, E1 1FR
Actively Recruiting
178
Stepping Hill Hospital
Stockport, United Kingdom, SK2 7JE
Actively Recruiting
Research Team
R
Reference Study ID Number: GA45332 https://forpatients.roche.com/
F
Fastest response: use the inquiry form. No email attachments. https://www.gene.com/contact-us/submit-medical-inquiry
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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