Actively Recruiting
A Study to Assess the Efficacy and Safety of Induction Therapy With Afimkibart (Also Known as RO7790121) in Participants With Moderately to Severely Active Ulcerative Colitis
Led by Hoffmann-La Roche · Updated on 2026-05-04
350
Participants Needed
199
Research Sites
320 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This Phase III, multicenter, double-blind, placebo-controlled study will evaluate the efficacy and safety of induction therapy with Afimkibart (RO7790121) compared with placebo in participants with moderately to severely active ulcerative colitis (UC).
CONDITIONS
Official Title
A Study to Assess the Efficacy and Safety of Induction Therapy With Afimkibart (Also Known as RO7790121) in Participants With Moderately to Severely Active Ulcerative Colitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed diagnosis of ulcerative colitis
- Moderately to severely active ulcerative colitis assessed by mMS
- Bodyweight greater than or equal to 40 kilograms
- Up to date with colorectal cancer screening as per local standards
- Inadequate response, loss of response, or intolerance to at least one conventional or advanced UC therapy
- Males and females of childbearing potential must meet contraception requirements
You will not qualify if you...
- Known complications of ulcerative colitis like fulminant colitis or toxic megacolon
- Current diagnosis of Crohn's disease, indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, or radiation colitis
- Presence of an ostomy or ileoanal pouch
- Current diagnosis or suspicion of primary sclerosing cholangitis
- Pregnancy, breastfeeding, or planning to become pregnant during the study
- Past or current definite low-grade or high-grade colonic dysplasia, adenomas, or incompletely removed neoplasia
- History of malignancy within 5 years except certain non-metastatic skin or cervical cancers
- Evidence of infection with C. difficile, CMV, HIV, HBV, or HCV
- Active tuberculosis, untreated latent tuberculosis, or inadequately treated tuberculosis
- Use of prohibited medicines including any anti-TL1A therapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 199 locations
1
Digestive Health Specialists of the Southeast (Gastroenterology Associates of Dothan) - Dothan
Dothan, Alabama, United States, 36305
Actively Recruiting
2
Mayo Clinic Hospital
Scottsdale, Arizona, United States, 85259
Actively Recruiting
3
Arizona Digestive Health, P.C (ADH)
Sun City, Arizona, United States, 85351
Actively Recruiting
4
Om Research LLC
Apple Valley, California, United States, 92307
Actively Recruiting
5
Valley View Internal Medicine
Garden Grove, California, United States, 92845
Actively Recruiting
6
Gastro Care Associates
Lancaster, California, United States, 93534
Actively Recruiting
7
University of Southern California
Los Angeles, California, United States, 90033-1057
Actively Recruiting
8
Hoag Memorial Hospital Presbyterian;Hoag Center for Research and Education
Newport Beach, California, United States, 92663
Actively Recruiting
9
Stanford Medicine Outpatient Center
Redwood City, California, United States, 94063
Actively Recruiting
10
Peak Gastroenterology Associates
Colorado Springs, Colorado, United States, 80907
Actively Recruiting
11
Hi Tech and Global Research, LLC
Coral Gables, Florida, United States, 33134
Actively Recruiting
12
The Sister Life Research
Hialeah, Florida, United States, 33013
Actively Recruiting
13
LCC Medical Research Institute, LLC
Miami, Florida, United States, 33126
Actively Recruiting
14
Allied Biomedical Research Institute
Miami, Florida, United States, 33155
Actively Recruiting
15
Ambert Medical Research
Miami, Florida, United States, 33176
Withdrawn
16
Integrity Trials LLC
Orlando, Florida, United States, 32807
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
University of South Florida School of Medicine Morsani Center for Advanced Health Care
Tampa, Florida, United States, 33612
Actively Recruiting
20
Guardian Angel Research Center, LLC
Tampa, Florida, United States, 33614
Actively Recruiting
21
Santos Research Center, CORP
Tampa, Florida, United States, 33615
Actively Recruiting
22
Cleveland Clinic Florida
Weston, Florida, United States, 33331
Actively Recruiting
23
Randomize Now, LLC
Atlanta, Georgia, United States, 30308
Actively Recruiting
24
Atlanta Gastroenterology Associates
Atlanta, Georgia, United States, 30342
Actively Recruiting
25
Gastroenterology Associates of Central Georgia
Macon, Georgia, United States, 31201
Actively Recruiting
26
Grand Teton Research Group, PLLC
Idaho Falls, Idaho, United States, 83404
Actively Recruiting
27
Illinois Gastroenterology Group-Glenview powered by GI Alliance
Glenview, Illinois, United States, 60026
Actively Recruiting
28
GI Alliance - Gurnee
Gurnee, Illinois, United States, 60031
Actively Recruiting
29
Gastro Health Partners, LLC
New Albany, Indiana, United States, 47150
Actively Recruiting
30
Kansas Gastroenterology, LLC under Clinical Trials Network
Wichita, Kansas, United States, 67226
Actively Recruiting
31
One GI: GHP - Gastroenterology Health Partners Louisville
Louisville, Kentucky, United States, 40218
Actively Recruiting
32
Louisiana Research Center - GastroIntestinal Associates
Shreveport, Louisiana, United States, 71105
Actively Recruiting
33
Allied Gastrointestinal Associates, PA
Flowood, Mississippi, United States, 39232
Actively Recruiting
34
Delta Gastroenterology & Endoscopy Center
Southaven, Mississippi, United States, 38671
Actively Recruiting
35
Dartmouth-Hitchcock Medical Center-Norris Cotton Cancer Center
Lebanon, New Hampshire, United States, 03756
Actively Recruiting
36
Ellipsis Research Group
Brooklyn, New York, United States, 11215
Actively Recruiting
37
NYU Inflammatory Bowel Disease Center
New York, New York, United States, 10016
Actively Recruiting
38
Weill Cornell Medical College
New York, New York, United States, 10021
Actively Recruiting
39
DiGiovanna Inst for Med Ed&Res
North Massapequa, New York, United States, 11758
Actively Recruiting
40
Queens Village Medical Care
Queens Village, New York, United States, 11428
Actively Recruiting
41
Gastroenterology Group Of Rochester, LLP
Rochester, New York, United States, 14618
Actively Recruiting
42
James J Peters Veterans Administration Medical Center - NAVREF
The Bronx, New York, United States, 10468
Actively Recruiting
43
Charlotte Gastroenterology and Hepatology, P.L.L.C
Charlotte, North Carolina, United States, 28207
Actively Recruiting
44
Omega Research North Carolina, LLC
Fuquay-Varina, North Carolina, United States, 27526
Actively Recruiting
45
Peters Medical Research (PMR), LLC
High Point, North Carolina, United States, 27260
Actively Recruiting
46
Dayton Gastroenterology, Inc.
Beavercreek, Ohio, United States, 45440
Actively Recruiting
47
University of Cincinnati Hospital
Cincinnati, Ohio, United States, 45267
Actively Recruiting
48
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Actively Recruiting
49
Ohio Gastroenterology Group
Columbus, Ohio, United States, 43202
Actively Recruiting
50
Ohio State University
Columbus, Ohio, United States, 43210
Actively Recruiting
51
Gastro Intestinal Research Institute of Northern Ohio
Westlake, Ohio, United States, 44145
Actively Recruiting
52
Frontier Clinical Re search, LLC
Uniontown, Pennsylvania, United States, 15401
Actively Recruiting
53
University Gastroenterology
Providence, Rhode Island, United States, 02904
Actively Recruiting
54
Gastroenterology Associates
Greenville, South Carolina, United States, 29607
Actively Recruiting
55
Gastro One
Cordova, Tennessee, United States, 38018
Actively Recruiting
56
Uni of Texas Medical Branch
Galveston, Texas, United States, 77555
Actively Recruiting
57
GI Alliance
Garland, Texas, United States, 75044
Actively Recruiting
58
Amel Med LLC
Georgetown, Texas, United States, 78628
Actively Recruiting
59
Cano Medical Center
Harlingen, Texas, United States, 78550
Actively Recruiting
60
Texas Digestive Specialists
Harlingen, Texas, United States, 78550
Actively Recruiting
61
Integrity Advanced Therapeutics PLLC
Houston, Texas, United States, 77090
Not Yet Recruiting
62
GI Alliance - Bay Area Gastroenterology
Lubbock, Texas, United States, 79410
Actively Recruiting
63
TDDC dba GI Alliance Research
Mansfield, Texas, United States, 76063
Not Yet Recruiting
64
Southern Star Research Institute, LLC.
San Antonio, Texas, United States, 78229
Actively Recruiting
65
Baylor Scott and White Medical Center
Temple, Texas, United States, 76508
Actively Recruiting
66
Tyler Research Institute, LLC
Tyler, Texas, United States, 75701
Actively Recruiting
67
University of Texas Health Center at Tyler
Tyler, Texas, United States, 75708
Actively Recruiting
68
TDDC GI Alliance research Webster
Webster, Texas, United States, 77598
Actively Recruiting
69
Gastroenterology Associates of Tidewater
Chesapeake, Virginia, United States, 23320
Actively Recruiting
70
Emeritas Research Group
Lansdowne Town Center, Virginia, United States, 20176
Actively Recruiting
71
Gastroenterology Consultants of SWVA
Roanoke, Virginia, United States, 24018
Actively Recruiting
72
Hospital Britanico
Ciudad Autonoma Bs As, Argentina, C1280AEB
Actively Recruiting
73
Instituto Medico CER
Quilmes, Argentina, B1878DVB
Actively Recruiting
74
Macquarie University Hospital
Macquarie Park, New South Wales, Australia, 2109
Active, Not Recruiting
75
Coral Sea Clinical Research Institute
Mackay, Queensland, Australia, 4740
Withdrawn
76
Footscray Hospital
Footscray, Victoria, Australia, 3011
Withdrawn
77
Royal Melbourne Hospital
Parkville, Victoria, Australia, 3050
Active, Not Recruiting
78
Ordensklinikum Linz Barmherzige Schwestern
Linz, Austria, 4010
Active, Not Recruiting
79
Klinikum Wels-Grieskirchen
Wels, Austria, 4600
Withdrawn
80
AZORG Campus Aalst-Moorselbaan
Aalst, Belgium, 9300
Withdrawn
81
CHU St Pierre (St Pierre)
Brussels, Belgium, 1000
Active, Not Recruiting
82
Cliniques Universitaires St-Luc
Brussels, Belgium, 1200
Active, Not Recruiting
83
AZ Oostende
Ostend, Belgium, 8400
Withdrawn
84
Instituto Lobus Unimed Volta Redonda
Volta Redonda, Rio de Janeiro, Brazil, 27258-000
Actively Recruiting
85
Hospital Moinhos de Vento
Porto Alegre, Rio Grande do Sul, Brazil, 90035-000
Actively Recruiting
86
Newdata Clinical Trials
Aracaju, Sergipe, Brazil, 49055-000
Actively Recruiting
87
CECIP - Centro de Estudos Clínicos do Interior Paulista
Jaú, São Paulo, Brazil, 17210-190
Actively Recruiting
88
Hospital Sírio-Libanês
São Paulo, São Paulo, Brazil, 01308-050
Actively Recruiting
89
Centro Paulista de Investigacao Clinica - CEPIC
São Paulo, São Paulo, Brazil, 04266-010
Actively Recruiting
90
Second Multiprofile Hospital For Active Treatment-Sofia
Sofia Town, Sofia, Bulgaria, 1202
Withdrawn
91
MC " Sveti Ivan Rilski Chudotvorets- 2010
Plovdiv, Bulgaria, 4003
Actively Recruiting
92
"City Clinic UMHAC" EOOD
Sofia, Bulgaria, 1407
Actively Recruiting
93
Barrie GI Associates
Barrie, Ontario, Canada, L4M 7G1
Actively Recruiting
94
GNRR Digestive Clinics and Research Center Inc.
Brampton, Ontario, Canada, L6S 0E2
Actively Recruiting
95
London Health Sciences Centre Uni Campus
London, Ontario, Canada, N6A 5A5
Actively Recruiting
96
TIDHI Innovation Inc.
Toronto, Ontario, Canada, M6A 3B4
Actively Recruiting
97
CIUSSS-de-l?Est-de-l?Île-de-Montréal
Montreal, Quebec, Canada, H1T 2M4
Actively Recruiting
98
Centro de Investigación Clínica UC-CICUC
Santiago, Chile, 8330034
Actively Recruiting
99
Beijing No.6 Hospital
Beijing, Beijing Municipality, China, 100007
Actively Recruiting
100
The First Affilliated Hospital of Kunming Medical University
Kunming, Yunnan, China, 650032
Actively Recruiting
101
Third Xiangya Hospital Centrel South University
Changsha, China, 410013
Actively Recruiting
102
West China Hospital of Sichuan University
Chengdu, China, 610041
Actively Recruiting
103
Guangzhou First People's Hospital
Guangzhou, China, 510180
Actively Recruiting
104
The second Affiliated Hospital of Guangzhou Medical University
Guangzhou, China, 510260
Actively Recruiting
105
Sir Run Run Shaw Hospital Zhejiang University
Hangzhou, China, 310016
Actively Recruiting
106
Huizhou Central People's Hospital
Huizhou, China, 516001
Actively Recruiting
107
The Second Affiliated Hospital of Nanchang University
Nanchang, China, 330008
Actively Recruiting
108
The First Affiliate Hospital of Guangxi Medical University
Nanning, China, 530021
Actively Recruiting
109
The First Affiliated Hospital of Ningbo University
Ningbo, China, 315000
Actively Recruiting
110
The Affiliated Hospital of Medical College Qingdao University
Qingdao, China, 266000
Actively Recruiting
111
Ruijin Hospital Shanghai Jiaotong University School of Medicine
Shanghai, China, 200025
Actively Recruiting
112
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, China, 200092
Actively Recruiting
113
Shengjing Hospital of China Medical University
Shenyang, China, 110004
Actively Recruiting
114
First Affiliated Hospital of Soochow University
Suzhou, China, 215006
Actively Recruiting
115
The First Affiliated Hospital of Xiamen University
Xiamen, China, 361003
Actively Recruiting
116
Zhongshan Hospital Xiamen University
Xiamen, China, 361004
Actively Recruiting
117
Borzan Polyclinic
Osijek, Croatia, 31000
Actively Recruiting
118
Clinical Hospital Center Sestre Milosrdnice
Zagreb, Croatia, 10000
Actively Recruiting
119
Hepato-Gastroenterologie HK, s.r.o.
Hradec Králové, Czechia, 500 12
Actively Recruiting
120
Fakultni nemocnice Ostrava
Ostrava - Poruba, Czechia, 708 52
Actively Recruiting
121
ISCARE a.s.
Prague, Czechia, 170 04
Actively Recruiting
122
Ålborg Universitets Hospital
Aalborg, Denmark, 9000
Actively Recruiting
123
CHU Tours - Hôpital Trousseau
Chambray-lès-Tours, France, 37170
Actively Recruiting
124
CHU Clermont Ferrand - Hôtel Dieu
Clermont-Ferrand, France, 63000
Actively Recruiting
125
Hôpital Henri Mondor
Créteil, France, 94000
Actively Recruiting
126
Polyclinique Grand Sud
Nîmes, France, 30900
Actively Recruiting
127
Hôpital de Brabois Adultes
Vandœuvre-lès-Nancy, France, 54511
Actively Recruiting
128
Universitätsklinikum Heidelberg
Heidelberg, Germany, 69120
Withdrawn
129
Medizinisches Zentrum Klinikum Lueneburg
Lüneburg, Germany, 21339
Actively Recruiting
130
Klinikum Ernst von Bergmann
Potsdam, Germany, 14467
Withdrawn
131
Észak-Pesti Centrumkórház-Honvédkórház
Budapest, Hungary, 1062
Withdrawn
132
Semmelweis Egyetem
Budapest, Hungary, 1082
Actively Recruiting
133
Vasutegeszsegugyi Kft. - Debreceni Egeszsegugyi Kozpont
Debrecen, Hungary, 4025
Actively Recruiting
134
Fejer Varmegyei Szent György Egyetemi Oktatokorhaz
Székesfehérvár, Hungary, 8000
Actively Recruiting
135
Vas-Oxy Egeszsegugyi Kft
Szombathely, Hungary, 9700
Actively Recruiting
136
Surat Institute of Digestive Sciences Hospitals
Surat, Gujarat, India, 395002
Actively Recruiting
137
Gujarat Gastro and Vascular Hospital
Surat, Gujarat, India, 395009
Actively Recruiting
138
Kingsway Hospital
Nagpur (urban), Maharashtra, India, 440001
Completed
139
MIDAS Multispeciality Hospital
Nagpur (urban), Maharashtra, India, 440018
Actively Recruiting
140
Sahyadri Super Speciality Hospital
Nashik, Maharashtra, India, 422001
Actively Recruiting
141
SR Kalla Memorial Gastro & General Hospital
Jaipur, Rajasthan, India, 302006
Actively Recruiting
142
SMS Superspeciality Hospital
Jaipur, Rajasthan, India, 302007
Actively Recruiting
143
AIG Hospitals
Gachibowli, Telangana, India, 500032
Actively Recruiting
144
Yashoda Hospitals
Secunderabad, Telangana, India, 500003
Actively Recruiting
145
Soroka Medical Center
Beersheba, Israel, 8410101
Actively Recruiting
146
The Chaim Sheba Medical Center
Ramat Gan, Israel, 5265601
Actively Recruiting
147
Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi-Via Massarenti
Bologna, Emilia-Romagna, Italy, 40138
Withdrawn
148
Policlinico Universitario Campus Biomedico Di Roma
Rome, Lazio, Italy, 00128
Actively Recruiting
149
Ospedale Isola Tiberina Gemelli
Rome, Lazio, Italy, 00186
Actively Recruiting
150
Asst Degli Spedali Civili Di Brescia
Brescia, Lombardy, Italy, 25123
Actively Recruiting
151
IRCCS Ospedale San Raffaele
Milan, Lombardy, Italy, 20132
Actively Recruiting
152
Azienda Ospedaliera San Gerardo di Monza
Monza MI, Lombardy, Italy, 20900
Actively Recruiting
153
Istituto Clinico Humanitas
Rozzano (MI), Lombardy, Italy, 20089
Actively Recruiting
154
IRCCS Ospedale Sacro Cuore Don Calabria
Negrar, Veneto, Italy, 37024
Actively Recruiting
155
Boca Clinical Trials Mexico S.C. (Cd. Mexico)
Miguel Hidalgo, Mexico CITY (federal District), Mexico, 01120
Actively Recruiting
156
FAICIC S de R.L. de C.V
Veracruz, Mexico, 91900
Actively Recruiting
157
ETZ Elisabeth
Tilburg, Netherlands, 5022 GC
Active, Not Recruiting
158
Szpital Zakonu Bonifratrow Sw. Jana Bozego w Lodzi sp. z o.o.
?ód?, Poland, 93-357
Active, Not Recruiting
159
Gastromed Kralisz, Romatowski, Stachurska sp.j.
Bia?ystok, Poland, 15-322
Withdrawn
160
Medical Center Kermed
Bydgoszcz, Poland, 85-231
Actively Recruiting
161
Szpital Miejski sw. Jana Paw?a II w Elblagu
Elblag, Poland, 82-300
Actively Recruiting
162
Centrum Medyczne CLW-med Aneta Cichomska , Joanna Luka -Wendrowska
Grudzadz, Poland, 86-300
Withdrawn
163
Osrodek Badan Klinicznych Bd Research
I?awa, Poland, 14-200
Actively Recruiting
164
MZ Badania Slowik Zymla Sp.j.
Knurów, Poland, 44-190
Active, Not Recruiting
165
Centrum Medyczne Promed
Krakow, Poland, 31-513
Active, Not Recruiting
166
Medrise sp z o.o
Lublin, Poland, 20-582
Actively Recruiting
167
Clinical Research Center Sp. z o.o. MEDIC-R Spó?ka Komandytowa
Poznan, Poland, 61-731
Actively Recruiting
168
EMC Instytut Medyczny SA
Późna, Poland, 60-309
Actively Recruiting
169
Gabinety Lekarskie Rivermed
Późna, Poland, 61-441
Actively Recruiting
170
Endoskopia Sp. z o.o.
Sopot, Poland, 81-756
Actively Recruiting
171
Sonomed Sp. z o.o.
Szczecin, Poland, 71-685
Actively Recruiting
172
Centrum Zdrowia-MDM
Warsaw, Poland, 00-189
Actively Recruiting
173
Medon Clinical Research sp. z o.o
Warsaw, Poland, 02-679
Actively Recruiting
174
Vivamed Spolka Z Ograniczona Odpowiedzialnoscia
Warsaw, Poland, 03-580
Actively Recruiting
175
PlanetMed sp. z o.o.
Wroc?aw, Poland, 52-210
Actively Recruiting
176
Centrum Medyczne Oporow
Wroclaw, Poland, 52-416
Actively Recruiting
177
Hospital de Braga
Braga, Portugal, 4710-243
Actively Recruiting
178
Hospital da Luz Lisboa
Lisbon, Portugal, 1500-650
Actively Recruiting
179
Centro Hospitalar do Algarve - Hospital de Portimao
Portimão, Portugal, 8500-338
Actively Recruiting
180
Hospital de Sao Joao
Porto, Portugal, 4202-451
Actively Recruiting
181
Centro Hospitalar de Entre Douro e Vouga - H. São Sebastião
Santa Maria da Feira, Portugal, 4520-211
Actively Recruiting
182
Hospital Sao Teotonio
Viseu, Portugal, 3504-509
Actively Recruiting
183
Klinical Investigations Group LLC
San Juan, Puerto Rico, 00909
Actively Recruiting
184
General Hospital "Djordje Joanovic"
Zrenjanin, Serbia, 23000
Actively Recruiting
185
KM Management spol. s r.o.
Nitra, Slovakia, 949 01
Withdrawn
186
Accout Center s.r.o.
Šahy, Slovakia, 936 01
Withdrawn
187
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, Madrid, Spain, 28222
Active, Not Recruiting
188
Hospital Clinico Univ. Lozano Blesa
Zaragoza, Spain, 50009
Withdrawn
189
Hospital Universitario Miguel Servet
Zaragoza, Spain, 50009
Active, Not Recruiting
190
China Medical University Hospital
Taichung, Taiwan, 40447
Actively Recruiting
191
Division of Gastroenterology, Depart of Internal Med., Fac of Med., Chiang Mai University
Chiang Mai, Thailand, 50200
Actively Recruiting
192
Burapha University Hospital
Chon Buri, Thailand, 20131
Actively Recruiting
193
Sunpasitthiprasong Hospital
Ubonratchathani, Thailand, 34000
Actively Recruiting
194
Leicester General Hospital
Leicester, United Kingdom, LE5 4PW
Actively Recruiting
195
Bronglais General Hospital
Llanrhystud, United Kingdom, SY23 1ER
Actively Recruiting
196
King College Hospital NHS Foundation Trust
London, United Kingdom, SE5 9RS
Actively Recruiting
197
Peterborough City Hospital
Peterborough, United Kingdom, PE 3 9GZ
Withdrawn
198
Stepping Hill Hospital
Stockport, United Kingdom, SK2 7JE
Actively Recruiting
199
New Cross Hospital
Wolverhampton, United Kingdom, WV10 0QP
Actively Recruiting
Research Team
R
Reference Study ID Number: GA45330 https://forpatients.roche.com/
CONTACT
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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