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
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
2 other identifiers
interventional
425
25 countries
169
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started May 2025
Longer than P75 for phase_3
169 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 6, 2025
CompletedFirst Posted
Study publicly available on registry
February 11, 2025
CompletedStudy Start
First participant enrolled
May 12, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 30, 2033
May 7, 2026
May 1, 2026
3.6 years
February 6, 2025
May 6, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Percentage of Participants with Clinical Remission per Crohn's Disease Activity Index (CDAI) Score
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
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 Outcomes (17)
Percentage of Participants with Symptomatic Remission
At Week 12
Percentage of Participants with Endoscopic Remission
At Week 12
Percentage of Participants with Ulcer-free Endoscopy
At Week 12
Average of Daily Number of Liquid or Very Soft Stools in the Past Week (SF)
Baseline through Week 12
Average of Daily Abdominal Pain Scores in the Past Week (APS)
Baseline through Week 12
- +12 more secondary outcomes
Study Arms (2)
Afimkibart
EXPERIMENTALParticipants will receive afimkibart intravenously (IV) followed by afimkibart subcutaneous (SC) injection.
Placebo
PLACEBO COMPARATORParticipants will receive placebo IV followed by afimkibart SC injection.
Interventions
Afimkibart will be administered as IV infusion. Afimkibart will be administered as SC injection.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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, 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hoffmann-La Rochelead
- Chugai Pharmaceuticalcollaborator
Study Sites (173)
Sun City Clinical Research
Glendale, Arizona, 85304, United States
Om Research LLC
Lancaster, California, 93534, United States
Hoag Memorial Hospital Presbyterian;Hoag Center for Research and Education
Newport Beach, California, 92663, United States
Empire Clinical Research
Pomona, California, 91767, United States
Stanford Medicine Outpatient Center
Redwood City, California, 94063, United States
Clinical Applications Laboratories, Inc.
San Diego, California, 92103, United States
Amicis Research Center
Santa Clarita, California, 91355, United States
Peak Gastroenterology Associates
Colorado Springs, Colorado, 80907, United States
J&A Clinical Research
Doral, Florida, 33126, United States
Homestead Associates in Research, Inc.
Miami, Florida, 33033, United States
Allied Biomedical Research Institute, Inc
Miami, Florida, 33155, United States
Rejuvaline Medical Research
Miami, Florida, 33155, United States
Miami Beach Clinical Research Center
Miami Beach, Florida, 33141, United States
Eminat Research Group
Miramar, Florida, 33027, United States
Digestive and Liver Center of Florida
Orlando, Florida, 32825, United States
Advanced Medical Research Center
Port Orange, Florida, 32127, United States
Santos Research Center, CORP
Tampa, Florida, 33615, United States
Cleveland Clinic Florida
Weston, Florida, 33331, United States
The University of Chicago
Chicago, Illinois, 60637, United States
Robley Rex VA Medical Center
Louisville, Kentucky, 40206, United States
Baton Rouge General Medical Center
Baton Rouge, Louisiana, 70809, United States
Louisiana Research Center - GastroIntestinal Associates
Shreveport, Louisiana, 71105, United States
Mercy Medical Center
Baltimore, Maryland, 21202, United States
Chevy Chase Clinical Research
Chevy Chase, Maryland, 20815, United States
University of Massachusetts Memorial Medical Center
North Worcester, Massachusetts, 01655, United States
Gastroenterology Associates of Western Michigan, P.L.C.
Wyoming, Michigan, 49519, United States
Gastrointestinal Associates Research
Flowood, Mississippi, 39232, United States
Virtua Crohns and Colitis Center
Moorestown, New Jersey, 08057, United States
Robert Wood Johnson University Hospital
New Brunswick, New Jersey, 08901, United States
Ellipsis Research Group
Brooklyn, New York, 11215, United States
Intercity Gastroenterology
Fresh Meadows, New York, 11366, United States
James J Peters Veterans Affairs Medical Center
The Bronx, New York, 10468, United States
Digestive Disease Medicine of Central New York
Utica, New York, 13502, United States
Charlotte Gastroenterology and Hepatology, P.L.L.C
Charlotte, North Carolina, 28207, United States
Clinical Inquest Center
Beavercreek, Ohio, 45431, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37212-1375, United States
University of Texas Southwestern Medical Center - Multidisciplinary Spine Clinic - James W. Aston Ambulatory Care Center
Dallas, Texas, 75390-8565, United States
GI Alliance - Fort Worth
Fort Worth, Texas, 76104, United States
GI Alliance
Garland, Texas, 75044, United States
Integrity Advanced Therapeutics PLLC
Houston, Texas, 77090, United States
Texas Digestive Disease Consultants-Lubbock powered by GI Alliance
Lubbock, Texas, 79410, United States
Carta - Clinical Associates In Research Therapeutics Of America;LLC
San Antonio, Texas, 78212, United States
University of Texas Health Center at Tyler
Tyler, Texas, 75708, United States
TDDC GI Alliance research Webster
Webster, Texas, 77598, United States
University Physicians and Surgeons Inc, dba Marshall Health
Huntington, West Virginia, 25701, United States
Instituto Medico CER
Quilmes, B1878DVB, Argentina
CICE 9 de Julio
San Miguel de Tucumán, T4000DPK, Argentina
Macquarie University Hospital
Macquarie Park, New South Wales, 2109, Australia
Coral Sea Clinical Research Institute
Mackay, Queensland, 4740, Australia
Footscray Hospital
Footscray, Victoria, 3011, Australia
Royal Melbourne Hospital
Parkville, Victoria, 3050, Australia
Ordensklinikum Linz Barmherzige Schwestern
Linz, 4010, Austria
Klinikum Wels-Grieskirchen
Wels, 4600, Austria
CHU St Pierre (St Pierre)
Brussels, 1000, Belgium
UZ Brussel
Brussels, 1090, Belgium
Cliniques Universitaires St-Luc
Brussels, 1200, Belgium
Instituto Lobus Unimed Volta Redonda
Volta Redonda, Rio de Janeiro, 27258-000, Brazil
Hospital Moinhos de Vento
Porto Alegre, Rio Grande do Sul, 90035-000, Brazil
Newdata Clinical Trials
Aracaju, Sergipe, 49055-000, Brazil
CECIP - Centro de Estudos Clínicos do Interior Paulista
Jaú, São Paulo, 17210-190, Brazil
Hospital de Base de Sao Jose do Rio Preto
São José do Rio Preto, São Paulo, 15090-000, Brazil
Hospital Sírio-Libanês
São Paulo, São Paulo, 01308-050, Brazil
MC " Sveti Ivan Rilski Chudotvorets- 2010
Plovdiv, 4003, Bulgaria
Barrie GI Associates
Barrie, Ontario, L4M 7G1, Canada
GNRR Digestive Clinics and Research Center Inc.
Brampton, Ontario, L6S 0E2, Canada
London Health Sciences Centre Uni Campus
London, Ontario, N6A 5A5, Canada
LDDI Clinical Trials Inc.
London, Ontario, N6K 1M6, Canada
Toronto Immune and Digestive Health Institute
North YORK, Ontario, M6A 3B4, Canada
CIUSSS de l Est de l Ile de Montreal - Hopital Maisonneuve Rosemont
Montreal, Quebec, H1T 2M4, Canada
Medicina de Precisión - Celerity
Las Condes, 7560908, Chile
Centro de Investigación Clínica UC-CICUC
Santiago, 8330034, Chile
First Affiliated Hospital of Gannan Medical University
Ganzhou, Jiangxi, 341000, China
The First Affilliated Hospital of Kunming Medical University
Kunming, Yunnan, 650032, China
Jinhua municipal central hospital
Jinhua, Zhejiang, 321013, China
Beijing Union Hospital
Beijing, 100730, China
Sichuan Provincial People's Hospital
Chengdu, 610072, China
Guangzhou First People's Hospital
Guangzhou, 510180, China
Zhujiang Hospital, Southern Medical University
Guangzhou, 510280, China
Hainan General Hospital
Haikou, 570311, China
Huizhou First Hospital
Huizhou, China
The Second Affiliated Hospital of Nanchang University
Nanchang, 330008, China
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, 200092, China
Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, 200127, China
Shengjing Hospital of China Medical University
Shenyang, 110004, China
Hebei Medical University - The Second Hospital
Shijiazhuang, 050004, China
The Second Affiliated Hospital of Soochow University
Suzhou, 215004, China
The Second Affiliated Hospital of Xi'an Jiao Tong University
Xi'an, 710004, China
The First Affiliated Hospital of Xiamen University
Xiamen, 361003, China
Affiliated Hospital of Jiangsu University
Zhenjiang, 212001, China
Hospital Universitario San Ignacio
Bogotá, 000472, Colombia
Clínica de la Mujer
Bogotá, 110221, Colombia
Clinica Colsanitas S.A. - Sede Clinica Reina Sofia
Bogotá, 111071, Colombia
Oncomedica S.A.
Montería, 230002, Colombia
Borzan Polyclinic
Osijek, 31000, Croatia
Clinical Hospital Centre Zagreb
Zagreb, 10000, Croatia
Hepato-Gastroenterologie HK, s.r.o.
Hradec Králové, 500 12, Czechia
Fakultni nemocnice Ostrava
Ostrava - Poruba, 708 52, Czechia
Institutu Klinicke a Experimentaini Mediciny (IKEM);Klinika hepatogastroenterologie
Prague, 140 21, Czechia
ISCARE a.s.
Prague, 170 04, Czechia
Krajska zdravotni, a.s. ? Masarykova nemocnice v Usti nad Labem, o.z., Ocni oddeleni
Ústí nad Labem, 401 13, Czechia
Centre hospitalier Lyon Sud
Pierre-Bénite, Rhône, 69310, France
CHU Tours - Hôpital Trousseau
Chambray-lès-Tours, 37170, France
CHU Clermont Ferrand - Hôpital d'Estaing
Clermont-Ferrand, 63000, France
Hôpital Henri Mondor
Créteil, 94000, France
CH Dptal Les Oudairies
La Roche-sur-Yon, 85925, France
CHRU de Lille - Hopital Claude Huriez
Lille, 59037, France
Hopital Dupuytren
Limoges, 87042, France
Hopital Saint-Eloi
Montpellier, 34295, France
Institut des MICI, Clinique Ambroise Paré
Neuilly-sur-Seine, 92200, France
Hôpital Saint-Louis
Paris, 75475, France
Hôpital de Brabois Adultes
Vandœuvre-lès-Nancy, 54511, France
Universitätsklinikum Heidelberg
Heidelberg, 69120, Germany
Klinikum Ernst von Bergmann
Potsdam, 14467, Germany
Észak-Pesti Centrumkórház-Honvédkórház
Budapest, 1062, Hungary
Geomedical Orvosi Kft
Budapest, 1066, Hungary
Semmelweis Egyetem
Budapest, 1082, Hungary
Endomedix Kft.
Budapest, 1139, Hungary
Vas-Oxy Egeszsegugyi Kft
Szombathely, 9700, Hungary
Shree Giriraj Multispeciality Hospital
Rajkot, Gujarat, 360005, India
Surat Institute of Digestive Sciences Hospitals
Surat, Gujarat, 395002, India
Gujarat Gastro and Vascular Hospital
Surat, Gujarat, 395009, India
Amrita Institute of Medical Sciences
Kochi, Kerala, 682041, India
MIDAS Multispeciality Hospital
Nagpur (urban), Maharashtra, 440018, India
All India Institute Of Medical Sciences (AIIMS)
New Delhi, National Capital Territory of Delhi, 110029, India
SR Kalla Memorial Gastro & General Hospital
Jaipur, Rajasthan, 302006, India
AIG Hospitals
Gachibowli, Telangana, 500032, India
Gandhi Hospital
Secunderabad, Telangana, 500003, India
Yashoda Hospitals
Secunderabad, Telangana, 500003, India
Shaare Zedek Medical Center
Jerusalem, 9103102, Israel
Hadassah Medical Center
Jerusalem, 9112001, Israel
Ospedale Madonna delle Grazie
Matera, Basilicate, 75100, Italy
Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi-Via Massarenti
Bologna, Emilia-Romagna, 40138, Italy
Policlinico Universitario Campus Biomedico Di Roma
Rome, Lazio, 00128, Italy
Policlinico Universitario Agostino Gemelli
Rome, Lazio, 00168, Italy
Asst Degli Spedali Civili Di Brescia
Brescia, Lombardy, 25123, Italy
IRCCS Ospedale San Raffaele
Milan, Lombardy, 20132, Italy
I.R.C.C.S Policlinico San Donato
San Donato Milanese (MI), Lombardy, 20097, Italy
IRCCS Ospedale Sacro Cuore Don Calabria
Negrar, Veneto, 37024, Italy
Gastromed Kralisz, Romatowski, Stachurska sp.j.
Bia?ystok, 15-322, Poland
Medical Center Kermed
Bydgoszcz, 85-231, Poland
Szpital Miejski sw. Jana Paw?a II w Elblagu
Elblag, 82-300, Poland
Osrodek Badan Klinicznych Bd Research
I?awa, 14-200, Poland
MZ Badania Slowik Zymla Sp.j.
Knurów, 44-190, Poland
Centrum Medyczne Promed
Krakow, 31-513, Poland
Amicare Sp. z o.o. S.K.
Lodz, 91-495, Poland
Medrise sp z o.o
Lublin, 20-582, Poland
Clinical Research Center Sp. z o.o. MEDIC-R Spó?ka Komandytowa
Poznan, 61-731, Poland
EMC Instytut Medyczny SA
Późna, 60-309, Poland
Gabinety Lekarskie Rivermed
Późna, 61-441, Poland
Endoskopia Sp. z o.o.
Sopot, 81-756, Poland
Sonomed Sp. z o.o.
Szczecin, 71-685, Poland
Centrum Zdrowia-MDM
Warsaw, 00-189, Poland
Medon Clinical Research sp. z o.o
Warsaw, 02-679, Poland
Vivamed Spolka Z Ograniczona Odpowiedzialnoscia
Warsaw, 03-580, Poland
PlanetMed sp. z o.o.
Wroc?aw, 52-210, Poland
Hospital de Braga
Braga, 4710-243, Portugal
Hospital de Santa Maria
Lisbon, 1649-035, Portugal
Hospital de Sao Joao
Porto, 4202-451, Portugal
Centro Hospitalar de Entre Douro e Vouga - H. São Sebastião
Santa Maria da Feira, 4520-211, Portugal
Hospital Sao Teotonio
Viseu, 3504-509, Portugal
Spital Digenio - Centrul de Excelen?? în Afec?iuni Digestive
Cluj-Napoca, Romania
ABAWI spol. s r.o.
Bratislava, 821 07, Slovakia
KM Management spol. s r.o.
Nitra, 949 01, Slovakia
Yeungnam University Medical Center
Daegu, 42415, South Korea
Fundacion Hospital de Alcorcon
Alcorcón, Madrid, 28922, Spain
Hospital Universitario Puerta de Hierro
Majadahonda, Madrid, 28222, Spain
Hospital General Universitario Gregorio Maranon
Madrid, 28040, Spain
Hospital Clinico Univ. Lozano Blesa
Zaragoza, 50009, Spain
Southmead Hospital
Bristol, BS10 5NB, United Kingdom
Fairfield General Hospital
Bury, BL9 7TD, United Kingdom
Bronglais General Hospital
Llanrhystud, SY23 1ER, United Kingdom
Royal London Hospital
London, E1 1FR, United Kingdom
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Central Study Contacts
Reference Study ID Number: GA45332 https://forpatients.roche.com/
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 6, 2025
First Posted
February 11, 2025
Study Start
May 12, 2025
Primary Completion (Estimated)
December 31, 2028
Study Completion (Estimated)
April 30, 2033
Last Updated
May 7, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
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