Moderately to Severely Active Crohns DiseasePhase 3SIBERITE-2NCT06819891
A Study to Assess the Efficacy and Safety of Induction Therapy With Afimkibart (RO7790121) in Participants With Moderately to Severely Active Crohn's Disease
A Phase 3 study testing Afimkibart in people with Moderately to Severely Active Crohns Disease, run by Hoffmann-La Roche at 203 sites in 27 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 16 to 80 years
- Conditions the study is for
- Moderately to Severely Active Crohns Disease
- What is being tested?
- Afimkibart
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 425 participants
- Where
- 203 sitesin 27 countries
- Study dates
- 12 May 2025to 30 Apr 2033
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
203 sites in 27 countries. Contact the study team or a site near you to ask about taking part.
Reference Study ID Number: GA45332 https://forpatients.roche.com/ No attachments to email below. contact
Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry contact
203 sites in 27 countries
United States61 sites, 59 recruiting
- Recruiting
Morehouse School Of Medicine
Atlanta, Georgia, 30310-1495
- Recruiting
Mercy Medical Center
Baltimore, Maryland, 21202
- Recruiting
Baton Rouge General Medical Center
Baton Rouge, Louisiana, 70809
- Recruiting
Clinical Inquest Center
Beavercreek, Ohio, 45431
- Recruiting
Ellipsis Research Group
Brooklyn, New York, 11215
- Recruiting
Charlotte Gastroenterology and Hepatology, P.L.L.C
Charlotte, North Carolina, 28207
- Recruiting
Chevy Chase Clinical Research
Chevy Chase, Maryland, 20815
- Recruiting
The University of Chicago
Chicago, Illinois, 60637
- Recruiting
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
- Recruiting
Peak Gastroenterology Associates
Colorado Springs, Colorado, 80907
- Recruiting
Va Heartland Network - Harry S. Truman Memorial Veterans' Hospital
Columbia, Missouri, 65201-5275
- Recruiting
Gastro One
Cordova, Tennessee, 38018
- Recruiting
University of Texas Southwestern Medical Center - Multidisciplinary Spine Clinic - James W. Aston Ambulatory Care Center
Dallas, Texas, 75390-8565
- Recruiting
J&A Clinical Research
Doral, Florida, 33126
- Recruiting
Digestive Health Specialists of the Southeast
Dothan, Alabama, 36305
- Recruiting
Gastrointestinal Associates Research
Flowood, Mississippi, 39232
- Recruiting
GI Alliance - Fort Worth
Fort Worth, Texas, 76104
- Recruiting
Intercity Gastroenterology
Fresh Meadows, New York, 11366
- Recruiting
GI Alliance
Garland, Texas, 75044
- Recruiting
Sun City Clinical Research
Glendale, Arizona, 85304
- Recruiting
Peters Medical Research (PMR), LLC
High Point, North Carolina, 27260
- Recruiting
Integrity Advanced Therapeutics PLLC
Houston, Texas, 77090
- Withdrawn
University Physicians and Surgeons Inc, dba Marshall Health
Huntington, West Virginia, 25701
- Recruiting
University of Kansas Medical Center
Kansas City, Kansas, 66160
- Recruiting
NYU Langone Long Island Clinical Research Associates
Lake Success, New York, 11042
- Recruiting
Auzmer Research
Lakeland, Florida, 33813
- Recruiting
Om Research LLC
Lancaster, California, 93534
- Recruiting
Dartmouth-Hitchcock Medical Center-Norris Cotton Cancer Center
Lebanon, New Hampshire, 03756
- Recruiting
Galenus Group Inc
Lehigh Acres, Florida, 33936
- Recruiting
Robley Rex VA Medical Center
Louisville, Kentucky, 40206
- Recruiting
One GI: GHP - Gastroenterology Health Partners Louisville
Louisville, Kentucky, 40218
- Recruiting
Texas Digestive Disease Consultants-Lubbock powered by GI Alliance
Lubbock, Texas, 79410
- Recruiting
Homestead Associates in Research, Inc.
Miami, Florida, 33033
- Recruiting
Allied Biomedical Research Institute, Inc
Miami, Florida, 33155
- Recruiting
Rejuvaline Medical Research
Miami, Florida, 33155
- Recruiting
Miami Beach Clinical Research Center
Miami Beach, Florida, 33141
- Recruiting
Eminat Research Group
Miramar, Florida, 33027
- Recruiting
Virtua Crohns and Colitis Center
Moorestown, New Jersey, 08057
- Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37212-1375
- Recruiting
Robert Wood Johnson University Hospital
New Brunswick, New Jersey, 08901
- Recruiting
Hoag Memorial Hospital Presbyterian;Hoag Center for Research and Education
Newport Beach, California, 92663
- Recruiting
University of Massachusetts Memorial Medical Center
North Worcester, Massachusetts, 01655
- Recruiting
Digestive and Liver Center of Florida
Orlando, Florida, 32825
- Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
- Withdrawn
Empire Clinical Research
Pomona, California, 91767
- Recruiting
Advanced Medical Research Center
Port Orange, Florida, 32127
- Recruiting
University Gastroenterology
Providence, Rhode Island, 02904
- Recruiting
Stanford Medicine Outpatient Center
Redwood City, California, 94063
- Recruiting
GI Alliance-Richmond
Richmond, Virginia, 23229
- Recruiting
Carta - Clinical Associates In Research Therapeutics Of America;LLC
San Antonio, Texas, 78212
- Recruiting
Clinical Applications Laboratories, Inc.
San Diego, California, 92103
- Recruiting
Amicis Research Center
Santa Clarita, California, 91355
- Recruiting
Louisiana Research Center - GastroIntestinal Associates
Shreveport, Louisiana, 71105
- Recruiting
Specialists in Gastroenterology
St Louis, Missouri, 63141
- Recruiting
Santos Research Center, CORP
Tampa, Florida, 33615
- Recruiting
James J Peters Veterans Affairs Medical Center
The Bronx, New York, 10468
- Recruiting
University of Texas Health Center at Tyler
Tyler, Texas, 75708
- Recruiting
Digestive Disease Medicine of Central New York
Utica, New York, 13502
- Recruiting
TDDC GI Alliance research Webster
Webster, Texas, 77598
- Recruiting
Cleveland Clinic Florida
Weston, Florida, 33331
- Recruiting
Gastroenterology Associates of Western Michigan, P.L.C.
Wyoming, Michigan, 49519
China19 sites, 19 recruiting
- Recruiting
Beijing Union Hospital
Beijing, 100730
- Recruiting
Sichuan Provincial People's Hospital
Chengdu, 610072
- Recruiting
First Affiliated Hospital of Gannan Medical University
Ganzhou, Jiangxi, 341000
- Recruiting
Guangzhou First People's Hospital
Guangzhou, 510180
- Recruiting
Zhujiang Hospital, Southern Medical University
Guangzhou, 510280
- Recruiting
Hainan General Hospital
Haikou, 570311
- Recruiting
Huai'an First People's Hospital
Huai'an
- Recruiting
Huizhou First Hospital
Huizhou
- Recruiting
Jinhua municipal central hospital
Jinhua, Zhejiang, 321013
- Recruiting
The First Affilliated Hospital of Kunming Medical University
Kunming, 650032
- Recruiting
The Second Affiliated Hospital of Nanchang University
Nanchang, 330008
- Recruiting
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, 200092
- Recruiting
Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, 200127
- Recruiting
Shengjing Hospital of China Medical University
Shenyang, 110004
- Recruiting
Hebei Medical University - The Second Hospital
Shijiazhuang, 050004
- Recruiting
The Second Affiliated Hospital of Soochow University
Suzhou, 215004
- Recruiting
The Second Affiliated Hospital of Xi'an Jiao Tong University
Xi'an, 710004
- Recruiting
The First Affiliated Hospital of Xiamen University
Xiamen, 361003
- Recruiting
Affiliated Hospital of Jiangsu University
Zhenjiang, 212001
Poland18 sites, 18 recruiting
- Recruiting
Gastromed Kralisz, Romatowski, Stachurska sp.j.
Bia?ystok, 15-322
- Recruiting
Medical Center Kermed
Bydgoszcz, 85-231
- Recruiting
Szpital Miejski sw. Jana Paw?a II w Elblagu
Elblag, 82-300
- Recruiting
Osrodek Badan Klinicznych Bd Research
I?awa, 14-200
- Recruiting
MZ Badania Slowik Zymla Sp.j.
Knurów, 44-190
- Recruiting
Centrum Medyczne Promed
Krakow, 31-513
- Recruiting
Amicare Sp. z o.o. S.K.
Lodz, 91-495
- Recruiting
Medrise sp z o.o
Lublin, 20-582
- Recruiting
EMC Instytut Medyczny SA
Późna, 60-309
- Recruiting
Gabinety Lekarskie Rivermed
Późna, 61-441
- Recruiting
Clinical Research Center Sp. z o.o. MEDIC-R Spó?ka Komandytowa
Poznan, 61-731
- Recruiting
Endoskopia Sp. z o.o.
Sopot, 81-756
- Recruiting
Nowe Zdrowie-CK Kieltucki I Wspolnicy Sp. j.
Staszów, 20-200
- Recruiting
Sonomed Sp. z o.o.
Szczecin, 71-685
- Recruiting
Centrum Zdrowia-MDM
Warsaw, 00-189
- Recruiting
Medon Clinical Research sp. z o.o
Warsaw, 02-679
- Recruiting
Vivamed Spolka Z Ograniczona Odpowiedzialnoscia
Warsaw, 03-580
- Recruiting
PlanetMed sp. z o.o.
Wroc?aw, 52-210
India13 sites, 13 recruiting
- Recruiting
AIG Hospitals
Gachibowli, Telangana, 500032
- Recruiting
SR Kalla Memorial Gastro & General Hospital
Jaipur, Rajasthan, 302006
- Recruiting
SMS Superspeciality Hospital
Jaipur, Rajasthan, 302007
- Recruiting
Amrita Institute of Medical Sciences
Kochi, Kerala, 682041
- Recruiting
Institute of Post Graduate Medical Education and Research (IPGMER) and SSKM Hospital
Kolkata, West Bengal, 700020
- Recruiting
Kurnool Medical College
Kurnool, Andhra Pradesh, 518002
- Recruiting
MIDAS Multispeciality Hospital
Nagpur (urban), Maharashtra, 440018
- Recruiting
All India Institute Of Medical Sciences (AIIMS)
New Delhi, National Capital Territory of Delhi, 110029
- Recruiting
Shree Giriraj Multispeciality Hospital
Rajkot, Gujarat, 360005
- Recruiting
Gandhi Hospital
Secunderabad, Telangana, 500003
- Recruiting
Yashoda Hospitals
Secunderabad, Telangana, 500003
- Recruiting
Surat Institute of Digestive Sciences Hospitals
Surat, Gujarat, 395002
- Recruiting
Gujarat Gastro and Vascular Hospital
Surat, Gujarat, 395009
France11 sites, 9 recruiting
- Recruiting
CHU Tours - Hôpital Trousseau
Chambray-lès-Tours, 37170
- Recruiting
CHU Clermont Ferrand - Hôpital d'Estaing
Clermont-Ferrand, 63000
- Recruiting
Hôpital Henri Mondor
Créteil, 94000
- Recruiting
CH Dptal Les Oudairies
La Roche-sur-Yon, 85925
- Recruiting
CHRU de Lille - Hopital Claude Huriez
Lille, 59037
- Recruiting
Hopital Dupuytren
Limoges, 87042
- Recruiting
Hopital Saint-Eloi
Montpellier, 34295
- Active, not recruiting
Institut des MICI, Clinique Ambroise Paré
Neuilly-sur-Seine, 92200
- Recruiting
Hôpital Saint-Louis
Paris, 75475
- Active, not recruiting
Centre hospitalier Lyon Sud
Pierre-Bénite, Rhône, 69310
- Recruiting
Hôpital de Brabois Adultes
Vandœuvre-lès-Nancy, 54511
Italy8 sites, 8 recruiting
- Recruiting
Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi-Via Massarenti
Bologna, Emilia-Romagna, 40138
- Recruiting
Asst Degli Spedali Civili Di Brescia
Brescia, Lombardy, 25123
- Recruiting
Ospedale Madonna delle Grazie
Matera, Basilicate, 75100
- Recruiting
IRCCS Ospedale San Raffaele
Milan, Lombardy, 20132
- Recruiting
IRCCS Ospedale Sacro Cuore Don Calabria
Negrar, Veneto, 37024
- Recruiting
Policlinico Universitario Campus Biomedico Di Roma
Rome, Lazio, 00128
- Recruiting
Policlinico Universitario Agostino Gemelli
Rome, Lazio, 00168
- Recruiting
I.R.C.C.S Policlinico San Donato
San Donato Milanese (MI), Lombardy, 20097
Brazil6 sites, 5 recruiting
- Recruiting
Newdata Clinical Trials
Aracaju, Sergipe, 49055-000
- Recruiting
CECIP - Centro de Estudos Clínicos do Interior Paulista
Jaú, São Paulo, 17210-190
- Recruiting
Hospital Moinhos de Vento
Porto Alegre, Rio Grande do Sul, 90035-000
- Recruiting
Hospital de Base de Sao Jose do Rio Preto
São José do Rio Preto, São Paulo, 15090-000
- Withdrawn
Hospital Sírio-Libanês
São Paulo, São Paulo, 01308-050
- Recruiting
Instituto Lobus Unimed Volta Redonda
Volta Redonda, Rio de Janeiro, 27258-000
Canada6 sites, 5 recruiting
- Recruiting
Barrie GI Associates
Barrie, Ontario, L4M 7G1
- Recruiting
GNRR Digestive Clinics and Research Center Inc.
Brampton, Ontario, L6S 0E2
- Withdrawn
London Health Sciences Centre Uni Campus
London, Ontario, N6A 5A5
- Recruiting
LDDI Clinical Trials Inc.
London, Ontario, N6K 1M6
- Recruiting
CIUSSS de l Est de l Ile de Montreal - Hopital Maisonneuve Rosemont
Montreal, Quebec, H1T 2M4
- Recruiting
Toronto Immune and Digestive Health Institute
North YORK, Ontario, M6A 3B4
Australia5 sites, 4 recruiting
- Recruiting
Footscray Hospital
Footscray, Victoria, 3011
- Withdrawn
Coral Sea Clinical Research Institute
Mackay, Queensland, 4740
- Recruiting
Macquarie University Hospital
Macquarie Park, New South Wales, 2109
- Recruiting
Royal Melbourne Hospital
Parkville, Victoria, 3050
- Recruiting
Sydney Adventist Hospital
Wahroonga, New South Wales, 2076
Colombia5 sites, 4 recruiting
- Recruiting
Hospital Universitario San Ignacio
Bogotá, 000472
- Withdrawn
Clínica de la Mujer
Bogotá, 110221
- Recruiting
Clinica Colsanitas S.A. - Sede Clinica Reina Sofia
Bogotá, 111071
- Recruiting
Oncomedica S.A.
Montería, 230002
- Recruiting
Fundacion Cardiovascular de Colombia - KM 7 Autopista
Piedecuesta, Santander Department, 681004
Czechia5 sites, 5 recruiting
- Recruiting
Hepato-Gastroenterologie HK, s.r.o.
Hradec Králové, 500 12
- Recruiting
Fakultni nemocnice Ostrava
Ostrava - Poruba, 708 52
- Recruiting
Institutu Klinicke a Experimentaini Mediciny (IKEM);Klinika hepatogastroenterologie
Prague, 140 21
- Recruiting
ISCARE a.s.
Prague, 170 04
- Recruiting
Krajska zdravotni, a.s. ? Masarykova nemocnice v Usti nad Labem, o.z., Ocni oddeleni
Ústí nad Labem, 401 13
Hungary5 sites, 5 recruiting
- Recruiting
Észak-Pesti Centrumkórház-Honvédkórház
Budapest, 1062
- Recruiting
Geomedical Orvosi Kft
Budapest, 1066
- Recruiting
Semmelweis Egyetem
Budapest, 1082
- Recruiting
Endomedix Kft.
Budapest, 1139
- Recruiting
Vas-Oxy Egeszsegugyi Kft
Szombathely, 9700
Portugal5 sites, 5 recruiting
- Recruiting
Hospital de Braga
Braga, 4710-243
- Recruiting
Hospital de Santa Maria
Lisbon, 1649-035
- Recruiting
Hospital de Sao Joao
Porto, 4202-451
- Recruiting
Centro Hospitalar de Entre Douro e Vouga - H. São Sebastião
Santa Maria da Feira, 4520-211
- Recruiting
Hospital Sao Teotonio
Viseu, 3504-509
South Korea5 sites, 5 recruiting
- Recruiting
Korea University Ansan Hospital
Ansan-si, Gyeonggi-do, 15355
- Recruiting
Yeungnam University Medical Center
Daegu, 42415
- Recruiting
Chosun University Hospital
Gwangju, 61453
- Recruiting
The Catholic University of Korea Eunpyeong St. Mary's Hospital
Seoul, 03312
- Recruiting
Hanyang University Seoul Hospital
Seoul, 04763
United Kingdom5 sites, 4 recruiting
- Recruiting
Southmead Hospital
Bristol, BS10 5NB
- Recruiting
Fairfield General Hospital
Bury, BL9 7TD
- Recruiting
Bronglais General Hospital
Llanrhystud, SY23 1ER
- Recruiting
Royal London Hospital
London, E1 1FR
- Active, not recruiting
Stepping Hill Hospital
Stockport, SK2 7JE
Spain4 sites, 4 recruiting
- Recruiting
Fundacion Hospital de Alcorcon
Alcorcón, Madrid, 28922
- Recruiting
Hospital General Universitario Gregorio Maranon
Madrid, 28040
- Recruiting
Hospital Universitario Puerta de Hierro
Majadahonda, Madrid, 28222
- Recruiting
Hospital Clinico Univ. Lozano Blesa
Zaragoza, 50009
Belgium3 sites, 3 recruiting
- Recruiting
CHU St Pierre (St Pierre)
Brussels, 1000
- Recruiting
UZ Brussel
Brussels, 1090
- Recruiting
Cliniques Universitaires St-Luc
Brussels, 1200
Chile3 sites, 3 recruiting
- Recruiting
Medicina de Precisión - Celerity
Las Condes, 7560908
- Recruiting
Medwal
Santiago, 7500000
- Recruiting
Centro de Investigación Clínica UC-CICUC
Santiago, 8330034
Argentina2 sites, 2 recruiting
- Recruiting
Instituto Medico CER
Quilmes, B1878DVB
- Recruiting
CICE 9 de Julio
San Miguel de Tucumán, T4000DPK
Austria2 sites, 2 recruiting
- Recruiting
Ordensklinikum Linz Barmherzige Schwestern
Linz, 4010
- Recruiting
Klinikum Wels-Grieskirchen
Wels, 4600
Bulgaria2 sites, 2 recruiting
- Recruiting
Multiprofile Hospital for Active Treatment Uni Hospital;Department of Gastroenterology.
Panagyurishte, 4500
- Recruiting
MC " Sveti Ivan Rilski Chudotvorets- 2010
Plovdiv, 4003
Croatia2 sites, 2 recruiting
- Recruiting
Borzan Polyclinic
Osijek, 31000
- Recruiting
Clinical Hospital Centre Zagreb
Zagreb, 10000
Germany2 sites, 2 recruiting
- Recruiting
Universitätsklinikum Heidelberg
Heidelberg, 69120
- Recruiting
Klinikum Ernst von Bergmann
Potsdam, 14467
Israel2 sites, 2 recruiting
- Recruiting
Shaare Zedek Medical Center
Jerusalem, 9103102
- Recruiting
Hadassah Medical Center
Jerusalem, 9112001
Slovakia2 sites, 2 recruiting
- Recruiting
ABAWI spol. s r.o.
Bratislava, 821 07
- Recruiting
KM Management spol. s r.o.
Nitra, 949 01
Puerto Rico1 site, 1 recruiting
- Recruiting
Galenus Group Of Puerto Rica Inc
Manati, 00674
Romania1 site, 1 recruiting
- Recruiting
Spital Digenio - Centrul de Excelen?? în Afec?iuni Digestive
Cluj-Napoca
About this study
Official title: 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).
- Being tested
- Afimkibart, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AfimkibartDrug
Also called PF-06480605, RVT-3101, RG6631, RO7790121
Afimkibart will be administered as IV infusion. Afimkibart will be administered as SC injection.
PlaceboDrug
Placebo matching IV afimkibart.
| Study group | Role | What they receive |
|---|---|---|
| Afimkibart | Experimental | Participants will receive afimkibart intravenously (IV) followed by afimkibart subcutaneous (SC) injection. Receives: Drug: Afimkibart |
| Placebo | Placebo comparator | Participants will receive placebo IV followed by afimkibart SC injection. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: At Week 12
Secondary outcomes (17)
Percentage of Participants with Symptomatic Remission
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.
Measured: At Week 12
Percentage of Participants with Endoscopic Remission
Percentage of participants with an SES-CD of 0 to 4 with a decrease from baseline >=2 and no subscore >1.
Measured: At Week 12
Percentage of Participants with Ulcer-free Endoscopy
Percentage of participants with an SES-CD ulcerated surface subscore of 0.
Measured: At Week 12
Average of Daily Number of Liquid or Very Soft Stools in the Past Week (SF)
Daily average number of liquid or very soft stools over 7 days.
Measured: Baseline through Week 12
Average of Daily Abdominal Pain Scores in the Past Week (APS)
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.
Measured: Baseline through Week 12
Bowel Urgency
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."
Measured: Baseline to Week 12
Fatigue
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."
Measured: Baseline to Week 12
Inflammatory Bowel Disease Questionnaire (IBDQ) Score
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.
Measured: Baseline to Week 12
Percentage of Participants with Clinical Remission: Among Biomarker-Defined Subgroups of Participants
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.
Measured: At Week 12
Percentage of Participants with Endoscopic Response: Among Biomarker-Defined Subgroups of Participants
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.
Measured: At Week 12
Percentage of Participants with Clinical Response
Percentage of participants with a decrease >=100 in CDAI from baseline.
Measured: At Week 12
Percentage of Participants with Symptomatic Response
Percentage of participants with a decrease >=30% in both SF and APS, with neither being greater than baseline.
Measured: At Week 12
Overall Change in CD Symptoms
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".
Measured: Baseline to Weeks 2, 6 and 12
Overall Severity in CD Symptoms
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".
Measured: Baseline to Weeks 2, 6 and 12
Change in General Well-being
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.
Measured: Baseline through Week 12
Incidence and Severity of Adverse Events (AEs)
Incidence and severity of AEs, including serious AEs, AEs leading to treatment discontinuation and AEs of special interest.
Measured: Up to 30 Weeks after Baseline
Presence of Draining Fistulas
Fistulas will be assessed for draining or closed status, where closed fistulas will be assessed by the investigator as no longer draining.
Measured: Baseline through Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2025
- Study start12 May 2025
- Primary completion31 Dec 2028 (estimated)
- Study completion30 Apr 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderately to Severely Active Crohns DiseaseStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 425 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Chugai Pharmaceutical
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06819891
- Sponsor's protocol ID
- GA45332
- Other IDs
- 2024-513054-30-00
- Acronym
- SIBERITE-2
- Status last verified
- Sep 2026
- First submitted
- 6 Feb 2025
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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