A Study to Assess the Efficacy and Safety of Induction Therapy With Afimkibart (RO7790121) in Participants With Moderately to Severely Active Crohn's Disease
Phase 3 · Testing Afimkibart · 203 sites · Hoffmann-La Roche
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Afimkibart (a drug) as a possible treatment. Condition(s) listed: Moderately to Severely Active Crohns Disease.
Participants are assigned to groups by chance (randomized).
Some participants receive a placebo or sham for comparison.
It is blinded: participants and the study team do not know who receives what.
Phase 3 studies are large studies comparing a treatment with placebo or standard care. They are often the last step before a company asks regulators for approval.
Who can join
- Ages 16 to 80
- Any sex
Some of the main requirements, copied from the record:
- 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
There are also 15 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 425 participants are expected to take part.
- The study has 2 groups.
- Start date: 2025-05-12.
- Main results expected around 2028-12-31 (estimate from the record).
- 203 study sites listed (194 marked recruiting) in Argentina, Australia, Austria, Belgium and Brazil and 22 more countries.
Groups in this study
- Afimkibart (listed as: experimental group)
- Placebo (listed as: placebo group)
Main thing being measured
- Percentage of Participants with Clinical Remission per Crohn's Disease Activity Index (CDAI) Score (At Week 12)
- Percentage of Participants with Endoscopic Response (At Week 12)
In the researchers’ words
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).
Words you might see
- Placebo: a look-alike pill or injection with no active drug, used for comparison.
- Endoscopy: a camera exam inside the digestive tract.
- CDAI: Crohn's Disease Activity Index, a score of how active Crohn's disease is.
- Remission: a period when the disease is quiet or under control.
- Induction: the first phase of treatment, aimed at getting the disease under control.
- Fistula: an abnormal tunnel between two parts of the body, which can happen in Crohn's disease.
- Stricture: a narrowing (of the bowel or of a bile duct).
General definitions, not specific to this trial.
This summary was written automatically from the official record using fixed templates (no AI), so it only says what the record says, and may leave things out.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Phase 3 |
| Study type | Interventional |
| Conditions | Moderately to Severely Active Crohns Disease |
| Lead sponsor | Hoffmann-La Roche |
| Collaborators | Chugai Pharmaceutical |
| Enrollment | 425 (estimated) |
| Start date | 2025-05-12 |
| Primary completion (est.) | 2028-12-31 |
| First posted | 2025-02-11 |
| Last updated | 2026-09-28 |
| 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 |
| ClinicalTrials.gov ID | NCT06819891 |
Interventions
- Afimkibart (Drug)
Afimkibart will be administered as IV infusion. Afimkibart will be administered as SC injection. - Placebo (Drug)
Placebo matching IV afimkibart.
Full eligibility criteria (from the record)
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
Locations (203)
Show all 203 sites
| Site | City | Country | Site status |
|---|---|---|---|
| Digestive Health Specialists of the Southeast | Dothan, Alabama | United States | Recruiting |
| Sun City Clinical Research | Glendale, Arizona | United States | Recruiting |
| Om Research LLC | Lancaster, California | United States | Recruiting |
| Hoag Memorial Hospital Presbyterian;Hoag Center for Research and Education | Newport Beach, California | United States | Recruiting |
| Empire Clinical Research | Pomona, California | United States | Withdrawn |
| Stanford Medicine Outpatient Center | Redwood City, California | United States | Recruiting |
| Clinical Applications Laboratories, Inc. | San Diego, California | United States | Recruiting |
| Amicis Research Center | Santa Clarita, California | United States | Recruiting |
| Peak Gastroenterology Associates | Colorado Springs, Colorado | United States | Recruiting |
| J&A Clinical Research | Doral, Florida | United States | Recruiting |
| Auzmer Research | Lakeland, Florida | United States | Recruiting |
| Galenus Group Inc | Lehigh Acres, Florida | United States | Recruiting |
| Homestead Associates in Research, Inc. | Miami, Florida | United States | Recruiting |
| Allied Biomedical Research Institute, Inc | Miami, Florida | United States | Recruiting |
| Rejuvaline Medical Research | Miami, Florida | United States | Recruiting |
| Miami Beach Clinical Research Center | Miami Beach, Florida | United States | Recruiting |
| Eminat Research Group | Miramar, Florida | United States | Recruiting |
| Digestive and Liver Center of Florida | Orlando, Florida | United States | Recruiting |
| Advanced Medical Research Center | Port Orange, Florida | United States | Recruiting |
| Santos Research Center, CORP | Tampa, Florida | United States | Recruiting |
| Cleveland Clinic Florida | Weston, Florida | United States | Recruiting |
| Morehouse School Of Medicine | Atlanta, Georgia | United States | Recruiting |
| The University of Chicago | Chicago, Illinois | United States | Recruiting |
| University of Kansas Medical Center | Kansas City, Kansas | United States | Recruiting |
| Robley Rex VA Medical Center | Louisville, Kentucky | United States | Recruiting |
| One GI: GHP - Gastroenterology Health Partners Louisville | Louisville, Kentucky | United States | Recruiting |
| Baton Rouge General Medical Center | Baton Rouge, Louisiana | United States | Recruiting |
| Louisiana Research Center - GastroIntestinal Associates | Shreveport, Louisiana | United States | Recruiting |
| Mercy Medical Center | Baltimore, Maryland | United States | Recruiting |
| Chevy Chase Clinical Research | Chevy Chase, Maryland | United States | Recruiting |
| University of Massachusetts Memorial Medical Center | North Worcester, Massachusetts | United States | Recruiting |
| Gastroenterology Associates of Western Michigan, P.L.C. | Wyoming, Michigan | United States | Recruiting |
| Gastrointestinal Associates Research | Flowood, Mississippi | United States | Recruiting |
| Va Heartland Network - Harry S. Truman Memorial Veterans' Hospital | Columbia, Missouri | United States | Recruiting |
| Specialists in Gastroenterology | St Louis, Missouri | United States | Recruiting |
| Dartmouth-Hitchcock Medical Center-Norris Cotton Cancer Center | Lebanon, New Hampshire | United States | Recruiting |
| Virtua Crohns and Colitis Center | Moorestown, New Jersey | United States | Recruiting |
| Robert Wood Johnson University Hospital | New Brunswick, New Jersey | United States | Recruiting |
| Ellipsis Research Group | Brooklyn, New York | United States | Recruiting |
| Intercity Gastroenterology | Fresh Meadows, New York | United States | Recruiting |
| NYU Langone Long Island Clinical Research Associates | Lake Success, New York | United States | Recruiting |
| James J Peters Veterans Affairs Medical Center | The Bronx, New York | United States | Recruiting |
| Digestive Disease Medicine of Central New York | Utica, New York | United States | Recruiting |
| Charlotte Gastroenterology and Hepatology, P.L.L.C | Charlotte, North Carolina | United States | Recruiting |
| Peters Medical Research (PMR), LLC | High Point, North Carolina | United States | Recruiting |
| Clinical Inquest Center | Beavercreek, Ohio | United States | Recruiting |
| Cleveland Clinic Foundation | Cleveland, Ohio | United States | Recruiting |
| University of Pennsylvania | Philadelphia, Pennsylvania | United States | Recruiting |
| University Gastroenterology | Providence, Rhode Island | United States | Recruiting |
| Gastro One | Cordova, Tennessee | United States | Recruiting |
| Vanderbilt University Medical Center | Nashville, Tennessee | United States | Recruiting |
| University of Texas Southwestern Medical Center - Multidisciplinary Spine Clinic - James W. Aston Ambulatory Care Center | Dallas, Texas | United States | Recruiting |
| GI Alliance - Fort Worth | Fort Worth, Texas | United States | Recruiting |
| GI Alliance | Garland, Texas | United States | Recruiting |
| Integrity Advanced Therapeutics PLLC | Houston, Texas | United States | Recruiting |
| Texas Digestive Disease Consultants-Lubbock powered by GI Alliance | Lubbock, Texas | United States | Recruiting |
| Carta - Clinical Associates In Research Therapeutics Of America;LLC | San Antonio, Texas | United States | Recruiting |
| University of Texas Health Center at Tyler | Tyler, Texas | United States | Recruiting |
| TDDC GI Alliance research Webster | Webster, Texas | United States | Recruiting |
| GI Alliance-Richmond | Richmond, Virginia | United States | Recruiting |
| University Physicians and Surgeons Inc, dba Marshall Health | Huntington, West Virginia | United States | Withdrawn |
| Instituto Medico CER | Quilmes | Argentina | Recruiting |
| CICE 9 de Julio | San Miguel de Tucumán | Argentina | Recruiting |
| Macquarie University Hospital | Macquarie Park, New South Wales | Australia | Recruiting |
| Sydney Adventist Hospital | Wahroonga, New South Wales | Australia | Recruiting |
| Coral Sea Clinical Research Institute | Mackay, Queensland | Australia | Withdrawn |
| Footscray Hospital | Footscray, Victoria | Australia | Recruiting |
| Royal Melbourne Hospital | Parkville, Victoria | Australia | Recruiting |
| Ordensklinikum Linz Barmherzige Schwestern | Linz | Austria | Recruiting |
| Klinikum Wels-Grieskirchen | Wels | Austria | Recruiting |
| CHU St Pierre (St Pierre) | Brussels | Belgium | Recruiting |
| UZ Brussel | Brussels | Belgium | Recruiting |
| Cliniques Universitaires St-Luc | Brussels | Belgium | Recruiting |
| Hospital Moinhos de Vento | Porto Alegre, Rio Grande do Sul | Brazil | Recruiting |
| Instituto Lobus Unimed Volta Redonda | Volta Redonda, Rio de Janeiro | Brazil | Recruiting |
| Newdata Clinical Trials | Aracaju, Sergipe | Brazil | Recruiting |
| CECIP - Centro de Estudos Clínicos do Interior Paulista | Jaú, São Paulo | Brazil | Recruiting |
| Hospital de Base de Sao Jose do Rio Preto | São José do Rio Preto, São Paulo | Brazil | Recruiting |
| Hospital Sírio-Libanês | São Paulo, São Paulo | Brazil | Withdrawn |
| Multiprofile Hospital for Active Treatment Uni Hospital;Department of Gastroenterology. | Panagyurishte | Bulgaria | Recruiting |
| MC " Sveti Ivan Rilski Chudotvorets- 2010 | Plovdiv | Bulgaria | Recruiting |
| Barrie GI Associates | Barrie, Ontario | Canada | Recruiting |
| GNRR Digestive Clinics and Research Center Inc. | Brampton, Ontario | Canada | Recruiting |
| London Health Sciences Centre Uni Campus | London, Ontario | Canada | Withdrawn |
| LDDI Clinical Trials Inc. | London, Ontario | Canada | Recruiting |
| Toronto Immune and Digestive Health Institute | North YORK, Ontario | Canada | Recruiting |
| CIUSSS de l Est de l Ile de Montreal - Hopital Maisonneuve Rosemont | Montreal, Quebec | Canada | Recruiting |
| Medicina de Precisión - Celerity | Las Condes | Chile | Recruiting |
| Medwal | Santiago | Chile | Recruiting |
| Centro de Investigación Clínica UC-CICUC | Santiago | Chile | Recruiting |
| Beijing Union Hospital | Beijing | China | Recruiting |
| Sichuan Provincial People's Hospital | Chengdu | China | Recruiting |
| Guangzhou First People's Hospital | Guangzhou | China | Recruiting |
| Zhujiang Hospital, Southern Medical University | Guangzhou | China | Recruiting |
| Hainan General Hospital | Haikou | China | Recruiting |
| Huai'an First People's Hospital | Huai'an | China | Recruiting |
| Huizhou First Hospital | Huizhou | China | Recruiting |
| The First Affilliated Hospital of Kunming Medical University | Kunming | China | Recruiting |
| The Second Affiliated Hospital of Nanchang University | Nanchang | China | Recruiting |
| Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine | Shanghai | China | Recruiting |
| Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine | Shanghai | China | Recruiting |
| Shengjing Hospital of China Medical University | Shenyang | China | Recruiting |
| Hebei Medical University - The Second Hospital | Shijiazhuang | China | Recruiting |
| The Second Affiliated Hospital of Soochow University | Suzhou | China | Recruiting |
| The Second Affiliated Hospital of Xi'an Jiao Tong University | Xi'an | China | Recruiting |
| The First Affiliated Hospital of Xiamen University | Xiamen | China | Recruiting |
| Affiliated Hospital of Jiangsu University | Zhenjiang | China | Recruiting |
| First Affiliated Hospital of Gannan Medical University | Ganzhou, Jiangxi | China | Recruiting |
| Jinhua municipal central hospital | Jinhua, Zhejiang | China | Recruiting |
| Hospital Universitario San Ignacio | Bogotá | Colombia | Recruiting |
| Clínica de la Mujer | Bogotá | Colombia | Withdrawn |
| Clinica Colsanitas S.A. - Sede Clinica Reina Sofia | Bogotá | Colombia | Recruiting |
| Oncomedica S.A. | Montería | Colombia | Recruiting |
| Fundacion Cardiovascular de Colombia - KM 7 Autopista | Piedecuesta, Santander Department | Colombia | Recruiting |
| Borzan Polyclinic | Osijek | Croatia | Recruiting |
| Clinical Hospital Centre Zagreb | Zagreb | Croatia | Recruiting |
| Hepato-Gastroenterologie HK, s.r.o. | Hradec Králové | Czechia | Recruiting |
| Fakultni nemocnice Ostrava | Ostrava - Poruba | Czechia | Recruiting |
| Institutu Klinicke a Experimentaini Mediciny (IKEM);Klinika hepatogastroenterologie | Prague | Czechia | Recruiting |
| ISCARE a.s. | Prague | Czechia | Recruiting |
| Krajska zdravotni, a.s. ? Masarykova nemocnice v Usti nad Labem, o.z., Ocni oddeleni | Ústí nad Labem | Czechia | Recruiting |
| CHU Tours - Hôpital Trousseau | Chambray-lès-Tours | France | Recruiting |
| CHU Clermont Ferrand - Hôpital d'Estaing | Clermont-Ferrand | France | Recruiting |
| Hôpital Henri Mondor | Créteil | France | Recruiting |
| CH Dptal Les Oudairies | La Roche-sur-Yon | France | Recruiting |
| CHRU de Lille - Hopital Claude Huriez | Lille | France | Recruiting |
| Hopital Dupuytren | Limoges | France | Recruiting |
| Hopital Saint-Eloi | Montpellier | France | Recruiting |
| Institut des MICI, Clinique Ambroise Paré | Neuilly-sur-Seine | France | Active, not recruiting |
| Hôpital Saint-Louis | Paris | France | Recruiting |
| Hôpital de Brabois Adultes | Vandœuvre-lès-Nancy | France | Recruiting |
| Centre hospitalier Lyon Sud | Pierre-Bénite, Rhône | France | Active, not recruiting |
| Universitätsklinikum Heidelberg | Heidelberg | Germany | Recruiting |
| Klinikum Ernst von Bergmann | Potsdam | Germany | Recruiting |
| Észak-Pesti Centrumkórház-Honvédkórház | Budapest | Hungary | Recruiting |
| Geomedical Orvosi Kft | Budapest | Hungary | Recruiting |
| Semmelweis Egyetem | Budapest | Hungary | Recruiting |
| Endomedix Kft. | Budapest | Hungary | Recruiting |
| Vas-Oxy Egeszsegugyi Kft | Szombathely | Hungary | Recruiting |
| Kurnool Medical College | Kurnool, Andhra Pradesh | India | Recruiting |
| Shree Giriraj Multispeciality Hospital | Rajkot, Gujarat | India | Recruiting |
| Surat Institute of Digestive Sciences Hospitals | Surat, Gujarat | India | Recruiting |
| Gujarat Gastro and Vascular Hospital | Surat, Gujarat | India | Recruiting |
| Amrita Institute of Medical Sciences | Kochi, Kerala | India | Recruiting |
| MIDAS Multispeciality Hospital | Nagpur (urban), Maharashtra | India | Recruiting |
| All India Institute Of Medical Sciences (AIIMS) | New Delhi, National Capital Territory of Delhi | India | Recruiting |
| SR Kalla Memorial Gastro & General Hospital | Jaipur, Rajasthan | India | Recruiting |
| SMS Superspeciality Hospital | Jaipur, Rajasthan | India | Recruiting |
| AIG Hospitals | Gachibowli, Telangana | India | Recruiting |
| Gandhi Hospital | Secunderabad, Telangana | India | Recruiting |
| Yashoda Hospitals | Secunderabad, Telangana | India | Recruiting |
| Institute of Post Graduate Medical Education and Research (IPGMER) and SSKM Hospital | Kolkata, West Bengal | India | Recruiting |
| Shaare Zedek Medical Center | Jerusalem | Israel | Recruiting |
| Hadassah Medical Center | Jerusalem | Israel | Recruiting |
| Ospedale Madonna delle Grazie | Matera, Basilicate | Italy | Recruiting |
| Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi-Via Massarenti | Bologna, Emilia-Romagna | Italy | Recruiting |
| Policlinico Universitario Campus Biomedico Di Roma | Rome, Lazio | Italy | Recruiting |
| Policlinico Universitario Agostino Gemelli | Rome, Lazio | Italy | Recruiting |
| Asst Degli Spedali Civili Di Brescia | Brescia, Lombardy | Italy | Recruiting |
| IRCCS Ospedale San Raffaele | Milan, Lombardy | Italy | Recruiting |
| I.R.C.C.S Policlinico San Donato | San Donato Milanese (MI), Lombardy | Italy | Recruiting |
| IRCCS Ospedale Sacro Cuore Don Calabria | Negrar, Veneto | Italy | Recruiting |
| Gastromed Kralisz, Romatowski, Stachurska sp.j. | Bia?ystok | Poland | Recruiting |
| Medical Center Kermed | Bydgoszcz | Poland | Recruiting |
| Szpital Miejski sw. Jana Paw?a II w Elblagu | Elblag | Poland | Recruiting |
| Osrodek Badan Klinicznych Bd Research | I?awa | Poland | Recruiting |
| MZ Badania Slowik Zymla Sp.j. | Knurów | Poland | Recruiting |
| Centrum Medyczne Promed | Krakow | Poland | Recruiting |
| Amicare Sp. z o.o. S.K. | Lodz | Poland | Recruiting |
| Medrise sp z o.o | Lublin | Poland | Recruiting |
| Clinical Research Center Sp. z o.o. MEDIC-R Spó?ka Komandytowa | Poznan | Poland | Recruiting |
| EMC Instytut Medyczny SA | Późna | Poland | Recruiting |
| Gabinety Lekarskie Rivermed | Późna | Poland | Recruiting |
| Endoskopia Sp. z o.o. | Sopot | Poland | Recruiting |
| Nowe Zdrowie-CK Kieltucki I Wspolnicy Sp. j. | Staszów | Poland | Recruiting |
| Sonomed Sp. z o.o. | Szczecin | Poland | Recruiting |
| Centrum Zdrowia-MDM | Warsaw | Poland | Recruiting |
| Medon Clinical Research sp. z o.o | Warsaw | Poland | Recruiting |
| Vivamed Spolka Z Ograniczona Odpowiedzialnoscia | Warsaw | Poland | Recruiting |
| PlanetMed sp. z o.o. | Wroc?aw | Poland | Recruiting |
| Hospital de Braga | Braga | Portugal | Recruiting |
| Hospital de Santa Maria | Lisbon | Portugal | Recruiting |
| Hospital de Sao Joao | Porto | Portugal | Recruiting |
| Centro Hospitalar de Entre Douro e Vouga - H. São Sebastião | Santa Maria da Feira | Portugal | Recruiting |
| Hospital Sao Teotonio | Viseu | Portugal | Recruiting |
| Galenus Group Of Puerto Rica Inc | Manati | Puerto Rico | Recruiting |
| Spital Digenio - Centrul de Excelen?? în Afec?iuni Digestive | Cluj-Napoca | Romania | Recruiting |
| ABAWI spol. s r.o. | Bratislava | Slovakia | Recruiting |
| KM Management spol. s r.o. | Nitra | Slovakia | Recruiting |
| Yeungnam University Medical Center | Daegu | South Korea | Recruiting |
| Chosun University Hospital | Gwangju | South Korea | Recruiting |
| The Catholic University of Korea Eunpyeong St. Mary's Hospital | Seoul | South Korea | Recruiting |
| Hanyang University Seoul Hospital | Seoul | South Korea | Recruiting |
| Korea University Ansan Hospital | Ansan-si, Gyeonggi-do | South Korea | Recruiting |
| Hospital General Universitario Gregorio Maranon | Madrid | Spain | Recruiting |
| Hospital Clinico Univ. Lozano Blesa | Zaragoza | Spain | Recruiting |
| Fundacion Hospital de Alcorcon | Alcorcón, Madrid | Spain | Recruiting |
| Hospital Universitario Puerta de Hierro | Majadahonda, Madrid | Spain | Recruiting |
| Southmead Hospital | Bristol | United Kingdom | Recruiting |
| Fairfield General Hospital | Bury | United Kingdom | Recruiting |
| Bronglais General Hospital | Llanrhystud | United Kingdom | Recruiting |
| Royal London Hospital | London | United Kingdom | Recruiting |
| Stepping Hill Hospital | Stockport | United Kingdom | Active, not recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.