Not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.
PSC Trial Watch
Crohn'sRecruiting

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

Some of the main requirements, copied from the record:

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

Groups in this study

Main thing being measured

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

Official details

StatusRecruiting
PhasePhase 3
Study typeInterventional
ConditionsModerately to Severely Active Crohns Disease
Lead sponsorHoffmann-La Roche
CollaboratorsChugai Pharmaceutical
Enrollment425 (estimated)
Start date2025-05-12
Primary completion (est.)2028-12-31
First posted2025-02-11
Last updated2026-09-28
Official titleA 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 IDNCT06819891

Interventions

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
SiteCityCountrySite status
Digestive Health Specialists of the SoutheastDothan, AlabamaUnited StatesRecruiting
Sun City Clinical ResearchGlendale, ArizonaUnited StatesRecruiting
Om Research LLCLancaster, CaliforniaUnited StatesRecruiting
Hoag Memorial Hospital Presbyterian;Hoag Center for Research and EducationNewport Beach, CaliforniaUnited StatesRecruiting
Empire Clinical ResearchPomona, CaliforniaUnited StatesWithdrawn
Stanford Medicine Outpatient CenterRedwood City, CaliforniaUnited StatesRecruiting
Clinical Applications Laboratories, Inc.San Diego, CaliforniaUnited StatesRecruiting
Amicis Research CenterSanta Clarita, CaliforniaUnited StatesRecruiting
Peak Gastroenterology AssociatesColorado Springs, ColoradoUnited StatesRecruiting
J&A Clinical ResearchDoral, FloridaUnited StatesRecruiting
Auzmer ResearchLakeland, FloridaUnited StatesRecruiting
Galenus Group IncLehigh Acres, FloridaUnited StatesRecruiting
Homestead Associates in Research, Inc.Miami, FloridaUnited StatesRecruiting
Allied Biomedical Research Institute, IncMiami, FloridaUnited StatesRecruiting
Rejuvaline Medical ResearchMiami, FloridaUnited StatesRecruiting
Miami Beach Clinical Research CenterMiami Beach, FloridaUnited StatesRecruiting
Eminat Research GroupMiramar, FloridaUnited StatesRecruiting
Digestive and Liver Center of FloridaOrlando, FloridaUnited StatesRecruiting
Advanced Medical Research CenterPort Orange, FloridaUnited StatesRecruiting
Santos Research Center, CORPTampa, FloridaUnited StatesRecruiting
Cleveland Clinic FloridaWeston, FloridaUnited StatesRecruiting
Morehouse School Of MedicineAtlanta, GeorgiaUnited StatesRecruiting
The University of ChicagoChicago, IllinoisUnited StatesRecruiting
University of Kansas Medical CenterKansas City, KansasUnited StatesRecruiting
Robley Rex VA Medical CenterLouisville, KentuckyUnited StatesRecruiting
One GI: GHP - Gastroenterology Health Partners LouisvilleLouisville, KentuckyUnited StatesRecruiting
Baton Rouge General Medical CenterBaton Rouge, LouisianaUnited StatesRecruiting
Louisiana Research Center - GastroIntestinal AssociatesShreveport, LouisianaUnited StatesRecruiting
Mercy Medical CenterBaltimore, MarylandUnited StatesRecruiting
Chevy Chase Clinical ResearchChevy Chase, MarylandUnited StatesRecruiting
University of Massachusetts Memorial Medical CenterNorth Worcester, MassachusettsUnited StatesRecruiting
Gastroenterology Associates of Western Michigan, P.L.C.Wyoming, MichiganUnited StatesRecruiting
Gastrointestinal Associates ResearchFlowood, MississippiUnited StatesRecruiting
Va Heartland Network - Harry S. Truman Memorial Veterans' HospitalColumbia, MissouriUnited StatesRecruiting
Specialists in GastroenterologySt Louis, MissouriUnited StatesRecruiting
Dartmouth-Hitchcock Medical Center-Norris Cotton Cancer CenterLebanon, New HampshireUnited StatesRecruiting
Virtua Crohns and Colitis CenterMoorestown, New JerseyUnited StatesRecruiting
Robert Wood Johnson University HospitalNew Brunswick, New JerseyUnited StatesRecruiting
Ellipsis Research GroupBrooklyn, New YorkUnited StatesRecruiting
Intercity GastroenterologyFresh Meadows, New YorkUnited StatesRecruiting
NYU Langone Long Island Clinical Research AssociatesLake Success, New YorkUnited StatesRecruiting
James J Peters Veterans Affairs Medical CenterThe Bronx, New YorkUnited StatesRecruiting
Digestive Disease Medicine of Central New YorkUtica, New YorkUnited StatesRecruiting
Charlotte Gastroenterology and Hepatology, P.L.L.CCharlotte, North CarolinaUnited StatesRecruiting
Peters Medical Research (PMR), LLCHigh Point, North CarolinaUnited StatesRecruiting
Clinical Inquest CenterBeavercreek, OhioUnited StatesRecruiting
Cleveland Clinic FoundationCleveland, OhioUnited StatesRecruiting
University of PennsylvaniaPhiladelphia, PennsylvaniaUnited StatesRecruiting
University GastroenterologyProvidence, Rhode IslandUnited StatesRecruiting
Gastro OneCordova, TennesseeUnited StatesRecruiting
Vanderbilt University Medical CenterNashville, TennesseeUnited StatesRecruiting
University of Texas Southwestern Medical Center - Multidisciplinary Spine Clinic - James W. Aston Ambulatory Care CenterDallas, TexasUnited StatesRecruiting
GI Alliance - Fort WorthFort Worth, TexasUnited StatesRecruiting
GI AllianceGarland, TexasUnited StatesRecruiting
Integrity Advanced Therapeutics PLLCHouston, TexasUnited StatesRecruiting
Texas Digestive Disease Consultants-Lubbock powered by GI AllianceLubbock, TexasUnited StatesRecruiting
Carta - Clinical Associates In Research Therapeutics Of America;LLCSan Antonio, TexasUnited StatesRecruiting
University of Texas Health Center at TylerTyler, TexasUnited StatesRecruiting
TDDC GI Alliance research WebsterWebster, TexasUnited StatesRecruiting
GI Alliance-RichmondRichmond, VirginiaUnited StatesRecruiting
University Physicians and Surgeons Inc, dba Marshall HealthHuntington, West VirginiaUnited StatesWithdrawn
Instituto Medico CERQuilmesArgentinaRecruiting
CICE 9 de JulioSan Miguel de TucumánArgentinaRecruiting
Macquarie University HospitalMacquarie Park, New South WalesAustraliaRecruiting
Sydney Adventist HospitalWahroonga, New South WalesAustraliaRecruiting
Coral Sea Clinical Research InstituteMackay, QueenslandAustraliaWithdrawn
Footscray HospitalFootscray, VictoriaAustraliaRecruiting
Royal Melbourne HospitalParkville, VictoriaAustraliaRecruiting
Ordensklinikum Linz Barmherzige SchwesternLinzAustriaRecruiting
Klinikum Wels-GrieskirchenWelsAustriaRecruiting
CHU St Pierre (St Pierre)BrusselsBelgiumRecruiting
UZ BrusselBrusselsBelgiumRecruiting
Cliniques Universitaires St-LucBrusselsBelgiumRecruiting
Hospital Moinhos de VentoPorto Alegre, Rio Grande do SulBrazilRecruiting
Instituto Lobus Unimed Volta RedondaVolta Redonda, Rio de JaneiroBrazilRecruiting
Newdata Clinical TrialsAracaju, SergipeBrazilRecruiting
CECIP - Centro de Estudos Clínicos do Interior PaulistaJaú, São PauloBrazilRecruiting
Hospital de Base de Sao Jose do Rio PretoSão José do Rio Preto, São PauloBrazilRecruiting
Hospital Sírio-LibanêsSão Paulo, São PauloBrazilWithdrawn
Multiprofile Hospital for Active Treatment Uni Hospital;Department of Gastroenterology.PanagyurishteBulgariaRecruiting
MC " Sveti Ivan Rilski Chudotvorets- 2010PlovdivBulgariaRecruiting
Barrie GI AssociatesBarrie, OntarioCanadaRecruiting
GNRR Digestive Clinics and Research Center Inc.Brampton, OntarioCanadaRecruiting
London Health Sciences Centre Uni CampusLondon, OntarioCanadaWithdrawn
LDDI Clinical Trials Inc.London, OntarioCanadaRecruiting
Toronto Immune and Digestive Health InstituteNorth YORK, OntarioCanadaRecruiting
CIUSSS de l Est de l Ile de Montreal - Hopital Maisonneuve RosemontMontreal, QuebecCanadaRecruiting
Medicina de Precisión - CelerityLas CondesChileRecruiting
MedwalSantiagoChileRecruiting
Centro de Investigación Clínica UC-CICUCSantiagoChileRecruiting
Beijing Union HospitalBeijingChinaRecruiting
Sichuan Provincial People's HospitalChengduChinaRecruiting
Guangzhou First People's HospitalGuangzhouChinaRecruiting
Zhujiang Hospital, Southern Medical UniversityGuangzhouChinaRecruiting
Hainan General HospitalHaikouChinaRecruiting
Huai'an First People's HospitalHuai'anChinaRecruiting
Huizhou First HospitalHuizhouChinaRecruiting
The First Affilliated Hospital of Kunming Medical UniversityKunmingChinaRecruiting
The Second Affiliated Hospital of Nanchang UniversityNanchangChinaRecruiting
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of MedicineShanghaiChinaRecruiting
Renji Hospital Affiliated to Shanghai Jiao Tong University School of MedicineShanghaiChinaRecruiting
Shengjing Hospital of China Medical UniversityShenyangChinaRecruiting
Hebei Medical University - The Second HospitalShijiazhuangChinaRecruiting
The Second Affiliated Hospital of Soochow UniversitySuzhouChinaRecruiting
The Second Affiliated Hospital of Xi'an Jiao Tong UniversityXi'anChinaRecruiting
The First Affiliated Hospital of Xiamen UniversityXiamenChinaRecruiting
Affiliated Hospital of Jiangsu UniversityZhenjiangChinaRecruiting
First Affiliated Hospital of Gannan Medical UniversityGanzhou, JiangxiChinaRecruiting
Jinhua municipal central hospitalJinhua, ZhejiangChinaRecruiting
Hospital Universitario San IgnacioBogotáColombiaRecruiting
Clínica de la MujerBogotáColombiaWithdrawn
Clinica Colsanitas S.A. - Sede Clinica Reina SofiaBogotáColombiaRecruiting
Oncomedica S.A.MonteríaColombiaRecruiting
Fundacion Cardiovascular de Colombia - KM 7 AutopistaPiedecuesta, Santander DepartmentColombiaRecruiting
Borzan PolyclinicOsijekCroatiaRecruiting
Clinical Hospital Centre ZagrebZagrebCroatiaRecruiting
Hepato-Gastroenterologie HK, s.r.o.Hradec KrálovéCzechiaRecruiting
Fakultni nemocnice OstravaOstrava - PorubaCzechiaRecruiting
Institutu Klinicke a Experimentaini Mediciny (IKEM);Klinika hepatogastroenterologiePragueCzechiaRecruiting
ISCARE a.s.PragueCzechiaRecruiting
Krajska zdravotni, a.s. ? Masarykova nemocnice v Usti nad Labem, o.z., Ocni oddeleniÚstí nad LabemCzechiaRecruiting
CHU Tours - Hôpital TrousseauChambray-lès-ToursFranceRecruiting
CHU Clermont Ferrand - Hôpital d'EstaingClermont-FerrandFranceRecruiting
Hôpital Henri MondorCréteilFranceRecruiting
CH Dptal Les OudairiesLa Roche-sur-YonFranceRecruiting
CHRU de Lille - Hopital Claude HuriezLilleFranceRecruiting
Hopital DupuytrenLimogesFranceRecruiting
Hopital Saint-EloiMontpellierFranceRecruiting
Institut des MICI, Clinique Ambroise ParéNeuilly-sur-SeineFranceActive, not recruiting
Hôpital Saint-LouisParisFranceRecruiting
Hôpital de Brabois AdultesVandœuvre-lès-NancyFranceRecruiting
Centre hospitalier Lyon SudPierre-Bénite, RhôneFranceActive, not recruiting
Universitätsklinikum HeidelbergHeidelbergGermanyRecruiting
Klinikum Ernst von BergmannPotsdamGermanyRecruiting
Észak-Pesti Centrumkórház-HonvédkórházBudapestHungaryRecruiting
Geomedical Orvosi KftBudapestHungaryRecruiting
Semmelweis EgyetemBudapestHungaryRecruiting
Endomedix Kft.BudapestHungaryRecruiting
Vas-Oxy Egeszsegugyi KftSzombathelyHungaryRecruiting
Kurnool Medical CollegeKurnool, Andhra PradeshIndiaRecruiting
Shree Giriraj Multispeciality HospitalRajkot, GujaratIndiaRecruiting
Surat Institute of Digestive Sciences HospitalsSurat, GujaratIndiaRecruiting
Gujarat Gastro and Vascular HospitalSurat, GujaratIndiaRecruiting
Amrita Institute of Medical SciencesKochi, KeralaIndiaRecruiting
MIDAS Multispeciality HospitalNagpur (urban), MaharashtraIndiaRecruiting
All India Institute Of Medical Sciences (AIIMS)New Delhi, National Capital Territory of DelhiIndiaRecruiting
SR Kalla Memorial Gastro & General HospitalJaipur, RajasthanIndiaRecruiting
SMS Superspeciality HospitalJaipur, RajasthanIndiaRecruiting
AIG HospitalsGachibowli, TelanganaIndiaRecruiting
Gandhi HospitalSecunderabad, TelanganaIndiaRecruiting
Yashoda HospitalsSecunderabad, TelanganaIndiaRecruiting
Institute of Post Graduate Medical Education and Research (IPGMER) and SSKM HospitalKolkata, West BengalIndiaRecruiting
Shaare Zedek Medical CenterJerusalemIsraelRecruiting
Hadassah Medical CenterJerusalemIsraelRecruiting
Ospedale Madonna delle GrazieMatera, BasilicateItalyRecruiting
Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi-Via MassarentiBologna, Emilia-RomagnaItalyRecruiting
Policlinico Universitario Campus Biomedico Di RomaRome, LazioItalyRecruiting
Policlinico Universitario Agostino GemelliRome, LazioItalyRecruiting
Asst Degli Spedali Civili Di BresciaBrescia, LombardyItalyRecruiting
IRCCS Ospedale San RaffaeleMilan, LombardyItalyRecruiting
I.R.C.C.S Policlinico San DonatoSan Donato Milanese (MI), LombardyItalyRecruiting
IRCCS Ospedale Sacro Cuore Don CalabriaNegrar, VenetoItalyRecruiting
Gastromed Kralisz, Romatowski, Stachurska sp.j.Bia?ystokPolandRecruiting
Medical Center KermedBydgoszczPolandRecruiting
Szpital Miejski sw. Jana Paw?a II w ElblaguElblagPolandRecruiting
Osrodek Badan Klinicznych Bd ResearchI?awaPolandRecruiting
MZ Badania Slowik Zymla Sp.j.KnurówPolandRecruiting
Centrum Medyczne PromedKrakowPolandRecruiting
Amicare Sp. z o.o. S.K.LodzPolandRecruiting
Medrise sp z o.oLublinPolandRecruiting
Clinical Research Center Sp. z o.o. MEDIC-R Spó?ka KomandytowaPoznanPolandRecruiting
EMC Instytut Medyczny SAPóźnaPolandRecruiting
Gabinety Lekarskie RivermedPóźnaPolandRecruiting
Endoskopia Sp. z o.o.SopotPolandRecruiting
Nowe Zdrowie-CK Kieltucki I Wspolnicy Sp. j.StaszówPolandRecruiting
Sonomed Sp. z o.o.SzczecinPolandRecruiting
Centrum Zdrowia-MDMWarsawPolandRecruiting
Medon Clinical Research sp. z o.oWarsawPolandRecruiting
Vivamed Spolka Z Ograniczona OdpowiedzialnosciaWarsawPolandRecruiting
PlanetMed sp. z o.o.Wroc?awPolandRecruiting
Hospital de BragaBragaPortugalRecruiting
Hospital de Santa MariaLisbonPortugalRecruiting
Hospital de Sao JoaoPortoPortugalRecruiting
Centro Hospitalar de Entre Douro e Vouga - H. São SebastiãoSanta Maria da FeiraPortugalRecruiting
Hospital Sao TeotonioViseuPortugalRecruiting
Galenus Group Of Puerto Rica IncManatiPuerto RicoRecruiting
Spital Digenio - Centrul de Excelen?? în Afec?iuni DigestiveCluj-NapocaRomaniaRecruiting
ABAWI spol. s r.o.BratislavaSlovakiaRecruiting
KM Management spol. s r.o.NitraSlovakiaRecruiting
Yeungnam University Medical CenterDaeguSouth KoreaRecruiting
Chosun University HospitalGwangjuSouth KoreaRecruiting
The Catholic University of Korea Eunpyeong St. Mary's HospitalSeoulSouth KoreaRecruiting
Hanyang University Seoul HospitalSeoulSouth KoreaRecruiting
Korea University Ansan HospitalAnsan-si, Gyeonggi-doSouth KoreaRecruiting
Hospital General Universitario Gregorio MaranonMadridSpainRecruiting
Hospital Clinico Univ. Lozano BlesaZaragozaSpainRecruiting
Fundacion Hospital de AlcorconAlcorcón, MadridSpainRecruiting
Hospital Universitario Puerta de HierroMajadahonda, MadridSpainRecruiting
Southmead HospitalBristolUnited KingdomRecruiting
Fairfield General HospitalBuryUnited KingdomRecruiting
Bronglais General HospitalLlanrhystudUnited KingdomRecruiting
Royal London HospitalLondonUnited KingdomRecruiting
Stepping Hill HospitalStockportUnited KingdomActive, 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.