Testing afimkibart for moderately to severely active Crohn's disease
Tests afimkibart against placebo in people with moderately to severely active Crohn's disease.
Plain-language title generated from the registry record
Registry title: A Study to Assess the Efficacy and Safety of Induction and Maintenance Therapy With Afimkibart (RO7790121) in Participants With Moderately to Severely Active Crohn's Disease
Key facts
- Where
- Arlington, Atlanta, Beavercreek, Boston, Brooksville, Brunswick, Charleston, Charlotte, Chesapeake, Chicago, Cincinnati, Clearwater, Cleveland, Columbus, Coral Gables, Crestview Hills, Dothan, El Paso, Farmington Hills, Fuquay-Varina, Garden Grove, Georgetown, Germantown, Glenview, Greenville, Gurnee, Harlingen, Hershey, Hialeah, Houston, Idaho Falls, Indianapolis, Inglewood, Kissimmee, La Jolla, Lakewood Rch, Lancaster, Lansdowne Town Center, Liberty Township, Littleton, Lone Tree, Los Alamitos, Louisville, Lynchburg, Macon, Mansfield, Mesquite, Miami, Monroe, Nashville, New Albany, New York, Norman, North Las Vegas, North Massapequa, Orlando, Oxford, Phoenix, Providence, Queens Village, Richmond Hill, Roanoke, Rochester, San Antonio, San Diego, San Francisco, Seattle, Southaven, Southlake, Sun City, Tampa, Temple, Temple Terrace, Tucson, Tyler, Uniontown, Vancouver, Westlake, Weston, Wichita, Williamsburg, and Zephyrhills, United StatesSee the 95 sites
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 16 and 80 years old?
Source: NCT06819878, who can take part
Where in United States
- Texas Clinical Research Institute, LLCArlington, United StatesTaking people
- Atlanta Gastroenterology AssociatesAtlanta, United StatesTaking people
- Digestive Healthcare of GeorgiaAtlanta, United StatesTaking people
- Dayton Gastroenterology, Inc.Beavercreek, United StatesTaking people
- Boston UniversityBoston, United StatesTaking people
- Brigham and Women's HospitalBoston, United StatesTaking people
- Access Research InstituteBrooksville, United StatesTaking people
- Digestive Disease ConsultantsBrunswick, United StatesTaking people
- Medical University of South CarolinaCharleston, United StatesTaking people
- Atrium Health, Carolinas Healthcare SystemCharlotte, United StatesTaking people
- Tidewater Gastroenterology Pllc T/A Gastro. Assoc. of TidewaterChesapeake, United StatesTaking people
- Northwestern Memorial HospitalChicago, United StatesTaking people
- University of Cincinnati HospitalCincinnati, United StatesTaking people
- Gastro FloridaClearwater, United StatesTaking people
- Cleveland Clinic FoundationCleveland, United StatesTaking people
- Ohio Gastroenterology GroupColumbus, United StatesTaking people
- The Ohio State University -Wexner Medical CenterColumbus, United StatesTaking people
- HealthMed Clinical Center Inc.Coral Gables, United StatesTaking people
- Hi Tech and Global Research, LLCCoral Gables, United StatesTaking people
- Tri-State Gastroenterology AssociatesCrestview Hills, United StatesTaking people
- Digestive Health Specialists of the Southeast (Gastroenterology Associates of Dothan) - DothanDothan, United StatesTaking people
- Proactive El Paso LLCEl Paso, United StatesTaking people
- Michigan Center of Medical ResearchFarmington Hills, United StatesTaking people
- Omega Research North Carolina, LLCFuquay-Varina, United StatesTaking people
- Valley View Internal MedicineGarden Grove, United StatesTaking people
- Amel Med LLCGeorgetown, United StatesTaking people
- Gastro OneGermantown, United StatesTaking people
- Illinois Gastroenterology Group-Glenview powered by GI AllianceGlenview, United StatesTaking people
- Gastroenterology AssociatesGreenville, United StatesTaking people
- GI Alliance GurneeGurnee, United StatesTaking people
- Cano Medical CenterHarlingen, United StatesTaking people
- Penn State Milton S. Hershey Medical CenterHershey, United StatesTaking people
- NeoClinical ResearchHialeah, United StatesTaking people
- The Sister Life ResearchHialeah, United StatesTaking people
- Baylor College of MedicineHouston, United StatesTaking people
- Grand Teton Research Group, PLLCIdaho Falls, United StatesTaking people
- Indiana University Health University HospitalIndianapolis, United StatesTaking people
- 310 Clinical ResearchInglewood, United StatesTaking people
- Clinical Research of Osceola, LLCKissimmee, United StatesTaking people
- UCSD Medical CenterLa Jolla, United StatesTaking people
- University of California San DiegoLa Jolla, United StatesTaking people
- Florida Research Institute - LakewoodLakewood Rch, United StatesTaking people
- Gastro Care AssociatesLancaster, United StatesTaking people
- Om Research LLCLancaster, United StatesTaking people
- Emeritas Research GroupLansdowne Town Center, United StatesTaking people
- Gastro Health- LibertyLiberty Township, United StatesTaking people
- Rocky Mountain GastroenterologyLittleton, United StatesTaking people
- Peak Gastroenterology Surgery CenterLone Tree, United StatesTaking people
- United GastroenterologistsLos Alamitos, United StatesTaking people
- Gastroenterology Health Partners, PLLCLouisville, United StatesTaking people
- Blue Ridge Medical Research - Gastroenterology Associates of Central VirginiaLynchburg, United StatesTaking people
- Gastroenterology Associates of Central GeorgiaMacon, United StatesTaking people
- TDDC dba GI Alliance ResearchMansfield, United StatesTaking people
- SMS Clinical Research, LLCMesquite, United StatesTaking people
- LCC Medical Research Institute, LLCMiami, United StatesTaking people
- Ambert Medical ResearchMiami, United StatesNo longer taking part
- Monroe Biomedical ResearchMonroe, United StatesTaking people
- Quality Medical ResearchNashville, United StatesTaking people
- Gastroenterology Health Partners, PLLCNew Albany, United StatesTaking people
- Lenox Hill HospitalNew York, United StatesTaking people
- Mount Sinai Hospital - IBD Clinical CenterNew York, United StatesTaking people
- Central Sooner ResearchNorman, United StatesTaking people
- Las Vegas Clinical Trials, LLCNorth Las Vegas, United StatesTaking people
- DiGiovanna Inst for Med Ed&ResNorth Massapequa, United StatesTaking people
- Orlando Regional HealthcareOrlando, United StatesTaking people
- Gastroenterology Associates and Endoscopy Center of North MississippiOxford, United StatesTaking people
- Mayo Clinic HospitalPhoenix, United StatesTaking people
- University GastroenterologyProvidence, United StatesTaking people
- Queens Village Medical CareQueens Village, United StatesTaking people
- Mainstreet - Richmond Hill ClinicRichmond Hill, United StatesTaking people
- Gastroenterology Consultants and Endoscopy Center of Southwest VirginiaRoanoke, United StatesTaking people
- Gastroenterology Group Of Rochester, LLPRochester, United StatesTaking people
- University of Rochester Medical CenterRochester, United StatesTaking people
- Gastroenterology Research of America, LLCSan Antonio, United StatesTaking people
- Acclaim Clinical Research, Inc.San Diego, United StatesNo longer taking part
- Kaiser PermanenteSan Francisco, United StatesTaking people
- UCSF Medical Center at Mount ZionSan Francisco, United StatesTaking people
- Virginia Mason Medical CenterSeattle, United StatesNo longer taking part
- Delta Gastroenterology & Endoscopy CenterSouthaven, United StatesTaking people
- GI Alliance - SouthlakeSouthlake, United StatesTaking people
- Arizona Digestive Health, P.C (ADH)Sun City, United StatesTaking people
- Guardian Angel Research Center, LLCTampa, United StatesTaking people
- Nodal Medical Center Research - NMCTampa, United StatesTaking people
- University of South Florida School of Medicine Morsani Center for Advanced Health CareTampa, United StatesTaking people
- Baylor Scott and White Medical CenterTemple, United StatesTaking people
- Theia Clinical Research Centers, LLCTemple Terrace, United StatesTaking people
- University of Arizona-CATS Research CenterTucson, United StatesTaking people
- Tyler Research Institute, LLCTyler, United StatesTaking people
- Frontier Clinical Re search, LLCUniontown, United StatesTaking people
- The Vancouver ClinicVancouver, United StatesTaking people
- Gastro Intestinal Research Institute of Northern Ohio,Westlake, United StatesTaking people
- Cleveland Clinic FloridaWeston, United StatesTaking people
- Kansas Gastroenterology, LLC under Clinical Trials NetworkWichita, United StatesTaking people
- Tidewater Physicians Multispecialty Group (TPMG) - Clinical Research Division - WilliamsburgWilliamsburg, United StatesTaking people
- Florida Medical Clinic Orlando HealthZephyrhills, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Hoffmann-La Roche
- Trial code
- NCT06819878EU 2024-513053-69-00
- Record updated
- 16 October 2026
- Original description
This Phase III, multicenter, double-blind, placebo-controlled treat-through study will evaluate the efficacy and safety of induction and maintenance therapy with Afimkibart (also known as RO7790121) in participants with moderately to severely active Crohn's disease (CD).Read full original descriptionShow less
A Phase III, Multicenter, Double-Blind, Placebo-Controlled, Treat-Through Study to Assess the Efficacy and Safety of Induction and Maintenance Therapy With RO7790121 in Patients With Moderately to Severely Active Crohn's Disease
This Phase III, multicenter, double-blind, placebo-controlled treat-through study will evaluate the efficacy and safety of induction and maintenance therapy with Afimkibart (also known as RO7790121) in participants with moderately to severely active Crohn's disease (CD).
Inclusion: 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: Current diagnosis of ulcerative colitis (UC) or indeterminate colitis, ischemic colitis, infectious colitis, radiation colitis, microscopic colitis; Has received protocol-specified prohibited medicines, including known exposure to any type of anti-TL1A therapy; 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 rectovaginal, enterovaginal, high output enterocutaneous fistula, enterovesical fistulas or perianal fistulas with >3 openings; 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; Presence of an ileostomy, colostomy or ileoanal pouch; Participants with symptomatic bowel strictures, fulminant colitis, or toxic megacolon; Presence of abdominal or perianal abscess; Current diagnosis or suspicion of primary sclerosing cholangitis; Pregnancy or breastfeeding, or intention of becoming pregnant during the study.