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

Part of paid clinical trials in Dothan, Alabama.

Sponsor
Hoffmann-La Roche
Study ID
NCT06819878
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Moderately to Severely Active Crohns Disease

Eligibility Criteria

Sex
ALL
Age
16 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Afimkibart — DRUG
    Afimkibart will be administered as IV infusion. Afimkibart will be administered as SC injection.
  • Placebo — DRUG
    Placebo matching IV afimkibart. Placebo matching SC afimkibart.

Study Details

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).

Key Dates

Start date
Mar 17, 2025
Status verified
Jun 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2033

Study Design

Enrollment
600 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1: Afimkibart
    Participants will receive afimkibart intravenously (IV) followed by afimkibart subcutaneous (SC) injection.
  • Experimental: Arm 2: Afimkibart
    Participants will receive afimkibart IV followed by afimkibart SC injection.
  • Placebo Comparator: Arm 3: Placebo
    Participants will receive placebo IV followed by placebo SC.

Primary Outcome Measure

Percentage of Participants with Clinical Remission per Crohn's Disease Activity Index (CDAI) Score [ Time Frame: At Week 52 ]

Central Contacts

  • Reference Study ID Number: GA45331 https://forpatients.roche.com/
    888-662-6728 (U.S. and Canada)
    [email protected]
  • Fastest response: use the inquiry form. No email attachments. https://www.gene.com/contact-us/submit-medical-inquiry

Locations (92)

FacilityCityStateZIPSite coordinators
Digestive Health Specialists of the Southeast (Gastroenterology Associates of Dothan) - DothanDothanAlabama36305-
Mayo Clinic HospitalPhoenixArizona85054-
Arizona Digestive Health, P.C (ADH)Sun CityArizona85351-
University of Arizona-CATS Research CenterTucsonArizona85724-
Valley View Internal MedicineGarden GroveCalifornia92845-2006-
310 Clinical ResearchInglewoodCalifornia90301-
UCSD Medical CenterLa JollaCalifornia92037-0897-
Gastro Care AssociatesLancasterCalifornia93534-
Om Research LLCLancasterCalifornia93534-
United GastroenterologistsLos AlamitosCalifornia90720-
Acclaim Clinical Research, Inc.San DiegoCalifornia92120-
Kaiser PermanenteSan FranciscoCalifornia94115-
UCSF/Medical Center at Mount ZionSan FranciscoCalifornia94115-
Rocky Mountain GastroenterologyLittletonColorado80120-
Peak Gastroenterology Surgery CenterLone TreeColorado80124-
Access Research InstituteBrooksvilleFlorida34613-
Gastro FloridaClearwaterFlorida33756-
HealthMed Clinical Center Inc.Coral GablesFlorida33134-
Hi Tech and Global Research, LLCCoral GablesFlorida33134-
NeoClinical ResearchHialeahFlorida33016-
The Sister Life ResearchHialeahFlorida33013-
Clinical Research of Osceola, LLCKissimmeeFlorida34741-
Florida Research Institute - LakewoodLakewood RchFlorida34211-
Ambert Medical ResearchMiamiFlorida33176-
LCC Medical Research Institute, LLCMiamiFlorida33126-
Orlando Regional HealthcareOrlandoFlorida32806-
Guardian Angel Research Center, LLCTampaFlorida33614-
Nodal Medical Center Research - NMCTampaFlorida33607-
University of South Florida School of Medicine Morsani Center for Advanced Health CareTampaFlorida33612-
Theia Clinical Research Centers, LLCTemple TerraceFlorida33617-
Cleveland Clinic FloridaWestonFlorida33331-
Florida Medical Clinic - Orlando HealthZephyrhillsFlorida33542-
Atlanta Gastroenterology AssociatesAtlantaGeorgia30342-
Digestive Healthcare of GeorgiaAtlantaGeorgia30327-
Gastroenterology Associates of Central GeorgiaMaconGeorgia31201-
Grand Teton Research Group, PLLCIdaho FallsIdaho83404-
Northwestern Memorial HospitalChicagoIllinois60611-
Illinois Gastroenterology Group-Glenview powered by GI AllianceGlenviewIllinois60026-
GI Alliance - GurneeGurneeIllinois60031-
Indiana University Health University HospitalIndianapolisIndiana46202-
Gastroenterology Health Partners, PLLCNew AlbanyIndiana47150-
Kansas Gastroenterology, LLC under Clinical Trials NetworkWichitaKansas67226-
Tri-State Gastroenterology AssociatesCrestview HillsKentucky41017-3409-
Gastroenterology Health Partners, PLLCLouisvilleKentucky40218-
Boston UniversityBostonMassachusetts02118-
Brigham and Women's HospitalBostonMassachusetts02115-
Michigan Center of Medical ResearchFarmington HillsMichigan48334-
Gastroenterology Associates and Endoscopy Center of North MississippiOxfordMississippi38655-
Delta Gastroenterology & Endoscopy CenterSouthavenMississippi38671-
Las Vegas Clinical Trials, LLCNorth Las VegasNevada89030-
Lenox Hill HospitalNew YorkNew York10075-
Mount Sinai Hospital - IBD Clinical CenterNew YorkNew York10029-
DiGiovanna Inst for Med Ed&ResNorth MassapequaNew York11758-
Queens Village Medical CareQueens VillageNew York11428-
Mainstreet - Richmond Hill ClinicRichmond HillNew York11418-
Gastroenterology Group Of Rochester, LLPRochesterNew York14618-
University of Rochester Medical CenterRochesterNew York14642-
Atrium Health, Carolinas Healthcare SystemCharlotteNorth Carolina28204-
Omega Research North Carolina, LLCFuquay-VarinaNorth Carolina27526-
Monroe Biomedical ResearchMonroeNorth Carolina28112-
Dayton Gastroenterology, Inc.BeavercreekOhio45440-
Digestive Disease ConsultantsBrunswickOhio44212-
University of Cincinnati HospitalCincinnatiOhio45267-
Cleveland Clinic FoundationClevelandOhio44195-
Ohio Gastroenterology GroupColumbusOhio43202-
The Ohio State University Wexner Medical CenterColumbusOhio43210-
Gastro Health- LibertyLiberty TownshipOhio45044-
Gastro Intestinal Research Institute of Northern OhioWestlakeOhio44145-
Central Sooner ResearchNormanOklahoma73071-
Penn State Milton S. Hershey Medical CenterHersheyPennsylvania17033-
Frontier Clinical Re search, LLCUniontownPennsylvania15401-9069-
University GastroenterologyProvidenceRhode Island02904-
Medical University of South CarolinaCharlestonSouth Carolina29425-
Gastroenterology AssociatesGreenvilleSouth Carolina29607-
Gastro OneGermantownTennessee38138-
Quality Medical ResearchNashvilleTennessee37211-
Texas Clinical Research Institute, LLCArlingtonTexas76012-
Proactive El Paso,LLCEl PasoTexas79902-
Amel Med LLCGeorgetownTexas78628-
Cano Medical CenterHarlingenTexas78550-
TDDC dba GI Alliance ResearchMansfieldTexas76063-
SMS Clinical Research, LLCMesquiteTexas75149-
Gastroenterology Research of America, LLCSan AntonioTexas78229-
GI Alliance - SouthlakeSouthlakeTexas76092-
Baylor Scott and White Medical CenterTempleTexas76508-
Tyler Research Institute, LLCTylerTexas75701-
Tidewater Gastroenterology Pllc T/A Gastro. Assoc. of TidewaterChesapeakeVirginia23320-
Emeritas Research GroupLansdowne Town CenterVirginia20176-
Blue Ridge Medical Research - Gastroenterology Associates of Central VirginiaLynchburgVirginia24502-
Gastroenterology Consultants and Endoscopy Center of Southwest VirginiaRoanokeVirginia24014-
Tidewater Physicians Multispecialty Group (TPMG) - Clinical Research Division - WilliamsburgWilliamsburgVirginia23188-
The Vancouver ClinicVancouverWashington98664-

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