A Study to Assess the Efficacy and Safety of Induction 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
NCT06819891
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.

Study Details

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).

Key Dates

First listed
Feb 11, 2025
Start date
May 12, 2025
Status verified
Jul 2026
Primary completion
Dec 31, 2028
Completion
Apr 30, 2033

Study Design

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

Arms

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

Primary Outcome Measure

Percentage of Participants with Clinical Remission per Crohn's Disease Activity Index (CDAI) Score [ Time Frame: At Week 12 ]

Central Contacts

  • Reference Study ID Number: GA45332 https://forpatients.roche.com/ No attachments to email below.
    888-662-6728 (U.S. and Canada)
    [email protected]
  • Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry

Locations (60)

FacilityCityStateZIPSite coordinators
Digestive Health Specialists of the SoutheastDothanAlabama36305-
Sun City Clinical ResearchGlendaleArizona85304-
Om Research LLCLancasterCalifornia93534-
Hoag Memorial Hospital Presbyterian;Hoag Center for Research and EducationNewport BeachCalifornia92663-
Empire Clinical ResearchPomonaCalifornia91767-
Stanford Medicine Outpatient CenterRedwood CityCalifornia94063-
Clinical Applications Laboratories, Inc.San DiegoCalifornia92103-
Amicis Research CenterSanta ClaritaCalifornia91355-
Peak Gastroenterology AssociatesColorado SpringsColorado80907-
J&A Clinical ResearchDoralFlorida33126-
Auzmer ResearchLakelandFlorida33813-
Galenus Group IncLehigh AcresFlorida33936-
Allied Biomedical Research Institute, IncMiamiFlorida33155-
Homestead Associates in Research, Inc.MiamiFlorida33033-
Rejuvaline Medical ResearchMiamiFlorida33155-
Miami Beach Clinical Research CenterMiami BeachFlorida33141-
Eminat Research GroupMiramarFlorida33027-
Digestive and Liver Center of FloridaOrlandoFlorida32825-
Advanced Medical Research CenterPort OrangeFlorida32127-
Santos Research Center, CORPTampaFlorida33615-
Cleveland Clinic FloridaWestonFlorida33331-
Morehouse School Of MedicineAtlantaGeorgia30310-1495-
The University of ChicagoChicagoIllinois60637-
University of Kansas Medical CenterKansas CityKansas66160-
One GI: GHP - Gastroenterology Health Partners LouisvilleLouisvilleKentucky40218-
Robley Rex VA Medical CenterLouisvilleKentucky40206-
Baton Rouge General Medical CenterBaton RougeLouisiana70809-
Louisiana Research Center - GastroIntestinal AssociatesShreveportLouisiana71105-
Mercy Medical CenterBaltimoreMaryland21202-
Chevy Chase Clinical ResearchChevy ChaseMaryland20815-
University of Massachusetts Memorial Medical CenterNorth WorcesterMassachusetts01655-
Gastroenterology Associates of Western Michigan, P.L.C.WyomingMichigan49519-
Gastrointestinal Associates ResearchFlowoodMississippi39232-
Va Heartland Network - Harry S. Truman Memorial Veterans' HospitalColumbiaMissouri65201-5275-
Specialists in GastroenterologySt LouisMissouri63141-
Dartmouth-Hitchcock Medical Center-Norris Cotton Cancer CenterLebanonNew Hampshire03756-
Virtua Crohns and Colitis CenterMoorestownNew Jersey08057-
Robert Wood Johnson University HospitalNew BrunswickNew Jersey08901-
Ellipsis Research GroupBrooklynNew York11215-
Intercity GastroenterologyFresh MeadowsNew York11366-
James J Peters Veterans Affairs Medical CenterThe BronxNew York10468-
Digestive Disease Medicine of Central New YorkUticaNew York13502-
Charlotte Gastroenterology and Hepatology, P.L.L.CCharlotteNorth Carolina28207-
Peters Medical Research (PMR), LLCHigh PointNorth Carolina27260-
Clinical Inquest CenterBeavercreekOhio45431-
Cleveland Clinic FoundationClevelandOhio44195-
University of PennsylvaniaPhiladelphiaPennsylvania19104-
University GastroenterologyProvidenceRhode Island02904-
Gastro OneCordovaTennessee38018-
Vanderbilt University Medical CenterNashvilleTennessee37212-1375-
University of Texas Southwestern Medical Center - Multidisciplinary Spine Clinic - James W. Aston Ambulatory Care CenterDallasTexas75390-8565-
GI Alliance - Fort WorthFort WorthTexas76104-
GI AllianceGarlandTexas75044-
Integrity Advanced Therapeutics PLLCHoustonTexas77090-
Texas Digestive Disease Consultants-Lubbock powered by GI AllianceLubbockTexas79410-
Carta - Clinical Associates In Research Therapeutics Of America;LLCSan AntonioTexas78212-
University of Texas Health Center at TylerTylerTexas75708-
TDDC GI Alliance research WebsterWebsterTexas77598-
GI Alliance-RichmondRichmondVirginia23229-
University Physicians and Surgeons Inc, dba Marshall HealthHuntingtonWest Virginia25701-

Find similar trials in Dothan, AL

By research site
Digestive Health Specialists of the Southeast· Dothan, ALSun City Clinical Research· Glendale, AZOm Research LLC· Lancaster, CAHoag Memorial Hospital Presbyterian;Hoag Center for Research and Education· Newport Beach, CAEmpire Clinical Research· Pomona, CAStanford Medicine Outpatient Center· Redwood City, CA

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