A Study to Assess the Efficacy and Safety of Afimkibart (Also Known as RO7790121) for Induction and Maintenance Therapy in Participants With Moderately to Severely Active Ulcerative Colitis

Part of paid clinical trials in Dothan, Alabama.

Sponsor
Hoffmann-La Roche
Study ID
NCT06589986
Phase
PHASE3
Status
Active Not Recruiting

Conditions

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 Afimkibart (RO7790121) compared with placebo in participants with moderately to severely active ulcerative colitis (UC).

Key Dates

First listed
Sep 19, 2024
Start date
Sep 17, 2024
Status verified
Jun 2026
Primary completion
Jan 30, 2027
Completion
Jan 30, 2031

Study Design

Enrollment
400 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 placebo SC.

Primary Outcome Measure

Percentage of Participants with Clinical Remission at Week 12 [ Time Frame: At Week 12 ]

Locations (58)

FacilityCityStateZIPSite coordinators
Digestive Health Specialists of the Southeast (Gastroenterology Associates of Dothan) - DothanDothanAlabama36305-
Om Research LLCLancasterCalifornia93534-
University of California IrvineOrangeCalifornia92868-
Amicis Research CenterSanta ClaritaCalifornia91355-
Peak Gastroenterology AssociatesColorado SpringsColorado80907-
Access Research InstituteBrooksvilleFlorida34613-
Gastro FloridaClearwaterFlorida33756-
J&A Clinical ResearchDoralFlorida33126-
Clinical Research of Osceola, LLCKissimmeeFlorida34741-
Auzmer ResearchLakelandFlorida33813-
Florida Research Institute - LakewoodLakewood RchFlorida34211-
Allied Biomedical Research Institute, IncMiamiFlorida33155-
Homestead Associates in Research, Inc.MiamiFlorida33033-
Miami Beach Clinical Research CenterMiami BeachFlorida33141-
Eminat Research GroupMiramarFlorida33027-
Nodal Medical Center, LLCTampaFlorida33607-
Theia Clinical Research Centers, LLCTampaFlorida33613-
Florida Medical ClinicZephyrhillsFlorida33542-
Gastroenterology Associates of Central GeorgiaMaconGeorgia31201-
Grand Teton Research Group, PLLCIdaho FallsIdaho83404-
The University of ChicagoChicagoIllinois60637-
Indiana University Health University HospitalIndianapolisIndiana46202-
Gastroenterology Health Partners, PLLCNew AlbanyIndiana47150-
Tri-State Gastroenterology AssociatesCrestview HillsKentucky41017-3409-
Gastroenterology Health Partners, PLLCLouisvilleKentucky40218-
Robley Rex VA Medical CenterLouisvilleKentucky40206-
Louisiana Research Center - GastroIntestinal AssociatesShreveportLouisiana71105-
Boston UniversityBostonMassachusetts02118-
Brigham & Womens HospBostonMassachusetts02115-
Michigan Center of Medical ResearchFarmington HillsMichigan48334-
Allied Gastrointestinal Associates, PAFlowoodMississippi39232-
Las Vegas Clinical Trials, LLCNorth Las VegasNevada89030-
Intercity GastroenterologyFresh MeadowsNew York11366-
Pioneer Clinical Research NYNew YorkNew York10016-
Mainstreet - Richmond Hill ClinicRichmond HillNew York11418-
Digestive Health Partners, PAAshevilleNorth Carolina28801-
Peters Medical Research (PMR), LLCHigh PointNorth Carolina27260-
Monroe Biomedical ResearchMonroeNorth Carolina28112-
Cleveland Clinic FoundationClevelandOhio44195-
Ohio Gastroenterology GroupColumbusOhio43202-
Gastro Intestinal Research Institute of Northern OhioWestlakeOhio44145-
University GastroenterologyProvidenceRhode Island02904-
Medical University of South Carolina (MUSC)CharlestonSouth Carolina29425-
Gastro OneCordovaTennessee38018-
Gastrointestinal Associates of Northeast TennesseeJohnson CityTennessee37604-
Texas Digestive Disease Consultants - Cedar ParkCedar ParkTexas78613-
The University of Texas Southwestern Medical Center at DallasDallasTexas75390-
GI AllianceGarlandTexas75044-
Baylor College of Medicine.HoustonTexas77030-
TDDC dba GI Alliance ResearchMansfieldTexas76063-
Carta - Clinical Associates In Research Therapeutics Of America;LLCSan AntonioTexas78212-
Southern Star Research Institute, LLC.San AntonioTexas78229-
GI Alliance - SouthlakeSouthlakeTexas76092-
Tyler Research Institute, LLCTylerTexas75701-
University of Texas Health Center at TylerTylerTexas75708-
Tidewater Gastroenterology Pllc T/A Gastro. Assoc. of TidewaterChesapeakeVirginia23320-
Gastroenterology Consultants of SWVARoanokeVirginia24018-
Univ of Wisconsin Hosp & ClinMadisonWisconsin53792-

Find similar trials in Dothan, AL

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By condition
Ulcerative colitis
By specialty
GastroenterologyInflammatory bowel diseaseAutoimmune disease
By research site
Digestive Health Specialists of the Southeast (Gastroenterology Associates of Dothan) - Dothan· Dothan, ALOm Research LLC· Lancaster, CAUniversity of California Irvine· Orange, CAAmicis Research Center· Santa Clarita, CAPeak Gastroenterology Associates· Colorado Springs, COAccess Research Institute· Brooksville, FL

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