A Study to Evaluate Axatilimab and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Incyte Corporation
Study ID
NCT06585774
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Chronic Graft-versus-host-disease

Eligibility Criteria

Sex
ALL
Age
12 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • INCA034176 — DRUG
    IV infusion
  • Placebo — DRUG
    IV infusion
  • Corticosteroids — DRUG
    Oral/IV Infusion

Study Details

This study will be conducted to compare the efficacy of axatilimab versus placebo in combination with corticosteroids as initial treatment for moderate or severe chronic graft-versus-host disease (cGVHD).

Key Dates

First listed
Sep 19, 2024
Start date
Jan 21, 2025
Status verified
Jun 2026
Primary completion
Sep 28, 2027
Completion
Mar 31, 2030

Study Design

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

Arms

  • Experimental: Axatilimab + Corticosteroids
    Axatilimab and Corticosteroids at the protocol-defined dose.
  • Experimental: Placebo + Corticosteroids
    Matching placebo and Corticosteroids at the protocol-defined dose.

Primary Outcome Measure

Event Free Survival (EFS) [ Time Frame: Up to 3 years ]

Central Contacts

Locations (34)

FacilityCityStateZIPSite coordinators
University of Alabama BirminghamBirminghamAlabama35294-
University of Arizona Cancer Center-Out Pt.TucsonArizona85719-
University of California San Diego Medical Center, Moores Cancer CenterLa JollaCalifornia92037-
University of Southern CaliforniaLos AngelesCalifornia90089-
Colorado Blood Cancer InstituteDenverColorado80218-
Childrens National HospitalWashington D.C.District of Columbia20010-
Miami Cancer InstituteMiamiFlorida33176-
Orlando Health Cancer Institute Downtown OrlandoOrlandoFlorida32806-
Memorial Cancer InstitutePembroke PinesFlorida33026-
Emory University-Winship Cancer InstituteAtlantaGeorgia30322-
Northwestern Memorial HospitalChicagoIllinois60611-
University of IllinoisChicagoIllinois60612-
The University of Kansas Cancer CenterKansas CityKansas66160-
John Hopkins HospitalBaltimoreMaryland21287-
Dana Farber Cancer InstituteBostonMassachusetts02215-
Massachusetts General HospitalBostonMassachusetts02114-
University of MichiganAnn ArborMichigan48109-
Henry Ford HospitalDetroitMichigan48202-
Corewell Health Hematology OncologyGrand RapidsMichigan49503-
Hackensack University Medical CenterHackensackNew Jersey07601-
Rutgers Cancer Institute of NjNew BrunswickNew Jersey08903-
University of Rochester Medical CenterRochesterNew York14642-
Stony Brook University Medical CenterStony BrookNew York11794-
Wake Forest Baptist Medical CenterWinston-SalemNorth Carolina27157-
Oregon Health and Science UniversityPortlandOregon97239-
Jefferson University HospitalsPhiladelphiaPennsylvania19107-
Medical University of South CarolinaCharlestonSouth Carolina29425-
Prisma Health UpstateGreenvilleSouth Carolina29615-
Baptist Cancer CenterMemphisTennessee38120-
St David'S South Austin Medical CenterAustinTexas78704-
Texas Transplant InstituteSan AntonioTexas78229-
Intermountain Blood and Marrow TransplantSalt Lake CityUtah84143-
Virginia Commonwealth University Massey Cancer CenterRichmondVirginia23298-
West Virginia University Cancer InstituteMorgantownWest Virginia26506-

Find similar trials in Birmingham, AL

By research site
University of Alabama Birmingham· Birmingham, ALUniversity of Arizona Cancer Center-Out Pt.· Tucson, AZUniversity of California San Diego Medical Center, Moores Cancer Center· La Jolla, CAUniversity of Southern California· Los Angeles, CAColorado Blood Cancer Institute· Denver, COChildrens National Hospital· Washington D.C., DC

Related Studies