Study of Ianalumab Versus Placebo in Addition to First-line Corticosteroids in Primary Immune Thrombocytopenia (ITP)

Part of paid clinical trials in Yuma, Arizona.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT05653349
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Primary Immune Thrombocytopenia (ITP)

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • Ianalumab — BIOLOGICAL
    Intravenous infusion, prepared from concentrate solution
  • Placebo — DRUG
    Intravenous infusion, prepared from matching placebo
  • Corticosteroids — DRUG
    Oral or parental (if clinically justified)

Study Details

The purpose of this study is to evaluate the effect of two different doses of ianalumab versus placebo in addition to first-line corticosteroids in maintaining platelet count ≥30 G/L in adult participants with primary ITP.

Key Dates

Start date
Feb 3, 2023
Status verified
Apr 2026
Primary completion
Oct 29, 2026
Completion
Dec 6, 2028

Study Design

Enrollment
226 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Ianalumab Lower dose
    Lower dose of ianalumab administered intravenously with corticosteroids oral or parental (if clinically justified)
  • Experimental: Ianalumab Higher dose
    Higher dose of ianalumab administered intravenously with corticosteroids oral or parental (if clinically justified)
  • Placebo Comparator: Placebo
    Placebo administered intravenously with corticosteroids oral or parental (if clinically justified)

Primary Outcome Measure

Time from randomization to treatment failure (TTF) [ Time Frame: Randomization to end of study (up to 39 months after randomization of last patient) ]

Locations (21)

FacilityCityStateZIPSite coordinators
Yuma Regional Medical CenterYumaArizona85349-
Community Cancer InstituteClovisCalifornia93611-
Compassionate Care Res Group IncFountain ValleyCalifornia92708-
University of Colorado AnschutzAuroraColorado80045-
DH Cancer Research Center LLCMargateFlorida33063-
Uni of Chi Medi Ctr Hema and OncoChicagoIllinois60637-
Parkview Research CenterFort WayneIndiana46845-
Oncology Care AssociatesBethesdaMaryland20817-
Beth Israel Deaconess Med CenterBostonMassachusetts02215-
Massachusetts General HospitalBostonMassachusetts02114-
Michigan Center of Medical ResearchFarmington HillsMichigan48334-
Mayo Clinic RochesterRochesterMinnesota55905-
Metro Minnesota CCOPSaint Louis ParkMinnesota55416-
St Vincent Frontier Cancer CenterBillingsMontana59102-
Optum HealthLake SuccessNew York11042-
Hematology Oncology Association of RocklandNyackNew York10960-
Cleveland Clinic FoundationClevelandOhio44195-
STAT Research IncDaytonOhio45402-
Rhode Island HospitalProvidenceRhode Island02903-
Mays Cancer Ctr Uthsa MdaccSan AntonioTexas78229-
Community Cancer Trials of UtahOgdenUtah84405-

Find similar trials in Yuma, AZ

By research site
Yuma Regional Medical Center· Yuma, AZCommunity Cancer Institute· Clovis, CACompassionate Care Res Group Inc· Fountain Valley, CAUniversity of Colorado Anschutz· Aurora, CODH Cancer Research Center LLC· Margate, FLUni of Chi Medi Ctr Hema and Onco· Chicago, IL

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