A Study of Efficacy and Safety of Ianalumab Versus Placebo in Addition to Eltrombopag in Primary Immune Thrombocytopenia Patients Who Failed Steroids

Part of paid clinical trials in Yuma, Arizona.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT05653219
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Primary Immune Thrombocytopenia

Eligibility Criteria

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

Interventions

  • Ianalumab — BIOLOGICAL
    Concentrate for solution for infusion for intravenous use
  • Eltrombopag — DRUG
    Film-coated tablet for oral use
  • Placebo — DRUG
    Concentrate for solution for infusion for intravenous use.

Study Details

The purpose of this study is to evaluate the effect of two different doses of ianalumab added to eltrombopag to prolong Time to Treatment Failure (TTF) in adults with primary ITP who failed previous first-line treatment with steroids.

Key Dates

Start date
Feb 2, 2023
Status verified
May 2026
Primary completion
Jun 19, 2025
Completion
Apr 8, 2028

Study Design

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

Arms

  • Experimental: Treatment arm 1
    Participants will receive eltrombopag and ianalumab lower dose
  • Experimental: Treatment arm 2
    Participants will receive eltrombopag and ianalumab higher dose
  • Placebo Comparator: Treatment arm 3
    Participants will receive eltrombopag and placebo

Primary Outcome Measure

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

Locations (9)

FacilityCityStateZIPSite coordinators
Yuma Regional Medical CenterYumaArizona85349-
University of Colorado AnschutzAuroraColorado80045-
NorthShore University Health SystemEvanstonIllinois60201-
Boston Medical CenterBostonMassachusetts02118-
UMASS Memorial Medical CenterWorcesterMassachusetts01665-
Michigan Center of Medical ResearchFarmington HillsMichigan48334-
St Vincent Frontier Cancer CenterBillingsMontana59102-
Hematology Oncology Association of RocklandNyackNew York10960-
Montefiore Medical CenterThe BronxNew York10461-

Related coverage on Hipa.ai

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Yuma Regional Medical Center· Yuma, AZUniversity of Colorado Anschutz· Aurora, CONorthShore University Health System· Evanston, ILBoston Medical Center· Boston, MAUMASS Memorial Medical Center· Worcester, MAMichigan Center of Medical Research· Farmington Hills, MI

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