๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-06-10

Study of Ianalumab Versus Placebo in Addition to First-line Corticosteroids in Primary Immune Thrombocytopenia (ITP) (NCT05653349)

A Phase III, Randomized, Double-blind Study of Ianalumab (VAY736) Versus Placebo in Addition to First-line Corticosteroids in Primary Immune Thrombocytopenia (VAYHIT1)

๐Ÿ”ต Active, Not Recruiting Phase3 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Novartis Pharmaceuticals

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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 increasing the rate of stable response off treatment at 12 months (SROT-12) in adult participants with primary ITP.

Who can join: Review the eligibility criteria below.

Location: Yuma Regional Medical Center โ€” Yuma, Arizona

Age range: 18 Years to 100 Years

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (111 Sites)

Showing the first 25 of 111 sites.

  • Yuma Regional Medical Center โ€” Yuma, Arizona
  • Community Cancer Institute โ€” Clovis, California
  • Compassionate Care Res Group Inc โ€” Fountain Valley, California
  • University of Colorado Anschutz โ€” Aurora, Colorado
  • DH Cancer Research Center LLC โ€” Margate, Florida
  • Uni of Chi Medi Ctr Hema and Onco โ€” Chicago, Illinois
  • Parkview Research Center โ€” Fort Wayne, Indiana
  • Oncology Care Associates โ€” Bethesda, Maryland
  • Massachusetts General Hospital โ€” Boston, Massachusetts
  • Beth Israel Deaconess Med Center โ€” Boston, Massachusetts
  • Michigan Center of Medical Research โ€” Farmington Hills, Michigan
  • Mayo Clinic Rochester โ€” Rochester, Minnesota
  • Metro Minnesota CCOP โ€” Saint Louis Park, Minnesota
  • St Vincent Frontier Cancer Center โ€” Billings, Montana
  • Optum Health โ€” Lake Success, New York
  • Hematology Oncology Association of Rockland โ€” Nyack, New York
  • STAT Research Inc โ€” Dayton, Ohio
  • Rhode Island Hospital โ€” Providence, Rhode Island
  • Mays Cancer Ctr Uthsa Mdacc โ€” San Antonio, Texas
  • Community Cancer Trials of Utah โ€” Ogden, Utah
  • Novartis Investigative Site โ€” CABA, Buenos Aires
  • Novartis Investigative Site โ€” CABA, Buenos Aires
  • Novartis Investigative Site โ€” San Miguel Tucuman, Tucumรกn Province
  • Novartis Investigative Site โ€” Caba,
  • Novartis Investigative Site โ€” Cรณrdoba,

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—