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Studies

Interventional Active not recruiting Phase 3

NCT05653219 on ClinicalTrials.gov

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

Official title: A Phase 3 Randomized, Double-blind Study of Ianalumab (VAY736) Versus Placebo in Addition to Eltrombopag in Patients With Primary Immune Thrombocytopenia (ITP) Who Had an Insufficient Response or Relapsed After First Line Steroid Treatment (VAYHIT2)

  • Sponsor: Novartis Pharmaceuticals Corporation
  • Enrollment: 152 (Actual)
  • Study start: 2023-02-02 (Actual)
  • Primary completion: 2025-06-19 (Actual)
  • Study completion: 2028-04-08 (Estimated)
  • Allocation: Randomized
  • InterventionModel: Parallel
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • PrimaryPurpose: Treatment

Brief Summary

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.

Conditions

  • Primary Immune Thrombocytopenia

Intervention / Treatment

  • Biological: Ianalumab
  • Drug: Eltrombopag
  • Drug: Eltrombopag
  • Drug: Placebo

Primary Outcome Measures

  • Time from randomization until treatment failure (Randomization to until end of study (up to 39 months after randomization of last participant))
    Time from randomization until treatment failure is defined as the time from randomization date until the first of the following events indicative of treatment failure: * platelet count below 30 G/L * start of a new ITP treatment * need for a rescue treatment * ineligibility to taper or inability to discontinue eltrombopag * death

Countries

Argentina, Austria, Belgium, China, Czechia, France, Germany, Hungary, India, Italy, Japan, Malaysia, Mexico, Netherlands, Philippines, Romania, Singapore, South Korea, Spain, Taiwan, Thailand, Turkey (Türkiye), United Kingdom, United States

Locations and Investigators

  • University Of Debrecen, Debrecen, Hungary
    • Arpad, Illes
  • Semmelweis University, Budapest VIII, Hungary
    • Zsolt, Nagy
  • Sykehuset Oestfold HF Kalnes, Graalum, Norway
    • Waleed, Ghanima
  • Hospital Del Mar, Barcelona, Spain
    • Blanca, Sanchez Gonzalez
  • Hospital Universitario De Salamanca, Salamanca, Spain
    • Jose Ramon, Gonzalez Porras
  • Hospital General Universitario Morales Meseguer, Murcia, Spain
    • Maria Luisa, Lozano Almela
  • Complexo Hospitalario Universitario De Santiago, Santiago De Compostela, Spain
    • Adrián, Mosquera Orgueira
  • Hospital Universitario 12 De Octubre, Madrid, Spain
    • Maria, Poza Santaella
  • Hospital Universitario La Paz, Madrid, Spain
    • Maria Teresa, Alvarez Roman
  • Gemeinschaftspraxis Haematologie Onkologie, Dresden, Germany
    • Thomas, Illmer
  • Universitaetsklinikum Bonn AöR, Bonn, Germany
    • Thomas, Zander
  • Universitaetsklinikum Aachen AöR, Aachen, Germany
    • Thomas, Zander
  • Universitaetsklinikum Jena KöR, Jena, Germany
    • Thomas, Stauch
  • Universitaetsklinikum Duesseldorf AöR, Duesseldorf, Germany
    • Thomas, Zander
  • University Hospital Cologne AöR, Cologne, Germany
    • Thomas, Zander
  • Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR, Dresden, Germany
    • Karolin, Trautmann-Grill
  • Universitair Medisch Centrum Utrecht, Utrecht, Netherlands
  • Leids Universitair Medisch Centrum (LUMC), Leiden, Netherlands
    • Jaap, Zwaginga
  • Azienda Unita Locale Socio Sanitaria N 8 Berica, Vicenza, Italy
    • GiusepApe, Carli
  • Azienda Unita Sanitaria Locale Di Bologna, Bologna, Italy
    • Francesca, Palandri
  • Azienda Ospedaliera Policlinico Universitario Tor Vergata, Rome, Italy
    • Francesco, Buccisano
  • Azienda Sanitaria Universitaria Giuliano Isontina, Trieste, Italy
    • Francesco, Zaja
  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy
    • Elena, Rossi
  • Algemeen Ziekenhuis Delta, Roeselare, Belgium
    • Lien, Deleu
  • Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur, Yvoir, Belgium
    • Julien, Devreux
  • Medical University Of Vienna, Vienna, Austria
    • Johanna, Gebhart
  • Klinikum Wels-Grieskirchen GmbH, Wels, Austria
    • Sonja, Heibl
  • Fakultni Nemocnice Brno, Brno, Czechia
    • Jiri, Mayer
  • Fakultni Nemocnice Kralovske Vinohrady, Prague, Czechia
    • Olga, Cerna
  • Vseobecna Fakultni Nemocnice V Praze, Prague, Czechia
  • Spitalul Clinic Municipal De Urgenta Timisoara, Timisoara, Romania
    • Ioana, Ionita
  • Spitalul Clinic Municipal Filantropia Craiova, Craiova, Romania
    • Luminita, Ocroteala
  • Clinique Victor Hugo, Le Mans, France
    • Kamel, Laribi
  • Centre Hospitalier Blois Simone Veil, Blois Cedex, France
    • Bertrand, Lioger
  • CHRU De Nancy, Vandoeuvre Les Nancy, France
    • Thomas, Moulinet

Study Officials

  • Novartis Pharmaceuticals (Study Director) — Novartis Pharmaceuticals