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

NCT05653349

Active Not RecruitingPhase 3

Sponsor: Novartis Pharmaceuticals

Conditions: Primary Immune Thrombocytopenia (ITP)

Interventions: Ianalumab, Placebo, Corticosteroids

Countries: United States, Argentina, Australia, Austria, Belgium, Bulgaria, China, Czechia

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 100 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* Signed informed consent prior to participation in the study.
* Male or female participants aged 18 years and older on the day of signing informed consent
* Primary ITP diagnosed within 3 months before initiating first-line ITP therapy (corticosteroids, IVIG)
* Platelet count below 30 G/L before starting any first-line ITP therapy (corticosteroids, IVIG)
* Response (platelet count \>=50 G/L) to corticosteroids (+/- IVIG) at any time prior to randomization. Note: Platelet count measured within 7 days of platelet transfusion will not be considered as response.

Key Exclusion Criteria:

* Evans syndrome or any other cytopenia (patients with low grade anemia related to bleeding or iron deficiency are eligible)
* Current life-threatening bleeding
* Previous ITP treatment, including splenectomy, except for corticosteroids and/or IVIG initiated as first-line therapy for up to 28 days before randomization and rescue corticosteroids and/or IVIG given prior to confirmed diagnosis of primary ITP .
* Prior use of B-cell depleting therapy (e.g., rituximab).
* Absolute neutrophil count below 1.0 G/L at randomization
* Participants with concurrent coagulation disorders and/or receiving anti-platelet or anticoagulant medication with an exemption of low dose of acetylsalicylic acid

Other protocol-defined Inclusion/Exclusion may apply.
Locations (111)
  • Yuma, Arizona, United States
  • Clovis, California, United States
  • Fountain Valley, California, United States
  • Aurora, Colorado, United States
  • Margate, Florida, United States
  • Chicago, Illinois, United States
  • Fort Wayne, Indiana, United States
  • Bethesda, Maryland, United States
  • Boston, Massachusetts, United States
  • Boston, Massachusetts, United States
  • Farmington Hills, Michigan, United States
  • Rochester, Minnesota, United States
  • Saint Louis Park, Minnesota, United States
  • Billings, Montana, United States
  • Lake Success, New York, United States
  • Nyack, New York, United States
  • Dayton, Ohio, United States
  • Providence, Rhode Island, United States
  • San Antonio, Texas, United States
  • Ogden, Utah, United States
  • CABA, Buenos Aires, Argentina
  • CABA, Buenos Aires, Argentina
  • San Miguel Tucuman, Tucumán Province, Argentina
  • Caba, Argentina
  • Córdoba, Argentina
  • Garran, Australian Capital Territory, Australia
  • Wooloongabba, Queensland, Australia
  • Clayton, Victoria, Australia
  • Melbourne, Victoria, Australia
  • Innsbruck, Tyrol, Austria
  • + 81 more on CT.gov