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

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Primary Immune Thrombocytopenia (ITP)

In brief

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.

Key facts

Study ID

NCT05653349

Run by

Novartis Pharmaceuticals

People needed

226

Starts

2023-02-03

Expected to finish

2029-01-05

Last updated by the study team

2026-06-15

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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