For Healthcare Professionals

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

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About the study

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 maintaining platelet count ≥30 G/L in adult participants with primary ITP.
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Inclusion Criteria:

  1. Signed informed consent prior to participation in the study.
  2. Male or female participants aged 18 years and older on the day of signing informed consent
  3. Primary ITP diagnosed within 3 months before initiating first-line ITP therapy (corticosteroids, IVIG)
  4. Platelet count below 30 G/L before starting any first-line ITP therapy (corticosteroids, IVIG)
  5. 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.

EXCLUSION CRITERIA

Key Exclusion Criteria:

  1. Evans syndrome or any other cytopenia (patients with anemia related to bleeding or iron deficiency are eligible)
  2. Current life-threatening bleeding
  3. 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 .
  4. Prior use of B-cell depleting therapy (e.g., rituximab).
  5. Absolute neutrophil count below 1.0 G/L at randomization
  6. 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.

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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.
Phone iconCall 1-888-669-6682Email iconEmail Study Center

Study Details


Contition

Primary Immune Thrombocytopenia (ITP)

Age

18+

Phase

PHASE3

Participants Needed

225

Est. Completion Date

Dec 18, 2028

Treatment Type

INTERVENTIONAL


Sponsor

Novartis

ClinicalTrials.gov NCT Identifier

NCT05653349

Study Number

CVAY736I12301

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