A Study of Ianalumab in Addition to Eltrombopag in Pediatric Patients With Primary ITP Who Failed Corticosteroids.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT07660172
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Primary Immune Thrombocytopenia (ITP)

Eligibility Criteria

Sex
ALL
Age
5 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Ianalumab — BIOLOGICAL
    Liquid in a vial Concentrate for solution for infusion
  • Eltrombopag — DRUG
    Film-coated tablet and also Powder for oral suspension

Study Details

The purpose of this study is to assess the efficacy, safety and pharmacokinetics (PK) of ianalumab (VAY736) in addition to eltrombopag treatment; and to inform the dose of ianalumab in pediatric patients (5 to \<18 years of age) with primary ITP who have had an insufficient response to or relapsed after first-line treatment with corticosteroids.

Key Dates

First listed
Jun 22, 2026
Start date
Feb 8, 2027
Status verified
Jun 2026
Primary completion
Apr 22, 2033
Completion
Apr 22, 2033

Study Design

Enrollment
36 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Ianalumab + eltrombopag
    Participants will receive ianalumab in addition to eltrombopag.

Primary Outcome Measure

Time to treatment failure (TTF) [ Time Frame: enrolled until end of study (up to 39 months from the last patient enrolled) ]

Central Contacts

  • Novartis Pharmaceuticals
    1-888-669-6682
    [email protected]
  • Novartis Pharmaceuticals
    +41613241111

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