Study of Ianalumab in Adults With Primary Immune Thrombocytopenia (ITP) and Warm-antibody Autoimmune Hemolytic Anemia (wAIHA) Who Have Previously Benefited From Ianalumab

Sponsor
Novartis Pharmaceuticals
Study ID
NCT07039422
Phase
PHASE2
Status
Recruiting
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Conditions

  • Primary Immune Thrombocytopenia
  • Warm Autoimmune Hemolytic Anemia

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • Ianalumab — BIOLOGICAL
    Concentrate for solution for infusion for intravenous use

Study Details

This study is intended to explore the efficacy and safety of a second course of ianalumab after experiencing treatment failure in the pivotal Primary Immune Thrombocytopenia (ITP) trials (CVAY736I12301, CVAY736Q12301) and after loss of durable response in the pivotal Warm Autoimmune Hemolytic Anemia (wAIHA) trial (CVAY736O12301).

Key Dates

Start date
Jun 26, 2026
Status verified
Jun 2026
Primary completion
Aug 30, 2030
Completion
Aug 30, 2030

Study Design

Enrollment
60 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment arm 1
    Participants will receive ianalumab lower dose
  • Experimental: Treatment arm 2
    Participants will receive ianalumab higher dose

Primary Outcome Measure

Treatment failure free (yes, no) for participants with Immune Thrombocytopenia (ITP) [ Time Frame: From treatment start date until the events indicative of treatment failure (up to 2 years after last dose) ]

Central Contacts

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

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