Actively Recruiting
Study of Ianalumab in Adults With Primary Immune Thrombocytopenia (ITP) and Warm-antibody Autoimmune Hemolytic Anemia (wAIHA) Who Have Previously Benefited From Ianalumab
Led by Novartis Pharmaceuticals · Updated on 2026-04-13
60
Participants Needed
14
Research Sites
226 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Study of Ianalumab in Adults With Primary Immune Thrombocytopenia (ITP) and Warm-antibody Autoimmune Hemolytic Anemia (wAIHA) Who Have Previously Benefited From Ianalumab
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent before joining the study
- Male or female aged 18 years or older at consent
- For Primary ITP: Previously treated with ianalumab/placebo in prior trials and experienced treatment failure at least 2 years after last infusion
- Rescue or bridging therapy allowed within 28 days before screening; platelet count must be documented before therapy start within 30 days prior to screening
- For Primary or Secondary wAIHA: Previously documented positive direct antiglobulin test, treated with ianalumab/placebo in prior trials, with durable response beyond 2 years or week 20 after last dose
- Relapsed wAIHA with hemoglobin 5 to less than 10 g/dL and anemia symptoms during screening or shortly before
- Rescue or bridging therapy allowed within 28 days before screening; hemoglobin measured before therapy start within 30 days prior
- Supportive care allowed if stable for at least 4 weeks before screening
You will not qualify if you...
- Evans syndrome or any cytopenia other than thrombocytopenia (ITP) or anemia (wAIHA), except grade 1 anemia due to blood loss or iron deficiency
- Secondary wAIHA with bone marrow involvement
- Current or history of life-threatening bleeding due to thrombocytopenia
- Therapies for ITP or wAIHA other than ianalumab/placebo, bridging/rescue, or supportive care before screening
- Participants who were unblinded and received placebo only in parent trials
- For ITP: concurrent coagulation disorders or use of anti-platelet or anti-coagulant drugs except low-dose aspirin (150 mg/day or less)
- Other protocol-defined criteria may apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 14 locations
1
Novartis Investigative Site
Roeselare, West-Vlaanderen, Belgium, 8800
Actively Recruiting
2
Novartis Investigative Site
Guangzhou, Guangdong, China, 510515
Actively Recruiting
3
Novartis Investigative Site
Tianjin, China, 300020
Actively Recruiting
4
Novartis Investigative Site
Ostrava, Poruba, Czechia, 708 52
Actively Recruiting
5
Novartis Investigative Site
Jena, Thuringia, Germany, 07740
Actively Recruiting
6
Novartis Investigative Site
Debrecen, Hajdu Bihar Megye, Hungary, 4032
Actively Recruiting
7
Novartis Investigative Site
Florence, FI, Italy, 50134
Actively Recruiting
8
Novartis Investigative Site
Trieste, TS, Italy, 34129
Actively Recruiting
9
Novartis Investigative Site
Vicenza, VI, Italy, 36100
Actively Recruiting
10
Novartis Investigative Site
George Town, Malaysia, 10050
Actively Recruiting
11
Novartis Investigative Site
Singapore, Singapore, 119074
Actively Recruiting
12
Novartis Investigative Site
Madrid, Spain, 28009
Actively Recruiting
13
Novartis Investigative Site
Samsun, Atakum, Turkey (Türkiye), 55200
Actively Recruiting
14
Novartis Investigative Site
London, United Kingdom, W12 0HS
Actively Recruiting
Research Team
N
Novartis Pharmaceuticals
CONTACT
N
Novartis Pharmaceuticals
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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