At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Ianalumab (biological)
- How long the study runs
- Study runs about 50 months (dates as stated)
- About the drug or intervention
- Ianalumab — biological: Concentrate for solution for infusion for intravenous use
- Patient visit burden
- Not specified by the sponsor
In plain English
This Novartis study is looking at ianalumab in adults with two blood conditions: primary immune thrombocytopenia (ITP), where the body destroys platelets, and warm-antibody autoimmune haemolytic anaemia (wAIHA), where the body destroys red blood cells. It is only for people who took part in earlier ianalumab trials and benefited from the treatment before their condition returned.
Who can take part
- Adults aged 18 or over who have given informed consent.
- ITP patients: previously took part in earlier ianalumab trials (with steroids or eltrombopag) and their treatment stopped working at least 2 years after their last ianalumab or placebo infusion. Platelet counts used to check eligibility must come from within 30 days before screening.
- wAIHA patients: previously tested positive on a direct antiglobulin test (DAT) for anti-IgG or anti-IgA, took part in an earlier ianalumab trial, and had a lasting response that carried on beyond 2 years after the last infusion (or beyond week 20 in the crossover arm).
- wAIHA patients must have relapsed, with haemoglobin levels between 5 and under 10 g/dL and symptoms of anaemia during or shortly before screening.
- Rescue medicine or bridging therapy is allowed shortly before or during screening; other eligibility rules may apply.
Who may not be able to
- People with Evans syndrome or any low blood cell count other than those caused by their ITP or wAIHA (mild anaemia from blood loss or low iron is allowed).
- wAIHA patients whose condition involves the bone marrow.
- People with current or past life-threatening bleeding caused by low platelets.
- Anyone who had treatment for ITP or wAIHA other than ianalumab or placebo, bridging/rescue therapy, or supportive care before the screening window.
- People who were unblinded after the parent trial analysis and only received placebo.
- ITP patients with blood clotting problems or taking anti-platelet or blood-thinning medicines, except low-dose aspirin (150 mg a day or less).
What taking part involves
- • Not stated — ask the trial team
Time commitment: Not stated — ask the trial team about the number of visits, how long the study lasts, and what taking part involves.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 18 Years to 100 Years
- Who
- All
- Number of participants
- 60
- Started
- 2026-06-26
- Last checked
- 2026-07
Plain English Summary
What is this study?
- • Testing a new treatment for primary immune thrombocytopenia
- • Phase2 - 60 participants
- • 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)
Who can take part?
- • Ages 18 Years to 100 Years
- • Diagnosed with primary immune thrombocytopenia
Where?
- • London - Novartis Investigative Site
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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).
More detail
This is a multicenter, Phase 2 exploratory study to assess the efficacy and safety of a second course of ianalumab in adults with ITP and wAIHA who have previously benefited from ianalumab. All participants will receive ianalumab at the dose of study treatment from which they previously derived benefit. After completion of the screening period, participants who do not meet treatment failure criteria during treatment period will enter the safety and efficacy follow-up, whereas participants who reported a treatment failure during the treatment period will enter the safety follow-up only. The study will end once all participants have completed safety and/or efficacy follow-up since their last dose of ianalumab or discontinued the study earlier.
How this trial compares with your answers
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What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years - 100 Years
- Who can join: All genders
Biomarkers mentioned
What the study is looking for
- ✓Signed agreement to take part obtained prior to participation in the study.
- ✓Male or female participants aged 18 years and older on the day of signing agreement to take part
- ✓Primary ITP patients:
- ✓For Primary or Secondary wAIHA patients:
- ✓Supportive care is allowed in the case the participant received it in the parent trial when the relapse occurred and...
Who cannot take part
- ✗Evans syndrome or any cytopenia other than thrombocytopenia (for ITP participants) or anemia (for wAIHA), except for...
- ✗Secondary wAIHA with BM involvement for wAIHA patients
- ✗Current life-threatening bleeding or history of life-threatening bleeding due to thrombocytopenia
- ✗Therapy for ITP or wAIHA other than ianalumab/placebo, bridging/rescue therapies and supportive care prior to the...
- ✗After primary analysis of each respective parent trial, participants whose treatment was unblinded and who received...
See the full criteria
Where Is This Study? (1 UK site)
Novartis Investigative Site
London W12 0HS, United Kingdom
How to Get in Touch
Novartis Pharmaceuticals
Sponsor contactCONTACT
Novartis Pharmaceuticals
Sponsor contactCONTACT
