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Looking for participantsPhase2

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

NCT ID: NCT07039422

View on ClinicalTrials.gov ↗

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.

Primary Immune ThrombocytopeniaWarm Autoimmune Hemolytic Anemia

How this trial compares with your answers

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What we know so far

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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

by a positive

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
Inclusion Criteria: * Signed informed consent obtained prior to participation in the study. * Male or female participants aged 18 years and older on the day of signing informed consent Primary ITP patients: * Previously enrolled and treated either with ianalumab/placebo in addition to first-line corticosteroids on protocol CVAY736I12301 or with ianalumab/placebo in addition to eltrombopag in the second line on protocol CVAY736Q12301, and who experienced treatment failure (TF) by parent trial definition ≥ 2 years after the last infusion of ianalumab/placebo * Rescue medication and/or bridging therapy are allowed to be started within the 28 days prior to screening; platelet count results obtained prior to the start of the therapy must be used to assess eligibility and have to be collected within 30 days prior to screening For Primary or Secondary wAIHA patients: * Previously documented by a positive direct antiglobulin test (DAT) specific for anti-IgG or anti-IgA, previously enrolled and treated with ianalumab/placebo in blinded cohort or placebo followed by crossover to open label ianalumab in protocol CVAY736O12301, having experienced durable response lasting beyond 2 years from the last infusion of ianalumab/placebo in blinded cohorts or a durable response beyond week 20 from last dose of first course of ianalumab in the crossover arm. * Relapsed wAIHA with hemoglobin concentration ≥5 g/dL and \<10 g/dL and presence of symptoms related to anemia during screening or within 14 days before screening window or within 28 days before screening window if rescue medication/bridging therapy has been initiated. * Rescue medication and/or bridging therapy are allowed to be started during the screening and within 28 days prior to screening; hemoglobin level result for eligibility assessment needs to be obtained prior to the start of the treatment within 30 days prior to screening * Supportive care is allowed in the case the participant received it in the parent trial when the relapse occurred and has remained stable at least 4 weeks prior screening Exclusion Criteria: * Evans syndrome or any cytopenia other than thrombocytopenia (for ITP participants) or anemia (for wAIHA), except for grade 1 anemia due to blood loss or iron deficiency. * 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 beginning of the screening window * After primary analysis of each respective parent trial, participants whose treatment was unblinded and who received placebo only will be excluded. * ITP participants only: Participants with concurrent coagulation disorders and/or receiving anti-platelet or anti-coagulant medication except for low dose of acetylsalicylic acid (≤150 mg per day) Other protocol-defined inclusion/exclusion criteria may apply.

Where Is This Study? (1 UK site)

Novartis Investigative Site

London W12 0HS, United Kingdom

Recruiting

How to Get in Touch

Novartis Pharmaceuticals

Sponsor contact

CONTACT

1-888-669-6682 novartis.email@novartis.com

Novartis Pharmaceuticals

Sponsor contact

CONTACT

+41613241111
Data sourced from ClinicalTrials.gov · Last verified: 2026-07