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Second course of ianalumab for adults with ITP or warm AIHA who previously benefited

A Phase 2 Study of Ianalumab in Adults With Primary Immune Thrombocytopenia (ITP) and Warm-antibody Autoimmune Hemolytic Anemia (wAIHA) Who Have Previously Benefited From Ianalumab.

Phase 2 Interventional Novartis · NCT07039422

This trial will try a second course of ianalumab in adults with ITP or warm autoimmune hemolytic anemia who previously responded to the drug to see if benefit returns after relapse or treatment failure.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment60 (estimated)
Ages18 Years to 100 Years
SexAll
SponsorNovartis Industry-sponsored
Drugs / interventionsianalumab
Locations14 sites (Roeselare, West-Vlaanderen and 13 other locations)
Trial IDNCT07039422 on ClinicalTrials.gov

What this trial studies

This is a multicenter Phase 2 exploratory study enrolling adults with primary immune thrombocytopenia (ITP) or warm autoimmune hemolytic anemia (wAIHA) who previously benefited from ianalumab in pivotal trials. All participants receive the same ianalumab dose they previously received and are followed for safety and efficacy. Participants who meet treatment-failure criteria during the treatment period move to safety follow-up only, while those who do not meet failure criteria continue on efficacy and safety follow-up. The study finishes when all participants complete their assigned follow-up or discontinue early.

Who should consider this trial

Good fit: Adults aged 18 or older with primary ITP or wAIHA who were enrolled in the specified parent ianalumab trials and previously showed clinical benefit are the intended candidates.

Not a fit: Patients who never responded to ianalumab previously, who have contraindications to the drug, or who cannot attend the specified Novartis sites are unlikely to gain benefit from participation.

Why it matters

Potential benefit: If successful, a second course could restore or extend platelet and hemoglobin responses in people who previously benefited from ianalumab.

How similar studies have performed: Prior pivotal trials of ianalumab demonstrated benefit for some patients, but repeating a course after later relapse is exploratory and has limited published evidence.

Eligibility criteria

Show full inclusion / exclusion 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 this trial is running

Roeselare, West-Vlaanderen and 13 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Primary Immune ThrombocytopeniaWarm Autoimmune Hemolytic AnemiaITPwAIHAVAY736IanalumabB-cell depletionB-cell Activating Factor Receptor blockade
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.