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Clinical Trials in China / NCT07039422
Recruiting 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

NCT07039422 · tracked via the Priya Life Science China tracker
Sponsor
Novartis Pharmaceuticals
Phase
Phase 2
Started
2026-06-26
Last updated
2026-07-17

Condition(s) studied

Primary Immune ThrombocytopeniaWarm Autoimmune Hemolytic Anemia

Investigational drug(s) / intervention(s)

Ianalumab

Ianalumab: Concentrate for solution for infusion for intravenous use

Study summary

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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
100 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (25)

FacilityCityRegionStatus
Novartis Investigative Site Buenos Aires Argentina Withdrawn
Novartis Investigative Site Roeselare West-Vlaanderen Recruiting
Novartis Investigative Site Guangzhou Guangdong Recruiting
Novartis Investigative Site Dalian Liaoning Recruiting
Novartis Investigative Site Tianjin China Recruiting
Novartis Investigative Site Ostrava Poruba Recruiting
Novartis Investigative Site Caen France Recruiting
Novartis Investigative Site Rennes France Recruiting
Novartis Investigative Site Jena Thuringia Recruiting
Novartis Investigative Site Debrecen Hajdu Bihar Megye Recruiting
Novartis Investigative Site Florence FI Recruiting
Novartis Investigative Site Roma RM Recruiting
Novartis Investigative Site Trieste TS Recruiting
Novartis Investigative Site Vicenza VI Recruiting
Novartis Investigative Site George Town Malaysia Recruiting
Novartis Investigative Site Johor Bahru Malaysia Recruiting
Novartis Investigative Site Kuala Selangor Malaysia Recruiting
Novartis Investigative Site Bucharest Romania Recruiting
Novartis Investigative Site Singapore Singapore Recruiting
Novartis Investigative Site Barcelona Spain Recruiting
Novartis Investigative Site Madrid Spain Recruiting
Novartis Investigative Site Murcia Spain Recruiting
Novartis Investigative Site Samsun Atakum Recruiting
Novartis Investigative Site Ankara Bilkent Cankaya Recruiting
Novartis Investigative Site London United Kingdom Recruiting

More Novartis Pharmaceuticals trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07039422 on ClinicalTrials.gov ↗ ← All trials in China