Recruiting
Phase 2

Ianalumab with IC TPO-RA

Sponsor:

Novartis Pharmaceuticals

Code:

NCT07421167

Conditions

Primary Immune Thrombocytopenia (ITP)

Primary Evans Syndrome (ES)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

ianalumab

thrombopoietin receptor agonist (TPO-RA)

Study Details

Brief summary:

The purpose of this study is to investigate the tolerability of ianalumab (9 mg/kg) with investigator's choice thrombopoietin receptor agonist (IC TPO-RA) in participants diagnosed with primary immune thrombocytopenia (ITP) who have been treated with at least one but no more than four prior treatments, and with no change in IC TPO-RA dose in at least the last 14 days prior to the start of ianalumab.

Conditions

Primary Immune Thrombocytopenia (ITP)

Primary Evans Syndrome (ES)

Study ID

NCT07421167

Start date

Aug 4, 2026

Status verified date

Aug, 2026

Completion date

Sep 13, 2030

Anticipated

Primary completion date

May 9, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Key Inclusion Criteria:

  • Signed informed consent must be obtained prior to participation in the study.
  • Patients aged 18 years and older on the day of signing the informed consent.
  • ITP cohort only: Confirmed diagnosis of primary ITP that has previously responded to corticosteroid treatment or IVIG treatment but the response was not sustained (response is defined as a platelet count ≥ 50 G/L).
  • ITP cohort only: Received at least one prior treatment for ITP.
  • ITP cohort only: Patients with a platelet count < 100 G/L who are receiving a TPO-RA. Patients may already be receiving a TPO-RA or may start a TPO-RA at the time of screening. All patients should be on a stable dose of TPO-RA for at least 14 days prior to first dose of ianalumab. Note: during the screening period, a documented assessment of platelets < 100 G/L is mandatory for enrollment. For patients who received rescue medication before screening, platelet count results obtained prior to the start of the rescue therapy should be used to assess eligibility if collected within 14 days prior to screening.
  • ES cohort only: Patients with clinical diagnosis of primary ES with active thrombocytopenia (< 100 G/L) with warm autoimmune hemolytic anemia (wAIHA) for whom a TPO-RA is appropriate per Investigator.
  • ES cohort only: Inadequate response to or relapse after treatment with corticosteroid therapy.
  • ES cohort only: Diagnosis confirmed by current or past positive direct antiglobulin test (DAT) (IgG+, with or without C3+) and evidence of hemolysis.
  • ES cohort only: any supportive care treatment administered for wAIHA must be stable for at least 4 weeks prior to enrollment.

Key Exclusion Criteria:

  • Patients being treated with TPO-RA for > 6 months.
  • Current life-threatening bleeding (related to thrombocytopenia).
  • Prior splenectomy within 6 months of first administration of ianalumab.
  • Patients with the following laboratory abnormalities:

  • Neutrophils: < 1000/mm3
  • Serum creatinine > 1.5 × upper limit of normal (ULN)
  • Aspartate aminotransferase (AST) > 3.0 × ULN
  • Alanine aminotransferase (ALT) > 3.0 × ULN
  • Immunoglobulin G (IgG) < 5 g/L
  • ITP cohort only: hemoglobin < 10 g/L, total bilirubin > 1.5 × ULN
  • Patients with significantly compromised liver disease (Child-Pugh 7 to 9) and decompensated liver disease (Child-Pugh 10 to 15).
  • Treatment with a B-cell depleting therapy (e.g. rituximab or anti-B cell Activating Factor (e.g. belimumab) within 12 weeks prior to the first administration of ianalumab. Patients who are refractory to rituximab will be excluded from this trial, where refractory is defined as:

\~ Patients who have not achieved a response (defined as platelet count ≥ 30 G/L and at least doubling from baseline within 12 weeks in the absence of rescue therapy) following completion of a standard course of rituximab
  • History of hypersensitivity to any of the study treatments or its excipients or to drugs of similar chemical classes.
  • Known history of primary or secondary immunodeficiency, or a positive human immunodeficiency virus (HIV) enzyme-linked immunosorbent assay (ELISA) and Western blot) test result.
  • Patients exposed to more than 4 prior treatments for ITP.
  • ITP cohort only: Diagnosis of secondary thrombocytopenia.
  • ITP cohort: Use of immunosuppressant drugs other than corticosteroids or rituximab.
  • ES cohort only: Diagnosis of secondary ES.
  • ES cohort only: Life-threatening hemolysis.
  • ES cohort only: patients with autoimmune hemolytic anemia other than wAIHA

Study Design

Enrollment

164 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Main cohort: Primary immune thrombocytopenia (ITP)

All participants will be assigned to ianalumab 9 mg/kg plus investigator's choice thrombopoietin receptor agonist (IC TPO-RA).

experimental: Exploratory cohort: Primary Evans syndrome (ES)

All participants will be assigned to ianalumab 9 mg/kg plus investigator's choice thrombopoietin receptor agonist (IC TPO-RA).

Interventions

ianalumab

9 mg per kilogram infusion every 4 weeks (Q4W) for 16 weeks

thrombopoietin receptor agonist (TPO-RA)

IC TPO-RAs will be administered according to the respective United States Prescribing Information (USPIs)

Primary outcome measure

  • (Main cohort: Primary immune thrombocytopenia (ITP)): Percentages of participants who are tolerable to ianalumab (9 mg/kg) [ Time Frame: Up to Week 16 ]

Central Contacts and Locations

Central contacts

Novartis Pharmaceuticals

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

Novartis Pharmaceuticals

novartis.email@novartis.com

Locations

Highlands Oncology Group

Recruiting

Fayetteville, Arkansas, United States, 72703

Contacts

Connor Ray

+1 479 587 1700JRay@hogonc.com

Principal Investigator:

Joseph Thaddeus Beck

Stamford Hospital

Recruiting

Stamford, Connecticut, United States, 06902

Contacts

Tiffany Mariscal

tmariscal@stamhealth.org

Principal Investigator:

Joshua Dower

Baptist MD Anderson Cancer Center

Recruiting

Jacksonville, Florida, United States, 32207

Contacts

Seth Waller

614-657-1463seth.waller@bmcjax.com

Principal Investigator:

Jorge Antunez de Mayolo

DH Cancer Research Center LLC

Recruiting

Margate, Florida, United States, 33063

Contacts

Maria Pena

mpena@nrcinc.com

Principal Investigator:

Mazyar Rouhani

University Of Miami

Recruiting

Miami, Florida, United States, 33136

Contacts

Tania Rodriguez

305-243-1169txr308@med.miami.edu

Principal Investigator:

Gerald Soff

Hope And Healing Care

Recruiting

Hinsdale, Illinois, United States, 60521

Contacts

Asma Jabeen

ajabeen@hopenheal.care

Principal Investigator:

Srilata Gundala

Mayo Clinic Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Aaron Littlefield

+1 507 284 2467littlefield.aaron@mayo.edu

Principal Investigator:

Alexandra Paula Wolanskyj-Spinner

Intermountain Healthcare

Recruiting

Billings, Montana, United States, 59102

Contacts

Cyndi Bowman

cyndi.bowman@imail.org

Principal Investigator:

Patrick Cobb

Summit Medical Group

Recruiting

Summit, New Jersey, United States, 07901

Contacts

Michelle Mackenzie

973-436-1755mmackenzie@summithealth.com

Principal Investigator:

Lalitha Anand

Montefiore Medical Center

Recruiting

The Bronx, New York, United States, 10467

Contacts

Akhil Aakunuri

718-405-8427aaakunuri@montefiore.org

Principal Investigator:

Irina Murakhovskaya

Avera Cancer Institute

Recruiting

Sioux Falls, South Dakota, United States, 57106

Contacts

Caleb Brouwer

605-322-3000caleb.brouwer@avera.org

Principal Investigator:

Waqas Jehangir

More Information

Sponsor

Novartis Pharmaceuticals

Last update posted

Aug 25, 2026

Last verified

Aug, 2026

Keywords

  • Immune thrombocytopenia (ITP)
  • Evans syndrome (ES)
  • Ianalumab
  • VAY736
  • B-cell depletion
  • B-cell Activating Factor Receptor (BAFF-R)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-04. This information was provided to ClinicalTrials.gov by Novartis Pharmaceuticals on 2026-08-25.