A Study to Assess the Tolerability of Ianalumab (VAY736) With Investigator's Choice Thrombopoietin Receptor Agonist (IC TPO-RA) in Patients With Primary Immune Thrombocytopenia (ITP)

Part of paid clinical trials in Stamford, Connecticut.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT07421167
Phase
PHASE2
Status
Recruiting
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Conditions

  • Primary Evans Syndrome (ES)
  • Primary Immune Thrombocytopenia (ITP)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ianalumab — BIOLOGICAL
    9 mg per kilogram infusion every 4 weeks (Q4W) for 16 weeks
  • thrombopoietin receptor agonist (TPO-RA) — DRUG
    IC TPO-RAs will be administered according to the respective United States Prescribing Information (USPIs)

Study Details

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.

Key Dates

First listed
Feb 19, 2026
Start date
Jun 29, 2026
Status verified
Jul 2026
Primary completion
Apr 1, 2028
Completion
Aug 10, 2030

Study Design

Enrollment
164 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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).

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

Locations (5)

FacilityCityStateZIPSite coordinators
Stamford HospitalStamfordConnecticut06902
Tiffany Mariscal
[email protected]
Joshua Dower (PRINCIPAL_INVESTIGATOR)
Baptist MD Anderson Cancer CenterJacksonvilleFlorida32207
Seth Waller
[email protected]
614-657-1463
Jorge Antunez de Mayolo (PRINCIPAL_INVESTIGATOR)
DH Cancer Research Center LLCMargateFlorida33063
Mazyar Rouhani (PRINCIPAL_INVESTIGATOR)
Hope And Healing CareHinsdaleIllinois60521
Srilata Gundala (PRINCIPAL_INVESTIGATOR)
Summit Medical GroupSummitNew Jersey07901
Michelle Mackenzie
[email protected]
973-436-1755
Lalitha Anand (PRINCIPAL_INVESTIGATOR)

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Stamford Hospital· Stamford, CTBaptist MD Anderson Cancer Center· Jacksonville, FLDH Cancer Research Center LLC· Margate, FLHope And Healing Care· Hinsdale, ILSummit Medical Group· Summit, NJ

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