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 Fayetteville, Arkansas.
- Sponsor
- Novartis Pharmaceuticals
- Study ID
- NCT07421167
- Phase
- PHASE2
- Status
- Recruiting
Conditions
- Primary Evans Syndrome (ES)
- Primary Immune Thrombocytopenia (ITP)
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- ianalumab — BIOLOGICAL9 mg per kilogram infusion every 4 weeks (Q4W) for 16 weeks
- thrombopoietin receptor agonist (TPO-RA) — DRUGIC 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
- Aug 4, 2026
- Status verified
- Aug 2026
- Primary completion
- May 9, 2028
- Completion
- Sep 13, 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
- Novartis Pharmaceuticals1-888-669-6682
- Novartis Pharmaceuticals
Locations (11)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Highlands Oncology Group | Fayetteville | Arkansas | 72703 | Joseph Thaddeus Beck (PRINCIPAL_INVESTIGATOR) |
| Stamford Hospital | Stamford | Connecticut | 06902 | Tiffany Mariscal Joshua Dower (PRINCIPAL_INVESTIGATOR) |
| Baptist MD Anderson Cancer Center | Jacksonville | Florida | 32207 | Jorge Antunez de Mayolo (PRINCIPAL_INVESTIGATOR) |
| DH Cancer Research Center LLC | Margate | Florida | 33063 | Maria Pena Mazyar Rouhani (PRINCIPAL_INVESTIGATOR) |
| University Of Miami | Miami | Florida | 33136 | Gerald Soff (PRINCIPAL_INVESTIGATOR) |
| Hope And Healing Care | Hinsdale | Illinois | 60521 | Asma Jabeen Srilata Gundala (PRINCIPAL_INVESTIGATOR) |
| Mayo Clinic Rochester | Rochester | Minnesota | 55905 | Alexandra Paula Wolanskyj-Spinner (PRINCIPAL_INVESTIGATOR) |
| Intermountain Healthcare | Billings | Montana | 59102 | Cyndi Bowman Patrick Cobb (PRINCIPAL_INVESTIGATOR) |
| Summit Medical Group | Summit | New Jersey | 07901 | Lalitha Anand (PRINCIPAL_INVESTIGATOR) |
| Montefiore Medical Center | The Bronx | New York | 10467 | Irina Murakhovskaya (PRINCIPAL_INVESTIGATOR) |
| Avera Cancer Institute | Sioux Falls | South Dakota | 57106 | Waqas Jehangir (PRINCIPAL_INVESTIGATOR) |
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