Study of Ianalumab Versus Placebo in Addition to First-line Corticosteroids in Primary Immune Thrombocytopenia (ITP)
Public ClinicalTrials.gov record NCT05653349. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase III, Randomized, Double-blind Study of Ianalumab (VAY736) Versus Placebo in Addition to First-line Corticosteroids in Primary Immune Thrombocytopenia (VAYHIT1)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to evaluate the effect of two different doses of ianalumab versus placebo in addition to first-line corticosteroids in increasing the rate of stable response off treatment at 12 months (SROT-12) in adult participants with primary ITP.
Study identification
- NCT ID
- NCT05653349
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 226 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 100 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 3, 2023 (Actual)
- Primary completion
- Oct 29, 2026 (Estimated)
- Completion
- Jan 5, 2029 (Estimated)
- Last update posted
- Jun 15, 2026
2023 – 2029
United States locations
- U.S. sites
- 20
- U.S. states
- 16
- U.S. cities
- 19
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Yuma Regional Medical Center | Yuma | Arizona | 85349 | — |
| Community Cancer Institute | Clovis | California | 93611 | — |
| Compassionate Care Res Group Inc | Fountain Valley | California | 92708 | — |
| University of Colorado Anschutz | Aurora | Colorado | 80045 | — |
| DH Cancer Research Center LLC | Margate | Florida | 33063 | — |
| Uni of Chi Medi Ctr Hema and Onco | Chicago | Illinois | 60637 | — |
| Parkview Research Center | Fort Wayne | Indiana | 46845 | — |
| Oncology Care Associates | Bethesda | Maryland | 20817 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| Beth Israel Deaconess Med Center | Boston | Massachusetts | 02215 | — |
| Michigan Center of Medical Research | Farmington Hills | Michigan | 48334 | — |
| Mayo Clinic Rochester | Rochester | Minnesota | 55905 | — |
| Metro Minnesota CCOP | Saint Louis Park | Minnesota | 55416 | — |
| St Vincent Frontier Cancer Center | Billings | Montana | 59102 | — |
| Optum Health | Lake Success | New York | 11042 | — |
| Hematology Oncology Association of Rockland | Nyack | New York | 10960 | — |
| STAT Research Inc | Dayton | Ohio | 45402 | — |
| Rhode Island Hospital | Providence | Rhode Island | 02903 | — |
| Mays Cancer Ctr Uthsa Mdacc | San Antonio | Texas | 78229 | — |
| Community Cancer Trials of Utah | Ogden | Utah | 84405 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 91 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05653349, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 15, 2026 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05653349 live on ClinicalTrials.gov.