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Study of Ianalumab Versus Placebo in Addition to First-line Corticosteroids in Primary Immune Thrombocytopenia (ITP)
NCT05653349 · View on ClinicalTrials.gov ↗
Study Summary
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 maintaining platelet count ≥30 G/L in adult participants with primary ITP.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Corticosteroids
- BIOLOGICAL Ianalumab
Study Locations (20)
California
- Community Cancer Institute — Clovis
- Compassionate Care Res Group Inc — Fountain Valley
Massachusetts
- Massachusetts General Hospital — Boston
- Beth Israel Deaconess Med Center — Boston
Minnesota
- Mayo Clinic Rochester — Rochester
- Metro Minnesota CCOP — Saint Louis Park
New York
- Clinical Research Alliance — Lake Success
- Hematology Oncology Association of Rockland — Nyack
Ohio
- Cleveland Clinic Foundation — Cleveland
- STAT Research Inc — Dayton
Arizona
- Yuma Regional Medical Center — Yuma
Colorado
- University of Colorado Anschutz — Aurora
Florida
- DH Cancer Research Center LLC — Margate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 226 participants |
| Start Date | 2023-02-03 |
| Est. Completion | 2028-09-07 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05653349
The ClinicalTrials.gov registry entry for NCT05653349 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 226 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 792 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Primary Immune Thrombocytopenia (ITP) appearing as the primary indexed condition, and to 3 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05653349 reports 20 study locations spanning 15 distinct geographic areas — top geographies include California, Massachusetts, Minnesota. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05653349 about?
NCT05653349 is a clinical study titled "Study of Ianalumab Versus Placebo in Addition to First-line Corticosteroids in Primary Immune Thrombocytopenia (ITP)". 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 maintaining platelet count ≥30 G/L in adult participants with primary ITP.
What is the current status of trial NCT05653349?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 226 participants. The study started on 2023-02-03. Estimated completion is 2028-09-07.
What conditions does trial NCT05653349 study?
This clinical trial studies the following conditions: Primary Immune Thrombocytopenia (ITP). These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05653349?
The interventions under investigation include: Placebo (DRUG), Corticosteroids (DRUG), Ianalumab (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05653349?
This trial is sponsored by Novartis Pharmaceuticals, which has 792 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05653349 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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