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NCT05653349 · ClinicalTrials.gov registry record · Phase 3
Study of Ianalumab Versus Placebo in Addition to First-line Corticosteroids in Primary Immune Thrombocytopenia (ITP)
A Phase 3 study of Primary Immune Thrombocytopenia (ITP), sponsored by Novartis Pharmaceuticals.
- Active
- Registry status
- Phase 3
- Development phase
- 226
- Enrollment target
- 20
- Study locations
NCT05653349 is a Phase 3 study of Primary Immune Thrombocytopenia (ITP) that is active but no longer recruiting, run by Novartis Pharmaceuticals. The registered enrollment target is 226 participants. The trial reports 20 study locations across 15 states.
The verdict
NCT05653349, a Phase 3 study of Primary Immune Thrombocytopenia (ITP), is active but no longer recruiting, sponsored by Novartis Pharmaceuticals.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 226 participants
- Enrollment target
- 20
- Study locations
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 |
Interested in This Trial?
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, categorized as Phase 3. 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 1,375 total studies on file at ClinicalTrials.gov.
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.
NCT05653349 reports 20 study locations spanning 15 distinct geographic areas - top geographies include California, Massachusetts, Minnesota.
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).
What interventions are being tested in trial NCT05653349?
The interventions under investigation include: Placebo (DRUG), Corticosteroids (DRUG), Ianalumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT05653349?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.