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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: Active Phase 3 study of Primary Immune Thrombocytopenia (ITP), sponsored by Novartis Pharmaceuticals.
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, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (71% lower). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
A participant will be considered in SROT-12 if at least 75% of the platelet counts collected between visits Week 53 Day 1 and Week 65 Day 1 (Study Days 352 and 463) qualify as Response. Response is any platelet counts of at least 50 G/L in the absence of rescue treatment or new immune thrombocytopenia (ITP) treatment).
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 |
What the registry record for NCT05653349 still lists
NCT05653349 is an interventional study that assigns participants to a tested intervention. The registered 226 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (71% lower).
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 names 20 study sites across 15 states, led by 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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Where NCT05653349's enrollment target sits among peer trials
226 1310th of 2000 higher than 690 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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