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NCT05653219 · ClinicalTrials.gov registry record · Phase 3

A Study of Efficacy and Safety of Ianalumab Versus Placebo in Addition to Eltrombopag in Primary Immune Thrombocytopenia Patients Who Failed Steroids

A Phase 3 study of Primary Immune Thrombocytopenia, sponsored by Novartis Pharmaceuticals.

Active
Registry status
Phase 3
Development phase
152
Enrollment target
20
Study locations

NCT05653219: Active Phase 3 study of Primary Immune Thrombocytopenia, sponsored by Novartis Pharmaceuticals.

NCT05653219 is a Phase 3 study of Primary Immune Thrombocytopenia that is active but no longer recruiting, run by Novartis Pharmaceuticals. The registered enrollment target is 152 participants, above the 102-participant average among 4 other Primary Immune Thrombocytopenia trials with a reported enrollment target (49% higher). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05653219, a Phase 3 study of Primary Immune Thrombocytopenia, is active but no longer recruiting, sponsored by Novartis Pharmaceuticals.

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
152 participants
Enrollment target
20
Study locations

Study Summary

The purpose of this study is to evaluate the effect of two different doses of ianalumab added to eltrombopag to prolong Time to Treatment Failure (TTF) in adults with primary ITP who failed previous first-line treatment with steroids.

Primary Outcome

Time from randomization until treatment failure is defined as the time from randomization date until the first of the following events indicative of treatment failure: * platelet count below 30 G/L * start of a new ITP treatment * need for a rescue treatment * ineligibility to taper or inability to discontinue eltrombopag * death

Conditions Studied

Primary Immune Thrombocytopenia

Interventions

  • DRUG Placebo
  • DRUG Eltrombopag
  • BIOLOGICAL Ianalumab

Study Locations (20)

Other

  • Novartis Investigative Site - CABA
  • Novartis Investigative Site - Vienna
  • Novartis Investigative Site - Beijing
  • Novartis Investigative Site - Jinan
  • Novartis Investigative Site - Tianjin

Massachusetts

  • Boston Medical Center - Boston
  • UMASS Memorial Medical Center - Worcester

New York

  • Hematology Oncology Association of Rockland - Nyack
  • Montefiore Medical Center - The Bronx

Arizona

  • Yuma Regional Medical Center - Yuma

Colorado

  • University of Colorado Anschutz - Aurora

Illinois

  • NorthShore University Health System - Evanston

Michigan

  • Michigan Center of Medical Research - Farmington Hills

Montana

  • St Vincent Frontier Cancer Center - Billings

Trial Details

FieldValue
Enrollment Target 152 participants
Start Date 2023-02-02
Est. Completion 2028-04-08
Phase Phase 3
Novartis Pharmaceuticals

1,375 total trials

What the registry record for NCT05653219 still lists

NCT05653219 is an interventional study that assigns participants to a tested intervention. The registered 152 participants enrollment target is mid-sized for trials with a published cap, above the 102-participant average among 4 other Primary Immune Thrombocytopenia trials with a reported enrollment target (49% higher).

The record links to 1 condition, with Primary Immune Thrombocytopenia appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.

NCT05653219 names 20 study sites across 14 states, led by Other, Massachusetts, New York.

Frequently Asked Questions

What is clinical trial NCT05653219 about?

NCT05653219 is a clinical study titled "A Study of Efficacy and Safety of Ianalumab Versus Placebo in Addition to Eltrombopag in Primary Immune Thrombocytopenia Patients Who Failed Steroids". The purpose of this study is to evaluate the effect of two different doses of ianalumab added to eltrombopag to prolong Time to Treatment Failure (TTF) in adults with primary ITP who failed previous first-line treatment with steroids.

What is the current status of trial NCT05653219?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 152 participants. The study started on 2023-02-02. Estimated completion is 2028-04-08.

What conditions does trial NCT05653219 study?

This clinical trial studies the following conditions: Primary Immune Thrombocytopenia.

What interventions are being tested in trial NCT05653219?

The interventions under investigation include: Placebo (DRUG), Eltrombopag (DRUG), Ianalumab (BIOLOGICAL).

Who is sponsoring clinical trial NCT05653219?

This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05653219 being conducted?

This trial has 20 study locations across Arizona, Colorado, Illinois, Massachusetts, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Related registry views

Source: ClinicalTrials.gov NCT05653219, the US trial registry maintained by the National Library of Medicine. NCT05653219 (mid enrollment · wide site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.