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NCT05885555 · ClinicalTrials.gov registry record · Phase 2
A Study of Ianalumab (VAY736) in Patients With Primary Immune Thrombocytopenia (ITP) Previously Treated With at Least Two Lines of Therapies
A Phase 2 study of Primary Immune Thrombocytopenia (ITP), sponsored by Novartis Pharmaceuticals.
- Active
- Registry status
- Phase 2
- Development phase
- 41
- Enrollment target
- 20
- Study locations
NCT05885555: Active Phase 2 study of Primary Immune Thrombocytopenia (ITP), sponsored by Novartis Pharmaceuticals.
NCT05885555 is a Phase 2 study of Primary Immune Thrombocytopenia (ITP) that is active but no longer recruiting, run by Novartis Pharmaceuticals. The registered enrollment target is 41 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (69% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05885555, a Phase 2 study of Primary Immune Thrombocytopenia (ITP), is active but no longer recruiting, sponsored by Novartis Pharmaceuticals.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 41 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to evaluate the therapeutic efficacy, safety and tolerability of ianalumab in adult patients with primary ITP previously treated with at least one corticosteroid and one TPO-RA.
Primary Outcome
Confirmed response is defined as a platelet count of equal or above 50 G/L at two (or more) consecutive assessments at least 7 days apart, in the absence of: * Rescue treatment for ≥4 weeks prior to the assessment of the platelet count, and * New immune thrombocytopenia (ITP) treatment before reaching a confirmed response.
Conditions Studied
Interventions
- BIOLOGICAL Ianalumab
Study Locations (20)
Other
- Novartis Investigative Site - CABA
- Novartis Investigative Site - Beijing
- Novartis Investigative Site - Jinan
- Novartis Investigative Site - Toulouse
- Novartis Investigative Site - Giessen
- Novartis Investigative Site - Johor Bahru
- Novartis Investigative Site - Katowice
- Novartis Investigative Site - Seoul
Massachusetts
- Massachusetts General Hospital - Boston
- Beth Israel Deaconess Med Center - Boston
Australian Capital Territory
- Novartis Investigative Site - Garran
Victoria
- Novartis Investigative Site - Melbourne
Hubei
- Novartis Investigative Site - Wuhan
Saxony
- Novartis Investigative Site - Dresden
Thuringia
- Novartis Investigative Site - Jena
TO
- Novartis Investigative Site - Torino
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 41 participants |
| Start Date | 2023-08-16 |
| Est. Completion | 2029-03-19 |
| Phase | Phase 2 |
What the registry record for NCT05885555 still lists
NCT05885555 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 41 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (69% lower).
The record links to 1 condition, with Primary Immune Thrombocytopenia (ITP) appearing as the primary indexed condition, and to 1 intervention - of which Ianalumab is the first listed.
NCT05885555 names 20 study sites across 12 states, led by Other, Massachusetts, Australian Capital Territory.
Frequently Asked Questions
What is clinical trial NCT05885555 about?
NCT05885555 is a clinical study titled "A Study of Ianalumab (VAY736) in Patients With Primary Immune Thrombocytopenia (ITP) Previously Treated With at Least Two Lines of Therapies". The purpose of this study is to evaluate the therapeutic efficacy, safety and tolerability of ianalumab in adult patients with primary ITP previously treated with at least one corticosteroid and one TPO-RA.
What is the current status of trial NCT05885555?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 41 participants. The study started on 2023-08-16. Estimated completion is 2029-03-19.
What conditions does trial NCT05885555 study?
This clinical trial studies the following conditions: Primary Immune Thrombocytopenia (ITP).
What interventions are being tested in trial NCT05885555?
The interventions under investigation include: Ianalumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT05885555?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05885555 being conducted?
This trial has 20 study locations across Massachusetts, Australian Capital Territory, Victoria, Hubei, Saxony. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05885555's enrollment target sits among peer trials
41 1352nd of 2000 higher than 639 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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