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NCT04596995 · ClinicalTrials.gov registry record · Phase 3
A Study to Investigate the Long-term Safety, Tolerability, and Efficacy of Rozanolixizumab in Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP)
A Phase 3 study, sponsored by UCB Biopharma SRL.
- Terminated
- Registry status
- Phase 3
- Development phase
- 43
- Enrollment target
NCT04596995: Clinical Trial Phase 3 study, sponsored by UCB Biopharma SRL.
NCT04596995 is a Phase 3 study that was terminated before completion, run by UCB Biopharma SRL. The registered enrollment target is 43 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04596995, a Phase 3 study, was terminated before completion, sponsored by UCB Biopharma SRL.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 43 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the long-term safety, tolerability and clinical efficacy of treatment with rozanolixizumab.
Primary Outcome
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of investigational medicinal product (IMP), whether or not considered related to the IMP. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of IMP. TEAEs are defined as AEs starting after the time of first IMP administration up to and
Interventions
- DRUG Rozanolixizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2021-01-06 |
| Est. Completion | 2022-12-21 |
| Phase | Phase 3 |
Why NCT04596995 stopped before completion
NCT04596995 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 43 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 1 intervention - of which Rozanolixizumab is the first listed.
NCT04596995 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04596995 about?
NCT04596995 is a clinical study titled "A Study to Investigate the Long-term Safety, Tolerability, and Efficacy of Rozanolixizumab in Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP)". The purpose of this study is to assess the long-term safety, tolerability and clinical efficacy of treatment with rozanolixizumab.
What is the current status of trial NCT04596995?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 43 participants. The study started on 2021-01-06. Estimated completion is 2022-12-21.
What interventions are being tested in trial NCT04596995?
The interventions under investigation include: Rozanolixizumab (DRUG).
Who is sponsoring clinical trial NCT04596995?
This trial is sponsored by UCB Biopharma SRL, which has 82 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04596995's enrollment target sits among peer trials
43 1876th of 2000 higher than 124 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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