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NCT04128371 · ClinicalTrials.gov registry record · Phase 2
Mepolizumab in Episodic Angioedema With Eosinophilia
A Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Terminated
- Registry status
- Phase 2
- Development phase
- 5
- Enrollment target
NCT04128371: Clinical Trial Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT04128371 is a Phase 2 study that was terminated before completion, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 5 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04128371, a Phase 2 study, was terminated before completion, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 5 participants
- Enrollment target
Study Summary
Background: Gleich syndrome is also called episodic angioedema with eosinophilia (EAE). People with EAE have episodes of swelling. They may also have itching, hives, fever, and weight gain. During episodes, the body has very high numbers of white blood cells, especially a kind called eosinophils. Researchers think a drug called mepolizumab could help. Objective: To see if mepolizumab causes EAE symptoms to be less severe and happen less often. Eligibility: People ages 18 or older with EAE. Design: Participants will be screened under NIH protocol 94-I-0079. Participants will have 8 visits over about 6 months. The timing of some visits will depend on each participant s EAE episodes. Visits will include: * Medical history * Physical exam * Blood and urine tests * Optional bone marrow collection at first or second visit. For this, a needle will be inserted through the participant s hip bone into the marrow. Participants will get mepolizumab 3 times over about 3 months. They will get their first dose when their eosinophils are at their lowest point. They will get the drug by IV. A needle will guide a thin plastic tube into an arm vein. The drug will be given through the tube over about 30 minutes. Participants will keep a daily online log for about 3 months. The log will track their weight, temperature, and EAE symptoms. During the whole study, they will complete 2 online questionnaires about their symptoms. They will fill out 1 daily and 1 monthly. Participants will have blood and urine tests 2-3 times a week. For these, they will go to their local doctor.
Primary Outcome
We measure the number and severity of clinical symptoms associated with episodic angioedema with eosinophilia (EAE) using the maximum of the patient reported daily angioedema activity score, a validated patient reported outcome measure. The daily score was used to measure changes in swelling within a cycle. Participants answered 5 questions each day that were scored from 0-3 for each item. The daily score consisted of a minimum score of 0 and a maximum score of 15, the sum of the 5 question answ
Interventions
- BIOLOGICAL mepolizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2021-01-14 |
| Est. Completion | 2022-10-31 |
| Phase | Phase 2 |
Why NCT04128371 stopped before completion
NCT04128371 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 1 intervention - of which mepolizumab is the first listed.
NCT04128371 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04128371 about?
NCT04128371 is a clinical study titled "Mepolizumab in Episodic Angioedema With Eosinophilia". Background: Gleich syndrome is also called episodic angioedema with eosinophilia (EAE). People with EAE have episodes of swelling. They may also have itching, hives, fever, and weight gain. During episodes, the body has very high numbers of white blood cells, especially a kind called eosinophils. R...
What is the current status of trial NCT04128371?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 5 participants. The study started on 2021-01-14. Estimated completion is 2022-10-31.
What interventions are being tested in trial NCT04128371?
The interventions under investigation include: mepolizumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT04128371?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04128371's enrollment target sits among peer trials
5 2000th of 2000 the lowest 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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