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NCT03111628 · ClinicalTrials.gov registry record · Phase 4
Role of Immunoglobulin E (IgE) Bearing Cells in Chronic Idiopathic Urticaria (CIU)
A Phase 4 study, sponsored by Johns Hopkins University.
- Completed
- Registry status
- Phase 4
- Development phase
- 18
- Enrollment target
NCT03111628: Completed Phase 4 study, sponsored by Johns Hopkins University.
NCT03111628 is a Phase 4 study that has completed, run by Johns Hopkins University. The registered enrollment target is 18 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03111628, a Phase 4 study, has completed, sponsored by Johns Hopkins University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 18 participants
- Enrollment target
Study Summary
This is a Phase IV, single-site study that will examine blood cells or tissue obtained from CIU ( chronic idiopathic Urticaria) patients receiving open-label treatment with omalizumab at the current FDA-approved dose of 300 mg/month for 12 weeks in addition to standard therapy with anti-histamines. Results from the 3 Phase III studies in CIU patients provide evidence that a meaningful change in symptoms is apparent at 1-2 wks. The Minimal Important Difference (MID) is achieved by 70% of patients by 2 wks on multiple background drugs for hives. The goal is to identity the IgE bearing cell type associated with clinical symptom change.
Interventions
- DRUG Omalizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2017-10-06 |
| Est. Completion | 2020-05-01 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03111628
The ClinicalTrials.gov registry entry for NCT03111628 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Johns Hopkins University, which has 1,448 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Omalizumab is the first listed.
NCT03111628 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03111628 about?
NCT03111628 is a clinical study titled "Role of Immunoglobulin E (IgE) Bearing Cells in Chronic Idiopathic Urticaria (CIU)". This is a Phase IV, single-site study that will examine blood cells or tissue obtained from CIU ( chronic idiopathic Urticaria) patients receiving open-label treatment with omalizumab at the current FDA-approved dose of 300 mg/month for 12 weeks in addition to standard therapy with anti-histamines. ...
What is the current status of trial NCT03111628?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 18 participants. The study started on 2017-10-06. Estimated completion is 2020-05-01.
What interventions are being tested in trial NCT03111628?
The interventions under investigation include: Omalizumab (DRUG).
Who is sponsoring clinical trial NCT03111628?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
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