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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, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower). 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.
Primary Outcome
The time (in days) to meaningful change in diary-based clinical symptoms as measured by the Urticaria Activity Score (UAS) from baseline (Wk -7 to Day -1) to the date at which an Minimally Important Difference (5 point change in weekly UAS 7) or achievement of \> 50% reduction in daily symptom score for 3 days if in the first week. The UAS score, which is the sum of pruritus and hives, will be used to calculate the UAS7. The UAS7 score obtained 1 week prior to randomization will be used as the b
Interventions
- DRUG Omalizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2017-10-06 |
| Est. Completion | 2020-05-01 |
| Phase | Phase 4 |
What the finished NCT03111628 record still lists
NCT03111628 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 1 intervention - of which Omalizumab is the first listed.
NCT03111628 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03111628's enrollment target sits among peer trials
18 1842nd of 2000 higher than 147 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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