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NCT06934200 · ClinicalTrials.gov registry record · Phase 2
Omalizumab for the Treatment of Food Allergy in Patients With Elevated Total IgE Levels
A Phase 2 study of Food Hypersensitivity, sponsored by Johns Hopkins University.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 32
- Enrollment target
- 1
- Study location
NCT06934200: Recruiting Phase 2 study of Food Hypersensitivity, sponsored by Johns Hopkins University.
NCT06934200 is a Phase 2 study of Food Hypersensitivity that is actively recruiting participants, run by Johns Hopkins University. The registered enrollment target is 32 participants, below the 4,656-participant average among 5 other Food Hypersensitivity trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06934200, a Phase 2 study of Food Hypersensitivity, is actively recruiting participants, sponsored by Johns Hopkins University.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 32 participants
- Enrollment target
- 1
- Study location
Study Summary
In this project, the investigators would like to learn if 24 weeks (about 5 and a half months) of omalizumab injections, given every 2 weeks, will be safe and effective for food allergic people who have a total immunoglobulin E (IgE) above the current FDA approved dosing regimen enabling a person to increase tolerance to the food(s) that the person is allergic to. The investigators would also like to learn if participants who demonstrate increased tolerance to food after 24 weeks of omalizumab, can introduce the food into the diet utilizing an additional 8 weeks (about 2 months) of twice weekly omalizumab injections.
Primary Outcome
Consumption of a single dose of 600mg or more of food protein without dose-limiting symptoms during the week 24 Double-blind, Placebo-controlled, Food Challenge
Conditions Studied
Interventions
- DRUG Omalizumab
Study Locations (1)
Maryland
- Johns Hopkins - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2025-05-19 |
| Est. Completion | 2027-10-15 |
| Phase | Phase 2 |
What NCT06934200 shows while recruiting
NCT06934200 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 4,656-participant average among 5 other Food Hypersensitivity trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Food Hypersensitivity appearing as the primary indexed condition, and to 1 intervention - of which Omalizumab is the first listed.
NCT06934200 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT06934200 about?
NCT06934200 is a clinical study titled "Omalizumab for the Treatment of Food Allergy in Patients With Elevated Total IgE Levels". In this project, the investigators would like to learn if 24 weeks (about 5 and a half months) of omalizumab injections, given every 2 weeks, will be safe and effective for food allergic people who have a total immunoglobulin E (IgE) above the current FDA approved dosing regimen enabling a person to...
What is the current status of trial NCT06934200?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 32 participants. The study started on 2025-05-19. Estimated completion is 2027-10-15.
What conditions does trial NCT06934200 study?
This clinical trial studies the following conditions: Food Hypersensitivity.
What interventions are being tested in trial NCT06934200?
The interventions under investigation include: Omalizumab (DRUG).
Who is sponsoring clinical trial NCT06934200?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06934200 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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