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NCT06618963 · ClinicalTrials.gov registry record · Phase 4
Effect of Omalizumab in the Skin of Food Allergy Patients
A Phase 4 study of Food Allergy and Food Allergy in Children, sponsored by National Jewish Health.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT06618963: Recruiting Phase 4 study of Food Allergy and Food Allergy in Children, sponsored by National Jewish Health.
NCT06618963 is a Phase 4 study of Food Allergy and Food Allergy in Children that is actively recruiting participants, run by National Jewish Health. The registered enrollment target is 40 participants, below the 962-participant average among 17 other Food Allergy trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06618963, a Phase 4 study of Food Allergy and Food Allergy in Children, is actively recruiting participants, sponsored by National Jewish Health.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study Summary
The goal of this interventional study is to evaluate whether skin barrier abnormalities occur in subjects with a food allergy, as determined by positive oral food challenge (OFC). The main question it aims to answer is whether these skin barrier abnormalities can be reversed by omalizumab. If there is a comparison group: Researchers will compare non-food allergic participants (who do not receive omalizumab) to see if they experience skin barrier abnormalities. All food allergic participants will receive 4 months of Omalizumab treatment as well as two Oral Food Challenges. Participants will all undergo skin barrier assessments.
Primary Outcome
Lipid measurements from Skin Tape Strips (STS), as detected at respective m/z from mass spectrometry
Conditions Studied
Interventions
- DRUG Omalizumab Injection
Study Locations (1)
Colorado
- National Jewish Health - Denver
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2024-10-01 |
| Est. Completion | 2026-12 |
| Phase | Phase 4 |
What NCT06618963 shows while recruiting
NCT06618963 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 962-participant average among 17 other Food Allergy trials with a reported enrollment target (96% lower).
The record links to 2 conditions, with Food Allergy appearing as the primary indexed condition, and to 1 intervention - of which Omalizumab Injection is the first listed.
NCT06618963 reports a single indexed study location in Colorado.
Frequently Asked Questions
What is clinical trial NCT06618963 about?
NCT06618963 is a clinical study titled "Effect of Omalizumab in the Skin of Food Allergy Patients". The goal of this interventional study is to evaluate whether skin barrier abnormalities occur in subjects with a food allergy, as determined by positive oral food challenge (OFC). The main question it aims to answer is whether these skin barrier abnormalities can be reversed by omalizumab. If there...
What is the current status of trial NCT06618963?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 40 participants. The study started on 2024-10-01. Estimated completion is 2026-12.
What conditions does trial NCT06618963 study?
This clinical trial studies the following conditions: Food Allergy, Food Allergy in Children.
What interventions are being tested in trial NCT06618963?
The interventions under investigation include: Omalizumab Injection (DRUG).
Who is sponsoring clinical trial NCT06618963?
This trial is sponsored by National Jewish Health, which has 83 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06618963 being conducted?
This trial has 1 study location across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Food Allergy
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06618963's enrollment target sits among peer trials
40 11th of 17 higher than 7 of 17 other Food Allergy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Food Allergy 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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