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NCT06943534 · ClinicalTrials.gov registry record · Phase 2
Omalizumab Weight-Based Dosing Efficacy Trial
A Phase 2 study of Food Allergy and Allergies, sponsored by Massachusetts General Hospital.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
- 3
- Study locations
NCT06943534: Recruiting Phase 2 study of Food Allergy and Allergies, sponsored by Massachusetts General Hospital.
NCT06943534 is a Phase 2 study of Food Allergy and Allergies that is actively recruiting participants, run by Massachusetts General Hospital. The registered enrollment target is 30 participants, below the 962-participant average among 17 other Food Allergy trials with a reported enrollment target (97% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06943534, a Phase 2 study of Food Allergy and Allergies, is actively recruiting participants, sponsored by Massachusetts General Hospital.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
- 3
- Study locations
Study Summary
This research is being conducted to assess the safety and effectiveness of increased dosing of Omalizumab for food allergies.
Primary Outcome
The primary analysis of outcome is on the proportion of subjects tolerating at least 600 mg at the post-treatment OFC in either group against the expected outcome without treatment based on OUTMATCH data.
Conditions Studied
Interventions
- DRUG 5mg/kg omalizumab injection
- DRUG 15mg/kg omalizumab injection
Study Locations (3)
Massachusetts
- Massachusetts General Hospital - Boston
North Carolina
- University of North Carolina at Chapel Hill - Chapel Hill
Texas
- University of Texas Southwestern - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2025-07-03 |
| Est. Completion | 2028-04-01 |
| Phase | Phase 2 |
What NCT06943534 shows while recruiting
NCT06943534 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 962-participant average among 17 other Food Allergy trials with a reported enrollment target (97% lower).
The record links to 2 conditions, with Food Allergy appearing as the primary indexed condition, and to 2 interventions - of which 5mg/kg omalizumab injection is the first listed.
NCT06943534 reports a single indexed study location in Massachusetts, North Carolina, Texas.
Frequently Asked Questions
What is clinical trial NCT06943534 about?
NCT06943534 is a clinical study titled "Omalizumab Weight-Based Dosing Efficacy Trial". This research is being conducted to assess the safety and effectiveness of increased dosing of Omalizumab for food allergies.
What is the current status of trial NCT06943534?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2025-07-03. Estimated completion is 2028-04-01.
What conditions does trial NCT06943534 study?
This clinical trial studies the following conditions: Food Allergy, Allergies.
What interventions are being tested in trial NCT06943534?
The interventions under investigation include: 5mg/kg omalizumab injection (DRUG), 15mg/kg omalizumab injection (DRUG).
Who is sponsoring clinical trial NCT06943534?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06943534 being conducted?
This trial has 3 study locations across Massachusetts, North Carolina, Texas. 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 NCT06943534's enrollment target sits among peer trials
30 14th of 17 higher than 3 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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