Omalizumab Weight-Based Dosing Efficacy Trial

NCT06943534 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-02-05

No results posted yet for this study

Summary

This research is being conducted to assess the safety and effectiveness of increased dosing of Omalizumab for food allergies.

Conditions

Interventions

DRUG

5mg/kg omalizumab injection

5mg/kg of omalizumab

DRUG

15mg/kg omalizumab injection

15mg/kg of omalizumab

Sponsors & Collaborators

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Wayne Shreffler, MD, PhD · Massachusetts General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-03
Primary Completion
2027-05-01
Completion
2028-04-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06943534 on ClinicalTrials.gov