• Home
  • Study Details
Open

Omalizumab Weight Based Dosing Efficacy

The goal of this study is to learn how well high and low doses of the study drug, omalizumab, work and compare how safe it is to the current dosing scheme with multiple food allergies, regardless of total IgE.

Age & Gender

  • 1 years ~ 55 years
  • Male, Female, Gender Inclusive

Visit Availability

  • Standard business hours (M-F, 8-5)

Location

North Carolina (Statewide)

What will be asked of you

You will be required to attend at least 11 visits to UNC over a 16-week period. Visits will vary in length, and the longest would take around 6 hours. If you agree to participate, you will be asked to come into the research clinic to get an exam, talk about your medical history and food allergies, obtain urine and blood samples, and eat increasing doses of small amounts of your allergen in visits called "Oral Food Challenges". You will return every two weeks to receive the study drug for a total of 12 injections. After the initial 16 weeks, participants will have the option to cross over into the high-dose group for 24 weeks if they are not already in that group.

Incentives

$95 per in person visit, Parking Validation

In-person visits:
11
Phone or online visits:
12
Total length of participation:
At least 4 months but up to 10 months

Looking for Specific Volunteers

Able to participate:

  • Peanut Allergy
  • Milk Allergy
  • Egg Allergy
  • Walnut Allergy
  • Cashew Allergy

Not eligible if:

  • Participated in food immunotherapy in past 6 months
  • Are pregnant, plan to become pregnant, or are breastfeeding
  • Weighing more than 176 lbs at screening
  • Currently receiving oral, IM, or IV corticosteroids, tricyclic antidepressants, or β-blockers
  • Past or current history of cancer, or currently being investigated for possible cancer.

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

Primary Visit Location

Clinical and Translational Research Center (CTRC)
Burnett-Womack Building (UNC-Chapel Hill)
160 Dental Cir, Chapel Hill, NC 27514, USA

Additional Study Information

Principal Investigator

Edwin Kim
Pediatrics - Allergy Immunology and Rheumatology

Study Type

Clinical or Medical
Interventional

Study Topics

Allergy

IRB Number

25-0864

ClinicalTrials.gov

NCT06943534

Research for Me logo

Copyright © 2013-2022 The NC TraCS Institute, the integrated home of the NIH Clinical and Translational Science Awards (CTSA) Program at UNC-CH.  This website is made possible by CTSA Grant UL1TR002489 and the National Center for Advancing Translational Sciences.

Questions?

  • This email address is being protected from spambots. You need JavaScript enabled to view it.
logo for the North Carolina Translational and Clinical Sciences Institute
logo for UNC Health
logo for UNC School of Medicine
logo for UNC Research