Recruiting
Phase 4

Omalizumab

Sponsor:

National Jewish Health

Code:

NCT06618963

Conditions

Food Allergy

Food Allergy in Children

Eligibility Criteria

Sex: All

Age: 1 - 55

Healthy Volunteers: Accepted

Interventions

Omalizumab Injection

Study Details

Brief 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.

Conditions

Food Allergy

Food Allergy in Children

Study ID

NCT06618963

Start date

Oct 1, 2024

Status verified date

Nov, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Nov 3, 2026

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 1 - 55

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Participant and/or parent/legal guardian must be able to understand and provide informed consent and/or assent, as applicable.
  • Male or female, 1-55 years old at screening.
  • Total IgE level within 1 year of screening and weight at screening visit that together result in an eligible omalizumab dose according to the dosing table for FA (Appendix 8).
  • Participant must meet the following clinical FA criteria: Food sensitization to peanut, hen's egg, a tree nut, sesame seed, cow's milk, wheat, or soy, within 1 year of screening AND experience dose-limiting, IgE mediated symptoms at or before 444mg of food protein cumulatively during screening OFC to peanut, hen's egg, a tree nut, sesame seed, cow's milk, wheat, or soy.
  • If female of child-bearing potential, must have a negative urine or serum pregnancy test. If participating as a healthy control, self-report of pregnancy status is acceptable.
  • For women of child-bearing potential, must agree to remain abstinent (refrain from heterosexual intercourse) or use acceptable contraceptive methods (barrier methods or oral, injected, or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy) during the treatment period and for 60 days after the last dose of study drug.
  • Be willing to be trained on the proper use of an epinephrine autoinjector and be willing to always have epinephrine autoinjector immediately available for the duration of the study.

Exclusion Criteria:

  • Inability or unwillingness of a participant and/or parent/legal guardian to give written informed consent and/or assent or comply with the study protocol.
  • Clinically significant laboratory abnormalities at Screening.
  • Sensitivity or suspected/known allergy to any ingredients (including excipients) of the active OFC material (other than the study food), or drugs related to omalizumab (e.g., monoclonal antibodies, polyclonal gamma globulin).
  • Poorly controlled AD at Screening, per the PI's discretion.
  • Poorly controlled or severe asthma/wheezing at Screening
  • History of severe anaphylaxis (defined as neurological compromise or requiring intubation) to a study food that is to be used for qualifying OFC in this study.
  • Treatment with oral, intramuscular (IM), or intravenous (IV) steroids of more than two days for an indication other than asthma/wheezing within 30 days of Screening.
  • Currently receiving oral, IM, or IV corticosteroids, tricyclic antidepressants, or β-blockers (oral or topical).
  • Past or current history of cancer, or currently being investigated for possible cancer.
  • Previous adverse reaction to omalizumab.
  • Past or current history of any immunotherapy to the OFC food (e.g., oral immunotherapy \[OIT\], sublingual immunotherapy \[SLIT\], or patch/epicutaneous immunotherapy \[EPIT)\] within 4 months of Screening.
  • Treatment with monoclonal antibody therapy, such as omalizumab (Xolair®), dupilumab (Dupixent®), benralizumab (Fasenra™), mepolizumab (Nucala®), reslizumab (Cinqair®), or other immunomodulatory therapy within four months of Screening.
  • Currently on "build-up phase" of inhalant allergen immunotherapy (i.e., has not reached maintenance dosing). Individuals tolerating maintenance allergen immunotherapy can be enrolled.
  • Inability to discontinue antihistamines for the minimum wash-out periods required for SPTs or OFCs
  • Current participation in another therapeutic or interventional clinical trial or participation within 90 days of Screening.
  • Use of investigational drugs within 24 weeks of Screening.
  • Pregnant or breastfeeding or intending to become pregnant during the study or within 60 days after the last dose of omalizumab.
  • Have any skin disease other than AD that might compromise the stratum corneum barrier.
  • History of serious life-threatening reaction to tape or adhesives.
  • Healthy Control Participants (non-Food Allergy participants) may not have atopic dermatitis, autoimmune, or other conditions which, in the opinion of the PI, could confound the results of the study assessments or samples.

Study Design

Enrollment

40 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

active comparator: Participants with Food Allergy

This group will receive 4 months of Omalizumab treatment, and undergo regular skin barrier assessments.

no intervention: Participants without Food Allergy

This group will undergo skin barrier assessment.

Interventions

Omalizumab Injection

Omalizumab is a monoclonal antibody FDA-approved for treatment of food allergy.

Primary outcome measure

  • Lipidomic analysis [ Time Frame: 5 months ]
  • Metabolomic analysis [ Time Frame: 5 months ]
  • Proteomic analysis [ Time Frame: 5 months ]
  • Cytokine analysis [ Time Frame: 5 months ]
  • Measurement of Transepidermal Water Loss [ Time Frame: 5 months ]

Central Contacts and Locations

Central contacts

Lead Coordinator

3033981409leungs@njhealth.org

Locations

National Jewish Health

Recruiting

Denver, Colorado, United States, 80206

Contacts

Lead Coordinator

303-398-1409leungs@njhealth.org

More Information

Sponsor

National Jewish Health

Last update posted

Nov 13, 2026

Last verified

Nov, 2026

Keywords

  • Food Allergy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-14. This information was provided to ClinicalTrials.gov by National Jewish Health on 2026-11-13. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.