Effect of Omalizumab in the Skin of Food Allergy Patients

NCT06618963 | Recruiting Phase 4 FDA Drug

• 1 other identifier: RO-IIS-1660
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

Food Allergy

Outcome Measures

Primary Outcomes (5)

• Lipidomic analysis

  Lipid measurements from Skin Tape Strips (STS), as detected at respective m/z from mass spectrometry

  5 months

• Metabolomic analysis

  Metabolomics from STS, evaluated as a relative signal proportion of metabolites against the sum of all signals in the samples

  5 months

• Proteomic analysis

  Proteomics from STS, comparison of global protein expression before vs after omalizumab treatment

  5 months

• Cytokine analysis

  Cytokine levels from STS measured using preconfigured multiplex assays normalized to the total protein in each sample. Cytokines that will be measured: IL-1a, IL-1b, IL-18, IL-6, IL-8, TARC, MDC, TSLP, IL-33, IL-4, IL-13, IL-22, IL-31, eotaxins, IL-10, IL-17A/F, IL-17C, IL-12p70, IL-23, IP-10

  5 months

• Measurement of Transepidermal Water Loss

  Transepidermal Water Loss (TEWL) is measured by the loss through the skin of grams of water per square meter per hour (g/m\^2/h).

  5 months

Secondary Outcomes (5)

• Measurement of Transepidermal Water Loss in non Food-Allergic Subjects

  5 months

• Lipidomic analysis in non Food-Allergic participants

  5 months

• Metabolomic analysis in non Food-Allergic Participants

  5 months

• Proteomic analysis in non Food-Allergic Participants

  5 months

• Cytokine analysis

  5 months

Study Arms (2)

Participants with Food Allergy

ACTIVE COMPARATOR

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

Drug: Omalizumab Injection

Participants without Food Allergy

NO INTERVENTION

This group will undergo skin barrier assessment.

Interventions

Omalizumab Injection DRUG

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

Also known as: Xolair

Participants with Food Allergy

Eligibility Criteria

• Age: 1 Year - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Jewish Health: lead
• Roche-Genentech: collaborator

Study Sites (1)

National Jewish Health

Denver, Colorado, 80206, United States

RECRUITING

MeSH Terms

Conditions

Food Hypersensitivity

Interventions

Omalizumab

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Anti-Idiotypic; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Serum Globulins; Globulins

Central Study Contacts

Lead Coordinator

CONTACT

3033981409; leungs@njhealth.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 30 subjects with food allergy 10 subjects without food allergy

Study Record Dates

• First Submitted: September 18, 2024
• First Posted: October 1, 2024
• Study Start: October 1, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 2, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)