NCT06618963 Effect of Omalizumab in the Skin of Food Allergy Patients
| NCT ID | NCT06618963 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | National Jewish Health |
| Condition | Food Allergy |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2024-10-01 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 40 participants in total. It began in 2024-10-01 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06618963 clinical trial?
This trial is open to participants of all sexes, aged 1 Year or older, up to 55 Years, studying Food Allergy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06618963 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06618963 currently recruiting?
Yes, NCT06618963 is actively recruiting participants. Contact the research team at leungs@njhealth.org for enrollment information.
Where is the NCT06618963 trial being conducted?
This trial is being conducted at Denver, United States.
Who is sponsoring the NCT06618963 clinical trial?
NCT06618963 is sponsored by National Jewish Health. The trial plans to enroll 40 participants.