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New treatment option for Food Allergy
Official title Effect of Omalizumab in the Skin of Food Allergy Patients
ClinicalTrials.gov ID: NCT06618963
What this study is testing
What is Omalizumab Injection?
Omalizumab Injection is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for food allergy.
Also referred to as Xolair.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Time commitment: about 12 months
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 to 55. Healthy volunteers may be eligible.
You may be able to join 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...
- 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...
- If female of child-bearing potential, must have a negative urine or serum pregnancy test. If participating as a healthy control, self-report of...
You likely can't join 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...
- 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...
- 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...
See the full eligibility 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...
- 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...
- 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.
- 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...
- 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...
- 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 treatment 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...
The study team makes the final eligibility decision.
Where it's taking place
- Denver, Colorado, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 12 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 1 year to 55 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Denver, Colorado, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.