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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

Omalizumab Before Onset of Exacerbations

Omalizumab Before Onset of Exacerbations (NCT05332067) is a Phase 2 interventional studying Asthma in Children and Atopy, sponsored by Children's National Research Institute. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

OBOE is a prospective, pilot, parallel group RCT with the overall aim of examining the effect of a single dose of anti-IgE (omalizumab) vs. placebo administered at the onset of URIs in the fall season among highly exacerbation-prone, urban, and atopic youth aged 6-17 years with persistent asthma. OBOE will recruit and randomize participants over 3 years (3 annual cohorts of participants). Recruitment for each of the yearly cohorts of OBOE will begin in February. Each cohort will be followed for a 2-6-month run-in period with the objective to gain control of each participant's asthma and to stabilize the required controller medication step level. Participants will receive routine asthma care every 1-2 months (a total of 2-4 times) during run-in using a previously described algorithm developed by the Inner-city Asthma Consortium and successfully employed in the PROSE study. The primary outcome is the change in the amount of nasal IFN-α recovered by nasal fluid absorption between two time points, within 72 hours of onset of a URI as defined by onset of (or substantial worsening of) rhinorrhea, nasal congestion or sneezing (single or multiple symptoms) and 3-6 days after study drug injection.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Asthma in Children and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

A target enrollment of 300 participants makes this a sizable late-stage trial. Studies in this range typically have enough power to detect clinically meaningful differences from a comparator and to characterize less-common side effects.

Who May Be Eligible (Plain English)

Inclusion Criteria at Study Entry: Participants must meet the following: 1. Parent or guardian must be able to understand and provide willing to sign a consent form in English and participants ≥7 must be able to provide assent 2. 6-17 years, inclusive at time of screening 3. Physician-diagnosed persistent asthma 4. ≥1 exacerbation of asthma requiring systemic corticosteroids in the 6-month period before the planned start of the participant's upcoming school year or ≥2 exacerbations of asthma requiring systemic corticosteroids in the 12-month period before the planned start of the participant's upcoming school year 5. Sensitization to ≥1 perennial aeroallergen 6. Total serum IgE and weight appropriate for omalizumab dosing 7. Insurance that covers standard of care medications 8. Primary family residence (home where child sleeps a majority of nights) in a Metropolitan Statistical Area where ≥10% of families have income below poverty line and/or publicly funded health insurance 9. At least one of the following criteria: 1. peripheral eosinophilia \>300µL 2. total serum IgE \>300kU/L 3. sensitization to ≥3 perennial aeroallergens 10. Females of childbearing potential must have a negative pregnancy test upon study entry 11. Females with reproductive potential must agree to use FDA approved methods of birth control for the duration of the study Additional Inclusion Criteria (these must be met prior to randomization at the fall season sick visit A (SVa) during the 90-day outcome period): In order to be eligible for randomization at the SVa visit, participants must also meet all of the following criteria: 1. Reporting onset of URI symptoms within 72 hours prior to SVa, confirmed by the study physician 2. Report no use of nasal corticosteroids or nasal vaccinations within 14 days prior to SVa 3. Have a negative rapid nasal swab antigen test for SARS-CoV-2 4. Be more than 14 days from the onset of any previous asthma exacerbation requiring systemic steroids ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria at Study Entry: Participants must meet the following: 1. Parent or guardian must be able to understand and provide informed consent in English and participants ≥7 must be able to provide assent 2. 6-17 years, inclusive at time of screening 3. Physician-diagnosed persistent asthma 4. ≥1 exacerbation of asthma requiring systemic corticosteroids in the 6-month period before the planned start of the participant's upcoming school year or ≥2 exacerbations of asthma requiring systemic corticosteroids in the 12-month period before the planned start of the participant's upcoming school year 5. Sensitization to ≥1 perennial aeroallergen 6. Total serum IgE and weight appropriate for omalizumab dosing 7. Insurance that covers standard of care medications 8. Primary family residence (home where child sleeps a majority of nights) in a Metropolitan Statistical Area where ≥10% of families have income below poverty line and/or publicly funded health insurance 9. At least one of the following criteria: 1. peripheral eosinophilia \>300µL 2. total serum IgE \>300kU/L 3. sensitization to ≥3 perennial aeroallergens 10. Females of childbearing potential must have a negative pregnancy test upon study entry 11. Females with reproductive potential must agree to use FDA approved methods of birth control for the duration of the study Additional Inclusion Criteria (these must be met prior to randomization at the fall season sick visit A (SVa) during the 90-day outcome period): In order to be eligible for randomization at the SVa visit, participants must also meet all of the following criteria: 1. Reporting onset of URI symptoms within 72 hours prior to SVa, confirmed by the study physician 2. Report no use of nasal corticosteroids or nasal vaccinations within 14 days prior to SVa 3. Have a negative rapid nasal swab antigen test for SARS-CoV-2 4. Be more than 14 days from the onset of any previous asthma exacerbation requiring systemic steroids 5. Have no current lower respiratory symptoms that, in the opinion of the study physician, require systemic corticosteroid treatment 6. Complete collection of nasal absorption sample within 72 hours of onset URI \[defined by onset of (or substantial worsening of) rhinorrhea, nasal congestion or sneezing (single or multiple symptoms)\] as determined by the study physician's assessment at the SVa visit Exclusion Criteria: 1. Inability or unwillingness of a participant's parent or guardian to give written informed consent or comply with study protocol or inability or unwillingness of a participant ≥7 to provide assent 2. Contraindication to receipt of omalizumab 3. Presence of a second chronic medical condition (including but not limited to serious cardiorespiratory disorders, cancer, sickle cell disease, uncontrolled seizure disorder, auto-immune disorders, or type 1 diabetes) 4. Pregnancy or active lactation 5. History of latex allergy 6. Treatment with omalizumab or other monoclonal antibody, or aeroallergen immunotherapy in the prior six months 7. Plan for home schooling during the 90-day outcome period 8. History of life-threatening asthma defined by requirement for intubation or cardiorespiratory arrest 9. Inability of primary caregiver and child to speak English 10. In the opinion of the investigator, participant will not be able to wean from nasal steroids or to avoid nasal vaccinations during the 90-day fall outcome period 11. Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study

Treatments Being Tested

DRUG

Omalizumab

Omalizumab dose for each specific participant is based on that participant's weight and total IgE level. Omalizumab is provided by the manufacturer in two strengths: • For Injection: 75 mg/0.5 mL and 150 mg/mL solution in a single-dose prefilled syringe

DRUG

Placebo

Matching placebo for omalizumab will be provided in 0.5 mL and 1 mL solution for injection in pre-filled syringes.

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Children's National Hospital
Washington D.C., District of Columbia, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT05332067), the sponsor (Children's National Research Institute), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT05332067 clinical trial studying?

OBOE is a prospective, pilot, parallel group RCT with the overall aim of examining the effect of a single dose of anti-IgE (omalizumab) vs. placebo administered at the onset of URIs in the fall season among highly exacerbation-prone, urban, and atopic youth aged 6-17 years with persistent asthma. OBOE will recruit and randomize participants over 3 years (3 annual cohorts of participants). Recruitment for each of the yearly cohorts of OBOE will begin in February. Each cohort will be followed for a 2-6-month run-in period with the objective to gain control of each participant's asthma and to sta… The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT05332067?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT05332067?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT05332067. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT05332067. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.