Omalizumab Before Onset of Exacerbations

NCT05332067 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: CAUSE-CNH-011U01AI160090-01
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Asthma in Children; Atopy; Viral Upper Respiratory Infection

Outcome Measures

Primary Outcomes (1)

• Nasal interferon-α (IFN-α)

  The change in the amount of nasal IFN-α recovered by nasal fluid absorption between two time points, when study drug/placebo is injected and 3-6 days later

  3-6 day period after injection of study drug/placebo

Secondary Outcomes (3)

• Nasal Type 2 Cytokines

  3-6 day period after injection of study drug/placebo

• Asthma Exacerbations

  two weeks after injection of study drug/placebo

• Change in type 2 cytokine levels as a function of nasal airway microbiome

  3-6 day period after injection of study drug/placebo

Other Outcomes (14)

• Local and systemic immune responses as measured by immune cellular phenotyping

  3-6 day period after injection of study drug/placebo

• Local and systemic immune responses as measured by gene expression profiling

  3-6 day period after injection of study drug/placebo

• Local and systemic immune responses as measured by proteome

  3-6 day period after injection of study drug/placebo

Study Arms (2)

Omalizumab

EXPERIMENTAL

Single dose of omalizumab at the start of a viral upper respiratory infection as defined by onset of (or substantial worsening of) rhinorrhea, nasal congestion or sneezing (single or multiple symptoms) during the fall outcome season (defined as the 90-day period beginning on each child's return to school)

Drug: Omalizumab

Placebo for omalizumab

PLACEBO COMPARATOR

Single dose of placebo for omalizumab at the start of a viral upper respiratory infection as defined by onset of (or substantial worsening of) rhinorrhea, nasal congestion or sneezing (single or multiple symptoms) during the fall outcome season (defined as the 90-day period beginning on each child's return to school)

Drug: Placebo

Interventions

Omalizumab DRUG

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

Also known as: Xolair

Omalizumab

Placebo DRUG

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

Also known as: Placebo for omalizumab

Placebo for omalizumab

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Participants must meet the following:
• Parent or guardian must be able to understand and provide informed consent in English and participants ≥7 must be able to provide assent
• years, inclusive at time of screening
• Physician-diagnosed persistent asthma
• ≥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
• Sensitization to ≥1 perennial aeroallergen
• Total serum IgE and weight appropriate for omalizumab dosing
• Insurance that covers standard of care medications
• 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
• At least one of the following criteria:
• peripheral eosinophilia \>300µL
• total serum IgE \>300kU/L
• sensitization to ≥3 perennial aeroallergens
• Females of childbearing potential must have a negative pregnancy test upon study entry
• Females with reproductive potential must agree to use FDA approved methods of birth control for the duration of the study

You may not qualify if:

• 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
• Contraindication to receipt of omalizumab
• 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)
• Pregnancy or active lactation
• History of latex allergy
• Treatment with omalizumab or other monoclonal antibody, or aeroallergen immunotherapy in the prior six months
• Plan for home schooling during the 90-day outcome period
• History of life-threatening asthma defined by requirement for intubation or cardiorespiratory arrest
• Inability of primary caregiver and child to speak English
• 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
• 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

Sponsors & Collaborators

• Children's National Research Institute: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

Children's National Hospital

Washington D.C., District of Columbia, 20010, United States

RECRUITING

MeSH Terms

Conditions

Common Cold

Interventions

Omalizumab

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract 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

Study Officials

• William Sheehan, MD

  Children's National Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

William Sheehan, MD

CONTACT

202-476-5000; wsheehan@cnmc.org

Alicia Mathis

CONTACT

202-476-5000; anewcome@childrensnational.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The study site's research pharmacy will dispense the study drug as per the randomization schedule provided by REDCap. Prior to injection, an unblinded site pharmacist will confirm the expiration date, the dose, and randomization assignment. The injections will be administered in the Clinical Research Center at the study site by unblinded and trained nursing staff. The product will remain blinded to the investigators, other site staff, the participant, and legal guardians.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor or Pediatrics

Model Details: Single site, prospective, parallel-group, double-blinded, randomized clinical trial conducted over three consecutive fall seasons.

Study Record Dates

• First Submitted: March 30, 2022
• First Posted: April 18, 2022
• Study Start: May 1, 2022
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: July 14, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)