Omalizumab as Monotherapy and as Adjunct Therapy to Multi-Allergen OIT in Food Allergic Participants
Public ClinicalTrials.gov record NCT03881696. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Omalizumab as Monotherapy and as Adjunct Therapy to Multi-Allergen Oral Immunotherapy (OIT) in Food Allergic Children and Adults (CoFAR-11)
Study identification
- NCT ID
- NCT03881696
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- NIH
- Enrollment
- 471 participants
Conditions and interventions
Conditions
Interventions
- Double-Blind Placebo-Controlled Food Challenge Based Treatment Other
- Multi-Allergen Oral Immunotherapy Drug
- Omalizumab Drug
- Placebo for Multi-Allergen Oral Immunotherapy Drug
- Placebo for Omalizumab Drug
Other · Drug
Eligibility (public fields only)
- Age range
- 1 Year to 55 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 21, 2019
- Primary completion
- Mar 12, 2023
- Completion
- Jun 30, 2025
- Last update posted
- Sep 9, 2025
2019 – 2025
United States locations
- U.S. sites
- 10
- U.S. states
- 10
- U.S. cities
- 10
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Arkansas Children's Hospital Research Institute: Department of Pediatrics, Allergy & Immunology | Little Rock | Arkansas | 72202 | — |
| Stanford School of Medicine: Sean N. Parker Center for Allergy & Asthma Research | Stanford | California | 94305 | — |
| National Jewish Health: Division of Pediatric Allergy and Clinical Immunology | Denver | Colorado | 80206 | — |
| Emory University School of Medicine: Children's Healthcare of Atlanta Pediatrics | Atlanta | Georgia | 30307 | — |
| Johns Hopkins Children's Center: Department of Allergy & Immunology | Baltimore | Maryland | 21287 | — |
| Massachusetts General Hospital, Department of Medicine: Allergy & Clinical Immunology Unit | Boston | Massachusetts | 02114 | — |
| Icahn School of Medicine at Mount Sinai: Department of Pediatrics Allergy & Immunology | New York | New York | 10029 | — |
| North Carolina Children's Hospital: Department of Pediatrics, Division of Allergy, Immunology and Rheumatology | Chapel Hill | North Carolina | 27599-7000 | — |
| Children's Hospital of Philadelphia: Division of Allergy and Immunology | Philadelphia | Pennsylvania | 19104 | — |
| University of Texas Southwestern Medical Center: Division of Allergy and Immunology | Dallas | Texas | 75390 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03881696, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 9, 2025 · Synced May 8, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03881696 live on ClinicalTrials.gov.