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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study is a multi-center, randomized, double-blind, placebo-controlled study in participants 1 to less than 56 years of age who are allergic to peanut and at least two other foods (including milk, egg, wheat, cashew, hazelnut, or walnut). While each participant may be allergic to more than two other foods, the primary endpoint/outcome in this study will only be assessed in peanut and two other foods for each participant. The primary objective of the study is to compare the ability to consume foods without dose-limiting symptoms during a double-blind placebo-controlled food challenge (DBPCFC), after treatment with either omalizumab or placebo for omalizumab.
Study identification
- NCT ID
- NCT03881696
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 458 participants
Conditions and interventions
Conditions
Interventions
- Omalizumab Drug
- Placebo for Omalizumab Drug
- Multi-Allergen Oral Immunotherapy Drug
- Placebo for Multi-Allergen Oral Immunotherapy Drug
- Double-Blind Placebo-Controlled Food Challenge Based Treatment Other
Drug · Other
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 22, 2019 (Actual)
- Primary completion
- Mar 13, 2023 (Actual)
- Completion
- Jul 1, 2025 (Actual)
- Last update posted
- Sep 22, 2026
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 22, 2026 · Synced Oct 20, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03881696 live on ClinicalTrials.gov.