# Omalizumab as Monotherapy and as Adjunct Therapy to Multi-Allergen OIT in Food Allergic Participants

> **NCT03881696** · PHASE3 · COMPLETED · sponsor: **National Institute of Allergy and Infectious Diseases (NIAID)** · enrollment: 471 (actual)

## Conditions studied

- Peanut Allergy
- Multi-food Allergy

## Interventions

- **DRUG:** Omalizumab
- **DRUG:** Placebo for Omalizumab
- **DRUG:** Multi-Allergen Oral Immunotherapy
- **DRUG:** Placebo for Multi-Allergen Oral Immunotherapy
- **OTHER:** Double-Blind Placebo-Controlled Food Challenge Based Treatment

## Key facts

- **NCT ID:** NCT03881696
- **Lead sponsor:** National Institute of Allergy and Infectious Diseases (NIAID)
- **Sponsor class:** NIH
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2019-07-22
- **Primary completion:** 2023-03-13
- **Final completion:** 2025-07-01
- **Target enrollment:** 471 (ACTUAL)
- **Last updated:** 2025-09-10

## Collaborators

- [object Object]
- [object Object]
- [object Object]

## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT03881696

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT03881696, "Omalizumab as Monotherapy and as Adjunct Therapy to Multi-Allergen OIT in Food Allergic Participants". Retrieved via AI Analytics 2026-06-30 from https://api.ai-analytics.org/clinical/NCT03881696. Licensed CC0.

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