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NCT03881696 · ClinicalTrials.gov registry record · Phase 3
Omalizumab as Monotherapy and as Adjunct Therapy to Multi-Allergen OIT in Food Allergic Participants
A Phase 3 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 3
- Development phase
- 471
- Enrollment target
NCT03881696: Completed Phase 3 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT03881696 is a Phase 3 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 471 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (39% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03881696, a Phase 3 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 471 participants
- Enrollment target
Study Summary
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.
Primary Outcome
Number of participants who successfully consume a single dose of ≥600 mg of peanut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the princ
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
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 471 participants |
| Start Date | 2019-07-22 |
| Est. Completion | 2025-07-01 |
| Phase | Phase 3 |
What the finished NCT03881696 record still lists
NCT03881696 is an interventional study that assigns participants to a tested intervention. The registered 471 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (39% lower).
The record links to 0 conditions, and to 5 interventions - of which Omalizumab is the first listed.
NCT03881696 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03881696 about?
NCT03881696 is a clinical study titled "Omalizumab as Monotherapy and as Adjunct Therapy to Multi-Allergen OIT in Food Allergic Participants". 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 o...
What is the current status of trial NCT03881696?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 471 participants. The study started on 2019-07-22. Estimated completion is 2025-07-01.
What interventions are being tested in trial NCT03881696?
The interventions under investigation include: 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).
Who is sponsoring clinical trial NCT03881696?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03881696's enrollment target sits among peer trials
471 812th of 2000 higher than 1,188 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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