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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 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.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03881696
The ClinicalTrials.gov registry entry for NCT03881696 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 471 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Omalizumab is the first listed.
NCT03881696 reports 0 study locations.
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.
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