NCT04037176

Behandling af Boern Med Foedevareallergi Med Omalizumab (Xolair)

Completed Phase 4 Last updated 5 December 2023

What this trial tests

Phase 4 trial testing Omalizumab in Food Allergy in 20 participants. Completed in 15 March 2022.

Timeline

1 November 2019

Primary endpoint
15 March 2022

15 March 2022

Quick facts

Lead sponsor	Carsten Bindslev-Jensen
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	20
Start date	1 November 2019
Primary completion	15 March 2022
Estimated completion	15 March 2022
Sites	1 location across Denmark

Drugs / interventions tested

• Omalizumab (omalizumab) — full drug profile →
• Placebo

Conditions studied

• Food Allergy — all drugs for Food Allergy →

Sponsor

Carsten Bindslev-Jensen

Who can join

Adults 6 to 18, any sex, with Food Allergy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Food allergy is a common disease in childhood affecting up to 8% of children in Westernized countries. About 30 percent of children with food allergies are allergic to more than one food, most often milk, egg, wheat, peanut and tree nut. Peanut and hazelnut are common triggers of severe and potentially fatal food-induced anaphylactic reactions. Currently, there is no curative treatment for food allergy. Novel therapies for this potentially life-threatening condition are therefore much needed.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Allergy: Mechanistic insights into new methods of prevention and therapy.
   Akdis CA, Akdis M, Boyd SD, Sampath V, et al · · 2023 · cited 52× · PMID 36652536 · DOI 10.1126/scitranslmed.add2563
2. The role of biologics in pediatric food allergy and eosinophilic gastrointestinal disorders.
   Sindher SB, Barshow S, Tirumalasetty J, Arasi S, et al · · 2023 · cited 24× · PMID 36872039 · DOI 10.1016/j.jaci.2023.01.007
3. Treatment of food allergy: Oral immunotherapy, biologics, and beyond.
   Sindher SB, Hillier C, Anderson B, Long A, et al · · 2023 · cited 22× · PMID 37100276 · DOI 10.1016/j.anai.2023.04.023
4. The Role of Biologics in the Treatment of Food Allergy.
   Sindher SB, Fiocchi A, Zuberbier T, Arasi S, et al · · 2024 · cited 21× · PMID 38013157 · DOI 10.1016/j.jaip.2023.11.032
5. Monoclonal Antibodies in Treating Food Allergy: A New Therapeutic Horizon.
   Manti S, Pecora G, Patanè F, Giallongo A, et al · · 2021 · cited 4× · PMID 34371821 · DOI 10.3390/nu13072314